Vertex Pharmaceuticals Incorporated (VRTX) received favorable news with the FDA’s Pulmonary Allergy Drugs Advisory Committee (PADAC) voted in favor (13-2) of clearing the company’s cystic fibrosis (CF) drug, Kalydeco in the U.S. for an additional patient population.
Vertex Pharma is looking to get Kalydeco approved for the treatment of patients (six years of age and above) with CF who have the R117H mutation in the cystic fibrosis transmembrane regulatory (CFTR) gene.
A response from the FDA is expected by Dec 30, 2014.
We are pleased with the panel’s voting in favor of approving Kalydeco. According to Vertex Pharma, there are nearly 700 patients with the R117H mutation in North America, Europe and Australia.
Kalydeco is already approved for the treatment of CF in patients aged ≥6 years, suffering from one of nine mutations including G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
We note that Kalydeco is the flagship product of Vertex Pharma. The company has been witnessing encouraging Kalydeco sales since its launch. Kalydeco’s net sales were $212.6 million in the first half of 2014 and its label expansion should boost sales further. Vertex Pharma expects Kalydeco sales in the range of $470 million to $500 million in 2014 (guidance provided with second quarter 2014 results).
We are pleased with Vertex Pharma’s efforts to expand Kalydeco’s label. Apart from Kalydeco, Vertex Pharma has a couple of CF correctors in its pipeline – lumacaftor and VX-661. Both are being studied in combination with Kalydeco.
We expect investor focus to remain on Kalydeco sales ramp up and the company’s label expansion efforts.
Vertex Pharma currently carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector include Halozyme Therapeutics, Inc. (HALO), Ligand Pharmaceuticals Inc. (LGND) and Medivation, Inc. (MDVN). All three carry a Zacks Rank #1 (Strong Buy).
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