Par Pharmaceutical Companies, Inc. Launches ProductBOTHELL, WA, Jun 09, 2009 (MARKETWIRE via COMTEX) -- 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(R) nasal
spray, marketed by Novartis Pharmaceuticals Corporation. U.S. sales of
Miacalcin(R) 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
"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
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.
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.
Matthew D. Haines
Senior Director, Investor Relations and Corporate Communications
(312) 944-6784 x 316 or
SOURCE: MDRNA, Inc.