Pharma news in brief

FDA nod to review Silodosin NDA
Watson Pharma said USFDA accepted its application for a new drug to treat enlarged prostates.Watson said the Food and Drug Administration agreed to review its silodosin application, which was backed by data from two late-stage clinical trials.Silodosin is an α1-adrenoceptor antagonist with high uroselectivity. It appears to be more effective than tamsulosin in relieving urinary symptoms associated with benign prostatic hyperplasia (BPH).
The company expects regulators to review the application in the fourth quarter.
Edwards Lifesciences sues CoreValve for patent infringement
Edwards Life sciences Corp a maker of replacement heart valves, said it filed a patent infringement lawsuit against CoreValve Inc of Irvine, California, for infringement of three patents related to Tran catheter heart valve technology. The relevant U.S. patents, part of the Andersen patent portfolio, relate to a valve prosthesis for implantation by means of a catheter.The product named in the suit is the CoreValve ReValving System, the company said.
US FDA nod for APP Pharma's bleomycin sulfate injection
APP Pharmaceuticals, Inc., a leading manufacturer of multi-source and branded injectable pharmaceutical products, has received approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for bleomycin sulfate for injection, USP, the equivalent of Bristol-Myers Squibb's Blenoxane.APP's bleomycin sulfate is AP-rated, preservative and latex-free, and bar-coded at the individual unit-of-use. According to 2007 IMS data, sales of bleomycin sulfate exceeded $7.2 million.Bleomycin sulfate for injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: squamous cell carcinoma, lymphomas, testicular carcinoma and malignant pleural effusion.APP is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on oncology, anti-infective and critical care markets. The company is one of the largest producers of injectables, with more than 100 generic products in more than 400 dosage formulations.
Biocon awaits registration of Insugen
Biocon has filed for registration of Insugen, the recombinant human insulin, in 40 countries. The company has gone in for registration of its product with the EMEA which is expected to take around 18 months, after which it will market the product in Germany. Insugen is already marketed in Middle East, Pakistan, South East Asia and Far East. In Germany alone the insulin market is valued at Euro 950 million and by 2015 it is expected to be around Euro 4-5 billion.As part of its innovative global business initiatives, the company has chalked out a plan to enter into exclusive marketing agreements (EMA) in several countries to grab a major share in the global market with formulations developed from innovative molecules. It signed an exclusive agreement with Bayer HealthCare to market Insugen in the Chinese market, which heralds its entry into the international branded formulations arena. The company launched Insugen in November 2004. It is recognized as the world's first recombinant human insulin developed by using Pichia expression. The company has managed to grab a substantial share in the Indian market. Insugen has been an important contributor to our top and bottom line growth. "We are gaining market share not only in India, but in other parts of the world. Going forward we see this as an important product for the company," Shaw said. The insulin market in India is valued at Rs 300 crore and growing at 20 per cent annually. The three insulin MNC majors in the country, Novo Nordisk, Eli Lily and Aventis, have captured 75 per cent market share. The remaining 25 per cent rests with Biocon, Wockhardt, Shreya, Ranbaxy and Dr Reddy's.