Medarex To Receive Milestone Payment For The Approval Of Ilaris For The Treatment Of Cryopyrin-Associated Periodic Syndrome

Main Category: Pediatrics / Children's Health
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 02 Jul 2009 - 4:00 PST

email to a friend   printer friendly   view / write opinions   rate article

Medarex, Inc. (NASDAQ:MEDX) announced it will receive a milestone payment of an undisclosed amount from Novartis Pharma AG (Novartis), in connection with the marketing approval from the U.S. Food and Drug Administration (FDA), to market Ilaris® (canakinumab, previously known as ACZ885) for the treatment of children as young as four years old and adults with cryopyrin-associated periodic syndrome, or CAPS, a serious life-long auto-inflammatory disease caused by rare genetic mutations.

CAPS comprises three disorders of increasing severity: familial cold auto-inflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS) and neonatal-onset multisystem inflammatory disease (NOMID). A clinical study is ongoing to evaluate the potential of Ilaris® to treat patients with NOMID. In addition to ongoing studies in CAPS, clinical trials are also under way with Ilaris® in systemic juvenile idiopathic arthritis (SJIA), and more common disorders such as some forms of gout, chronic obstructive pulmonary disorder (COPD) and type 2 diabetes.

Ilaris® is a fully human monoclonal antibody generated using Medarex's UltiMAb® technology that rapidly and selectively blocks interleukin-1 beta (IL-1β). Regulatory applications have also been filed in Europe, Switzerland, Australia and other countries. Under the agreement with Novartis, Medarex will receive future sales-based royalty payments from the commercial sales of Ilaris®.

"Ilaris® represents the third antibody generated from our UltiMAb® technology to receive regulatory approval and reinforces the important role of our antibody technology platform in developing new treatment options for unmet medical needs," said Howard H. Pien, Chairman and CEO of Medarex. "The royalty stream generated from future product sales will provide valuable financial support to advancing our own maturing product pipeline toward commercialization."

Source
Medarex, Inc.