Uncertain About HCV, Vertex Doubles Down On CF, Looks To Sell Off Pipeline Assets
As it nears a crucial inflexion point for its hepatitis C business, Vertex shifts focus to building on its strong early start in cystic fibrosis. The Boston-area firm plans to out-license its mid-stage candidates for autoimmune disease and influenza A.
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Cystic Fibrosis Market Snapshot: Disease-Modifying Drugs Elusive 24 Years After Discovery Of Root Cause
The discovery in 1989 of the underlying genetics causing cystic fibrosis was expected to spur broad development of disease-modifying therapies. As of 2013, however, only one such drug is on the market, for a small subset of CF patients, and a few other candidates are in clinical development.
Despite controversies about incorrectly reported data and allegations of incomplete data, Vertex has demonstrated lung function benefit for a combination of Kalydeco and VX-809 in Phase II and will move the combination into Phase III trials early next year.
A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.