Pfizer received approval for Lyrica capsules for the management of fibromyalgia, a chronic, widespread pain condition affecting more than six million Americans. Characterized by relentless chronic pain, fibromyalgia is usually accompanied by poor sleep, stiffness and fatigue, deep tenderness, soreness and flu-like aching.

Fibromyalgia is thought to result from neurological changes in how patients perceive pain, specifically a heightened sensitivity to stimuli that are not normally painful. Lyrica binds to a specific protein within overexcited nerve cells and works to calm damaged nerves. This is thought to reduce the level of pain in patients suffering from fibromyalgia, although the exact mechanism of how Lyrica acts in fibromyalgia is not known.

In the clinical trials, Lyrica demonstrated rapid and sustained improvements in pain compared with placebo. In addition, patients taking Lyrica reported feeling better and improvements in physical function.

Novartis received approval from the FDA for Exforge, a once-daily tablet combination of two high blood pressure medicines: Diovan, an angiotensin receptor blocker, and Norvasc, a calcium channel blocker.

The approval was supported by an extensive clinical program involving more than 5,000 patients. In two placebo-controlled trials, Exforge helped nine out of 10 patients reach their treatment goal of diastolic blood pressure under 90 mmHg, or more than a 10 mmHg reduction in diastolic blood pressure from baseline levels.

Exforge was approved in January 2007 in the EU and is currently available in nine EU countries, including Germany and the UK. Exforge is also available in Switzerland.

Akorn, Inc. and Cipla, Ltd., a pharmaceutical company located in Mumbai, India, have signed an exclusive development and supply agreement for an oral ANDA drug product for the prevention of organ transplant rejection.

Under the terms of the 10-year agreement, Cipla will be responsible for the development, manufacturing and supply of the drug product. Akorn will be responsible for the bioequivalency clinical trial, ANDA submission and marketing and distribution in the U.S. and PR. Cipla will receive milestone fees for the ANDA development and Akorn will own the ANDA. Akorn expects to launch the product in late 2009. Under the agreement, Akorn and Cipla will share revenues on a 60/40 basis.

Arthur S. Przybyl, Akorn's president and chief executive officer, stated, "This exclusive drug development and supply agreement reinforces our commitment to expanding our business relationship with Cipla." According to 2006 IMS data, the total market size for this drug is approximately $750 million for all indications.

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