Wockhardt gets USFDA nod for Comtan; stock hits 52-wk high

Pharmaceutical and biotechnology major Wockhardt has received US FDA approval for marketing a generic version of 200mg tablets containing Entacapone, which is used in the treatment of Parkinson’s disease. Entacapone tablet is the generic name for the brand Comtan®, owned by Orion Corporation and marketed in the US by Novartis. Wockhardt will launch the product on September 30, 2012, according to the company's press release.

Incidence of Parkinson’s disease is increasing worldwide. According to IMS Health, the total market for this product in the US is about $98 million.

“Wockhardt was the first--‐to--‐file with paragraph--‐IV certification on this product,” said Dr. Habil Khorakiwala, Wockhardt Founder Chairman & Group CEO. “Pursuant to a settlement of the litigation between Wockhardt and Orion Corporation, Finland, the holder of the NDA, Wockhardt will launch an authorized generic version from Sept 30, 2012, with 180--‐days of exclusivity. The product involved development of a complex API as well as a challenging formulation. Generic Entacapone is the second authorized generic with 180--‐days exclusivity for Wockhardt, which will further accelerate growth of our US business,” he further added.

In the US generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. In many instances, Wockhardt, by virtue of being amongst the few players to market technically challenging products has reaped the advantage of being an early entrant.

The share touched a 52-week high of Rs 1,325. At 09:24 hrs the share was quoting at Rs 1,318.00, up Rs 19.35, or 1.49%.
 
It was trading with volumes of 28,596 shares. In the previous trading session, the share closed up 2.07% or Rs 26.35 at Rs 1,298.65.