The Burrill Report


The National Institutes of Health has halted a study of Abbott Laboratories’ Niaspan 18 months earlier than planned because it found adding the extended release niacin to statin treatment in people with heart and vascular disease failed to reduce the risk of cardiovascular events including heart attack and stroke. The NIH said that during the study's 32 months of follow-up, participants who took high dose, extended-release niacin and statin treatment had increased HDL cholesterol and lowered triglyceride levels compared to participants who took a statin alone. However, the combination treatment did not reduce fatal or non-fatal heart attacks, strokes, hospitalizations for acute coronary syndrome, or revascularization procedures to improve blood flow in the arteries of the heart and brain. Based on an interim analysis of the data, there were a small number of ischemic strokes observed in the study, and more ischemic strokes were observed in the Niaspan plus simvastatin arm of the study. This contributed to the decision to stop the trial before its planned conclusion. Abbott added Niaspan to its pipeline through its $3.7 billion acquisition of Kos Pharmaceuticals in 2006.

A New York web designer is charging in a lawsuit that Abbott Laboratories drug Humira, which she used to treat her Crohn’s disease, caused permanent damage to her optic nerves, Bloomberg reports. Plaintiff Jamie Bixby says when she called the company’s telephone helpline because she was experiencing eye pain, the nurse who took the call told her the pain was not related to the drug. A month later a doctor found she suffered permanent damage to the myelin sheath of her optic nerves. In the complaint she said that had Abbott warned her or her gastroenterologist that Humira could be the source of her eye pain, she would have immediately discontinued taking the drug and sought emergency medical treatment. Humira was originally approved in 2003 as a treatment for rheumatoid arthritis. Indications for the drug have since expanded to include five additional autoimmune diseases, including Crohn’s. Humira had reported 2010 worldwide sales of $6.5 billion.

Genta said that a late-stage trial of its Genasense in combination with chemotherapy failed to significantly extend survival in patients with advanced melanoma compared to chemotherapy alone. In the trial, median survival was 13.5 months in the Genasense group versus 13.1 months in the chemotherapy-only group. The trial was a randomized, double-blind, placebo-controlled test of dacarbazine administered with or without Genasense in patients who had not previously received chemotherapy. As defined in a prior randomized trial, the study employed a biomarker to define patients who might maximally benefit from such treatment. "We are keenly disappointed in this result, which terminates our 10-year effort to achieve a clinically meaningful benefit for patients with melanoma," says Raymond Warrell, Jr., Genta's CEO. "In view of these results, we will review the company's pipeline portfolio and provide further guidance in the near future.

The European Union’s Committee for Medicinal Products for Human Use, in a preliminary vote, decided not to recommend approval of Pharmaxis’ application for its cystic fibrosis drug Bronchitol. The vote followed a presentation by the company to address outstanding issues over its marketing application. The preliminary vote was to see how members were inclined following the presentation. A formal vote is set for June 23. Pharmaxis said it believes it is unlikely that this position will change before the formal vote is undertaken next month and it is in the process of reviewing its alternatives with respect to the European Union marketing application.

Bayer HealthCare is shifting its production of the MS drug Betaseron out of Emeryville, California and eliminating 540 jobs in the process, the San Francisco Business Times reported. Production at the site is expected to be phased out during the next two years. Once it closes in 2013, the production facility will return to Novartis, which leased it to Bayer. Betaseron is already being produce in Europe for Bayer through a contract manufacturer.



May 27, 2011
http://www.burrillreport.com/article-nih_halts_trial_of_abbott%e2%80%99s_niaspan_early.html