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MDRNA, Inc. Announces Tentative FDA Approval of Generic Calcitonin-Salmon Nasal Spray for Osteoporosis
| Source: MDRNA, Inc.
BOTHELL, WA--(Marketwire - December 15, 2008) - 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®
marketed by Novartis Pharmaceuticals Corporation. U.S. sales of
Miacalcin® 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 following commercialization.
"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."
About Calcitonin
MDRNA's calcitonin-salmon nasal spray is a generic version of Miacalcin®,
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® 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 http://www.mdrnainc.com.
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 subsequent events.