PITTSBURGH and NEW YORK, Feb. 16, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) and Pfizer Inc. (NYSE: PFE) today 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 Chief Executive Officer Heather Bresch commented, "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.About EpiPen Auto-Injector EpiPen® (epinephrine) 0.3mg and EpiPen Jr® (epinephrine) 0.15 mg Auto-Injectors are for the emergency treatment of severe allergic reactions (anaphylaxis). As with any medication, EpiPen Auto-Injector has an expiration date printed directly on the side of the auto-injector and end side of the carton and should be replaced when the unit expires. The product should be stored at room temperature, protected from light and never refrigerated or kept where it might be exposed to extreme temperatures, such as in the glove compartment of a car. IndicationsEpiPen® and EpiPen Jr® (0.3 and 0.15 mg epinephrine) Auto-Injectors are for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions. EpiPen and EpiPen Jr are intended for immediate self-administration as emergency supportive therapy only. Seek immediate emergency medical treatment after use. Important Safety InformationEpiPen ® Auto-Injectors contain a single dose of epinephrine, which you inject into your outer thigh. DO NOT INJECT INTRAVENOUSLY. DO NOT INJECT INTO YOUR BUTTOCK, as this may not be effective. In case of accidental injection, please seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms. If you take certain medicines, you may develop serious life-threatening side effects from the epinephrine in EpiPen Auto-Injectors. Be sure to tell your doctor all the medicines you take, especially medicines for asthma. Side effects may be increased in patients with certain medical conditions, or who take certain medicines. These include asthma, allergies, depression, thyroid disease, Parkinson's disease, diabetes, high blood pressure and heart disease. The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness or anxiety. These side effects usually go away quickly, especially if you rest. Please click here to view the EpiPen prescribing information. Please click here for the EpiPen patient insert. You are encouraged to report negative side effects of prescription drugs to the FDA.
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