Vertex Pharmaceuticals Incorporated’s VRTX shares fell almost 4% after the company reported disappointing data from a 12-week phase II study evaluating VX-661 in combination with Kalydeco (ivacaftor) in patients suffering from cystic fibrosis (CF) aged 18 years and above with two copies of the F508del mutation.
The randomized, double-blind, placebo-controlled phase II study (n=39) evaluated two doses of VX-661 (100 mg once daily or 50 mg every 12 hours) in combination with Kalydeco (150 mg every 12 hours).
Results revealed that the VX-661 plus Kalydeco combination regimen demonstrated a within-group, absolute mean improvement in lung function of 4.4 percentage points when observed over a period of four weeks. However, the improvement in lung function declined to 3 percentage points through 12 weeks of treatment. On the safety front, the combination was found to be well tolerated and all patients completed 12 weeks of treatment.
On the basis of phase II data generated to date, Vertex is currently conducting a broad phase III development program consisting of four studies including a study evaluating the combination of VX-661 (100 mg once daily) and Kalydeco (150 mg every 12 hours) in patients with one or two copies of the F508del mutation (enrolment of patients underway).
We note that a Kalydeco – lumacaftor combination is currently under review in the U.S. (FDA action date: Jul 5) and EU (approval could come in the fourth quarter).
Vertex’s flagship product, Kalydeco, has been witnessing encouraging sales since its launch. Kalydeco is approved in the U.S. for CF patients aged two years and older with the R117H mutation or any one of these mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R. Vertex is working on expanding the product’s label further.
Vertex expects Kalydeco sales in the range of $560 million to $580 million in 2015.
Vertex currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Acorda Therapeutics, Inc. ACOR, Cytokinetics, Incorporated CYTK and Horizon Pharma plc HZNP. All three hold a Zacks Rank #1 (Strong Buy).
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