FDA Approves Antares Pharma's Otrexup for Arthritis and Psoriasis

Andrew Klips  |

Shares of self injection drug delivery technology company Antares Pharma, Inc. (ATRS) are trading higher on Monday after the U.S. Food and Drug Administration approved Otrexup, a once-per-week injectable of methotrexate in adults with severe active rheumatoid arthritis who have not responded to other drugs, children with active polyarticular juvenile idiopathic arthritis, and patients with psoriasis.  The company noted that Otrexup is the first approved drug of its type that comes in a single dose, disposable auto injector that patients can administer themselves.

About six million prescriptions were written from methotrexate, a long-approved drug commonly used to treat arthritis and psoriasis, in the United States in 2012.  It is generally prescribed in tablet form, but patients sometimes experience an inadequate response or intolerability issues with the pill.  Because of the ease of the delivery system, Antares believes Otrexup will provide a viable alternative that overcomes obstacles of administration that have kept a thumb on wide acceptance of injectable methrotrexate. The product launch is expected early in 2014.

Clinical data showed the Otrexup outperformed orally administered methotrexate at every dosing level.  According to Antares, oral methotrexate’s bioavailability plateaus at 15 milligrams.  The company will be presenting the findings from the latest clinical trial at the American College of Rheumatology Scientific Meeting this month.

“This approval represents a strategic milestone for Antares because we believe it validates our proprietary VIBEX® Medi-Jet™ technology which provides a significant advance in improving health outcomes with high tech but easy self-administration of SC medications. Antares has several other products in development, where this auto-injector technology could provide substantial benefits if the product candidates are approved,” said Dr. Paul Wotton, president and chief executive of Antares.

Otrexup is the latest in a growing line of approved products for Antares and its partners, which include Pfizer (PFE) , Teva Pharmaceuticals (TEVA) , Meda AB – who was brought into the mix when it bought six women’s health products from Jazz Pharma (JAZZ) – and Watson Pharmaceuticals.  Several deals have been struck with Teva for licensing Antares’ injection technologies, including marketing of TevTropin for delivery of a human growth hormone to children who have growth failure because of inadequate secretion of normal endogenous growth hormone.

The licensing deal with Pfizer is for an undisclosed over-the-counter product that has kept investors guessing for about two years as to what the product is and how much the deal is worth. Shares of ATRS surged to new 52-week highs following this morning’s news, printing as high as $5.15 before profit-taking set in, pulling the stock price down to the $4.70 area with about two hours left in the trading day.  Through Friday’s closing price of $4.53, share were up about 20 percent in 2013.

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