Antares Pharma, Inc. (NASDAQ: ATRS) today announced LEO Pharma's launch of OTREXUP to Dermatologists, the first U.S. Food and Drug Administration (FDA) approved subcutaneous (SC) methotrexate (MTX) product for once weekly self-administration with an easy-to-use, single dose, disposable auto injector.
"We are very pleased that OTREXUP is now available for adult patients with severe recalcitrant psoriasis," said Paul K. Wotton, Ph.D., President and Chief Executive Officer. "Collaborating with LEO Pharma on the launch of OTREXUP gives Antares an opportunity to team up with a proven and successful commercial organization while LEO expands their portfolio with a new product in their field of expertise. With a dedicated sales force focused solely on the treatment of psoriasis and approximately 50,000 psoriasis patients enrolled in their QualityCare program, we believe LEO Pharma will be able to introduce and establish OTREXUP as an important new treatment option with significant growth potential in dermatology."
OTREXUP is indicated for use in adults who need symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy. OTREXUP is also indicated for adults with severe active rheumatoid arthritis who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy including full dose non-steroidal anti-inflammatory agents, or children with active polyarticular juvenile idiopathic arthritis. OTREXUP was approved by the FDA in October 2013.
"We are very excited to be working with Antares to bring OTREXUP to psoriasis patients in the US. The addition of the novel OTREXUP auto injector to the LEO Psoriasis Portfolio allows us to expand our offering in Dermatology and will help dermatologists and their patients manage a severe and debilitating condition," said John Koconis, President and Chief Executive Officer LEO Pharma Inc.
Psoriasis is a chronic autoimmune skin disease that most commonly appears as raised, red patches with a white build-up of dead skin cells. Psoriasis can affect skin on any part of the body and occurs when the immune system sends out faulty signals that speed the growth cycle of skin cells. Psoriasis is considered recalcitrant psoriasis when it does not respond to therapy, and can be disabling. Psoriasis is generally considered to be severe if it covers more than 5%-10% of body surface, recalcitrant when it does not adequately respond to treatment and disabling when it interferes with basic functions such as self-care, walking, sleep, etc.
"As many as 7.5 million patients have psoriasis in the United States and many of them have severe, disabling recalcitrant disease. Methotrexate can be an important treatment option to consider when treating these patients. The greater bioavailability of subcutaneous methotrexate may provide benefits for many of these patients who have had an inadequate response to oral methotrexate due to either tolerability or efficacy," said Robert E Kalb, M.D., Buffalo Medical Group, PC; Clinical Professor of Dermatology, State University of New York at Buffalo.