PHARMACY

Elan Corp. to have its day before a judge

BY Alaric DeArment

NEW YORK Elan Corp.’s lawsuit against Biogen Idec in Federal Court in New York will soon go before a judge.

According to published reports, presiding judge Deborah Batts ordered that the first hearing, originally announced in early August, will take place Thursday at 11 a.m. The hearing was originally scheduled to take place next week.

Elan filed the suit to obtain declaratory and injunctive relief that a deal it made with Johnson & Johnson – whereby J&J would buy 18% of Elan and Elan’s rights to the multiple sclerosis drug Tysabri (natalizumab) – complied with its development and marketing agreement with Biogen Idec. In July, Biogen Idec alleged in a letter to Elan that Elan breached the agreement between the two companies by giving J&J the option of providing financing for Elan to buy Biogen Idec’s rights to Tysabri if Biogen Idec ever undergoes a change of control.

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Bayer Schering Pharma completes patient enrollment for ROCKET AF study

BY Alaric DeArment

BARCELONA, Spain Bayer Schering Pharma has finished enrolling patients into its late-stage clinical trial of a drug for preventing complications of atrial fibrillation, the German drug maker announced Sunday.

Bayer said the 14,269-patient phase 3 study, called ROCKET AF, would compare the safety and efficacy of Xarelto (rivaroxaban) in 20 mg doses to warfarin as a way to prevent stroke and non-centrial nervous system systemic embolism in patients with AF.

“We are encouraged by the excellent progress of the ROCKET AF study in atrial fibrillation and look forward to the study results in 2010,” Bayer HealthCare chief medical officer Kemal Malik said in a statement.

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Researchers link Type 1 diabetes to immune response to wheat

BY Allison Cerra

NEW YORK Scientists at the Ottawa Hospital Research Institute and the University of Ottawa have discovered what may be an important clue to the cause of Type 1 diabetes: immunity to wheat proteins.

Early in life, the immune system is supposed to learn to attack such foreign invaders as viruses and bacteria, while leaving the body’s own tissues and harmless molecules in the environment alone (including food in the gut). When this process goes awry, autoimmune diseases and allergies can develop. The new research concluded that immune cells (known as T cells) from people with Type 1 diabetes are also more likely to over-react to wheat.

“The immune system has to find the perfect balance to defend the body against foreign invaders without hurting itself or over-reacting to the environment and this can be particularly challenging in the gut, where there is an abundance of food and bacteria,” said Fraser Scott, a senior scientist at the Ottawa Hospital Research Institute and Professor of Medicine at the University of Ottawa. “Our research suggests that people with certain genes may be more likely to develop an over-reaction to wheat and possibly other foods in the gut and this may tip the balance with the immune system and make the body more likely to develop other immune problems, such as Type 1 diabetes.”

Scott’s previous research has shown that a wheat-free diet can reduce the risk of developing diabetes in animal models, but he notes that more research will be required to confirm the link and determine possible effects of diet changes in humans. Research is also needed to investigate links with celiac disease, another autoimmune disease that has been linked to wheat.

In a commentary accompanying the paper, diabetes expert Dr. Mikael Knip of Finland said “These observations add to the accumulating concept that the gut is an active player in the diabetes disease process.”

This research was funded by the Juvenile Diabetes Research Foundation and the Canadian Institutes of Health Research. The authors include Dr. Majid Mojibian, Dr. Habiba Chakir, Dr. David E. Lefebvre, Jennifer A. Crookshank, Brigitte Sonier and Dr. Erin Keely, as well as Dr. Scott. Patients were enrolled at The Ottawa Hospital and the Children’s Hospital of Eastern Ontario.

The 42-patient study, published in the August 2009 issue of the journal Diabetes.

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