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.