Contact Information: Contacts: MDRNA, Inc.: June Ameen, RN, MBA VP of Corporate Development (425) 908-3677 jameen@mdrnainc.com Mark Bales, Ph.D. IP Counsel (425) 908-3634 mbales@mdrnainc.com Westwicke Partners (Investors): John Woolford (443) 213-0506 john.woolford@westwicke.com McKinney|Chicago (Media): Alan Zachary (312) 944-6784 x 316 (708) 707-6834 azachary@mckinneychicago.com
MDRNA, Inc. Announces Allowance of European Patent Covering Formulations for Rapid Acting Insulin
Allowance Further Strengthens Intranasal IP Portfolio and Potential for Out-Licensing Assets
| Source: MDRNA, Inc.
BOTHELL, WA--(Marketwire - January 21, 2010) - MDRNA, Inc. (NASDAQ : MRNA ), a leading
RNAi-based drug discovery and development company, today announced that the
European Patent Office intends to grant a patent for application EP06826368
covering formulations for the intranasal delivery of rapid acting insulin,
and its use for the treatment of diabetes.
"While our focus remains the development of RNAi-based therapeutics, we
believe that the intranasal assets from our predecessor company, Nastech
Pharmaceuticals, have considerable value," said J. Michael French,
President and CEO of MDRNA. "Specifically, we believe that our insulin
intellectual property assets, with the positive results from the Phase II
clinical trial completed in 2008, have out-licensing potential."
The intranasal formulation would help people with diabetes, for whom
managing blood sugar levels within acceptable limits is a constant
challenge. Post-meal glucose levels frequently "spike" requiring immediate
insulin intervention. However, there is a risk that such interventions can
lead to excess insulin in the blood stream resulting in post-meal
hypoglycemia (or low blood sugar levels). Intranasal insulin taken after a
meal reduces hypoglycemia significantly faster than injectable insulin.
The proprietary intranasal insulin formulation covered by EP06826368
provides for a rapid-acting therapy using non-modified forms of insulin.
Phase II clinical studies have demonstrated that the intranasal insulin
formulation was superior to oral anti-diabetic medications and non-inferior
to injectable insulin for control of blood glucose immediately (60 and
90-minutes) after a meal. Intranasal insulin provided a significant
reduction in hypoglycemia at 4 hours after a meal, as compared to
injectable insulin. These attributes are expected to provide for improved
glycemic control. Importantly, the nasal administration did not result in
insulin entering the lungs, further improving the potential safety profile
of this product. The nasal delivery device used in the trials is compact
and easily stored for patient convenience.
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 oncology. 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 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.