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Medac Pharma, Inc. Announces Successful FDA Inspection Of Its Exclusive Methotrexate Manufacturer


5/15/2014 12:19:07 PM

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CHICAGO
, May 14, 2014 /PRNewswire/ -- Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, announced that ONCOTEC Pharma Produktion GmbH, a partially owned subsidiary of Medac Pharma's parent company, medac GmbH, has completed a successful FDA inspection. ONCOTEC will serve as Medac Pharma's exclusive methotrexate (MTX) manufacturer for its lead product currently under FDA review, Rasuvo. Concurrently, Medac Pharma announced the PDUFA date for Rasuvo is July 10, 2014.

"The successful inspection of ONCOTEC's facilities is yet another important inflection point as we look forward to a July 10 PDUFA date for Rasuvo," said Ms. Terri Shoemaker, President and CEO of Medac Pharma. "We believe our product has the potential to significantly enhance the therapeutic experience of patients with rheumatoid arthritis (RA), psoriasis and poly-articular-course juvenile RA. With potentially the widest range of dosing options available in an easy-to-inject autopen, we believe Rasuvo will become a preferred choice among healthcare providers and patients seeking a way to fully optimize methotrexate therapy."

Medac Pharma is preparing to launch Rasuvo with its fully integrated commercial organization, including its own sales force and managed markets team.

Dr. Jan-Arne Gewert, Managing Director of ONCOTEC, remarked, "We're pleased to expand our long-term relationship of 15 years with medac GmbH by serving as the exclusive supplier of methotrexate for its wholly-owned subsidiary, Medac Pharma, in the U.S. Given our company's extensive history of quality manufacturing, we're confident we'll meet the needs of Medac Pharma as it prepares to launch Rasuvo."

Currently under FDA review, Rasuvo is designed to improve bioavailability and overcome tolerability issues associated with today's oral MTX therapies. Medac Pharma plans to offer Rasuvo in 10 dosage strengths, ranging from 7.5 mg to 30 mg in 2.5 mg increments.

About Medac Pharma, Inc.

Medac Pharma, Inc. 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.

Medac Pharma, Inc. is focused on developing therapies with the potential to make meaningful differences in patients' lives. The company's approach is to improve existing agents by enhancing the mode of delivery, addressing safety profiles and inventing ways to maximize efficacy.

For more information, please visit www.medacpharma.com.

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

SOURCE Medac Pharma, Inc.



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