Biogen Idec India obtains approval for Avonex Pen for patients of multiple sclerosis

Company Brief

New Delhi, March 14, 2012

Biogen Idec Biotech India Pvt. Ltd. (Biogen Idec India) has received the approval of the first single-use, intramuscular autoinjector for interferon beta-1a to be used by patients with multiple sclerosis (MS) in India. The new device, known as Avonex Pen, represents a significant new administration option for MS patients in India.

Approved by the Drug Controller General of India (DCGI), the new autoinjector is designed to enable easier, more convenient interferon beta-1a administration, improving the treatment experience for MS patients. It was approved based on data from a specific clinical study supporting its effectiveness as a new treatment administration option. Biogen Idec recently received approval in the United States and European Union, for the autoinjector. It is hoped that the autoinjectorwill help ease administration for patients who use interferon beta-1a therapy and those who otherwise may skip treatment due to fear of needle. The device is likely to be available across the country by the end of March 2012.

“Interferon beta-1a has been an effective treatment with an established safety profile for MS patients for more than five years in India,” said Managing Director of Biogen Idec India, Sameer Savkur. “The approval of this first single-use, intramuscular autoinjector is an important milestone in Biogen Idec’s ongoing drive to bring new innovations to MS patients. Launching Avonex Pen, here is part of our company’s long-standing commitment to improve the lives of MS patients in India.”

About Autoinjectors

Compliance to therapy plays a vital role in ensuring desired outcomes in chronic therapies. Autoinjectors for chronic therapies have been proven to be useful in improving ease of injection and reducing needle anxiety*, thereby improving compliance to therapy. (*Ref. Phillips et al. BMC Neurology 2011, 11:126)

Thousands of patients with MS in India administer interferon beta-1a therapy to treat their MS. Once-weekly interferon beta-1a (intramuscular) is one of the most prescribed treatments for relapsing forms of MS worldwide. It has been shown to slow the progression of physical disability and reduce relapses. It has been available for use in the United States for more than 15 years and in India for the past five years. The most common side effects associated with interferon beta-1a treatment are flu-like symptoms, including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain and asthenia.

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