Par Pharmaceutical Companies, Inc. Launches Product
BOTHELL, WA -- (Marketwire) -- 06/09/09 -- MDRNA, Inc. (NASDAQ: MRNA) announced today that
it has obtained full U.S. Food and Drug Administration (FDA) approval of
its Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon
nasal spray for the treatment of osteoporosis and that Par Pharmaceutical
Companies, Inc. (NYSE: PAR) has launched the product.
Calcitonin-salmon nasal spray, a legacy product developed by MDRNA in the
early 2000s, is the generic equivalent of MiacalcinĀ® nasal spray,
marketed by Novartis Pharmaceuticals Corporation. U.S. sales of
MiacalcinĀ® were approximately $112 million in 2008, according to IMS
Health data.
On March 31, 2009, MDRNA and Par entered into an agreement under which Par
acquired the Company's Abbreviated New Drug Application (ANDA) for generic
calcitonin-salmon nasal spray and the Company's FDA-approved, cGMP
manufacturing facility in Hauppauge, New York, for an upfront cash payment
and profit sharing on commercial sales for five years.
"We are pleased that generic calcitonin-salmon nasal spray has received
full FDA approval and has been launched by Par," stated J. Michael French,
President and CEO of MDRNA. "Revenue generated from the sale of
calcitonin-salmon by Par will provide us with working capital to help
advance our RNAi programs. I thank the team at MDRNA and Par for their
superb efforts to bring this product to market."
For additional product information, please visit www.parpharm.com/products.
About MDRNA, Inc.
MDRNA is a biotechnology company focused on the development and
commercialization of therapeutic products based on RNA interference (RNAi).
Our goal is to improve human health by combining novel RNAi-based compounds
and proprietary peptide- and liposomal-based drug delivery technologies to
provide superior therapeutic options. Our multi-disciplinary portfolio of
capabilities includes molecular biology, cellular biology, formulation
expertise, peptide and alkylated amino acid chemistry, pharmacology,
toxicology and bioinformatics. We are applying this expertise to a single,
integrated drug discovery platform that will be the engine for our clinical
pipeline and a versatile platform for establishing broad therapeutic
partnerships. We are also building on new technologies, such as UsiRNAs
that incorporate the non-nucleotide moiety Unlocked Nucleobase Analog (UNA)
within the siRNA molecule, that we expect to lead to safer and more
effective RNAi-based therapeutics. By combining broad expertise in siRNA
science with proven delivery platforms and a strong and growing IP
position, MDRNA is well positioned as a leading RNAi therapeutics company
and value-added collaborator for our research partners.