Most pharmaceutical companies fuel their growth by creating more product lines within their core strengths. Entering highly contested therapeutic areas is a risky endeavor, but one a large pharmaceutical company is capable of funding. Novartis (NVS) currently has only a moderate presence in Neurology, with modestly successful products including Exelon for Alzheimer’s and Stalevo for Parkinson’s.

Novartis is employing several strategies to enter the field of Multiple Sclerosis therapeutics. Strategies employed include in-house development, early to mid-stage partnering and development of bio-generics. Further details of current studies and future potential of these agents and others are further explored in reports available through neuropipeline.com.

Large price swings frequently occur when botech companies release data from a phase III study. If primary endpoints do not reach significance, NDA submission to the FDA is unlikely. Strong results with good safety data bring the drug one step closer to approval. Narrow hits and misses or safety concerns result in continued uncertainty until longer term data or a second phase III becomes available.

These can be binary events for smaller companies that have only one lead candidate, often resulting in price drops greater than 50% or increases greater than 200%. Larger companies, not dependent on one or two candidates, are unlikely to see price changes greater than 10-20 % after release. A lag period of 1 to 3 months is common between study completion and topline data release. More complete data is typically presented at conferences 3 to 6 months later.

Cypress Bioscience, Inc (CYPB) is a small company with a 287 million dollar market cap that will soon begin to receive royalties for its first FDA approved product. Savella (milnacipran) was approved on January 14, 2009 by the FDA for the management of FMS (Fibromyalgia Syndrome) and became available at pharmacies on April 28. This drug will be marketed by Forest Laboratories (FRX), a company that already has a large sales force marketing Namenda for Alzheimer’s and Lexapro for depression and generalized anxiety.

Fibromyalgia

The American Academy of Neurology (AAN) meeting will be held during the last week of April. Several pills are in later stages of development for the treatment of multiple sclerosis (MS) and good efficacy data has led to anticipation of FDA approval of one or more of these agents over the next few years. This report will detail findings on cladribine and FTY-720, the two oral drugs that are furthest along in development and analyze their strengths and weaknesses in an increasingly more crowded arena. The larger report here adds further details about 3 more oral drugs in development.

CLADRIBINE

Overview