USPTO Grants Santaris' Request for Inter-Partes Reexamination of Patent licensed to Regulus

HOERSHOLM, Denmark and SAN DIEGO, Jan. 7, 2013 /PRNewswire/ -- Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that the USPTO has issued an Order granting their request for inter-partes re-examination of US patent 7,838,504 (the '504 patent), in the name of The Board of Trustees of the Leland Stanford Junior University, and licensed to Regulus Therapeutics Inc. 

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The Order indicates that Santaris's request "establishes a reasonable likelihood that Santaris will prevail" with respect to the claims under re-examination.  In conjunction with the Order, the USPTO also issued an Office Action rejecting the re-examined claims.

The '504 patent refers to a method of reducing viral genome amount in a cell infected with Hepatitis C with an antisense oligonucleotide complementary to miR-122, and at least one additional agent selected from the group consisting of an antiviral agent and an interferon.           

Henrik Stage, CEO of Santaris Pharma A/S stated:  "We are very pleased that the USPTO has ordered  inter-partes re-examination of the '504 patent. Appropriately reducing the scope of the patent in the U.S., is part of our worldwide strategy that currently includes opposition proceedings in Europe and Australia as well."    

About Locked Nucleic Acid (LNA) Drug Platform
The LNA Drug Platform and Drug Discovery Engine developed by Santaris Pharma A/S combines the company's proprietary LNA chemistry with its highly specialized and targeted drug development capabilities to rapidly deliver LNA-based drug candidates against RNA targets, both mRNA and microRNA, for a range of diseases including infectious and inflammatory diseases, cardiometabolic disorders, cancer and rare genetic disorders. LNA-based drugs are a promising new class of therapeutics that are enabling scientists to develop drug candidates that target previously inaccessible clinical pathways. The LNA Drug Platform overcomes the limitations of earlier antisense and siRNA technologies to deliver potent single-stranded LNA-based drug candidates across a multitude of disease states. The unique combination of small size and very high affinity allows this new class of drug candidates to potently and specifically inhibit RNA targets in many different tissues without the need for complex delivery vehicles. The most important features of LNA-based drugs include excellent specificity providing optimal targeting; increased affinity to targets providing improved potency; and favorable pharmacokinetic and tissue-penetrating properties that allow systemic delivery of these drugs without complex and potentially troublesome delivery vehicles.

About Santaris Pharma A/S
Santaris Pharma A/S is a privately held clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies. The LNA Drug Platform and Drug Discovery Engine developed by Santaris Pharma A/S combine the company's proprietary LNA chemistry with its highly specialized and targeted drug development capabilities to rapidly deliver potent single-stranded LNA-based drug candidates across a multitude of disease states. The company's research and development activities focus on infectious diseases and cardiometabolic disorders, while partnerships with major pharmaceutical companies include a range of therapeutic areas including cancer, cardiovascular disease, infectious and inflammatory diseases, and rare genetic disorders. The company has strategic partnerships with miRagen Therapeutics, Shire PLC, Pfizer, GlaxoSmithKline, and Enzon Pharmaceuticals. As part of its broad patent estate, the company holds exclusive worldwide rights to manufacture, have manufactured and sell products that contain LNA as an active ingredient for studies performed with a view to obtaining marketing approval. Santaris Pharma A/S, founded in 2003, is headquartered in Denmark with operations in the United States. Please visit www.santaris.com for more information.