Biotech Values

[DewDiligence]

Novartis gets FDA approvable letter for Aclasta

[Aclasta is another brand name for the active ingredient in Zometa, NVS’ blockbuster oncology drug for bone mets (4Q05 annualized sales: $1.2B). The current approvable letter refers to Paget’s disease. Osteoporosis is the next planned indication, which is not surprising because the drug belongs to the bisphosphonate class that already contains several osteoporosis blockbusters.]

http://yahoo.reuters.com/stocks/QuoteCompanyNewsArticle.aspx?storyID=urn:newsml:reuters.com:20060227...


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Mon Feb 27, 2006 1:36 AM ET

ZURICH, Feb 27 (Reuters) - Swiss drug maker Novartis < NVS > has received an "approvable letter" from U.S. drug regulators for its Aclasta drug for use in the treatment of Paget's disease, a painful bone disorder, the firm said.

Aclasta, also known as zoledronic acid, received a previous approvable letter from the U.S. Food and Drug Administration in March 2005, delaying a possible U.S. market launch. Approvable letters mean that the FDA is ready to give the green light to a drug in theory but that it requires further information before doing so.

"In this case, the FDA has requested additional data from the ongoing clinical trial programme in osteoporosis," Novartis said.

The drug is already on sale in Germany, and other launches in Europe are planned in 2006, while Novartis also hopes to file for regulatory approval for the drug as a treatment for osteoporosis next year in the United States and Europe.
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