Contact Information: Contacts: Matthew D. Haines Senior Director, Investor Relations and Corporate Communications (212) 209-3874 McKinney|Chicago (Media) Alan Zachary (312) 944-6784 x 316 or (708) 707-6834
MDRNA, Inc. Receives Full FDA Approval of Generic Calcitonin-Salmon Nasal Spray for Osteoporosis
Par Pharmaceutical Companies, Inc. Launches Product
| Source: MDRNA, Inc.
BOTHELL, WA--(Marketwire - June 9, 2009) - 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 Miacalcin® nasal spray,
marketed by Novartis Pharmaceuticals Corporation. U.S. sales of
Miacalcin® 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. Additional
information about MDRNA, Inc. is available at http://www.mdrnainc.com.
Forward-Looking Statements
Statements made in this news release may be forward-looking statements
within the meaning of Federal Securities laws that are subject to certain
risks and uncertainties and involve factors that may cause actual results
to differ materially from those projected or suggested. Factors that could
cause actual results to differ materially from those in forward-looking
statements include, but are not limited to: (i) the ability of MDRNA to
obtain additional funding; (ii) the ability of MDRNA to attract and/or
maintain manufacturing, research, development and commercialization
partners; (iii) the ability of MDRNA and/or a partner to successfully
complete product research and development, including preclinical and
clinical studies and commercialization; (iv) the ability of MDRNA and/or a
partner to obtain required governmental approvals; and (v) the ability of
MDRNA and/or a partner to develop and commercialize products that can
compete favorably with those of competitors. Additional factors that could
cause actual results to differ materially from those projected or suggested
in any forward-looking statements are contained in MDRNA's most recent
periodic reports on Form 10-K and Form 10-Q that are filed with the
Securities and Exchange Commission. MDRNA assumes no obligation to update
and supplement forward-looking statements because of subsequent events.