BASKING RIDGE, N.J., Dec. 23, 2010
BASKING RIDGE, N.J., Dec. 23, 2010 /PRNewswire-FirstCall/ -- Dey Pharma, L.P. today announced that it has signed a license agreement with Meda, a leading international specialty pharma company headquartered in Sweden, for the exclusive marketing and distribution rights of EpiPen® (epinephrine) Auto-Injector in Europe. EpiPen Auto-Injector is used for emergency treatment of severe allergic reactions (anaphylaxis). Anaphylaxis can occur quickly, often within a couple of minutes, and may be life-threatening.
Dey Pharma President Carolyn Myers, Ph.D. commented: "It's been long known and understood that one of our primary objectives is to expand the growth and breadth of our EpiPen franchise. After a careful and thorough analysis, we are extremely pleased to partner with Meda, a company with a strong and proven expertise in the allergy category as well as an expansive pan-European marketing platform. This collaboration strategically positions us to grow the EpiPen franchise and expand access to this important product in Europe. Many Europeans are at risk for an allergic emergency, some of whom don't even know it. Along with expanded educational programs, we plan to continue to grow the EpiPen Auto-Injector franchise in Europe, including the upcoming launch of our next generation EpiPen product with Meda."
EpiPen is a well-established brand and is the global market leader in the epinephrine auto-injector market. Beginning in 2011, the distribution rights to EpiPen Auto-Injector for Europe will be transferred to Meda from current distributors.
"EpiPen strengthens our allergy franchise in Europe, and we look forward to working closely with Dey to ensure that this important product is accessible to those who are at-risk of an allergic emergency, which may be life threatening," said Anders Lonner, CEO Meda AB.
Meda's exclusive rights to the product also include the next generation EpiPen Auto-Injector, featuring more patient-friendly features. The next generation EpiPen Auto-Injector is currently available in many markets outside of Europe, including the U.S. Meda will be responsible for regulatory filings in Europe.
Dey Pharma L.P., a subsidiary of Mylan Inc. (Nasdaq: MYL), is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases, severe allergic reactions and psychiatric disorders. The company puts patients first and facilitates efficient, cost-effective partnerships with customers. For more information, please visit www.dey.com.
EpiPen and EpiPen Jr. (0.3 and 0.15 mg epinephrine) Auto-Injectors are for the emergency treatment of severe allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for patients who are at increased risk for these reactions.
EpiPen and EpiPen Jr. Auto-Injectors are designed for you to use immediately in an emergency, to treat an allergic reaction fast and give you time to get to a hospital or medical center. EpiPen and EpiPen Jr. Auto-Injectors are not a substitute for emergency medical treatment.
Important Safety Information
Each EpiPen Auto-Injector contains a single dose of a medicine called epinephrine, which you inject into your outer thigh. DO NOT INJECT INTRAVENOUSLY. DO NOT INJECT INTO YOUR BUTTOCK, as this may not be effective for a severe allergic reaction. 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.
Side effects may include an increase in heart rate, a 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. If you have high blood pressure or an overactive thyroid, these side effects may be more severe or longer lasting. If you have heart disease, you could experience chest pain (angina). If you have diabetes, your blood sugar levels may increase after use. If you have Parkinson's disease, your symptoms may temporarily get worse.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
SOURCE Mylan Inc.