BOTHELL, WA, Dec 15, 2008 (MARKET WIRE via COMTEX News Network) -- MDRNA, Inc. (NASDAQ: MRNA) announced today that the U.S. Food and
Drug Administration (FDA) has granted tentative approval of MDRNA's
Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon
nasal spray for the treatment of osteoporosis. Full FDA approval
would follow the completion of Apotex's 180-day exclusivity period,
or June 2009.
MDRNA's generic calcitonin-salmon nasal spray, a legacy product
developed by MDRNA in the early 2000s, is the generic equivalent of
Miacalcin(R) marketed by Novartis Pharmaceuticals Corporation. U.S.
sales of Miacalcin(R) were approximately $147 million in 2007.
On December 23, 2003, FDA accepted for filing MDRNA's 505(j)
paragraph 4 ANDA for the product. In October 2004, MDRNA and Par
Pharmaceutical Companies, Inc. entered into an exclusive license and
supply agreement for U.S. distribution and marketing of the product.
Under terms of the agreement, MDRNA is responsible for obtaining
regulatory approval and manufacturing, and will receive product
transfer payments for manufactured product and profit sharing
"We are pleased that our generic calcitonin-salmon nasal spray has
received tentative FDA approval and we look forward to full FDA
approval in mid 2009," stated J. Michael French, President and CEO of
MDRNA. "Although we are now a company solely focused in the research
and development of RNAi-based therapeutics, we are pleased to see the
successful culmination of years of hard work on the part of many
current and former members of the MDRNA/Nastech team. I want to
personally thank them all for their efforts in bringing this product
forward. We are assessing our short- and long-term options to
understand how this tentative approval can be leveraged toward the
continued advancement of our RNAi drug discovery engine."
MDRNA's calcitonin-salmon nasal spray is a generic version of
Miacalcin(R), an FDA approved calcitonin-salmon nasal spray marketed
by Novartis for the treatment of osteoporosis. Calcitonin is a
natural peptide hormone produced by the thyroid gland that acts
primarily on bone. Calcitonin-salmon appears to have actions
essentially identical to calcitonins of mammalian origin, but its
potency is greater due to a longer duration of action. Novartis'
Miacalcin(R) has been shown to increase spinal bone mass in
post-menopausal women with established osteoporosis.
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 through the development of
RNAi-based compounds and drug delivery technologies that together
provide superior therapeutic options for patients. Over the past
decade, we have developed substantial capabilities in molecular
biology, cellular biology, lipid chemistry, peptide chemistry,
pharmacology and bioinformatics, which we are applying to a wide
range of RNAi technologies and delivery approaches. These
capabilities plus the in-licensing of key RNAi-related intellectual
property have rapidly enabled us to become a leading RNAi-based
therapeutics company with a pre-clinical pipeline in key therapeutic
areas including oncology, metabolic disorders and inflammation.
Through our capabilities, expertise and know-how, we are
incorporating multiple RNAi technologies as well as peptide- and
lipid-based delivery approaches into a single integrated drug
discovery platform that will be the engine for our clinical pipeline
as well as a versatile platform for establishing broad therapeutic
partnerships with biotechnology and pharmaceutical companies. We are
also investing in new technologies that we expect to lead to safer
and more effective RNAi-based therapeutics while aggressively
building upon our broad and extensive intellectual property estate.
By combining broad expertise in siRNA science with proven delivery
platforms and a strong IP position, MDRNA is well positioned as a
leading RNAi-based drug discovery and development company. Additional
information about MDRNA, Inc. is available at
MDRNA Forward-Looking Statement
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 or a subsidiary to obtain
additional funding; (ii) the ability of MDRNA or a subsidiary to
attract and/or maintain manufacturing, research, development and
commercialization partners; (iii) the ability of MDRNA, a subsidiary
and/or a partner to successfully complete product research and
development, including preclinical and clinical studies and
commercialization; (iv) the ability of MDRNA, a subsidiary and/or a
partner to obtain required governmental approvals; and (v) the
ability of MDRNA, a subsidiary 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
Matthew D. Haines
Senior Director, Investor Relations and Corporate Communications
(312) 944-6784 x 316 or
SOURCE: MDRNA, Inc.