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November 14, 2013

New Drug Approvals

Reslizumab(CINQUIL) is a humanized monoclonal antibody
targeted against IL-5 that is being developed by Cephalon for the
treatment of eosinophilic asthma. In September 2010, Cephalon
indicated that it hopes to file a BLA in 2013, focusing on this subset of
severe asthmatics. Such patients are ca. 30% of the asthmatic population,
with the 750,000 patients in the United States suggested to offer the potential for peak market sales of $1 billion. However, previous

attempts to develop recombinant IL-5 antagonists for the treatment of asthma saw very disappointing clinical results with both mepolizumab

(GlaxoSmithKline) and reslizumab (Schering-Plough and Celltech).
Schering-Plough (now Merck) had been developing reslizumab in
partnership with Celltech (now UCB), utilizing the latter’s antibody
technology, but terminated development in 2002 after disappointing
clinical results. The rights were acquired by Ception Therapeutics in
2007, with development reinitiated for both pediatric eosinophilic
esophagitis and eosinophilic asthma. Cephalon acquired an option to
acquire Ception…

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