MDRNA gets FDA nod for generic osteoporosis nasal spray

Shares of MDRNA Inc more than doubled after the company said U.S. health regulators approved its generic nasal spray to treat osteoporosis, adding that its partner Par Pharmaceutical Cos Inc had launched the product.

The calcitonin-salmon nasal spray is the copycat version of Miacalcin nasal spray that is marketed by Novartis (NOVN.VX) in the United States.

The nasal spray is indicated for the treatment of osteoporosis in females who have low bone mass, after five years or more of menopause, relative to healthy premenopausal females, Par Pharma said in a statement.

U.S. sales of Miacalcin were about $112 million in 2008, the company said, citing IMS Health data.

In March, Par agreed to buy MDRNA's abbreviated new drug application for the generic nasal spray and its cGMP manufacturing facility in Hauppauge, New York, for an upfront cash payment and profit sharing on sales of the drug for five years.

"Any revenue generated from that product will go into our RNA interference research programmes," MDRNA's spokesman Matthew Haines said.

However, Haines declined to give more details about the nuances of the profit-sharing agreement.

RNAi or gene silencing as a way to fight disease, is one of the hottest areas of biotechnology research and has attracted investment from a range of major drugmakers.

MDRNA currently has a liver cancer programme in preclinical stage development.

MDRNA shares touched a high of $3.55 before paring some gains to trade up about 90 percent at $2.94 Tuesday morning on Nasdaq. Shares of Par Pharma were up 1 percent at $14.70 on the New York Stock Exchange.

Source : www.reuters.com