Vertex Pharmaceuticals Incorporated VRTX received encouraging news with its supplemental new drug application for cystic fibrosis (CF) drug, Kalydeco, being accepted for priority review by the FDA. This means a response should be out by Feb 6, 2016.
Vertex is looking to get Kalydeco approved for the treatment of patients with CF aged 2 years and above with one of 23 residual function mutations including 2789+5G- > A, 3849+10kbC- > T, 3272-26A- > G, 711+3A- > G, E56K, P67L, R74W, D110E, D110H, R117C, L206W, R347H, R352Q, A455E, D579G, E831X, S945L, S977F, F1052V, R1070W, F1074L, D1152H and D1270N.
We are encouraged by the company’s efforts to expand Kalydeco’s label. According to the company, more than 1,500 patients fall in this category.
Kalydeco is Vertex’s flagship product and is currently approved for the treatment of CF in patients (2 years and older) who have one of 10 mutations in the CFTR gene including G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R or R117H.
Kalydeco’s net sales were $285.1 million in the first half of 2015 and its label expansion should boost sales further. Vertex expects Kalydeco sales in the range of $575 million to $590 million in 2015 (guidance provided with second-quarter 2015 results).
We remind investors that Vertex gained approval for another CF treatment in Jul 2015, Orkambi (lumacaftor-ivacaftor combination), for the treatment of the underlying cause of CFTR in patients (aged 12 and above) with two copies of the F508del mutation.
Currently, Vertex is working on expanding Kalydeco’s label further and is studying it in combination with VX-661.
Vertex is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Apricus Biosciences, Inc. APRI, Endo International plc ENDP and Alcobra Ltd. ADHD. All three hold a Zacks Rank #1 (Strong Buy).
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