Cadence Pharmaceuticals Inc. (CADX) is only a day away from knowing the fate of its investigational drug Acetavance (intravenous acetaminophen), a potential treatment of acute pain and fever in adults and children if the FDA sticks to its deadline. The regulatory agency is slated to make a decision on Acetavance on November 13.
The company acquired the exclusive rights to Acetavance in the United States and Canada in 2006 from Bristol-Myers Squibb Co. (BMY), which markets the product as Perfalgan in Europe and other parts of the world.
Acetavance is Cadence Pharma's proprietary intravenous formulation of acetaminophen. Acetaminophen is the most widely used medication for the treatment of pain and fever in the United States and is available in more than 600 combination and single-ingredient prescription and over-the-counter products.
Intravenous acetaminophen is approved in approximately 80 countries, including major markets in Europe, where the product is the market leader among all injectable analgesics. According to Cadence, about 90 million vials of intravenous acetaminophen were sold in Europe in 2008.
Cadence submitted its New Drug Application for Acetavance in May and was granted a priority review with the FDA action date set for November 13.
Cadence is optimistic that it will gain FDA approval for Acetavance and it has even hired its sales management team for the potential launch of the drug and is currently recruiting sales representatives contingent on FDA approval.
Some analysts are of the view that given the encouraging data submitted, Acetavance will gain regulatory approval. If approved, Acetavance would become the first new intravenous analgesic approved in the United States in more than 20 years and the only approved intravenous agent for the treatment of fever in the United States.
For the just reported third-quarter, Cadence net loss narrowed to $11.4 million or $0.23 per share from $13.7 million or $0.36 per share, for the same period in 2008. As of September 30, Cadence held cash, cash equivalents and short-term investments of $96.6 million.
CADX has thus far hit a 52-week low of $4.39 and 52-week high of $12.68. The stock closed Wednesday's trading at $9.40.
Being a one-trick pony with no other investigational drugs in its pipeline, Cadence has a lot riding on the FDA's decision. Will it pass muster with the FDA without any pain? Stay tuned...
For comments and feedback: editorial@rttnews.com