2014

USPTO issues Inter Partes Reexamination Certificate of key LNA patent

HOERSHOLM, Denmark and SAN DIEGO, April 5, 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 issued an Inter Partes Reexamination Certificate for U.S. Pat. No. 6,770,748 (the '748 patent) on April 1, 2013.  The certificate, which follows a decision by the USPTO to dismiss an appeal that had been filed by Isis Pharmaceuticals during the proceeding, confirms the patentability of original claims 1-4, amended claim 5, and five new claims (claims 6-10) added by Santaris during the proceeding.

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The '748 patent is a continuation-in-part of U.S. Pat. No. 6,268,490 (the 'Imanishi Patent).  The 'Imanishi patent was previously subject to an ex parte reexamination request also brought by Isis, which ended with the USPTO issuing an Ex Parte Reexamination Certificate on December 6, 2011, confirming the patentability of all the original claims. The Imanishi and '748 patents claim rights to the Locked Nucleic Acid (LNA) or Bicyclic Nucleic Acid (BNA) chemical structure used for developing antisense molecules.

Commenting on the USPTO decision,  Henrik Stage, President & CEO of Santaris Pharma, said: "We are delighted that these lengthy procedures have been successfully concluded with USPTO confirming the patentability of our '748 and 'Imanishi patents. These are two of our fundamental patents, which provide broad protection for our state-of-the-art antisense drug platform based on the Locked Nucleic acid/Bicyclic Nucleic Acid chemistries."

Santaris is represented by Eric Steffe and John Covert of Sterne, Kessler, Goldstein & Fox, located in Washington, D.C.

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.

SOURCE Santaris Pharma A/S



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