MDRNA wins tentative approval for generic osteoporosis drug

MDRNA’s generic calcitonin-salmon nasal spray is the generic equivalent of Miacalcin marketed by Novartis Pharmaceuticals. Full FDA approval would follow the completion of Apotex’s 180-day exclusivity period, or June 2009, the company said.

In October 2004, MDRNA and Par Pharmaceutical Companies entered into an exclusive license and supply agreement for the US distribution and marketing of the product. Under the terms of the agreement, MDRNA is responsible for obtaining regulatory approval and manufacturing, and will receive product transfer payments for manufactured product and profit sharing following commercialization.

Michael French, president and CEO of MDRNA, said: Although we are now a company solely focused in the R&D of RNAi-based therapeutics, we are pleased to see the successful culmination of years of hard work on the part of many current and former members of the MDRNA/Nastech team.

I want to personally thank them all for their efforts in bringing this product forward. We are assessing our short- and long-term options to understand how this tentative approval can be leveraged toward the continued advancement of our RNAi drug discovery engine.