BMP Sunstone Corporation (NSDQ: BJGP) said its Clinical Trial Application for Enablex (Darifenacin) was accepted by the SFDA, allowing the company to begin clinical trials of the treatment for overactive bladder [OAB]. BMP will start human trials in the first half of 2009 and expects that approval will follow sometime in 2011.
BMP Sunstone, formerly known as Beijing Med-Pharm, is in the business of registering drugs and drug distribution. By acquiring Sunstone Pharmaceutical, which took place in 2007, BMP Sunstone gained its first drug-making facility and a line of OTC products.
Novartis (NYSE: NVS), which owns Enablex, signed an agreement with BMP Sunstone in November 2007, authorizing the company to seek marketing approval for the drug. If the drug is approved for use in China, BMP Sunstone will have ten years of marketing exclusivity for Enablex. Terms of the deal between Novartis and BMP Sunstone were not disclosed.
BMP Sunstone noted that global annual sales of OAB medications are estimated at $2.25 billion. In China, OAB afflicts an estimated 24-29% of the population over the age of 24, or over 200 million people. Currently, treatment rates of this population are very low: less than 15% of OAB sufferers in China seek treatment.
Novartis bought Enablex from Pfizer (NYSE: PFE) when the latter acquired Pharmacia in 2003. Approval was granted in the US and Europe in late 2004, and marketing of the drug began in 2005.