AstraZeneca (NYSE: AZN) and POZEN Inc. (Nasdaq: POZN) announced pivotal data from two POZEN clinical trials that were presented at the American College of Rheumatology (ACR) 2009 Annual Scientific Meeting in Philadelphia, PA.
The data demonstrated that patients at risk for developing NSAID-associated gastric ulcers taking VIMOVO(TM) (naproxen/esomeprazole magnesium, formerly known as PN 400) experienced significantly fewer endoscopically confirmed gastric ulcers (GU) compared with patients taking enteric-coated (EC) naproxen (500 mg) alone. Data from study PN400-301 showed a 4.1% incidence of GU in patients taking VIMOVO, compared to 23.1% among patients taking EC naproxen (p
The most frequently reported adverse events among patients taking both VIMOVO and EC naproxen were GI disorders, including dyspepsia, erosive esophagitis and erosive duodentis. Commonly reported treatment emergent adverse events (experienced by > than 10% patients in either treatment group) included erosive gastritis, gastritis, dyspepsia and erosive duodentis. In PN400-301 (n=434), 21% patients taking VIMOVO experienced erosive gastritis, as compared to 37% taking EC naproxen. Among patients taking VIMOVO, 18% experienced gastritis, as compared to 13% taking EC naproxen, and 16% of the patients reported dyspepsia, as compared to 30% taking EC naproxen. 2% of patients taking VIMOVO experienced erosive duodentis as compared to 14% taking EC Naproxen. In PN400-302 (n=420), incidences of erosive gastritis were reported by 18% patients taking VIMOVO, as compared to 39% taking EC naproxen. 16% of patients taking VIMOVO experienced gastritis, as compared to 15% taking EC naproxen, and 19% patients taking VIMOVO reported dyspepsia, as compared to 23% taking EC naproxen.
PN400-301 and PN400-302 were 6-month, Phase III, randomized, double-blind, controlled, multi-center clinical trials that together enrolled approximately 800 H. pylori-negative adults with OA, RA, AS, or any other condition that required daily NSAID therapy and were at risk of ulcers. Subjects in each study were randomized to receive either VIMOVO/E20 (EC naproxen 500 mg/IR esomeprazole 20 mg) tablets twice-daily or EC naproxen 500 mg twice-daily, over a six-month treatment period. Subjects underwent upper endoscopies at baseline and at one, three, and six months.
On August 31, 2009, the US Food and Drug Administration (FDA) informed AstraZeneca and POZEN Inc. that it had accepted the New Drug Application (NDA) for VIMOVO, submitted on June 30, 2009. AstraZeneca submitted a Marketing Authorization Application (MAA) to the European Union via the Decentralized Procedure for VIMOVO on October 16, 2009.
ABOUT VIMOVO:
VIMOVO is an investigational product under co-development by AstraZeneca and POZEN, Inc. that combines enteric coated naproxen (an NSAID) with immediate release esomeprazole, a proton pump inhibitor (PPI). VIMOVO is under investigation for the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients who are at risk of developing NSAID-associated gastric ulcers.
ABOUT OSTEOARTHRITIS:
Osteoarthritis (OA) is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints. Osteoarthritis is the most common form of arthritis and the most common cause of chronic pain, affecting nearly 151 million individuals worldwide, and impacting approximately 18% of women and 9.6% of men aged 60 and above. A combination of factors can contribute to osteoarthritis, including being overweight, aging, joint injury or stress, heredity and muscle weakness. Osteoarthritis commonly affects the hands, feet, spine or large weight-bearing joints, such as the hips and knees.
ABOUT RHEUMATOID ARTHRITIS:
Rheumatoid arthritis (RA) is a chronic disease, mainly characterized by inflammation of the lining, or synovium, of the joints. It can lead to long-term joint damage, resulting in chronic pain, loss of function and disability. RA affects approximately 1.3 million Americans.
ABOUT ANKYLOSING SPONDYLITIS:
Ankylosing spondylitis (AS) is a chronic inflammatory disease that primarily causes pain and inflammation of the joints between the vertebrae of the spine and the joints between the spine and pelvis (sacroiliac joints). Ankylosing spondylitis may also cause inflammation and pain in other parts of the body as well.
ABOUT POZEN:
POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases and unmet medical needs where it can improve efficacy, safety and o/or patient convenience. POZEN's efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has development and commercialization alliances with AstraZeneca for VIMOVO(TM), the proposed trade name for the proprietary fixed dose combination of naproxen with the proton pump inhibitor esomeprazole magnesium in a single tablet under development for conditions including osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers. The Company's common stock is traded on The NASDAQ Stock Market under the symbol "POZN."
ABOUT ASTRAZENECA:
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines
Source: AstraZeneca
View drug information on Vimovo.
суббота, 30 июля 2011 г.
среда, 27 июля 2011 г.
Treatment With REMICADE(reg) Improved Bone Erosion Scores in Early RA Study
Clinical Trial Results Demonstrate Twice as Many Patients With Progressive Disease Experienced Improvement Versus Current Standard of Care.
New data show that more than 55 percent of patients treated with REMICADE(reg) (infliximab) plus methotrexate (REMICADE(reg) regimen) demonstrated improvement in bone erosion scores (a key indicator of joint destruction in rheumatoid arthritis), compared with 26.8 percent for methotrexate alone in early rheumatoid arthritis (RA) patients with progressive disease and bone erosions.
Previously presented data from the ASPIRE trial (Active Controlled Study of Patients Receiving Infliximab for Treatment of Rheumatoid Arthritis of Early Onset) demonstrated that the REMICADE(reg) regimen prevented the progression of structural damage in the overall patient population, but these new analyses demonstrate improvement in those patients with progressive disease. These new data emerged from a retrospective sub-analysis of the ASPIRE trial and were presented today at The European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology.
"The new results from the ASPIRE trial contribute to the growing body of clinical evidence that supports earlier initiation of therapy for RA patients," said Paul Emery, MA, MD, FRCP, ACR professor of rheumatology, Leeds University, and clinical director, rheumatology, Leeds Teaching Hospital Trust, UK. "Our findings clearly demonstrate that early treatment with REMICADE(reg) can prevent the progression of this debilitating disease and can improve bone erosion scores, suggesting that repair may be possible."
About ASPIRE
ASPIRE was a Phase lll, 54 week, randomized, double-blind, active control study involving 1,049 patients with early RA (< or = three years duration) enrolled in 125 centers in North America and Europe evaluating the efficacy and safety of REMICADE(reg) in combination with methotrexate compared with methotrexate alone.
Patients in the ASPIRE study had an average of only seven months of disease duration and more than 80 percent already had evidence of erosive joint destruction. At randomization, all patients received methotrexate and either placebo, REMICADE(reg) 3 mg/kg or REMICADE(reg) 6 mg/kg at weeks zero, two and six and then every eight weeks thereafter. The ASPIRE trial had three co-primary endpoints at one year: reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function.
All three primary endpoints were met, with the REMICADE(reg) regimen being superior to methotrexate alone on all primary and major secondary endpoints.
The most commonly reported adverse events were upper respiratory infection, nausea and headache. Serious adverse events reported were similar to those observed in other controlled clinical trials and clinical experience with REMICADE(reg) as described in the prescribing information.
About the ASPIRE Sub-Analysis
Of 838 patients with an evaluable change in erosion score in the ASPIRE trial, 213 patients had an erosion score of 10.75 or greater at baseline representing the highest quartile. Among patients with a baseline erosion score of 10.75 or greater, the mean change from baseline in erosion score for the combined REMICADE(reg) group at week 54 was -0.75 (improvement), whereas the mean change for the placebo group was 3.57 (worsening) (p 0.5 and experienced no worsening in any joint compared with only 27 percent in the placebo group. No worsening was defined as a radiographic score that was equal to or less than the baseline value.
REMICADE(reg) is currently indicated for use in patients with moderately to severely active RA who have had an inadequate response to methotrexate alone. In April 2004, the Committee for Proprietary Medicinal Products (CPMP) issued a positive opinion recommending approval of expanded labeling for REMICADE(reg) as first line therapy, in combination with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs), for the treatment of early RA patients with severe, active, progressive disease. Centocor, Inc., has filed an sBLA (supplemental Biologics License Application) with the U.S. Food and Drug Administration (FDA) for the use of REMICADE(reg) plus methotrexate in patients with early disease of moderate or greater severity who have not previously demonstrated an adequate response to methotrexate therapy. The sBLA filing is under review by the FDA.
About Early Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic, progressive disease and research demonstrates that a critical therapeutic window exists within the first two years of disease onset when the rate of radiographic progression of the disease can be "reset."1,2,3 Radiographic changes occur within two years of disease onset in 50 percent to 70 percent of RA patients.4 The American College of Rheumatology (ACR) suggests control of disease progression should start early to limit joint damage in RA.3 RA is associated with substantial disability and economic losses, and one study showed that one-third of patients in the United Kingdom who were employed became work-disabled within two years of disease onset.5 Rheumatologic disorders also account for 25 percent of Social Security disability payments in the United States.6
About REMICADE(reg)
REMICADE(reg) is a monoclonal antibody that specifically targets and irreversibly binds to tumor necrosis factor-alpha (TNF-alpha) on the cell membrane and in the blood. Overproduction of TNF-alpha is believed to play a role in RA, ankylosing spondylitis (AS), a serious inflammatory disease that leads to stiffening and subsequent fusion of the spine, and Crohn's disease (CD), a serious gastrointestinal disorder, in addition to a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which REMICADE(reg) is currently being studied.
REMICADE(reg) is the only anti-TNF biologic therapy that has received marketing authorizations for the treatment of both RA and CD and, in the European Union, AS. In most countries where it has received marketing authorization, REMICADE(reg), in combination with methotrexate, is indicated for the treatment of patients with moderately to severely active RA who have had an inadequate response to methotrexate alone. REMICADE(reg) is the only biologic indicated for the treatment of patients with moderately to severely active CD who have had an inadequate response to conventional therapy. REMICADE(reg) is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD. In addition, in the European Union, REMICADE(reg) is indicated for the treatment of AS in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.
REMICADE(reg) is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE(reg) is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. In RA and CD patients, REMICADE(reg) is typically received every eight weeks, following a standard induction regimen that requires treatment at weeks zero, two and six. As a result, REMICADE(reg) patients may require as few as six treatments each year. In AS, REMICADE(reg) is administered every six to eight weeks following a standard induction regimen that requires treatment at weeks zero, two and six. The safety and efficacy of REMICADE(reg) have been well established in clinical trials conducted over the past 10 years and through commercial experience, with now more than 500,000 patients treated worldwide.7
Important Information
Many people with heart failure should not take REMICADE(reg); so, prior to treatment you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of your ankles or feet).
There are reports of serious infections, including tuberculosis (TB) and sepsis. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for TB and perform a skin test. If you have latent (inactive) TB your doctor should begin TB treatment before you start REMICADE(reg). If you are prone to or have a history of infections, currently have one, or develop one while taking REMICADE(reg), tell your doctor right away. Also tell your doctor if you have lived in a region where histoplasmosis or coccidioidomycosis is common or if you have or have had a disease that affects the nervous system or if you experience any numbness, weakness, tingling or visual disturbances.
There are also reports of serious infusion reactions with hives, difficulty breathing and low blood pressure. In clinical studies, some people experienced the following common side effects: respiratory infections (that may include sinus infections and sore throat), coughing and stomach pain or mild reactions to infusion such as rash or itchy skin. Please read important information about REMICADE(reg), including full U.S. prescribing information, at remicade. For a complete copy of REMICADE(reg) E.U. prescribing information, please contact Schering-Plough Corporation at +1-908-298-7616.
About Centocor, Inc.
Centocor, Inc., is a leading biopharmaceutical company that creates, acquires and markets cost-effective therapies that yield long-term benefits for patients and the health care community. The company is dedicated to the research and development of treatments for a wide range of diseases including cancer, infectious diseases, cardiovascular and metabolic diseases and Immune-Mediated Inflammatory Disorders (I.M.I.D.), such as arthritis and inflammatory skin diseases. Centocor's products, developed primarily through monoclonal antibody technology, help physicians deliver innovative treatments to improve human health and restore patients' quality of life. Centocor, Inc., is a wholly owned subsidiary of Johnson & Johnson, the worldwide manufacturer of health care products.
Centocor, Inc., discovered REMICADE(reg) and has exclusive marketing rights to the product in the United States. Schering-Plough Corporation has rights to market REMICADE(reg) in all countries outside of the United States, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd., markets the product.
Johnson & Johnson Disclosure Notice
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99(b) of the Company's Annual Report on Form 10-K for the fiscal year ended December 28, 2003. Copies of this Form 10-K are available online at sec or on request from the Company. The Company assumes no obligation to update any forward- looking statements as a result of new information or future events or developments.
1 Landewe RB, Boers M, Verhoeven AC, et al. COBRA combination therapy in patients with early rheumatoid arthritis: long-term structural benefits of a brief intervention. Arthritis Rheum. 2002;46:347-356.
2 Egsmose C, Lund B, Borg G, et al. Patients with rheumatoid arthritis benefit from early second line therapy: five year follow up of a prospective double blind placebo controlled study. J. Rheumatol. 1995;22:2208-2213.
3 American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines, 2002 Update.
4 van der Heijde DM. Joint erosions and patients with early rheumatoid arthritis. Br J Rheumatol. 1995;34(suppl 2):74-78.
5 Barrett EM, Scott DGI, Wiles NJ, Symmons DPM. The impact of rheumatoid arthritis on employment status in the early years of disease: a UK community-based study. Rheumatology. 2000;39:1403-1409.
6 Social Security Disability Insurance Program.
7 Data on file at Centocor, Inc.
New data show that more than 55 percent of patients treated with REMICADE(reg) (infliximab) plus methotrexate (REMICADE(reg) regimen) demonstrated improvement in bone erosion scores (a key indicator of joint destruction in rheumatoid arthritis), compared with 26.8 percent for methotrexate alone in early rheumatoid arthritis (RA) patients with progressive disease and bone erosions.
Previously presented data from the ASPIRE trial (Active Controlled Study of Patients Receiving Infliximab for Treatment of Rheumatoid Arthritis of Early Onset) demonstrated that the REMICADE(reg) regimen prevented the progression of structural damage in the overall patient population, but these new analyses demonstrate improvement in those patients with progressive disease. These new data emerged from a retrospective sub-analysis of the ASPIRE trial and were presented today at The European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology.
"The new results from the ASPIRE trial contribute to the growing body of clinical evidence that supports earlier initiation of therapy for RA patients," said Paul Emery, MA, MD, FRCP, ACR professor of rheumatology, Leeds University, and clinical director, rheumatology, Leeds Teaching Hospital Trust, UK. "Our findings clearly demonstrate that early treatment with REMICADE(reg) can prevent the progression of this debilitating disease and can improve bone erosion scores, suggesting that repair may be possible."
About ASPIRE
ASPIRE was a Phase lll, 54 week, randomized, double-blind, active control study involving 1,049 patients with early RA (< or = three years duration) enrolled in 125 centers in North America and Europe evaluating the efficacy and safety of REMICADE(reg) in combination with methotrexate compared with methotrexate alone.
Patients in the ASPIRE study had an average of only seven months of disease duration and more than 80 percent already had evidence of erosive joint destruction. At randomization, all patients received methotrexate and either placebo, REMICADE(reg) 3 mg/kg or REMICADE(reg) 6 mg/kg at weeks zero, two and six and then every eight weeks thereafter. The ASPIRE trial had three co-primary endpoints at one year: reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function.
All three primary endpoints were met, with the REMICADE(reg) regimen being superior to methotrexate alone on all primary and major secondary endpoints.
The most commonly reported adverse events were upper respiratory infection, nausea and headache. Serious adverse events reported were similar to those observed in other controlled clinical trials and clinical experience with REMICADE(reg) as described in the prescribing information.
About the ASPIRE Sub-Analysis
Of 838 patients with an evaluable change in erosion score in the ASPIRE trial, 213 patients had an erosion score of 10.75 or greater at baseline representing the highest quartile. Among patients with a baseline erosion score of 10.75 or greater, the mean change from baseline in erosion score for the combined REMICADE(reg) group at week 54 was -0.75 (improvement), whereas the mean change for the placebo group was 3.57 (worsening) (p 0.5 and experienced no worsening in any joint compared with only 27 percent in the placebo group. No worsening was defined as a radiographic score that was equal to or less than the baseline value.
REMICADE(reg) is currently indicated for use in patients with moderately to severely active RA who have had an inadequate response to methotrexate alone. In April 2004, the Committee for Proprietary Medicinal Products (CPMP) issued a positive opinion recommending approval of expanded labeling for REMICADE(reg) as first line therapy, in combination with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs), for the treatment of early RA patients with severe, active, progressive disease. Centocor, Inc., has filed an sBLA (supplemental Biologics License Application) with the U.S. Food and Drug Administration (FDA) for the use of REMICADE(reg) plus methotrexate in patients with early disease of moderate or greater severity who have not previously demonstrated an adequate response to methotrexate therapy. The sBLA filing is under review by the FDA.
About Early Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic, progressive disease and research demonstrates that a critical therapeutic window exists within the first two years of disease onset when the rate of radiographic progression of the disease can be "reset."1,2,3 Radiographic changes occur within two years of disease onset in 50 percent to 70 percent of RA patients.4 The American College of Rheumatology (ACR) suggests control of disease progression should start early to limit joint damage in RA.3 RA is associated with substantial disability and economic losses, and one study showed that one-third of patients in the United Kingdom who were employed became work-disabled within two years of disease onset.5 Rheumatologic disorders also account for 25 percent of Social Security disability payments in the United States.6
About REMICADE(reg)
REMICADE(reg) is a monoclonal antibody that specifically targets and irreversibly binds to tumor necrosis factor-alpha (TNF-alpha) on the cell membrane and in the blood. Overproduction of TNF-alpha is believed to play a role in RA, ankylosing spondylitis (AS), a serious inflammatory disease that leads to stiffening and subsequent fusion of the spine, and Crohn's disease (CD), a serious gastrointestinal disorder, in addition to a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which REMICADE(reg) is currently being studied.
REMICADE(reg) is the only anti-TNF biologic therapy that has received marketing authorizations for the treatment of both RA and CD and, in the European Union, AS. In most countries where it has received marketing authorization, REMICADE(reg), in combination with methotrexate, is indicated for the treatment of patients with moderately to severely active RA who have had an inadequate response to methotrexate alone. REMICADE(reg) is the only biologic indicated for the treatment of patients with moderately to severely active CD who have had an inadequate response to conventional therapy. REMICADE(reg) is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD. In addition, in the European Union, REMICADE(reg) is indicated for the treatment of AS in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.
REMICADE(reg) is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE(reg) is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. In RA and CD patients, REMICADE(reg) is typically received every eight weeks, following a standard induction regimen that requires treatment at weeks zero, two and six. As a result, REMICADE(reg) patients may require as few as six treatments each year. In AS, REMICADE(reg) is administered every six to eight weeks following a standard induction regimen that requires treatment at weeks zero, two and six. The safety and efficacy of REMICADE(reg) have been well established in clinical trials conducted over the past 10 years and through commercial experience, with now more than 500,000 patients treated worldwide.7
Important Information
Many people with heart failure should not take REMICADE(reg); so, prior to treatment you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of your ankles or feet).
There are reports of serious infections, including tuberculosis (TB) and sepsis. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for TB and perform a skin test. If you have latent (inactive) TB your doctor should begin TB treatment before you start REMICADE(reg). If you are prone to or have a history of infections, currently have one, or develop one while taking REMICADE(reg), tell your doctor right away. Also tell your doctor if you have lived in a region where histoplasmosis or coccidioidomycosis is common or if you have or have had a disease that affects the nervous system or if you experience any numbness, weakness, tingling or visual disturbances.
There are also reports of serious infusion reactions with hives, difficulty breathing and low blood pressure. In clinical studies, some people experienced the following common side effects: respiratory infections (that may include sinus infections and sore throat), coughing and stomach pain or mild reactions to infusion such as rash or itchy skin. Please read important information about REMICADE(reg), including full U.S. prescribing information, at remicade. For a complete copy of REMICADE(reg) E.U. prescribing information, please contact Schering-Plough Corporation at +1-908-298-7616.
About Centocor, Inc.
Centocor, Inc., is a leading biopharmaceutical company that creates, acquires and markets cost-effective therapies that yield long-term benefits for patients and the health care community. The company is dedicated to the research and development of treatments for a wide range of diseases including cancer, infectious diseases, cardiovascular and metabolic diseases and Immune-Mediated Inflammatory Disorders (I.M.I.D.), such as arthritis and inflammatory skin diseases. Centocor's products, developed primarily through monoclonal antibody technology, help physicians deliver innovative treatments to improve human health and restore patients' quality of life. Centocor, Inc., is a wholly owned subsidiary of Johnson & Johnson, the worldwide manufacturer of health care products.
Centocor, Inc., discovered REMICADE(reg) and has exclusive marketing rights to the product in the United States. Schering-Plough Corporation has rights to market REMICADE(reg) in all countries outside of the United States, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd., markets the product.
Johnson & Johnson Disclosure Notice
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99(b) of the Company's Annual Report on Form 10-K for the fiscal year ended December 28, 2003. Copies of this Form 10-K are available online at sec or on request from the Company. The Company assumes no obligation to update any forward- looking statements as a result of new information or future events or developments.
1 Landewe RB, Boers M, Verhoeven AC, et al. COBRA combination therapy in patients with early rheumatoid arthritis: long-term structural benefits of a brief intervention. Arthritis Rheum. 2002;46:347-356.
2 Egsmose C, Lund B, Borg G, et al. Patients with rheumatoid arthritis benefit from early second line therapy: five year follow up of a prospective double blind placebo controlled study. J. Rheumatol. 1995;22:2208-2213.
3 American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines, 2002 Update.
4 van der Heijde DM. Joint erosions and patients with early rheumatoid arthritis. Br J Rheumatol. 1995;34(suppl 2):74-78.
5 Barrett EM, Scott DGI, Wiles NJ, Symmons DPM. The impact of rheumatoid arthritis on employment status in the early years of disease: a UK community-based study. Rheumatology. 2000;39:1403-1409.
6 Social Security Disability Insurance Program.
7 Data on file at Centocor, Inc.
воскресенье, 24 июля 2011 г.
Garlic Could Protect Against Hip Osteoarthritis
Researchers at King's College London and the University of East Anglia have discovered that women who consume a diet high in allium vegetables, such as garlic, onions and leeks, have lower levels of hip osteoarthritis.
The findings, published in the BMC Musculoskeletal Disorders journal, not only highlight the possible effects of diet in protecting against osteoarthritis, but also show the potential for using compounds found in garlic to develop treatments for the condition.
A relationship between body weight and osteoarthritis was previously recognised, although it is not yet completely understood. This study is the first of its kind to delve deeper into the dietary patterns and influences that could impact on development and prevention of the condition.
Osteoarthritis is the most common form of arthritis in adults, affecting around 8 million people in the UK, and women are more likely to develop it than men. It causes pain and disability by affecting the hip, knees and spine in the middle-aged and elderly population. Currently there is no effective treatment other than pain relief and, ultimately, joint replacement.
The study, funded by Arthritis Research UK, the Wellcome Trust and Dunhill Medical Trust, looked at over 1,000 healthy female twins, many of whom had no symptoms of arthritis.
The team carried out a detailed assessment of the diet patterns of the twins and analysed these alongside x-ray images, which captured the extent of early osteoarthritis in the participants' hips, knees and spine.
They found that in those who consumed a healthy diet with a high intake of fruit and vegetables, particularly alliums such as garlic, there was less evidence of early osteoarthritis in the hip joint.
To investigate the potential protective effect of alliums further, researchers studied the compounds found in garlic. They found that that a compound called diallyl disulphide limits the amount of cartilage-damaging enzymes when introduced to a human cartilage cell-line in the laboratory.
Dr Frances Williams, lead author from the Department of Twin Research at King's College London, says: "While we don't yet know if eating garlic will lead to high levels of this component in the joint, these findings may point the way towards future treatments and prevention of hip osteoarthritis.
"It has been known for a long time that there is a link between body weight and osteoarthritis. Many researchers have tried to find dietary components influencing the condition, but this is the first large scale study of diet in twins. If our results are confirmed by follow-up studies, this will point the way towards dietary intervention or targeted drug therapy for people with osteoarthritis."
Professor Ian Clark of the University of East Anglia said: "Osteoarthritis is a major health issue and this exciting study shows the potential for diet to influence the course of the disease. With further work to confirm and extend these early findings, this may open up the possibility of using diet or dietary supplements in the future treatment osteoarthritis."
The paper: 'Dietary garlic and hip osteoarthritis: evidence of a protective effect and putative mechanism of action' published in BMC Musculoskeletal Disorders.
Source:
King's College London
The findings, published in the BMC Musculoskeletal Disorders journal, not only highlight the possible effects of diet in protecting against osteoarthritis, but also show the potential for using compounds found in garlic to develop treatments for the condition.
A relationship between body weight and osteoarthritis was previously recognised, although it is not yet completely understood. This study is the first of its kind to delve deeper into the dietary patterns and influences that could impact on development and prevention of the condition.
Osteoarthritis is the most common form of arthritis in adults, affecting around 8 million people in the UK, and women are more likely to develop it than men. It causes pain and disability by affecting the hip, knees and spine in the middle-aged and elderly population. Currently there is no effective treatment other than pain relief and, ultimately, joint replacement.
The study, funded by Arthritis Research UK, the Wellcome Trust and Dunhill Medical Trust, looked at over 1,000 healthy female twins, many of whom had no symptoms of arthritis.
The team carried out a detailed assessment of the diet patterns of the twins and analysed these alongside x-ray images, which captured the extent of early osteoarthritis in the participants' hips, knees and spine.
They found that in those who consumed a healthy diet with a high intake of fruit and vegetables, particularly alliums such as garlic, there was less evidence of early osteoarthritis in the hip joint.
To investigate the potential protective effect of alliums further, researchers studied the compounds found in garlic. They found that that a compound called diallyl disulphide limits the amount of cartilage-damaging enzymes when introduced to a human cartilage cell-line in the laboratory.
Dr Frances Williams, lead author from the Department of Twin Research at King's College London, says: "While we don't yet know if eating garlic will lead to high levels of this component in the joint, these findings may point the way towards future treatments and prevention of hip osteoarthritis.
"It has been known for a long time that there is a link between body weight and osteoarthritis. Many researchers have tried to find dietary components influencing the condition, but this is the first large scale study of diet in twins. If our results are confirmed by follow-up studies, this will point the way towards dietary intervention or targeted drug therapy for people with osteoarthritis."
Professor Ian Clark of the University of East Anglia said: "Osteoarthritis is a major health issue and this exciting study shows the potential for diet to influence the course of the disease. With further work to confirm and extend these early findings, this may open up the possibility of using diet or dietary supplements in the future treatment osteoarthritis."
The paper: 'Dietary garlic and hip osteoarthritis: evidence of a protective effect and putative mechanism of action' published in BMC Musculoskeletal Disorders.
Source:
King's College London
четверг, 21 июля 2011 г.
New Treatment Against Osteoarthritis: Orthokine Therapy Highly Effective Against Knee Arthritis After Two Years
An international team of researchers has evaluated the effectiveness of Orthokine therapy for osteoarthritis of the knee, and the results have been published in the February edition of the specialist journal "Osteoarthritis and Cartilage". The researchers followed 376 patients to determine the effectiveness of various osteoarthritis treatments. After six months as well as after two years, patients who received Orthokine therapy experienced significantly less pain and more improved joint function than those who received hyaluronic acid or a placebo. Orthokine therapy is a biotechnology-based method in which proteins that inhibit inflammation are obtained from the patient's own blood and injected into the affected joint.
"In this study and for several thousand patients whom we have treated, Orthokine has proven an extraordinarily safe and effective way of treating osteoarthritis of the knee. I am delighted that distinguished experts have now confirmed these findings," said Dr. Peter Wehling, CEO of ORTHOGEN AG, in Dasseldorf on February 21. "We are now planning to distribute the IP-protected Orthokine technology world- wide. Orthokine is already being distributed in various EU countries through ORTHOGEN or other distributors."
Orthokine is the first scientifically proven, placebo-controlled autologous therapy in the orthopaedic field.
This kind of therapy was recently discussed in The New York Times. Two of the Pittsburgh Steelers' biggest stars, Hines Ward and Troy Polamalu, used their own blood cells in an innovative injury treatment before winning the Super Bowl.
Orthogen AG
orthogen
"In this study and for several thousand patients whom we have treated, Orthokine has proven an extraordinarily safe and effective way of treating osteoarthritis of the knee. I am delighted that distinguished experts have now confirmed these findings," said Dr. Peter Wehling, CEO of ORTHOGEN AG, in Dasseldorf on February 21. "We are now planning to distribute the IP-protected Orthokine technology world- wide. Orthokine is already being distributed in various EU countries through ORTHOGEN or other distributors."
Orthokine is the first scientifically proven, placebo-controlled autologous therapy in the orthopaedic field.
This kind of therapy was recently discussed in The New York Times. Two of the Pittsburgh Steelers' biggest stars, Hines Ward and Troy Polamalu, used their own blood cells in an innovative injury treatment before winning the Super Bowl.
Orthogen AG
orthogen
понедельник, 18 июля 2011 г.
Getting A Grip On Common Hand Conditions
When a wrist hurts, it could be carpal tunnel syndrome -- or something else. Over time, many conditions can affect crucial parts of the hands, causing everything from pain to the loss of normal function. The August issue of Mayo Clinic Women's HealthSource offers an overview of common hand conditions and treatments:
Thumb arthritis: This occurs when the joint at the wrist and base of the thumb develops osteoarthritis. It's more common after age 40. A combination of factors, including aging, joint injury or stress, and heredity may lead to thumb arthritis.
Carpal tunnel syndrome: This can start with a vague aching in the wrist that can extend to the hand or up to the arm. Other symptoms can include tingling or numbness in the fingers, especially at night. Over time, the hand can become weak or numb. Too much time at the keyboard often is blamed for this condition. But any activity that requires the repeated flexing and extending of the tendons in the hand or wrist or repeated and prolonged gripping can cause the problem.
Ganglion cyst: These appear as raised fluid-filled lumps near the wrist or finger joints. They are noncancerous and typically develop along the tendons or joints of the wrist and hands. Often, they are painless, but not always. Ganglion cysts also can cause pain, weakness or numbness in the hand if they put pressure on nerves near a joint. The cause of ganglion cysts isn't clear. The risk may be great in people with osteoarthritis or with injured joints or tendons in the hands.
Trigger finger: This condition -- stenosing tenosynovitis -- is typically a painful condition in which one finger or thumb catches in the bent position. In severe cases, the finger may become locked in bent or straight position. The cause is a thickening of the liner, or sheath, which surrounds the tendon in the affected finger. Trigger finger tends to be more common in people whose work or hobby requires repetitive gripping motions, or those who have rheumatoid arthritis, diabetes or hypothyroidism.
Tendonitis of the wrist: The most common symptoms of wrist tendonitis, called de Quervain's tenosynovitis, are pain and swelling about a half-inch back from the base of the thumb. Pinching, grasping or other thumb and wrist movement may aggravate the pain. Without treatment, the pain may spread in the thumb, forearm or both. Wrist tendonitis is caused by irritation and swelling of the sheath that surrounds the major tendons connecting the wrist and lower thumb. It can result from overuse of the wrist and thumb together. Often called the "new mother's" disease, it is common in new parents who pick up infants with their thumbs out and wrists bent backwards.
Treatment for these conditions should start with talking to a doctor about pain, swelling or discomfort in the hands and wrists. Depending on the diagnosis, treatment options include self-care (applying heat and cold), physical therapy, medications to reduce pain and swelling, and surgery.
Mayo Clinic
200 First St. SW
Rochester, MN 55902
United States
mayoclinic
Thumb arthritis: This occurs when the joint at the wrist and base of the thumb develops osteoarthritis. It's more common after age 40. A combination of factors, including aging, joint injury or stress, and heredity may lead to thumb arthritis.
Carpal tunnel syndrome: This can start with a vague aching in the wrist that can extend to the hand or up to the arm. Other symptoms can include tingling or numbness in the fingers, especially at night. Over time, the hand can become weak or numb. Too much time at the keyboard often is blamed for this condition. But any activity that requires the repeated flexing and extending of the tendons in the hand or wrist or repeated and prolonged gripping can cause the problem.
Ganglion cyst: These appear as raised fluid-filled lumps near the wrist or finger joints. They are noncancerous and typically develop along the tendons or joints of the wrist and hands. Often, they are painless, but not always. Ganglion cysts also can cause pain, weakness or numbness in the hand if they put pressure on nerves near a joint. The cause of ganglion cysts isn't clear. The risk may be great in people with osteoarthritis or with injured joints or tendons in the hands.
Trigger finger: This condition -- stenosing tenosynovitis -- is typically a painful condition in which one finger or thumb catches in the bent position. In severe cases, the finger may become locked in bent or straight position. The cause is a thickening of the liner, or sheath, which surrounds the tendon in the affected finger. Trigger finger tends to be more common in people whose work or hobby requires repetitive gripping motions, or those who have rheumatoid arthritis, diabetes or hypothyroidism.
Tendonitis of the wrist: The most common symptoms of wrist tendonitis, called de Quervain's tenosynovitis, are pain and swelling about a half-inch back from the base of the thumb. Pinching, grasping or other thumb and wrist movement may aggravate the pain. Without treatment, the pain may spread in the thumb, forearm or both. Wrist tendonitis is caused by irritation and swelling of the sheath that surrounds the major tendons connecting the wrist and lower thumb. It can result from overuse of the wrist and thumb together. Often called the "new mother's" disease, it is common in new parents who pick up infants with their thumbs out and wrists bent backwards.
Treatment for these conditions should start with talking to a doctor about pain, swelling or discomfort in the hands and wrists. Depending on the diagnosis, treatment options include self-care (applying heat and cold), physical therapy, medications to reduce pain and swelling, and surgery.
Mayo Clinic
200 First St. SW
Rochester, MN 55902
United States
mayoclinic
пятница, 15 июля 2011 г.
New Report Reveals Inequality Of Patient Access Across Europe To Innovative Treatments For Rheumatoid Arthritis
European patients still face inequalities in access to the majority of innovative biologics treatments for rheumatoid arthritis (RA). Speed and levels of access depend on where patients live, a report published today. The proportion of patients diagnosed with rheumatoid arthritis who are treated with biologics can range from 30% in Norway to less than 1% in Bulgaria.
"It is particularly appropriate that this report is published today, on World Arthritis Day", commented Brian Ager, Director General of EFPIA, the Federation of the research-based pharmaceutical industry in Europe. "It helps shed light on the reasons why patients face these inequalities in access to RA treatments. We hope it will stimulate discussions on how we achieve the optimal use of new technologies and treatment for all patients."
The report shows that new treatments, despite being shown to be extremely effective, are not used to their full potential. "There are many factors explaining differences in uptake of innovative treatments," said Dr. Gisela Kobelt, President of European Health Economics, France and researcher at the Department of Orthopedics at Lund University, Sweden, the report's lead researcher. "One of the most important of them is insufficient consideration being given to societal costs in authorities' public health strategies, despite these representing more than half of all disease cost."
The report indicates that the greatest differences in access result from large variations in affordability among countries in Europe, a problem exacerbated by standardised drug prices caused by Europe's regulatory environment. Affordability concerns lead to different assessments of the cost-effectiveness of treatments, which increasingly steer authorities' decisions in treatment guidelines.
The report authors call on European public authorities to realize the potential benefits of early and wide access to innovative treatments in RA. For the 2 million people affected by RA in Europe, disease remission is today a realistic goal, by using innovative treatments for the right patients, at the right time and in the right way. This can contribute to healthcare savings in both the short and long-term, through fewer hospital admissions, less surgical interventions and longer activity in workforce.
This report is the latest in a series of publications in the European Journal of Health Economics examining 'The burden of rheumatoid arthritis and access to treatment: uptake of new therapies'1. It was supported by an unrestricted grant from EFPIA, with analyses conducted by i3 Innovus, a company specializing in health economics and outcomes research.
The full report is available for download here: comparatorreports.se
1 J?¶nsson B, Kobelt G, Smolen J., Eur J Health Econ 2008;8 (Suppl 2):S33-106.
Source
EFPIA
"It is particularly appropriate that this report is published today, on World Arthritis Day", commented Brian Ager, Director General of EFPIA, the Federation of the research-based pharmaceutical industry in Europe. "It helps shed light on the reasons why patients face these inequalities in access to RA treatments. We hope it will stimulate discussions on how we achieve the optimal use of new technologies and treatment for all patients."
The report shows that new treatments, despite being shown to be extremely effective, are not used to their full potential. "There are many factors explaining differences in uptake of innovative treatments," said Dr. Gisela Kobelt, President of European Health Economics, France and researcher at the Department of Orthopedics at Lund University, Sweden, the report's lead researcher. "One of the most important of them is insufficient consideration being given to societal costs in authorities' public health strategies, despite these representing more than half of all disease cost."
The report indicates that the greatest differences in access result from large variations in affordability among countries in Europe, a problem exacerbated by standardised drug prices caused by Europe's regulatory environment. Affordability concerns lead to different assessments of the cost-effectiveness of treatments, which increasingly steer authorities' decisions in treatment guidelines.
The report authors call on European public authorities to realize the potential benefits of early and wide access to innovative treatments in RA. For the 2 million people affected by RA in Europe, disease remission is today a realistic goal, by using innovative treatments for the right patients, at the right time and in the right way. This can contribute to healthcare savings in both the short and long-term, through fewer hospital admissions, less surgical interventions and longer activity in workforce.
This report is the latest in a series of publications in the European Journal of Health Economics examining 'The burden of rheumatoid arthritis and access to treatment: uptake of new therapies'1. It was supported by an unrestricted grant from EFPIA, with analyses conducted by i3 Innovus, a company specializing in health economics and outcomes research.
The full report is available for download here: comparatorreports.se
1 J?¶nsson B, Kobelt G, Smolen J., Eur J Health Econ 2008;8 (Suppl 2):S33-106.
Source
EFPIA
вторник, 12 июля 2011 г.
New SIMPONI(TM) Data Show Long-Term Efficacy In Treatment Of Rheumatoid Arthritis
New long-term data from two pivotal, Phase 3 clinical trials showed that patients with active rheumatoid arthritis (RA) receiving SIMPONI(TM) (golimumab) every four weeks achieved sustained improvements in signs and symptoms and physical function response through one year. These new data were presented at the 2009 American College of Rheumatology (ACR) Annual Scientific Meeting.
"New data demonstrate sustained efficacy of golimumab dosed every four weeks in patients with RA who were previously treated with anti-TNF agents," said Dr. Jonathan Kay, Professor of Medicine and Director of Clinical Research in the Rheumatology Division at the University of Massachusetts Medical School in Worcester, Massachusetts and lead study investigator.
Findings from the GOlimumab After Former anti-TNF Therapy Evaluated in RA (GO-AFTER) study demonstrated that patients with RA previously treated with adalimumab, etanercept or infliximab responded to, and maintained response to, SIMPONI through one year. At week 52, 63 percent of patients receiving SIMPONI 50 mg achieved at least a 20 percent improvement in arthritis signs and symptoms as measured by American College of Rheumatology (ACR 20) response, and 41 percent achieved a 50 percent improvement in arthritis signs and symptoms as measured by ACR 50 response.
SIMPONI-treated patients who had discontinued previous anti-TNF treatment for any reason sustained improvements in physical function, as measured by the Health Assessment Questionnaire (HAQ). At week 52, patients receiving SIMPONI 50 mg maintained a clinically relevant improvement (decrease in HAQ score of at least 0.25) from baseline. Similar results were previously reported at week 24. HAQ assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and other activities of daily living). The data also showed that 81 percent and 61 percent of patients receiving SIMPONI 50 mg reported improvements from baseline in the number of tender and swollen joints, respectively.
Results from the GOlimumab FOR subjects With Active RA Despite Methotrexate (GO-FORWARD) study showed the efficacy of SIMPONI in patients with active RA despite prior treatment with methotrexate. At week 52, 64 percent of patients taking SIMPONI 50 mg plus methotrexate achieved ACR 20 response, and 25 percent achieved a 70 percent improvement in arthritis signs and symptoms as measured by ACR 70 response. There was no clear evidence of improved ACR response with the higher SIMPONI dose group (100 mg). Importantly, investigators also reported that 48 percent of patients receiving SIMPONI 50 mg plus methotrexate achieved a low level of disease activity as measured by Disease Activity Score 28 (DAS 28) C-reactive protein (CRP)
"These data show that patients receiving golimumab, a once-monthly anti-TNF therapy, sustained clinical response through one year," said Dr. Mark Genovese, Division Co-Chief of Immunology and Rheumatology at Stanford University and study investigator.
In April 2009, the U.S. Food and Drug Administration (FDA) and Health Canada approved SIMPONI 50 mg as a once-monthly subcutaneous injection for the treatment of moderately to severely active RA, active psoriatic arthritis (PsA) and active ankylosing spondylitis. In October 2009, the European Commission approved SIMPONI as a once-monthly, subcutaneous injection for the treatment of moderate to severe, active RA, active and progressive PsA and severe, active ankylosing spondylitis.
About the GO-AFTER Trial
GO-AFTER is the first placebo-controlled, double-blind, Phase 3 registration trial that demonstrates the efficacy and safety of an anti-TNF-alpha agent in patients previously treated with other anti-TNFs. The trial included patients with active RA of 8.65 years mean duration. Discontinuation of previous anti-TNF-alpha therapy was to occur at least eight to 12 weeks prior to enrollment in the study. At baseline, 66 percent of patients were receiving methotrexate; five percent and eight percent of patients were receiving sulfasalazine and hydroxychloroquine, respectively. Patients continued to receive stable doses of methotrexate, sulfasalazine and/or hydroxychloroquine if receiving them at baseline. At week 16, patients with less than a 20 percent improvement in tender and swollen joint counts were entered into a double-blinded early escape. Those who did not achieve ACR 20 response at week 16 while taking placebo were given SIMPONI 50 mg every four weeks. Those who qualified for early escape and had been taking SIMPONI 50 mg were given SIMPONI 100 mg and those who had been receiving SIMPONI 100 mg continued to receive that dosing.
At least one adverse event was reported in 76 percent of patients receiving SIMPONI 50 mg or SIMPONI 100 mg with 13 and eight percent of patients, respectively, experiencing a serious adverse event. Serious infections were reported in four percent of patients receiving SIMPONI 50 mg and three percent of patients taking SIMPONI 100 mg, and injection site reactions were reported in one percent and two percent of patients, respectively.
About the GO-FORWARD Trial
GO-FORWARD, a Phase 3, multi-center clinical trial, includes adult patients with active RA and more than four tender and swollen joints, despite methotrexate therapy. Patients were randomly assigned to receive SIMPONI (50 or 100 mg) plus methotrexate, SIMPONI 100 mg plus placebo or placebo plus methotrexate at weeks 0, 4, 8, 12, 16 and 20. At week 16, patients with at least a 20 percent response (ACR 20) were entered into an early escape and patients who had been receiving placebo plus methotrexate received SIMPONI 50 mg plus methotrexate; methotrexate was added to the SIMPONI 100 mg with placebo group, the group receiving SIMPONI 50 mg plus methotrexate was given SIMPONI 100 mg and the SIMPONI 100 mg plus methotrexate group was not changed. The patients continued receiving treatment through 52 weeks.
Serious adverse events were reported in 11, 17, 14 and 18 percent of patients in each group, respectively, and two, six, two and eight percent of patients, in each group respectively, experienced a serious infection. From week 24 through week 52, nine serious infections were reported; three in patients receiving SIMPONI 50 mg plus methotrexate, four in patients receiving SIMPONI 100 mg plus placebo and two in patients taking SIMPONI 100 mg plus methotrexate. There were also four malignancies reported between week 24 and week 52; two patients receiving SIMPONI 50 mg plus methotrexate were diagnosed with squamous and basal cell cancer and breast cancer, respectively, and two patients receiving SIMPONI 100 mg plus methotrexate were diagnosed with basal cell cancer and breast cancer, respectively.
About Rheumatoid Arthritis
Rheumatoid arthritis is characterized by persistent and progressive joint inflammation, causing pain, stiffness and functional disability. The Arthritis Foundation estimates that approximately 1.3 million people in the United States are affected by RA. For more information, visit the Arthritis Foundation.
About SIMPONI
SIMPONI is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. The first once-monthly subcutaneous anti-TNF-alpha therapy, SIMPONI is approved for the treatment of RA, PsA and ankylosing spondylitis in the United States, Europe and Canada, and is available either through the SIMPONI SmartJect autoinjector or a prefilled syringe.
Centocor Ortho Biotech Inc. developed and discovered SIMPONI and has exclusive marketing rights to the product in the United States. Following regulatory approvals, Schering-Plough will assume exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan, where SIMPONI will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where SIMPONI will be exclusively marketed by Janssen-Cilag; and China, where SIMPONI will be exclusively marketed by Xian-Janssen. Centocor Ortho Biotech, Janssen-Cilag and Xian-Janssen are wholly owned subsidiaries of Johnson & Johnson.
Important Safety Information
SIMPONI is a prescription medicine. SIMPONI can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
You should not start SIMPONI if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:
-- fever, sweat, or chills
-- muscle aches
-- cough
-- shortness of breath
-- blood in phlegm
-- weight loss
-- warm, red, or painful skin or sores on your body
-- diarrhea or stomach pain
-- burning when you urinate or urinate more than normal
-- feel very tired
Tell your doctor about all the medications you take or if you are scheduled to or recently received a vaccine.
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blocker medicines, such as SIMPONI. Some of these cases have been fatal. Your doctor may do blood tests before and after you start treatment with SIMPONI. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:
-- feel very tired
-- skin or eyes look yellow
-- little or no appetite
-- vomiting
-- muscle aches
-- dark urine
-- clay-colored bowel movements
-- fevers
-- chills
-- stomach discomfort
-- skin rash
If you take SIMPONI or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancers.
Heart failure can occur or get worse in people who use TNF blockers like SIMPONI. Your doctor will monitor you closely if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath or swelling of your lower legs or feet.
Rarely, people using TNF blockers can have nervous system problems such as multiple sclerosis. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.
Liver problems can happen in people using TNF blockers. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.
Low blood counts have been seen with people using TNF blockers. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.
Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles, and/or legs.
Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber.
Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI such as hives, swollen face, breathing trouble, or chest pain. Common side effects of SIMPONI include: upper respiratory tract infection, nausea, abnormal liver tests, redness at site of injection, high blood pressure, bronchitis, dizziness, sinus infection, flu, runny nose, fever, cold sores, numbness or tingling.
About Centocor Ortho Biotech Inc.
Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology, and oncology. The company was created when Ortho Biotech Inc. merged into Centocor, Inc., and Centocor, Inc. was renamed Centocor Ortho Biotech Inc. Built upon a pioneering history, Centocor Ortho Biotech Inc. harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Centocor Ortho Biotech Inc. and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign healthcare reforms and governmental laws and regulations; and trends toward healthcare cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at sec, jnj or on request from Johnson & Johnson. Neither Centocor Ortho Biotech Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential market for SIMPONI. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A. "Risk Factors" in the Company's second quarter 2009 10-Q, filed July 24, 2009.
Source: Centocor Ortho Biotech Inc
View drug information on Simponi.
"New data demonstrate sustained efficacy of golimumab dosed every four weeks in patients with RA who were previously treated with anti-TNF agents," said Dr. Jonathan Kay, Professor of Medicine and Director of Clinical Research in the Rheumatology Division at the University of Massachusetts Medical School in Worcester, Massachusetts and lead study investigator.
Findings from the GOlimumab After Former anti-TNF Therapy Evaluated in RA (GO-AFTER) study demonstrated that patients with RA previously treated with adalimumab, etanercept or infliximab responded to, and maintained response to, SIMPONI through one year. At week 52, 63 percent of patients receiving SIMPONI 50 mg achieved at least a 20 percent improvement in arthritis signs and symptoms as measured by American College of Rheumatology (ACR 20) response, and 41 percent achieved a 50 percent improvement in arthritis signs and symptoms as measured by ACR 50 response.
SIMPONI-treated patients who had discontinued previous anti-TNF treatment for any reason sustained improvements in physical function, as measured by the Health Assessment Questionnaire (HAQ). At week 52, patients receiving SIMPONI 50 mg maintained a clinically relevant improvement (decrease in HAQ score of at least 0.25) from baseline. Similar results were previously reported at week 24. HAQ assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and other activities of daily living). The data also showed that 81 percent and 61 percent of patients receiving SIMPONI 50 mg reported improvements from baseline in the number of tender and swollen joints, respectively.
Results from the GOlimumab FOR subjects With Active RA Despite Methotrexate (GO-FORWARD) study showed the efficacy of SIMPONI in patients with active RA despite prior treatment with methotrexate. At week 52, 64 percent of patients taking SIMPONI 50 mg plus methotrexate achieved ACR 20 response, and 25 percent achieved a 70 percent improvement in arthritis signs and symptoms as measured by ACR 70 response. There was no clear evidence of improved ACR response with the higher SIMPONI dose group (100 mg). Importantly, investigators also reported that 48 percent of patients receiving SIMPONI 50 mg plus methotrexate achieved a low level of disease activity as measured by Disease Activity Score 28 (DAS 28) C-reactive protein (CRP)
"These data show that patients receiving golimumab, a once-monthly anti-TNF therapy, sustained clinical response through one year," said Dr. Mark Genovese, Division Co-Chief of Immunology and Rheumatology at Stanford University and study investigator.
In April 2009, the U.S. Food and Drug Administration (FDA) and Health Canada approved SIMPONI 50 mg as a once-monthly subcutaneous injection for the treatment of moderately to severely active RA, active psoriatic arthritis (PsA) and active ankylosing spondylitis. In October 2009, the European Commission approved SIMPONI as a once-monthly, subcutaneous injection for the treatment of moderate to severe, active RA, active and progressive PsA and severe, active ankylosing spondylitis.
About the GO-AFTER Trial
GO-AFTER is the first placebo-controlled, double-blind, Phase 3 registration trial that demonstrates the efficacy and safety of an anti-TNF-alpha agent in patients previously treated with other anti-TNFs. The trial included patients with active RA of 8.65 years mean duration. Discontinuation of previous anti-TNF-alpha therapy was to occur at least eight to 12 weeks prior to enrollment in the study. At baseline, 66 percent of patients were receiving methotrexate; five percent and eight percent of patients were receiving sulfasalazine and hydroxychloroquine, respectively. Patients continued to receive stable doses of methotrexate, sulfasalazine and/or hydroxychloroquine if receiving them at baseline. At week 16, patients with less than a 20 percent improvement in tender and swollen joint counts were entered into a double-blinded early escape. Those who did not achieve ACR 20 response at week 16 while taking placebo were given SIMPONI 50 mg every four weeks. Those who qualified for early escape and had been taking SIMPONI 50 mg were given SIMPONI 100 mg and those who had been receiving SIMPONI 100 mg continued to receive that dosing.
At least one adverse event was reported in 76 percent of patients receiving SIMPONI 50 mg or SIMPONI 100 mg with 13 and eight percent of patients, respectively, experiencing a serious adverse event. Serious infections were reported in four percent of patients receiving SIMPONI 50 mg and three percent of patients taking SIMPONI 100 mg, and injection site reactions were reported in one percent and two percent of patients, respectively.
About the GO-FORWARD Trial
GO-FORWARD, a Phase 3, multi-center clinical trial, includes adult patients with active RA and more than four tender and swollen joints, despite methotrexate therapy. Patients were randomly assigned to receive SIMPONI (50 or 100 mg) plus methotrexate, SIMPONI 100 mg plus placebo or placebo plus methotrexate at weeks 0, 4, 8, 12, 16 and 20. At week 16, patients with at least a 20 percent response (ACR 20) were entered into an early escape and patients who had been receiving placebo plus methotrexate received SIMPONI 50 mg plus methotrexate; methotrexate was added to the SIMPONI 100 mg with placebo group, the group receiving SIMPONI 50 mg plus methotrexate was given SIMPONI 100 mg and the SIMPONI 100 mg plus methotrexate group was not changed. The patients continued receiving treatment through 52 weeks.
Serious adverse events were reported in 11, 17, 14 and 18 percent of patients in each group, respectively, and two, six, two and eight percent of patients, in each group respectively, experienced a serious infection. From week 24 through week 52, nine serious infections were reported; three in patients receiving SIMPONI 50 mg plus methotrexate, four in patients receiving SIMPONI 100 mg plus placebo and two in patients taking SIMPONI 100 mg plus methotrexate. There were also four malignancies reported between week 24 and week 52; two patients receiving SIMPONI 50 mg plus methotrexate were diagnosed with squamous and basal cell cancer and breast cancer, respectively, and two patients receiving SIMPONI 100 mg plus methotrexate were diagnosed with basal cell cancer and breast cancer, respectively.
About Rheumatoid Arthritis
Rheumatoid arthritis is characterized by persistent and progressive joint inflammation, causing pain, stiffness and functional disability. The Arthritis Foundation estimates that approximately 1.3 million people in the United States are affected by RA. For more information, visit the Arthritis Foundation.
About SIMPONI
SIMPONI is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. The first once-monthly subcutaneous anti-TNF-alpha therapy, SIMPONI is approved for the treatment of RA, PsA and ankylosing spondylitis in the United States, Europe and Canada, and is available either through the SIMPONI SmartJect autoinjector or a prefilled syringe.
Centocor Ortho Biotech Inc. developed and discovered SIMPONI and has exclusive marketing rights to the product in the United States. Following regulatory approvals, Schering-Plough will assume exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan, where SIMPONI will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where SIMPONI will be exclusively marketed by Janssen-Cilag; and China, where SIMPONI will be exclusively marketed by Xian-Janssen. Centocor Ortho Biotech, Janssen-Cilag and Xian-Janssen are wholly owned subsidiaries of Johnson & Johnson.
Important Safety Information
SIMPONI is a prescription medicine. SIMPONI can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
You should not start SIMPONI if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:
-- fever, sweat, or chills
-- muscle aches
-- cough
-- shortness of breath
-- blood in phlegm
-- weight loss
-- warm, red, or painful skin or sores on your body
-- diarrhea or stomach pain
-- burning when you urinate or urinate more than normal
-- feel very tired
Tell your doctor about all the medications you take or if you are scheduled to or recently received a vaccine.
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blocker medicines, such as SIMPONI. Some of these cases have been fatal. Your doctor may do blood tests before and after you start treatment with SIMPONI. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:
-- feel very tired
-- skin or eyes look yellow
-- little or no appetite
-- vomiting
-- muscle aches
-- dark urine
-- clay-colored bowel movements
-- fevers
-- chills
-- stomach discomfort
-- skin rash
If you take SIMPONI or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancers.
Heart failure can occur or get worse in people who use TNF blockers like SIMPONI. Your doctor will monitor you closely if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath or swelling of your lower legs or feet.
Rarely, people using TNF blockers can have nervous system problems such as multiple sclerosis. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.
Liver problems can happen in people using TNF blockers. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.
Low blood counts have been seen with people using TNF blockers. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.
Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles, and/or legs.
Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber.
Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI such as hives, swollen face, breathing trouble, or chest pain. Common side effects of SIMPONI include: upper respiratory tract infection, nausea, abnormal liver tests, redness at site of injection, high blood pressure, bronchitis, dizziness, sinus infection, flu, runny nose, fever, cold sores, numbness or tingling.
About Centocor Ortho Biotech Inc.
Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology, and oncology. The company was created when Ortho Biotech Inc. merged into Centocor, Inc., and Centocor, Inc. was renamed Centocor Ortho Biotech Inc. Built upon a pioneering history, Centocor Ortho Biotech Inc. harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Centocor Ortho Biotech Inc. and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign healthcare reforms and governmental laws and regulations; and trends toward healthcare cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at sec, jnj or on request from Johnson & Johnson. Neither Centocor Ortho Biotech Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential market for SIMPONI. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A. "Risk Factors" in the Company's second quarter 2009 10-Q, filed July 24, 2009.
Source: Centocor Ortho Biotech Inc
View drug information on Simponi.
суббота, 9 июля 2011 г.
Lubris, Biomodels Report On Potential New Therapy For Osteoarthritis
Medical researchers will report findings (Oct. 19) that demonstrate that injecting the protein lubricin into knee joints can dramatically reduce cartilage degeneration.
The discovery by scientists at Biomodels, a preclinical drug research organization, and Lubris, a Massachusetts-based startup company, could result in a new therapy for individuals at risk for osteoarthritis, researchers said.
The study, by Gregory D. Jay, MD, PhD, a Professor of Emergency Medicine and Biomedical Engineering at Rhode Island Hospital and Brown University, will be presented Monday morning at the American College of Rheumatology/Association of Rheumatology Health Professionals Conference.
In the study performed at Biomodels, the transection of the ACL (anterior cruciate ligament) in untreated rats resulted in progressive degeneration of the knee joints and the articular cartilage. In rats treated with recombinant human lubricin, however, the degeneration was far less pronounced, indicating that treatment with lubricin can slow the development of osteoarthritis following traumatic joint injury, and possibly reverse the process, according to Dr. Jay.
Dr. Jay said the study shows that recombinant human lubricin, given as direct injections, "significantly reduced the extent of cartilage degeneration in the knees of rats with post-traumatic osteoarthritis."
"If the research can be successfully translated into humans, it would represent the first successful attempt to protect cartilage and improve boundary lubrication in compromised joints, which could revolutionize both the treatment of osteoarthritis and traumatic joint injury," he said
Dr. Jay's ongoing research suggests that lubricin injections could delay or even prevent the onset of osteoarthritis and reduce or eliminate the need for costly joint-replacement surgery.
The findings are supportive of more than two decades of research by Dr. Jay and his team, in which they have shown that lubricin is a key component of human synovial fluid, itself a requirement for the normal function and lubrication of healthy joints.
About Lubris LLC
Lubris, a Massachusetts-based startup company, is developing lubricin commercially and holds exclusive worldwide patent rights to make, use, and sell lubricin. The company is in the process of accessing capital markets to develop and commercialize lubricin-containing products in various orthopedic and other indications.
About Biomodels LLC
Biomodels, a preclinical drug research organization founded in 1997, develops and conducts predictive translational studies for biotechnology and pharmaceutical companies, particularly in the areas of cancer, cancer supportive care, radiation therapy, and inflammatory diseases.
The company, based in Watertown, MA, specializes in (non-GLP) efficacy studies that optimize dose, schedule and define mechanism of action. The company also has expertise in modeling inflammatory diseases, including those conditions affecting the gastrointestinal tract. Biomodels' studies enable organizations to more readily identify lead compounds, decrease the time to a clinical trial and increase the chance of clinical success.
Source: Biomodels
The discovery by scientists at Biomodels, a preclinical drug research organization, and Lubris, a Massachusetts-based startup company, could result in a new therapy for individuals at risk for osteoarthritis, researchers said.
The study, by Gregory D. Jay, MD, PhD, a Professor of Emergency Medicine and Biomedical Engineering at Rhode Island Hospital and Brown University, will be presented Monday morning at the American College of Rheumatology/Association of Rheumatology Health Professionals Conference.
In the study performed at Biomodels, the transection of the ACL (anterior cruciate ligament) in untreated rats resulted in progressive degeneration of the knee joints and the articular cartilage. In rats treated with recombinant human lubricin, however, the degeneration was far less pronounced, indicating that treatment with lubricin can slow the development of osteoarthritis following traumatic joint injury, and possibly reverse the process, according to Dr. Jay.
Dr. Jay said the study shows that recombinant human lubricin, given as direct injections, "significantly reduced the extent of cartilage degeneration in the knees of rats with post-traumatic osteoarthritis."
"If the research can be successfully translated into humans, it would represent the first successful attempt to protect cartilage and improve boundary lubrication in compromised joints, which could revolutionize both the treatment of osteoarthritis and traumatic joint injury," he said
Dr. Jay's ongoing research suggests that lubricin injections could delay or even prevent the onset of osteoarthritis and reduce or eliminate the need for costly joint-replacement surgery.
The findings are supportive of more than two decades of research by Dr. Jay and his team, in which they have shown that lubricin is a key component of human synovial fluid, itself a requirement for the normal function and lubrication of healthy joints.
About Lubris LLC
Lubris, a Massachusetts-based startup company, is developing lubricin commercially and holds exclusive worldwide patent rights to make, use, and sell lubricin. The company is in the process of accessing capital markets to develop and commercialize lubricin-containing products in various orthopedic and other indications.
About Biomodels LLC
Biomodels, a preclinical drug research organization founded in 1997, develops and conducts predictive translational studies for biotechnology and pharmaceutical companies, particularly in the areas of cancer, cancer supportive care, radiation therapy, and inflammatory diseases.
The company, based in Watertown, MA, specializes in (non-GLP) efficacy studies that optimize dose, schedule and define mechanism of action. The company also has expertise in modeling inflammatory diseases, including those conditions affecting the gastrointestinal tract. Biomodels' studies enable organizations to more readily identify lead compounds, decrease the time to a clinical trial and increase the chance of clinical success.
Source: Biomodels
среда, 6 июля 2011 г.
Tilapia Contains Potentially Dangerous Fatty Acid Combination
Farm-raised tilapia, one of the most highly consumed fish in America, has very low levels of beneficial omega-3 fatty acids and, perhaps worse, very high levels of omega-6 fatty acids, according to new research from Wake Forest University School of Medicine.
The researchers say the combination could be a potentially dangerous food source for some patients with heart disease, arthritis, asthma and other allergic and auto-immune diseases that are particularly vulnerable to an "exaggerated inflammatory response." Inflammation is known to cause damage to blood vessels, the heart, lung and joint tissues, skin, and the digestive tract.
"In the United States, tilapia has shown the biggest gains in popularity among seafood, and this trend is expected to continue as consumption is projected to increase from 1.5 million tons in 2003 to 2.5 million tons by 2010," write the Wake Forest researchers in an article published this month in the Journal of the American Dietetic Association.
They say their research revealed that farm-raised tilapia, as well as farmed catfish, "have several fatty acid characteristics that would generally be considered by the scientific community as detrimental." Tilapia has higher levels of potentially detrimental long-chain omega-6 fatty acids than 80-percent-lean hamburger, doughnuts and even pork bacon, the article says.
"For individuals who are eating fish as a method to control inflammatory diseases such as heart disease, it is clear from these numbers that tilapia is not a good choice," the article says. "All other nutritional content aside, the inflammatory potential of hamburger and pork bacon is lower than the average serving of farmed tilapia."
The article notes that the health benefits of omega-3 fatty acids, known scientifically as "long-chain n-3 polyunsaturated fatty acids" (PUFAs), have been well documented. The American Heart Association now recommends that everyone eat at least two servings of fish per week, and that heart patients consume at least 1 gram a day of the two most critical omega-3 fatty acids, known as EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid).
But, the article says, the recommendation by the medical community for people to eat more fish has resulted in consumption of increasing quantities of fish such as tilapia that may do more harm than good, because they contain high levels of omega-6 fatty acids, also called n-6 PUFAs, such as arachidonic acid.
"The ratio of arachidonic acid (AA) to very long-chain n-3 PUFAs (EPA and DHA) in diets of human beings appears to be an important factor that dictates the anti-inflammatory effects of fish oils," the researchers write. They cite numerous studies, including a recent one that predicts "that changes in arachidonic acid to EPA or DHA ratios shift the balance from pro-inflammatory [agents] to protective chemical mediators ??¦ which are proposed to play a pivotal role in resolving inflammatory response" in the body.
For their study, the authors obtained a variety of fish from several sources, including seafood distributors that supply restaurants and supermarkets, two South American companies, fish farms in several countries, and supermarkets in four states. All samples were snap-frozen for preservation pending analysis, which was performed with gas chromatography.
The researchers found that farmed tilapia contained only modest amounts of omega-3 fatty acids - less than half a gram per 100 grams of fish, similar to flounder and swordfish. Farmed salmon and trout, by contrast, had nearly 3 and 4 grams, respectively.
At the same time, the tilapia had much higher amounts of omega-6 acids generally and AA specifically than both salmon and trout. Ratios of long-chain omega-6 to long-chain omega-3, AA to EPA respectively, in tilapia averaged about 11:1, compared to much less than 1:1 (indicating more EPA than AA) in both salmon and trout.
The article notes that "there is a controversy among scientists in this field as to the importance of arachidonic acid or omega-6:omega-3 ratios vs. the concentration of long-chain omega-3 alone with regard to their effects in human biology." Those issues are raised in an editorial in the same issue of the Journal.
The Wake Forest article anticipates that criticism and notes that one human study involving AA showed a probable gene-nutrient connection to coronary heart disease in a specific group of heart disease patients. In another study, four subjects were removed after consumption of high amounts of AA due to concerns about the effect of the acid on their blood platelets.
Floyd H. "Ski" Chilton, Ph.D., professor of physiology and pharmacology and director of the Wake Forest Center for Botanical Lipids, is the senior author of the Journal article. He said that in next month's Journal, he will publish a rebuttal to this month's editorial.
"We have known for three decades that arachidonic acid is the substrate for all pro-inflammatory lipid mediators," Chilton said in an interview. "The animal studies say unequivocally that if you feed arachidonic acid, the animals show signs of inflammation and get sick.
"A New England Journal of Medicine article three years ago said if you had heart disease and had a certain genetic makeup, and you ate arachidonic acid, the diameter of your coronary artery was smaller, a major risk factor for a heart attack," said Chilton. "My point is that it's likely not worth the risk in this or other vulnerable populations."
Chilton said tilapia is easily farmed using inexpensive corn-based feeds, which contain short chain omega-6s that the fish very efficiently convert to AA and place in their tissues. This ability to feed the fish inexpensive foods, together with their capacity to grow under almost any condition, keeps the market price for the fish so low that it is rapidly becoming a staple in low-income diets.
"We are all familiar with the classical Hippocratic admonition, Primum no nocere, 'First, do no harm.' I think it behooves us to consider this critical directive when making dietary prescriptions for the sake of health," Chilton said.
"Cardiologists are telling their patients to go home and eat fish, and if the patients are poor, they're eating tilapia. And that could translate into a dangerous situation."
Co-authors of the study are Kelly L. Weaver, Ph.D., Priscilla Ivester, Joshua A. Chilton, Martha D. Wilson, Ph.D., and Prativa Pandey, all with Wake Forest School of Medicine. The research was funded by the National Center for Complementary and Alternative Medicine and the Office of Dietary Supplements of the National Institutes of Health (NIH), and by an NIH Molecular Medicine training grant.
Wake Forest University Baptist Medical Center (wfubmc/) is an academic health system comprised of North Carolina Baptist Hospital, Brenner Children's Hospital, Wake Forest University Physicians, and Wake Forest University Health Sciences, which operates the university's School of Medicine and Piedmont Triad Research Park. The system comprises 1,154 acute care, rehabilitation and long-term care beds and has been ranked as one of "America's Best Hospitals" by U.S. News & World Report since 1993. Wake Forest Baptist is ranked 32nd in the nation by America's Top Doctors for the number of its doctors considered best by their peers. The institution ranks in the top third in funding by the National Institutes of Health and fourth in the Southeast in revenues from its licensed intellectual property.
Source: Mark Wright
Wake Forest University Baptist Medical Center
The researchers say the combination could be a potentially dangerous food source for some patients with heart disease, arthritis, asthma and other allergic and auto-immune diseases that are particularly vulnerable to an "exaggerated inflammatory response." Inflammation is known to cause damage to blood vessels, the heart, lung and joint tissues, skin, and the digestive tract.
"In the United States, tilapia has shown the biggest gains in popularity among seafood, and this trend is expected to continue as consumption is projected to increase from 1.5 million tons in 2003 to 2.5 million tons by 2010," write the Wake Forest researchers in an article published this month in the Journal of the American Dietetic Association.
They say their research revealed that farm-raised tilapia, as well as farmed catfish, "have several fatty acid characteristics that would generally be considered by the scientific community as detrimental." Tilapia has higher levels of potentially detrimental long-chain omega-6 fatty acids than 80-percent-lean hamburger, doughnuts and even pork bacon, the article says.
"For individuals who are eating fish as a method to control inflammatory diseases such as heart disease, it is clear from these numbers that tilapia is not a good choice," the article says. "All other nutritional content aside, the inflammatory potential of hamburger and pork bacon is lower than the average serving of farmed tilapia."
The article notes that the health benefits of omega-3 fatty acids, known scientifically as "long-chain n-3 polyunsaturated fatty acids" (PUFAs), have been well documented. The American Heart Association now recommends that everyone eat at least two servings of fish per week, and that heart patients consume at least 1 gram a day of the two most critical omega-3 fatty acids, known as EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid).
But, the article says, the recommendation by the medical community for people to eat more fish has resulted in consumption of increasing quantities of fish such as tilapia that may do more harm than good, because they contain high levels of omega-6 fatty acids, also called n-6 PUFAs, such as arachidonic acid.
"The ratio of arachidonic acid (AA) to very long-chain n-3 PUFAs (EPA and DHA) in diets of human beings appears to be an important factor that dictates the anti-inflammatory effects of fish oils," the researchers write. They cite numerous studies, including a recent one that predicts "that changes in arachidonic acid to EPA or DHA ratios shift the balance from pro-inflammatory [agents] to protective chemical mediators ??¦ which are proposed to play a pivotal role in resolving inflammatory response" in the body.
For their study, the authors obtained a variety of fish from several sources, including seafood distributors that supply restaurants and supermarkets, two South American companies, fish farms in several countries, and supermarkets in four states. All samples were snap-frozen for preservation pending analysis, which was performed with gas chromatography.
The researchers found that farmed tilapia contained only modest amounts of omega-3 fatty acids - less than half a gram per 100 grams of fish, similar to flounder and swordfish. Farmed salmon and trout, by contrast, had nearly 3 and 4 grams, respectively.
At the same time, the tilapia had much higher amounts of omega-6 acids generally and AA specifically than both salmon and trout. Ratios of long-chain omega-6 to long-chain omega-3, AA to EPA respectively, in tilapia averaged about 11:1, compared to much less than 1:1 (indicating more EPA than AA) in both salmon and trout.
The article notes that "there is a controversy among scientists in this field as to the importance of arachidonic acid or omega-6:omega-3 ratios vs. the concentration of long-chain omega-3 alone with regard to their effects in human biology." Those issues are raised in an editorial in the same issue of the Journal.
The Wake Forest article anticipates that criticism and notes that one human study involving AA showed a probable gene-nutrient connection to coronary heart disease in a specific group of heart disease patients. In another study, four subjects were removed after consumption of high amounts of AA due to concerns about the effect of the acid on their blood platelets.
Floyd H. "Ski" Chilton, Ph.D., professor of physiology and pharmacology and director of the Wake Forest Center for Botanical Lipids, is the senior author of the Journal article. He said that in next month's Journal, he will publish a rebuttal to this month's editorial.
"We have known for three decades that arachidonic acid is the substrate for all pro-inflammatory lipid mediators," Chilton said in an interview. "The animal studies say unequivocally that if you feed arachidonic acid, the animals show signs of inflammation and get sick.
"A New England Journal of Medicine article three years ago said if you had heart disease and had a certain genetic makeup, and you ate arachidonic acid, the diameter of your coronary artery was smaller, a major risk factor for a heart attack," said Chilton. "My point is that it's likely not worth the risk in this or other vulnerable populations."
Chilton said tilapia is easily farmed using inexpensive corn-based feeds, which contain short chain omega-6s that the fish very efficiently convert to AA and place in their tissues. This ability to feed the fish inexpensive foods, together with their capacity to grow under almost any condition, keeps the market price for the fish so low that it is rapidly becoming a staple in low-income diets.
"We are all familiar with the classical Hippocratic admonition, Primum no nocere, 'First, do no harm.' I think it behooves us to consider this critical directive when making dietary prescriptions for the sake of health," Chilton said.
"Cardiologists are telling their patients to go home and eat fish, and if the patients are poor, they're eating tilapia. And that could translate into a dangerous situation."
Co-authors of the study are Kelly L. Weaver, Ph.D., Priscilla Ivester, Joshua A. Chilton, Martha D. Wilson, Ph.D., and Prativa Pandey, all with Wake Forest School of Medicine. The research was funded by the National Center for Complementary and Alternative Medicine and the Office of Dietary Supplements of the National Institutes of Health (NIH), and by an NIH Molecular Medicine training grant.
Wake Forest University Baptist Medical Center (wfubmc/) is an academic health system comprised of North Carolina Baptist Hospital, Brenner Children's Hospital, Wake Forest University Physicians, and Wake Forest University Health Sciences, which operates the university's School of Medicine and Piedmont Triad Research Park. The system comprises 1,154 acute care, rehabilitation and long-term care beds and has been ranked as one of "America's Best Hospitals" by U.S. News & World Report since 1993. Wake Forest Baptist is ranked 32nd in the nation by America's Top Doctors for the number of its doctors considered best by their peers. The institution ranks in the top third in funding by the National Institutes of Health and fourth in the Southeast in revenues from its licensed intellectual property.
Source: Mark Wright
Wake Forest University Baptist Medical Center
воскресенье, 3 июля 2011 г.
1 Out Of Every 3 Arthritis Sufferers Is Affected In Ability To Work
Arthritis, a leading cause of disability among US adults, affects 46 million people. Arthritis-attributable work limitation (AAWL) can have substantial social and economic impacts including absenteeism, reduced productivity, work loss and lower income. Some studies have examined work limitations for people with specific rheumatic conditions, but none have presented a complete picture for the entire spectrum of arthritis in the general population. A new study published in the April 2007 issue of Arthritis Care & Research (Click here) estimated the prevalence of AAWL in adults between the ages of 18 and 64 and examined characteristics related to AAWL in this age group.
Led by Kristina A. Theis, MPH, of the Centers for Disease Control and Prevention in Atlanta, Georgia, researchers analyzed data from the 2002 National Health Interview Survey, which was administered to more than 31,000 adults over the age of 18. The survey included questions about whether respondents had been diagnosed with arthritis by a doctor and whether arthritis or joint symptoms affected whether they worked, and the type or the amount of work they did. Based on their answers, an estimated 6.9 million individuals have AAWL. Respondents were also asked about their physical activity, the presence of chronic co-conditions, limitations not related to work, the severity of their joint pain, their work status and disability payments, and their health access and utilization.
The results showed that among working age adults, 1 in 20 reported AAWL, and, among those with arthritis, 1 in 3 reported AAWL. Adults with arthritis and AAWL had multiple indicators of poor physical health and function, such as high body mass index, joint pain, physical limitations in several activities, and frequent doctor's office visits. AAWL was more common in older age groups and, when adjusted for age, was found to have a higher prevalence among women, non-Hispanic blacks, and individuals with lower education and income.
The authors point out that the findings of the study are subject to limitations typical of observational studies. The information was collected by self-report, which may reflect recall bias, and the presence of arthritis was not confirmed by a health professional; it may be difficult to attribute work limitation to arthritis, especially if the person is suffering from multiple chronic conditions; the wording of the questionnaire did not distinguish between those who could not work and those whose work was simply affected in some way.
Nonetheless the size of the study enabled the authors to develop US national prevalence estimates for AAWL, the results of which can be used as a benchmark for future studies and to help monitor progress in reducing the number of people with AAWL. In addition, by identifying characteristics associated with AAWL, the study may be useful in developing timely interventions for those at risk of work disability. This could have a major impact not just on these individuals, but on society at large. Indirect costs of arthritis have been estimated at $35.1 billion for 1997, and the authors note that "protecting workers from disability, injury, and prolonged negative effects of illness makes simple social and economic sense."
The authors note that future research on public health and arthritis management could address what types of work people with arthritis are unable to do, which groups are more affected and why, and how interventions can be tested, targeted and delivered. They point out that describing and addressing work limitations is an important part of preventing disability. They conclude, "This initial characterization of AAWL will aid in informing research and the development and evaluation of interventions to decrease work limitation experienced by individuals with arthritis."
Arthritis-attributable work limitation affects nearly 7 million U.S. adults, disproportionately affects minority groups, and presents opportunities to reduce arthritis impact by implementing effective interventions to preserve and improve function.
Article: "Prevalence and Correlates of Arthritis-Attributable Work Limitation in the US Population Among Persons Ages 18-64: 2002 National Health Interview Survey Data," Theis et al., Arthritis Care & Research, April 2007; (DOI: 10.1002/art.22622).
Contact: Amy Molnar
John Wiley & Sons, Inc.
Led by Kristina A. Theis, MPH, of the Centers for Disease Control and Prevention in Atlanta, Georgia, researchers analyzed data from the 2002 National Health Interview Survey, which was administered to more than 31,000 adults over the age of 18. The survey included questions about whether respondents had been diagnosed with arthritis by a doctor and whether arthritis or joint symptoms affected whether they worked, and the type or the amount of work they did. Based on their answers, an estimated 6.9 million individuals have AAWL. Respondents were also asked about their physical activity, the presence of chronic co-conditions, limitations not related to work, the severity of their joint pain, their work status and disability payments, and their health access and utilization.
The results showed that among working age adults, 1 in 20 reported AAWL, and, among those with arthritis, 1 in 3 reported AAWL. Adults with arthritis and AAWL had multiple indicators of poor physical health and function, such as high body mass index, joint pain, physical limitations in several activities, and frequent doctor's office visits. AAWL was more common in older age groups and, when adjusted for age, was found to have a higher prevalence among women, non-Hispanic blacks, and individuals with lower education and income.
The authors point out that the findings of the study are subject to limitations typical of observational studies. The information was collected by self-report, which may reflect recall bias, and the presence of arthritis was not confirmed by a health professional; it may be difficult to attribute work limitation to arthritis, especially if the person is suffering from multiple chronic conditions; the wording of the questionnaire did not distinguish between those who could not work and those whose work was simply affected in some way.
Nonetheless the size of the study enabled the authors to develop US national prevalence estimates for AAWL, the results of which can be used as a benchmark for future studies and to help monitor progress in reducing the number of people with AAWL. In addition, by identifying characteristics associated with AAWL, the study may be useful in developing timely interventions for those at risk of work disability. This could have a major impact not just on these individuals, but on society at large. Indirect costs of arthritis have been estimated at $35.1 billion for 1997, and the authors note that "protecting workers from disability, injury, and prolonged negative effects of illness makes simple social and economic sense."
The authors note that future research on public health and arthritis management could address what types of work people with arthritis are unable to do, which groups are more affected and why, and how interventions can be tested, targeted and delivered. They point out that describing and addressing work limitations is an important part of preventing disability. They conclude, "This initial characterization of AAWL will aid in informing research and the development and evaluation of interventions to decrease work limitation experienced by individuals with arthritis."
Arthritis-attributable work limitation affects nearly 7 million U.S. adults, disproportionately affects minority groups, and presents opportunities to reduce arthritis impact by implementing effective interventions to preserve and improve function.
Article: "Prevalence and Correlates of Arthritis-Attributable Work Limitation in the US Population Among Persons Ages 18-64: 2002 National Health Interview Survey Data," Theis et al., Arthritis Care & Research, April 2007; (DOI: 10.1002/art.22622).
Contact: Amy Molnar
John Wiley & Sons, Inc.
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