вторник, 5 июля 2011 г.

Winston Laboratories, Inc. Receives Notice Of Non-Compliance In Canada For Its New Drug Submission Of CIVANEX To Treat Osteoarthritis

Winston Laboratories, Inc. ("Winston Labs"), a wholly-owned subsidiary of Winston Pharmaceuticals, Inc. (OTC BB: WPHM) today announced that it has received a Notice of Non-compliance ("NON") from the Therapeutics Drug Directorate, Health Canada (the "Directorate") for its New Drug Submission (NDS) for CIVANEX (zucapsaicin cream 0.075%) for the treatment of the signs and symptoms of osteoarthritis. The Directorate remarked that the analysis of the pivotal trial did not support the requested indication. Winston Labs has a period of ninety days to submit a response to the Directorate's NON, which it intends to do.


"Winston Labs intends to fully address the comments in the NON, and believes that the clearly favorable risk-benefit profile of CIVANEX should lead to approval in Canada," stated Joel E. Bernstein, MD, President and Chief Executive Officer of Winston Pharmaceuticals, Inc. "We believe CIVANEX represents an advance over current topical therapies for osteoarthritis as it is not absorbed, and thus has minimal risk for systemic side effects or interactions with other medications a patient might be using."


About Osteoarthritis


Osteoarthritis is the most common form of arthritis, affecting more than 21 million Americans, mainly adults over age 45. Women are more susceptible to this condition. Osteoarthritis affects the fingers, spinal column and weight-bearing joints such as the hips, knees and feet. The main symptom of osteoarthritis is pain, the degree of which ranges from mildly inconvenient to debilitating. By 2030, an estimated 67 million Americans aged 18 years or older will have doctor-diagnosed arthritis. For some patients with osteoarthritis, relief of mild-to-moderate joint pain is afforded by acetaminophen or an NSAID. A topical medication without systemic absorption and systemic side effects would be advantageous. An alternative approach to oral agents is the use of intra-articular therapy such as hyaluronic acid, but the efficacy of this treatment is very modest. In patients with osteoarthritis of the knee who have moderate-to-severe pain, and in whom signs of joint inflammation are present, intra-articular glucocorticoids can also be used.


Source

Winston Pharmaceuticals

понедельник, 4 июля 2011 г.

Detecting Bone Erosion In Rheumatoid Arthritis

Both magnetic resonance imaging (MRI) and computed tomography (CT) are more sensitive than radiography - the standard imaging technique - for detecting bone erosions in rheumatoid arthritis (RA), according to research published in the open access journal Arthritis Research & Therapy. The early detection of bone erosions is crucial for identifying those people most at risk from RA.



Uffe M??ller D??hn from the Copenhagen University Hospital at Hvidovre in Denmark and co-workers carried out CT, MRI and radiography on the wrist joints of 17 RA patients and four healthy controls.



Taking CT as the reference method for detecting bone erosions, radiography and MRI both showed good specificity (99% and 93%, respectively) but radiography showed low sensitivity (24%) compared to the moderate sensitivity (61%) of MRI. They also found that there was strong agreement between the CT and MRI measurements of erosion volumes. The measured volumes also correlated closely with the Outcome Measures in Rheumatology (OMERACT) erosion scores, thus validating this scoring method further.



The researchers said the results show that CT may be useful for detecting and monitoring bone erosion in RA. Dr M??ller D??hn stated: "The number of erosions detected on CT indicate that CT is a very sensitive method for detecting bone erosions in RA wrist bones, possibly even more sensitive than MRI." However, he acknowledged that the technique's sensitivity to change was not yet established and that its use of ionizing radiation and inability to detect soft tissue changes did count against it.







1. Detection of bone erosions in rheumatoid arthritis wrist joints with magnetic resonance imaging, computed tomography and radiography

Uffe M??ller D??hn, Bo J. Ejbjerg, Maria Hasselquist, Eva Narvestad, Jakob M??ller, Henrik S. Thomsen and Mikkel ??stergaard

Arthritis Research & Therapy (in press)



Article available at the journal website


All articles are available free of charge, according to BioMed Central's open access policy.



2. Arthritis Research & Therapy is an international, peer-reviewed online and print journal, publishing original research, reviews, commentaries and reports. Studies relate to the rationale and treatment of arthritis, autoimmune disease and diseases of bone and cartilage. The journal is edited by Prof Peter E Lipsky (USA) and Prof Sir Ravinder N Maini (UK) and has an Impact Factor of 3.8.



3. BioMed Central (biomedcentral/) is an independent online publishing house committed to providing immediate access without charge to the peer-reviewed biological and medical research it publishes. This commitment is based on the view that open access to research is essential to the rapid and efficient communication of science.



Source: Charlotte Webber


BioMed Central

воскресенье, 3 июля 2011 г.

Mesoblast Limited Stem Cells Regrow Knee Cartilage In Severe Post-Menopausal Osteoarthritis

Australia's regenerative medicine company, Mesoblast Limited (ASX:MSB)(PINK:MBLTY), announced successful preclinical trial results which showed that its proprietary adult stem cells regenerated and regrew damaged knee cartilage in post-menopausal osteoarthritis.


Key points:


- Preclinical trial results show that Mesoblast's stem cell product may be highly effective for treatment of post-menopausal knee osteoarthritis


- Single injection of Mesoblast's proprietary allogeneic, or "off-the-shelf", adult stem cells into post-menopausal osteoarthritic knees resulted in significant and sustained cartilage regeneration for at least six months relative to baseline


- Post-menopausal women represent largest target market for Mesoblast's knee osteoarthritis product


- Cartilage regenerative results mean that Mesoblast will expand commercial product focus to inclu! de both post-menopausal and post-traumatic knee osteoarthritis! markets


- Sufficient funds in place for initial Phase 2 clinical trial


"These outstanding results indicate that Mesoblast's cells are able to support sustained regeneration of knee cartilage in post-menopausal osteoarthritis, an effect not seen with any competitor therapies currently on the market," said Professor Peter Ghosh, Mesoblast's Vice President for Cartilage Regenerative Programs and a world-renowned cartilage expert.


Around 40 per cent of ageing women suffer from post-menopausal knee osteoarthritis. This degenerative condition of cartilage loss is the leading cause of joint pain and disability among the elderly, and affects more than 10 million people in the US alone. Current therapies attempt to alleviate painful symptoms but are unable to preserve the cartilage lining the joint, with joint replacement often being the only option for restoring function.


Mesoblast Executive Director, Professor Silviu Itescu, said the exciting! cartilage regenerative results meant that the Company would now target product commercialisation for both post-menopausal and post-traumatic knee osteoarthritis markets.


"We are sufficiently funded to commence Phase 2 trials of our therapy in patients with osteoarthritis of the knee, he said.


A single injection of Mesoblast's proprietary allogeneic, or "off-the-shelf", adult stem cells into arthritic knees of post-menopausal ewes with well established osteoarthritis, three months after initial joint damage, resulted in sustained, progressive regeneration and regrowth of knee cartilage for at least six months.


In 18 post-menopausal ewes, osteoarthritis developed following bilateral removal of the knee meniscus cartilage. Three months later, one group of six was examined to document the extent of osteoarthritis prior to treatment, and the other two groups received hyaluronic acid alone in one knee and hyaluronic acid plus Mesoblast's allogen! eic cells in the other knee. One of these groups was then foll! owed out for three months, and the other group for six months.















Prior to receiving any treatment, three months after removal of the knee meniscus the knee joints showed extensive osteoarthritis as evidenced by severe erosions and loss of cartilage. Six months after a single injection, osteoarthritic knees that received Mesoblast's allogeneic cells had as much as 20-25% thicker and greater area of cartilage lining the damaged joint than knees that received an injection of hyaluronic acid alone (both parameters p

суббота, 2 июля 2011 г.

Shed Pounds To Ease Foot Pain, Suggests Report From Harvard Medical School

Add foot problems to the
long list of conditions that being overweight can cause or exacerbate, says
Foot Care Basics: Preventing and treating common foot conditions, a newly
updated report from Harvard Medical School. Each time you take a step, you
put about one and a half times your weight on your foot. If you run or play
tennis, three to four times your weight lands on each foot whenever it hits
the ground. Every pound you gain in weight adds to the pounding on your
feet.


Excess weight can contribute to the misery of heel pain (particularly
plantar fasciitis) and arthritis, among other foot problems. When too much
pressure or strain is placed on the plantar fascia -- the ligament-like
structure that runs from your heel to the ball of your foot -- it may
become inflamed. The inflammation usually causes a sharp pain at the heel.



If you are overweight or obese, you're likely to leave your foot
doctor's office not only with pain medication and instructions for
stretching exercises, but also with some advice on losing weight.



Of course, foot problems develop for many reasons. All told, more than
three out of four Americans will suffer some kind of foot ailment in their
lifetimes. And there are more than 300 types of foot problems that can
develop, according to Foot Care Basics.



Foot Care Basics was edited by Christopher P. Chiodo, M.D., Instructor
in Orthopedic Surgery at Harvard Medical School and Orthopedic Surgeon at
Brigham and Women's Hospital, and James P. Ioli, D.P.M., Instructor in
Orthopedic Surgery at Harvard Medical School and Chief of Podiatry at
Brigham and Women's Hospital.


Harvard Health Publications

health.harvard/FCB

пятница, 1 июля 2011 г.

First Anti-TNF Biologic Therapy To Treat 1 Million Patients Worldwide

Centocor, Inc., Schering-Plough Corporation, and Mitsubishi Tanabe Pharma Corporation have announced that an estimated one million patients have now been treated with REMICADE® (infliximab), the leading anti-tumor necrosis factor (TNF)-alpha therapy worldwide. In fact, REMICADE has been used to treat more patients worldwide than all other anti-TNF-alpha agents combined. REMICADE was the first anti-TNF-alpha treatment approved by the U.S. Food and Drug Administration (FDA), when it was indicated for the treatment of acute moderate to severe Crohn's disease in 1998. The indication for Crohn's disease was quickly followed by additional indications, such as rheumatoid arthritis.



"Rheumatoid arthritis derailed my life," said Ellen Shmueli, RA patient. "Simple tasks like lifting my child or holding a pen were nearly impossible. It's hard to put into words what REMICADE has meant to me."



Through a long line of firsts in the biotechnology industry, the history of REMICADE includes 15 FDA indications spanning across inflammatory diseases that include Crohn's disease (adult and pediatric), ulcerative colitis, rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis and psoriasis.



"This significant milestone was achieved as a result of nearly three decades of expanding and improving access for people living with life-altering inflammatory diseases," said Neal Fowler, President, Centocor, Inc. "In partnership with Centocor R&D, we will continue our pledge of bringing the promise of biomedicine to physicians and patients through continued research and development, REMICADE and our promising pipeline portfolio."



REMICADE has been studied in more than 37 clinical trials, evaluating its use in a wide variety of diseases of the immune system and is approved for use in 88 countries.



"Having been a part of its initial approval in 1998, I have personally witnessed how REMICADE has satisfied unmet therapeutic needs and resulted in significant life-changing improvements in patients," said Thomas F. Schaible, PhD, Vice President, Medical Affairs, Centocor, Inc. "Almost a decade later, REMICADE continues to positively affect patients' lives and Centocor continues its commitment to developing novel and important therapies for diseases of the immune system."



"Around the world, the treatment of patients with inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis and Crohn's disease, has been transformed by the availability of REMICADE," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "Schering-Plough is committed to bringing the benefits of REMICADE, with its proven efficacy and rapid onset of action, to relieve the suffering of patients with these chronic inflammatory conditions."
















Important firsts for REMICADE include:



* In August 1998, REMICADE was approved on an accelerated basis for the acute treatment of moderate-to-severe Crohn's disease in patients who have had an inadequate response to conventional therapy and fistulizing disease. This approval made REMICADE the first TNF-alpha inhibitor available in the U.S.



* In August 1999, REMICADE became the first TNF-alpha inhibitor approved in the European Union (EU) for the short-term treatment of severe, active Crohn's disease and fistulizing, active Crohn's disease in patients who have not responded to conventional therapy.



* In December 2001, REMICADE became the first TNF-alpha inhibitor approved in Japan for the treatment of moderate-to-severe Crohn's disease.



* In February 2002, REMICADE became the first TNF-alpha inhibitor indicated in the U.S. to improve physical function in patients with moderate to severe RA who have had an inadequate response to methotrexate.



* In June 2002, REMICADE became the first TNF-alpha inhibitor approved by the FDA for maintenance therapy in patients with moderate to severe Crohn's disease. And in April 2003, it became the first TNF-alpha inhibitor approved for maintenance therapy of fistulising Crohn's disease.



* In May 2003, REMICADE became the first TNF-alpha inhibitor approved in the EU for the treatment of ankylosing spondylitis in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.



* In October 2004, REMICADE became the first TNF-alpha inhibitor approved for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease modifying anti-rheumatic drug therapy.



* In September 2005, the FDA approved REMICADE as the first and only biologic for reducing signs and symptoms, achieving clinical remission and mucosal healing and eliminating corticosteroid use in adults with moderately to severely active UC who have had an inadequate response to conventional therapy. The FDA extended the indication to include maintenance therapy for UC in October 2006.



* In March 2006, REMICADE became the first biologic therapy approved to treat moderately to severely active UC in the European Union (EU), in patients with an inadequate response to conventional therapy, including corticosteroids and 6-MP or AZA, or those intolerant to or contraindicated for such therapies.



* In May 2006, REMICADE became the first and only biologic indicated to reduce signs and symptoms and induce and maintain clinical remission in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.



About REMICADE



REMICADE is a monoclonal antibody that specifically targets TNF-alpha, which has been shown to play a role in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS) psoriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn's disease (PCD) and psoriasis (PsO). REMICADE is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and the only agent approved globally in the 3 regions of North America, the EU and Japan for the treatment of both RA and CD. Additionally, REMICADE is the only anti-TNF approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology. The safety and efficacy of REMICADE have been well established in clinical trials over the past 15 years and through commercial experience with more than one million patients treated worldwide.



In the U.S., REMICADE, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active RA. REMICADE is the only biologic indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients with moderately to severely active CD who have had an inadequate response to conventional therapy. REMICADE is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD. In December 2004, REMICADE was approved for reducing signs and symptoms in patients with active AS. In May 2005, REMICADE was approved for reducing signs and symptoms of active arthritis in patients with PsA. Additionally, in September 2005, REMICADE was approved for reducing signs and symptoms, achieving clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy. This approval makes REMICADE the first and only biologic approved for the treatment of moderate to severe UC. In May 2006, REMICADE was approved for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. This approval establishes REMICADE as the first and only biologic therapy approved for the treatment of PCD. In August 2006, REMICADE was approved for inhibiting progression of structural damage and improving physical function in patients with psoriatic arthritis. In September 2006, REMICADE was approved for the treatment of adults with chronic, severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. In October 2006, REMICADE was approved for maintaining clinical remission and mucosal healing in patients with moderately to severely active UC, who have had an inadequate response to conventional therapy.



In the EU, REMICADE is indicated for the treatment of severe, active CD in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. REMICADE also is indicated for the treatment of fistulizing, active CD in patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).



For RA patients in the EU, REMICADE, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in patients with active disease when the response to disease-modifying drugs, including methotrexate, has been inadequate, and in patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated. In carefully selected patients with RA who have tolerated three initial two-hour infusions of REMICADE, consideration may be given to administering subsequent infusions over a period of not less than one hour.



In the EU, REMICADE is also 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 is also approved for the treatment of active and progressive PsA in adults when the response to previous disease modifying anti-rheumatic drug therapy has been inadequate. REMICADE should be administered in combination with methotrexate or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. REMICADE is also approved in the EU for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or have a contraindication to, or are intolerant of other systemic therapy including cyclosporine, methotrexate or PUVA (psoralen plus ultraviolet A light).



In February 2006, REMICADE was approved in the EU for the treatment of moderately to severely active UC in patients who have had an inadequate response to conventional therapy, including corticosteroids and 6-MP or azathioprine, or who are intolerant to or have medical contraindications for such therapies. This approval made REMICADE the first and only biologic therapy approved to treat moderate to severe UC in the EU. In May 2007, REMICADE was indicated for the treatment of severe, active Crohn's disease, in pediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. REMICADE has been studied only in combination with conventional immunosuppressive therapy



REMICADE is available in an IV form. REMICADE is actually a powder to be reconstituted as a solution for IV infusion. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. In RA (3 mg/kg), CD (5 mg/kg), PsA (5 mg/kg), UC (5 mg/kg), PCD (5 mg/kg), and PsO (5 mg/kg), REMICADE is a two-hour infusion administered every 8 weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6. As a result, REMICADE patients may require as few as six treatments each year. In AS (5 mg/kg), REMICADE is a two-hour infusion administered every 6 weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6.



Centocor discovered REMICADE and has exclusive marketing rights to the product in the United States.



Schering-Plough markets REMICADE in all countries outside of the United States, except in Japan, China and parts of the Far East. In China, Xian-Janssen markets REMICADE. In Japan and other parts of the Far East, Mitsubishi Tanabe Pharma Corporation markets the product.







Important Safety Information



There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia. 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 TB test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start REMICADE. REMICADE can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, flu or warm, red or painful skin while taking REMICADE, tell your doctor right away. Also, tell your doctor if you are scheduled to receive a vaccine or if you have lived in a region where histoplasmosis or coccidioidomycosis is common.



Reports of a type of blood cancer called lymphoma in patients on REMICADE or other TNF blockers are rare but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, or psoriatic arthritis for a long time, particularly those with highly active disease may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. Rarely, children and young adults who have been treated for Crohn's disease with REMICADE in combination with azathioprine or 6-mercaptopurine have developed a rare type of lymphoma, hepatosplenic T cell lymphoma (HSTL), that often results in death. If you take REMICADE or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should also tell your doctor if you have had or develop lymphoma or other cancers or if you have a lung disease called chronic obstructive pulmonary disease (COPD).



Many people with heart failure should not take REMICADE; 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, swelling of your ankles or feet, or sudden weight gain).



Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blockers, such as REMICADE. Some of these cases have been fatal. 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 feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.



There have been rare cases of serious liver injury in people taking REMICADE, some fatal. Tell your doctor if you have liver problems and contact your doctor immediately if you develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe fatigue.



Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding, or paleness while taking REMICADE. Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, visual disturbances or seizures while taking REMICADE.



Allergic reactions, some severe have been reported during or after infusions with REMICADE. Signs of an allergic reaction include hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills. Tell your doctor if you have experienced a severe allergic reaction. The most common side effects of REMICADE are: respiratory infections, such as sinus infections and sore throat, headache, rash, coughing, and stomach pain.



Please read important information about REMICADE, including full U.S. prescribing information and Medication Guide, at remicade/. For complete EU prescribing information, please visit emea.eu.int/.



About Centocor



Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.



The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.



CENTOCOR 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 Centocor 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 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at sec/, jnj/ or on request from Johnson & Johnson. Centocor does not undertake to update any forward-looking statements as a result of new information or future events or developments.



About Schering-Plough



Schering-Plough is a global science-based healthcare company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site isschering-plough/.



SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the international market potential for REMICADE. 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 Schering-Plough's third quarter 2007 10-Q.



About Mitsubishi Tanabe Pharma Corporation



Mitsubishi Tanabe Pharma Corporation, one of the leading Japanese pharmaceutical companies, specializes in developing and marketing globally competitive pharmaceutical products in the fields of cardiovascular and metabolic diseases, brain and nerve diseases, and renal and urinary system diseases. The company, established through the merger of Tanabe Seiyaku Co., Ltd. and Mitsubishi Pharma Corporation in October 2007, drives for the expansion of its operations and the reinforcement of its future growth with the aim of becoming a global research-driven pharmaceutical company and taking on challenge of new business opportunities. Mitstubishi Tanabe Pharma Corporation is committed to protect the health of people around the world and contribute to comfortable lifestyles through creating pharmaceuticals. For more information, please visit the web site at mt-pharma.co.jp/.



Source:



Melissa Katz


Centocor, Inc.



Catherine Cantone

Schering Plough Corporation



View drug information on Remicade.

четверг, 30 июня 2011 г.

Lead Poisoning Associated with Ayurvedic Medications in Five US States

Although approximately 95% of lead poisoning among U.S. adults results from occupational exposure (1), lead poisoning also can occur from use of traditional or folk remedies (2--5). Ayurveda is a traditional form of medicine practiced in India and other South Asian countries. Ayurvedic medications can contain herbs, minerals, metals, or animal products and are made in standardized and nonstandardized formulations (2). During 2000--2003, a total of 12 cases of lead poisoning among adults in five states associated with ayurvedic medications or remedies were reported to CDC (Table). This report summarizes these 12 cases. Culturally appropriate educational efforts are needed to inform persons in populations using traditional or folk medications of the potential health risks posed by these remedies.


The first three cases described in this report were reported to CDC by staff at Dartmouth Hitchcock Medical Center at Dartmouth Medical School, New Hampshire; the California Childhood Lead Poisoning Prevention Program; and the California Department of Health Services. To ascertain whether other lead poisoning cases associated with ayurvedic medicines had occurred, an alert was posted on the Epidemic Information Exchange (Epi-X), and findings from the cases in California were posted on the Adult Blood Lead Epidemiology and Surveillance (ABLES) listserv. Nine additional cases were reported by state health departments in Massachusetts, New York, and Texas (Table).


Case Reports


New Hampshire. A woman aged 37 years with rheumatoid arthritis visited an emergency department (ED) with diffuse abdominal pain, nausea, and vomiting of 6 days' duration. Tests revealed microcytic anemia, moderate basophilic stippling, and no identifiable source of blood loss. Her blood lead level (BLL) was 81 µg/dL (geometric mean BLL = 1.75 µg/dL for U.S. population aged >20 years [6]), and her zinc protoporphyrin (ZPP) concentration was 286 µg/dL (normal:







California. A woman aged 31 years visited an ED with nausea, vomiting, and lower abdominal pain 2 weeks after a spontaneous abortion. One week later, she was hospitalized for severe, persistent microcytic anemia with prominent basophilic stippling that was not improving with iron supplementation. A heavy metals screen revealed a BLL of 112 µg/dL; a repeat BLL 10 days later was 71 µg/dL, before initiation of oral chelation therapy.

A ZPP measurement performed at that time was >400 µg/dL. Her husband's BLL was 6 µg/dL. No residential or occupational lead sources were identified, but the woman reported taking nine different ayurvedic medications prescribed by a practitioner in India for fertility during a 2-month period, including one pill four times daily.

She discontinued the medications after an abnormal fetal ultrasound 1 month before her initial BLL. Analysis of her medications revealed 73,900 ppm lead in the pill taken four times daily and 21, 65, and 285 ppm lead in three other remedies. Her BLL was 22 µg/dL when she was tested 9.5 months after the initial BLL testing.


A man aged 34 years was evaluated twice in an ED for back pain and abdominal pain. A screen for heavy metals revealed a BLL of 80 µg/dL. He was hospitalized for chelation therapy and disclosed that he had been taking ayurvedic medications prescribed by a practitioner in India to increase fertility. He had discontinued use the previous day.

The 10 preparations included pills, powders, and syrups, most of which were not labeled. He had taken one type of tablet once daily for 3 months; samples of one of these tablets contained 78,000 ppm lead. A second variety of pill contained 36 ppm lead. A home investigation revealed no other sources of lead. His BLL was 17 µg/dL when tested 7.5 months after the initial BLL test.


Massachusetts, New York, and Texas. Nine additional cases were reported from Massachusetts, New York, and Texas (Table). The median age of patients was 52 years; five patients were female. The five women were taking the medications for arthritis (one), menstrual health (one), and diabetes (three). The four men were taking the medications for arthritis (one) and diabetes (three).


Reported by: J Araujo, MD, AP Beelen, MD, LD Lewis, MD, Dartmouth Hitchcock Medical Center, Dartmouth Medical School, Lebanon; GG Robinson, MS, New Hampshire Public Health Laboratories; C DeLaurier, New Hampshire Dept of Health and Human Svcs. M Carbajal, B Ericsson, California Childhood Lead Poisoning Prevention Program; Y Chin, MD, K Hipkins, MPH, California Dept of Health Svcs. SN Kales, MD, RB Saper, MD, Harvard Medical School; R Nordness, MD, Harvard School of Public Health, Boston; R Rabin, MSPH, Massachusetts Dept of Labor and Workforce Development. N Jeffery, MPH, J Cone, MD, C Ramaswamy, MBBS, P Curry-Johnson, EdD, New York City Dept of Health and Mental Hygiene, New York; KH Gelberg, PhD, New York State Dept of Health. D Salzman, MPH, Texas Dept of Health. J Paquin, PhD, Environmental Protection Agency. DM Homa, PhD, Div of Emergency and Environmental Health Svcs, National Center for Environmental Health; RJ Roscoe, MS, Div of Surveillance, Hazard Evaluations, and Field Studies, National Institute for Occupational Safety and Health, CDC.


Editorial Note:


Although the majority of cases of lead poisoning in adults result from occupational exposures, use of traditional or folk medications also can cause lead poisoning. In the United States, lead exposure in adults has decreased substantially during the preceding two decades because of removal of lead from gasoline and regulation of lead exposure in the workplace. Nevertheless, 10,658 cases of BLLs >25 µg/dL in adults (aged >16 years) were reported from the 35 states that provided data to the ABLES program in 2002 (1).


Certain traditional or folk medications used in East Indian, Indian, Middle Eastern, West Asian, and Hispanic cultures contain lead and other adulterants (3). In this report, the majority of persons affected were of Asian Indian or other East Indian descent. Several ayurvedic and other traditional medications do not contain lead; however, lead content has ranged from 0.4 to 261,200 ppm in certain common ayurvedic preparations (8). Certain branches of ayurvedic medicine consider heavy metals to be therapeutic and encourage their use in the treatment of certain ailments.


Symptoms of lead toxicity in adults often vary and are nonspecific; these include abdominal pain, fatigue, decreased libido, headache, irritability, arthralgias, myalgias, and neurologic dysfunction ranging from subtle neurocognitive deficits to a predominantly motor peripheral neuropathy to encephalopathy (9). The number and severity of symptoms typically increase as BLLs increase; however, the toxic effects of lead can occur without overt symptoms. In assessing patients with nonspecific, multisystemic symptoms, medical and public health professionals should consider lead toxicity in the differential diagnosis and request BLL testing. The finding of a high BLL without an obvious occupational or environmental source should elicit inquiries about traditional or folk medications as a potential source of exposure. Primary management of lead toxicity is source identification and exposure cessation. In adults, chelation therapy usually is reserved for patients with substantial symptoms or signs of lead toxicity or BLLs of >80 µg/dL (9).


Culturally appropriate educational efforts are needed to inform persons of the potential health risks posed by these remedies, particularly in populations in which traditional or folk medication use is prevalent. For remedies known to contain lead or to be possibly adulterated with lead, educational materials should state the potential health effects. Young children and fetuses of pregnant women are at added risk for the toxic effects of lead, particularly because of the use of these products to treat infertility in women (10).


Identification of the additional nine cases underscores the value of electronic health communications systems, such as listservs and Epi-X. These systems disseminate information quickly for geographically dispersed events that could be missed by routine surveillance systems.


Continues…………..

среда, 29 июня 2011 г.

Lupin Announces Approval Of Meloxicam Tablets

Lupin Pharmaceuticals, Inc.
announced today that the U.S. Food and Drug Administration (FDA) has
granted final approval for its Abbreviated New Drug Application (ANDA) for
Meloxicam Tablets, 7.5 mg and 15 mg. The Company intends to initiate
shipments immediately.


Lupin's Meloxicam Tablets are the AB-rated generic equivalent of
Boehringer Ingelheim's MOBIC(R) Tablets. Meloxicam is a member of the
enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). It is
indicated for the relief of the signs and symptoms of osteoarthritis and
rheumatoid arthritis. U.S. sales for MOBIC(R) Tablets were approximately
$1.1 billion for the 12-month period ending December 2005 according to IMS
Health.


Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals,
Inc., stated, "We are extremely pleased to launch Meloxicam Tablets. The
approval of our Meloxicam ANDA further reinforces Lupin's ability on
submitting high-quality dossiers and gaining approval in time."


This is Lupin's 14th ANDA approval by the US FDA to date and the fourth
in its fiscal year.


About Lupin


Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company
with a strong research focus. It has a program for developing New Chemical
Entities. The Company has a state-of-the-art R&D center in Pune. The
Company is a leading global player in Anti-TB, Cephalosporins
(anti-infectives) and Cardiovascular drugs (prils and statins) and has a
notable presence in the areas of diabetology, NSAIDs and Asthma.


For the financial year ended March 2006, the Company's Revenues and
Profit after Tax were Rs.16,610 million (US$ 375 million) and Rs.1,827
million (US$ 41 million), respectively. Please visit
lupinworld for more information about Lupin Ltd.


Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of
Lupin Limited, which is among the top six Pharmaceutical companies in
India. Through its sales and marketing headquarters in Baltimore, Maryland,
Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality,
affordable generic medicines trusted by healthcare professionals and
patients across geographies. For more information, visit
lupinpharmaceuticals.


Safe Harbor Statement under the U.S. Private Securities Litigation
Reform Act of 1995:


This release contains forward-looking statements that involve known and
unknown risks, uncertainties and other factors that may cause actual
results to be materially different from any future results, performance or
achievements expressed or implied by such statements. Many of these risks,
uncertainties and other factors include failure of clinical trials, delays
in development, registration and product approvals, changes in the
competitive environment, increased government control over pricing,
fluctuations in the capital and foreign exchange markets and the ability to
maintain patent and other intellectual property protection. The information
presented in this release represents management's expectations and
intentions as of this date. Lupin expressly disavows any obligation to
update the information presented in this release.


Lupin Pharmaceuticals, Inc.

lupinpharmaceuticals