The deal will make Mylan a global leader in injectable generics, significantly expanding and strengthening Mylan’s injectables capability and providing Mylan entry into new high-growth geographic markets.

India-based Agila has a broad product portfolio, with more than 300 filings approved globally and marketed in 70 countries, including 61 abbreviated new drug applications (ANDAs) approved by FDA. Agila has a global pipeline of approximately 350 filings pending approval, including 122 ANDAs pending FDA approval.

Agila has nine manufacturing facilities in Brazil, India and Poland, eight of which have been approved by FDA. The company’s manufacturing capabilities include vials, prefilled syringes, ampoules, lyophilization (freeze drying), cytotoxics and antibiotics. Agila has one of the largest capacities for sterile injectables in India and one of the largest freeze drying capacities in the world. In addition to its established presence in developed markets, Agila has a strong position in high-growth emerging markets, including Brazil.

Drug shortages in generic injectables may be fuelling Mylan’s move. In 2011, drug shortages reached unprecedented levels, with 251 medically necessary drugs affected, 73% of which involved sterile injectable drugs [1].

Agila’s capabilities complement Mylan’s existing injectables platform of more than 500 products marketed globally, including 55 ANDAs, and its high quality sterile manufacturing facilities in India and Ireland.

According to IMS, the global generic injectables market is expected to grow at a compound annual growth rate (CAGR) of 13% from 2011–2017 driven by patent expiries, outpacing most other dosage forms. The combined Mylan/Agila portfolio will represent approximately 70% of regulated market demand for injectables and the combined R & D platform and manufacturing capabilities will position Mylan to be a significant participant in advanced new technologies to drive future growth.

Mylan will also pay Strides Arcolab an additional US$250 million in potential payments subject to the satisfaction of certain conditions. The deal is expected to be finalized in the fourth quarter of 2013, subject to regulatory approvals and certain closing conditions.

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Drug shortages linked to quality control costs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 15]. Available from: www.gabionline.net/Pharma-News/Drug-shortages-linked-to-quality-control-costs

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