Japan–Sept. 22, 2011– Mylan Seiyaku, a subsidiary of Mylan Inc. (Nasdaq: MYL), today announced that the Ministry of Health, Labour and Welfare (MHLW) approved National Health Insurance (NHI) price listing for EpiPen Injection 0.3/0.15 mg, an adrenaline self-injection for people with a history of or who are at risk for anaphylaxis, a life-threatening allergic reaction. Under the new NHI price listing, EpiPen Injection 0.15 mg will cost 8,112 JPY and EpiPen Injection 0.3 mg will cost 10,950 JPY. Although the actual cost to the patient will vary, typically, a patient will pay up to 30% of the NHI price.

Mylan President Heather Bresch commented: “We are thrilled with the MHLW’s recognition of and decision to approve NHI pricing for EpiPen Injection. The new price significantly reduces the cost for patients and, as a result, more people with severe allergies will be able to obtain an EpiPen Injection and be prepared when anaphylaxis occurs. This news is especially welcomed as the number of school children in Japan with food allergy and anaphylaxis continues to rise, with food allergies now affecting approximately 2.6% of school children in Japan.”¹

For the people of Japan who have serious allergies and may be at risk for anaphylaxis, EpiPen Injection, a potentially life-saving device, is their first line of defense. According to the 2011 World Allergy Organization (WAO) anaphylaxis guidelines, the World Health Organization classifies adrenaline as the first-line medication for the treatment of anaphylaxis. Additionally, the WAO guidelines state that more than one dose of adrenaline is needed in up to 23% of adults receiving an adrenaline injection for anaphylaxis.²

Mylan Seiyaku President Akihiko Honda commented: “This announcement is a critical milestone in Mylan Seiyaku’s aim to increase affordability of, and access to, EpiPen Injection for patients who have a history of or who may be at risk for anaphylaxis.”

Dr. Kazuo Akiyama, Administrative Director of the Japanese Society of Allergology, added: “The MHLW`s decision demonstrated their understanding of the seriousness of anaphylaxis and the importance of early medical treatment with EpiPen Injection to prevent the life-threatening condition from worsening. This is a major milestone for not only patients living with severe allergy but also healthcare professionals.”

If you have any questions regarding this announcement, please call Mylan Seiyaku’s Customer Support Center at 0120.194.701.

About Anaphylaxis and Food Allergies

Anaphylaxis is a severe allergic reaction that is rapid in onset and may cause death, either through swelling that shuts off airways or through a significant drop in blood pressure.^3,4  Anaphylaxis can be triggered by certain foods, insect stings, medications, latex or other allergens.²

A food allergy is a medical condition in which the immune system incorrectly identifies a food protein as a threat and attempts to protect the body against it by releasing chemicals into the blood. The release of these chemicals results in the symptoms of anaphylaxis. According to Japan’s “Food Allergy Management Guideline 2008,” the foods that most commonly cause anaphylaxis in Japan include hen’s eggs, cow’s milk products, wheat, shellfish, fruits, buckwheat, fish and peanuts.¹

About EpiPen Injection

EpiPen Injection 0.3/0.15 mg is an adjunctive treatment for anaphylactic reactions caused by allergens, such as bee-poison, foods and drugs. EpiPen Injection is indicated for patients with a history of anaphylaxis or patients who are at high-risk for developing anaphylaxis. Patients should seek immediate emergency medical treatment after use of EpiPen Injection. For more information about EpiPen Injection, please visit www.epipen.jp.

About Mylan Seiyaku

Mylan Seiyaku is the Japanese subsidiary of Mylan Inc., one of the world’s leading pharmaceutical companies, providing products to customers in more than 150 countries and territories. Mylan Seiyaku has set a new standard in Japan for generic and Specialty pharmaceuticals, a standard that reflects our commitment to delivering the highest quality products, backed by Mylan’s global, proven and longstanding track record for excellence - excellence that also is carried out through our exceptional customer service based on our understanding of customers’ needs and our ability to respond quickly, openly and reliably. We are the company you can trust. For more information, please visit www.mylan.co.jp.

About Mylan

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit www.mylan.com.

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References

1. Ebisawa M. Management of Food Allergy in Japan “Food Allergy Management Guideline 2008 (Revision from 2005)” and “Guidelines for the Treatment of Allergic Diseases in Schools.” Allergology International. 2009 Nov; 58(4):1-9.
2. Simons FE, Ardusso LR, Bilò MB, et al; World Allergy Organization. World allergy organization anaphylaxis guidelines: summary. J Allergy Clin Immunol. 2011;127(3):587-593.e22.
3. Simons FER. Anaphylaxis. J Allergy Clin Immunol. 2010;125(2)(suppl 2):S161-S181.
4. Sampson HA, Munoz-Furlong AM, Campbell RL, et al. Second symposium on the definition and management of anaphylaxis: Summary report–Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol. 117:391-397.

Contact:

Mayumi Takeuchi

Corporate Communications

Tel   :   +81-3-5733-9820

Fax   :   +81-3-5733-9644

Email   :   mayumi.takeuchi@mylan.co.jp