Medac Pharma announces FDA acceptance of New Drug Application for MPI-2505

Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, announced the FDA acceptance of its New Drug Application (NDA) for its lead product candidate, MPI-2505, a subcutaneous injectable methotrexate (MTX) in a ready-to-use injection device, for which the proposed indications are rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis. Concurrently, medac GmbH, the parent company of Medac Pharma, Inc., announced the allowance of a U.S. patent application directed to a method for the treatment of inflammatory autoimmune diseases by subcutaneously administering MTX at a concentration of more than 30 mg/ml.

The subcutaneous mode of delivery of MPI-2505, with a wide range of dosing options, has been designed to improve bioavailability and overcome tolerability issues associated with today's oral MTX therapies.  Additionally, by providing patients with a ready-to-use autopen and concentrated formulations that allow for reduced drug volume, the MTX subcutaneous autopen addresses the stigmas associated with injectable medicines.

"The FDA's acceptance of Medac Pharma Inc.'s NDA marks a significant milestone not only for our company, but also patients seeking a more personalized method for managing their disease," said Terri Shoemaker, President and CEO of Medac Pharma, Inc.  "While methotrexate has proven itself as a highly effective medicine for treating several forms of arthritis, there remains a substantial need to make treatment for this patient demographic more manageable.  As a newly-founded company, we believe this inflection point, combined with our patent allowance for a broad dosing range of methotrexate, serve as stepping stones for our commitment to providing valuable resources for the immunology market."

"Securing the U.S. patent allowance is an additional step in medac GmbH's effort to be a global leader in the treatment of inflammatory autoimmune diseases with subcutaneous methotrexate," said Dr. Ulrich Kosciessa, Managing Director of medac GmbH.

Medac Pharma, Inc. expects to self commercialize its subcutaneous MTX autopen device in the U.S. later this year upon FDA approval.  As a wholly owned subsidiary of medac GmbH, a global pharmaceutical company that has been developing, manufacturing and marketing pharmaceuticals for more than 40 years in 70 countries, Medac Pharma, Inc. will receive a continuous supply of MTX for its product.

Rheumatologist Eric Ruderman, MD, Professor of Medicine, Northwestern University Feinberg School of Medicine, remarked, "As we work to manage our patients with a wide-range of immunological disorders, it is enormously helpful to have additional effective treatment options that can enhance their quality of life."

Among the multiple indications for which MPI-2505 is expected include RA, an incurable, progressive, inflammatory, autoimmune disease affecting the lining of joints resulting in pain, swelling, reduced mobility and requires lifelong treatment with potent drugs, with MTX remaining the first-in-line therapy.  Medac Pharma Inc.'s fully integrated infrastructure with experienced management team and significant resources make it well positioned to develop, in-license and commercialize personalized therapies in autoimmune and oncology therapeutics.