Strike three: Allergan slides on potential Restasis generics
This article was originally published in Scrip
Allergan came out swinging at the beginning of 2013, but the Irvine, California-based company faced its third strike of the year when the US FDA issued guidance for generic drug makers developing reduced-priced competition for the dry eye drug Restasis (cyclosporine).
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Pfizer’s CEO will likely shed more light on the company’s on-off-on attitude towards its consumer health business, while Allergan will certainly have a lot of explaining to do regarding its Restasis patent protection strategy. Sanofi, Teva and AstraZeneca are also scheduled to report Q3 results in the coming days. Scrip outlines the key issues to watch for.
Bristol became a major hematology player through its acquisition of Celgene and it has a multi-pronged plan for maintaining its position as generics approach for Revlimid and other key products.
The company will seek US FDA approval after intranasally administered zavegepant passes its second pivotal test in the treatment of migraine attacks, followed by ex-US approvals with partner Pfizer.