Tuesday, biotechnology company MDRNA, Inc. (MRNA) said it received full approval from the U.S. Food and Drug Administration, or FDA, for calcitonin-salmon nasal spray for the treatment of osteoporosis. MDRNA's stock surged more than 100% Tuesday morning.
With the FDA approval secured, Par Pharmaceutical Cos., Inc. (PAR) has launched the spray. On March 31, 2009, Par bought MDRNA's Abbreviated New Drug Application, or ANDA, for generic calcitonin-salmon nasal spray and its cGMP manufacturing facility in Hauppauge, New York. The deal included an upfront cash payment by Par and profit-sharing on commercial sales for five years.
On December 15, 2008, Bothell, Washington-based MDRNA said it received tentative approval from the FDA for the ANDA of calcitonin-salmon nasal spray. MDRNA, however, had to wait for Apotex Corporation's 180-day exclusivity period to be up.
MDRNA's generic calcitonin-salmon nasal spray is the generic equivalent of Miacalcin marketed by Novartis Pharmaceuticals Corporation. Currently, generic Miacalcin nasal spray is made by Apotex. MDRNA noted that according to IMS Health data, U.S. sales of Miacalcin were about $112 million in 2008.
Michael French, the president and chief executive officer of MDRNA stated, "Revenue generated from the sale of calcitonin-salmon by Par will provide us with working capital to help advance our RNAi programs."
MRNA is currently trading up $1.35 or 87.66% at $2.89, while PAR is up by 26 cents or 2.31% at $11.50.
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