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Court Focuses Patent Suit on Santaris Pharma A/S's Safe Harbor Defense


9/24/2012 10:45:04 AM

HOERSHOLM, Denmark and SAN DIEGO, Sept. 24, 2012 /PRNewswire/ -- Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that the federal court in the Southern District of California granted Santaris significant relief in the patent infringement lawsuit brought by Isis.

(Logo: http://photos.prnewswire.com/prnh/20100111/SPLOGO )

The Court stayed all discovery in the case except for discovery specifically related to the Safe Harbor issue raised by Santaris's motion for summary judgment to dismiss the complaint. In that motion, Santaris showed that its accused activities -- which use cutting-edge LNA antisense technology -- all relate to drug design and development work that are protected by the statutory safe harbor.

The stay ordered by the Court came on the heels of its decision holding that it could not find, as a matter of law, that Santaris's accused activities were protected by the Safe Harbor based on the limited record that existed at the time Santaris brought its motion, but that Santaris could renew its motion following a 120-day period of limited discovery directed to the Safe Harbor issue.

Henrik Stage, CEO of Santaris stated: "We are pleased that the Court recognized that the Safe Harbor issue can dispose of the case in its entirety, and that the Court narrowed discovery to that issue alone. We are confident that when a more complete record is developed, the Court will recognize that all of Santaris's accused activities are protected by the statutory Safe Harbor."

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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