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Medac Pharma, Inc. Brings Motion to Preliminarily Prohibit Antares Sales of Otrexup to New Patients

U.S. Court of Appeals for the Federal Circuit Concurrently Affirms Denial of Antares Pharma’s Motion to Prohibit the Marketing of Rasuvo

Chicago, IL, November 24, 2014

Medac Pharma, Inc., a privately held pharmaceutical company, today announced that it has filed a motion for a preliminary injunction against Antares Pharma, Inc. to prohibit sales of the 15, 20 and 25 mg doses of Otrexup™ (methotrexate) injection to new patients. The motion was filed in the United States District Court for the District of New Jersey in a suit for infringement of the U.S. patent 8,664,231 (the ‘231 patent). The patent, titled, “Concentrated Methotrexate Solutions,” is directed to a method for the treatment of inflammatory autoimmune diseases by subcutaneously administrating methotrexate at a concentration of more than 30 mg/mL. Medac Pharma’s Rasuvo™ (methotrexate injection) is available to fill the treatment needs of any patient affected by the requested injunction.

Concurrently, the U.S. Court of Appeals for the Federal Circuit has denied Antares Pharma’s motion to cease the marketing of Rasuvo, which was launched in early October 2014 in the U.S.

Earlier this year, on March 11, 2014, Medac Pharma announced that it had filed a lawsuit in the United States District Court of New Jersey against Antares Pharma, Inc., LEO Pharma A/S and LEO Pharma Inc. for infringement of the ‘231 patent, which includes the making and sale of concentrated methotrexate products for treating rheumatoid arthritis, polyarticular idiopathic arthritis and psoriasis. The preliminary injunction seeks an order to prohibit Antares from manufacturing and selling those products to new patients.

Terri Shoemaker, President and CEO of Medac Pharma, Inc., stated, “We are delighted that, as a result of the Federal Circuit’s decision, we can continue providing Rasuvo to patients for these chronic inflammatory autoimmune diseases. Given the successful development of our internal sales force and commercial teams, as well as our consistent and reliable supply chain of methotrexate, we are well positioned to provide all patients in need of subcutaneous methotrexate with Rasuvo.”

About Medac Pharma: Practicing a patient-first philosophy

Medac Pharma, Inc. is a privately held specialty pharmaceutical company focused on the development, in-licensing and commercialization of late-stage molecules. The company strives to bring new life to products and solve everyday patient challenges in autoimmune disease and cancer.

Medac Pharma is the wholly-owned subsidiary of medac GmbH, a well known and respected global pharmaceutical company that has been making scientific and therapeutic discoveries for more than 40 years.

For complete prescribing information, including Boxed Warning, and information on Medac Pharma’s CORE Connections program, please visit

For Media:
Tiberend Strategic Advisors, Inc.
Andrew Mielach; (212) 375-2694