Mylan Inc. and Pfizer Inc. have announced that Meridian Medical Technologies, a Pfizer subsidiary, has entered into a settlement agreement with Intelliject and Sanofi-Aventis that will resolve pending patent litigation related to Intelliject's 505(b)(2) new drug application (NDA) for its epinephrine auto-injector known as e-cue, which will be manufactured and marketed by Sanofi-Aventis. According to the terms of the settlement, Intelliject and Sanofi-Aventis may launch e-cue no earlier than Nov. 15, 2012, subject to receipt of final approval from the U.S. Food and Drug Administration.
Meridian manufactures EpiPen Auto-Injector and Mylan Specialty markets and distributes the product in the United States.
Mylan CEO Heather Bresch comments, "We are pleased with this settlement, and are confident that the EpiPen Auto-Injector will continue to be a market leader, given the proud, 20-year heritage of this important treatment for anaphylaxis. Anaphylaxis poses a life-threatening risk for many, and yet there continues to be low awareness of the signs, symptoms or steps that can be taken to be prepared to respond when anaphylaxis occurs—including ensuring immediate access to epinephrine auto-injectors. That is why we believe that, in addition to our significant efforts in this area, people with life-threatening allergic reactions will benefit from more voices in the fight to raise anaphylaxis awareness, preparedness and access to treatment."
Additional terms of the agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.
Source: Mylan Inc.