SOURCE: MDRNA, Inc.

MDRNA, Inc.

April 12, 2010 08:01 ET

MDRNA, Inc. Announces Patent Allowance Covering Intranasal Formulations for Y2-Receptor Agonists

Allowance Broadens Portfolio for the Treatment of Obesity and Related Diseases

BOTHELL, WA--(Marketwire - April 12, 2010) -  MDRNA, Inc. (NASDAQ: MRNA), a leading RNA interference (RNAi)-based drug discovery and development company, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application U.S. 12/234,547 covering formulations for the intranasal delivery of Y2 receptor selective agonists.

Y2-receptor agonists are a family of peptides (pancreatic polypeptide, peptide YY, and neuropeptide Y) that play a central role in caloric intake. The natural release of these peptides in association with meals directly influences how efficient and effective the body utilizes sugars, carbohydrates and other nutrients. Y2-receptor agonists can regulate food intake at the level of the brain, pancreas, and intestinal tract, and may provide treatment to prevent overeating and excessive weight gain, and the numerous adverse health effects associated with obesity.

"MDRNA's focus remains the development of therapeutic products based on RNAi, however we believe that our legacy nasal assets have significant value," said J. Michael French, President and CEO of MDRNA. "This patent allowance considerably broadens the scope of protection for our intranasal formulations used in the treatment of high profile diseases such as obesity and related diseases. Based on the breadth of the allowed claims and the success of our formulations to deliver a drug via a nasal spray, we believe our nasal delivery technology has excellent commercial potential."

While representing an attractive means of therapy, peptide-based drugs generally require injections, and in the case of obesity and related diseases, chronic administration. Intranasal sprays provide an easy and convenient means of therapy, and are appropriate for chronic use. To this end, intranasal formulations developed by MDRNA have demonstrated effective and safe delivery in clinical trials of numerous peptides, including Y2-receptor agonists. Furthermore, commercial scale procedures and processes for these formulations have been established and can be expected to allow for rapid development and commercialization.

A patent allowance confirms the substantive examination of a patent application and will result in a final issuance of a U.S. patent once an administrative process is completed.

About MDRNA's Technology

MDRNA has a broad intellectual property estate that encompasses four key RNAi technology platforms: siRNA constructs, chemistry, nucleic acid delivery, and gene targets. The MDRNA-owned siRNA constructs and chemistry include its proprietary UsiRNA construct, which is a duplex siRNA chemically modified with non-nucleotide acyclic monomers (UNAs), and is distinct from the standard siRNA construct used by others in the industry. UsiRNAs are fully recognized by the RNAi machinery and provide for potent RNAi activity while specific placement of UNAs in a duplex siRNA minimizes potential off-target effects by the guide strand and reduces undesired passenger strand activity. Furthermore, UsiRNAs escape the surveillance mechanisms associated with cytokine induction, and provide protection from nuclease degradation. 

The MDRNA delivery platforms include DiLA2 and nanoparticle forming peptides. DiLA2 is an MDRNA proprietary delivery platform of novel synthetic di-alklylated amino acid compounds used to make liposomal delivery formulations. The DiLA2 platform enables MDRNA to tailor the charge, linker and acyl chains of amino acids in order to configure liposomes for delivery to target tissues of interest. In addition, the platform is designed to permit attachment of various peptides and other targeting molecules to improve a variety of delivery characteristics. The MDRNA peptide nanoparticle platform includes exclusively in-licensed and developed IP surrounding the use of peptides for nanoparticle formulations that increase cellular uptake and endosomal release of siRNAs. MDRNA is currently biopanning its patented phage display library to identify additional peptides for targeted delivery, cellular uptake and endosomal release of siRNA. 

MDRNA owns or controls 16 issued or allowed patents, and has 36 pending patent applications, 126 pending foreign patent applications and 7 PCT applications.

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; (v) the ability of MDRNA and/or a partner to develop and commercialize products that can compete favorably with those of competitors; and (vi) the failure of the stockholders of MDRNA to approve the merger with Cequent, the failure of either party to meet any of the other conditions to closing the merger, contractual restrictions on the conduct of our business included in the merger agreement, and any impact on our relationships with third parties as a result of the announcement of the proposed merger. 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.

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