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Medac Pharma, Inc. Secures FDA Approval of Trade Name Rasuvo(TM) for Lead Methotrexate Subcutaneous Injectable Product

April 15, 2014

Potential U.S. Commercialization in 2014

CHICAGO, April 15, 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 the U.S. Food and Drug Administration (FDA) has granted approval for the name Rasuvo(TM) for the company’s lead compound, MPI-2505, a subcutaneous injectable methotrexate (MTX) delivered in a ready-to-use autopen.

Currently under FDA review, Rasuvo is being developed for multiple indications, including rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis, and 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.

“Securing name approval for our lead compound is another important milestone as we prepare for a potential U.S. launch of Rasuvo later this year,” said Ms. Terri Shoemaker, President and CEO of Medac Pharma, Inc. “With its planned 10 dosage strengths and ease of administration, Rasuvo is well-positioned to offer patients an optimal therapeutic option for managing rheumatoid arthritis and other related diseases as our product will offer the widest range of dosing options compared to other subcutaneous methotrexate therapies.”

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.


Source: PR Newswire



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