Vertex Pharmaceuticals' New Kalydeco Data Out - Analyst Blog

Vertex Pharmaceuticals Incorporated VRTX announced the presentation of data from a phase III study and long-term extension studies on Kalydeco at the 37th European Cystic Fibrosis Society (ECFS) conference. The studies evaluated Kalydeco in patients suffering from cystic fibrosis CF having the G551D mutation.

Results from the studies revealed that Kalydeco was successful in reducing the annual loss in lung function by half over three years in comparison to untreated CF patients. Moreover, results from a rollover study following the phase III KONDUCT study showed lung function improvements in people aged 18 years and older and suffering from CF with the R117H mutation.

Vertex Pharma also presented new data from the second part of the phase III KONNECTION study in patients suffering from CF with certain non-G551D gating mutations. Data revealed that lung function improvements (reported previously) were maintained through 24 weeks of treatment in people with certain non-G551D gating mutations.

Kalydeco is approved for treating CF patients (age ≥ 6 years) who have at least one copy of the G551D mutation. In Feb 2014, Kalydeco was approved in the U.S. for treating patients (age ≥ 6 years) suffering from CF who have one of eight additional mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Following the approval, Kalydeco is now used to treat CF patients with the following nine mutations: G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P and G1349D.

Kalydeco has put up an impressive performance since its launch. The company reported Kalydeco sales of $99.5 million in the first quarter of 2014, an increase of 61% from the year-ago period. Kalydeco sales are expected in the range of $470 million to $500 million in 2014.

We are encouraged by Vertex Pharma's progress with Kalydeco. Vertex Pharma has a series of Kalydeco related events lined up in the coming quarters. We expect investor focus to remain on the product going forward.

Vertex Pharma carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Regeneron Pharmaceuticals, Inc. REGN, Gilead Sciences Inc. GILD and Alexion Pharmaceuticals, Inc. ALXN. While Regeneron and Gilead carry a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy).

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