Yahoo Finance Vertex's Kalydeco Gets FDA Nod for Additional Indication - Analyst Blog
Vertex Pharmaceuticals VRTX announced that the FDA has approved its cystic fibrosis (CF) drug, Kalydeco, for the treatment of children aged 2 to 5 years with CF who have one of ten mutations (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R and R117H) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
According to the company press release, there are nearly 300 children in the U.S. who will be covered by this label expansion, including 150 who have the R117H mutation and 150 who have one of the other nine mutations. It is estimated that following the current approval, more than 3,400 people will be eligible for Kalydeco in the U.S., Europe, Canada and Australia. Vertex is also seeking EU approval for the above indication.
In its 2015 guidance, Vertex revealed that it expects Kalydeco revenues in the range of $560 to $580 million. This takes into account the assumption that eligible patients in Australia will use Kalydeco now that reimbursement discussions have been completed. There should be rapid uptake in Australia in the first half of this year where more than 200 children and adults with CF are expected to be eligible for treatment.
Meanwhile, Kalydeco should benefit from the latest label expansion (2 to 5 years age group) in the second half of this year.
Vertex expects the number of patients eligible for Kalydeco treatment to increase from 3,100 (estimate at the end of 2014) to more than 3,700 by year end.
Meanwhile, Vertex has another important regulatory event coming up with the FDA expected to respond on the approval status of its Kalydeco – lumacaftor combination (for CF patients (age ≥12 years) who have two copies of the F508del mutation in the CFTR gene) by Jul 5. The combination is under review in the EU as well where a response should come out in the fourth quarter of this year.
Vertex is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Cambrex Corp. CBM, Lannett Company, Inc. LCI and Cytokinetics Inc. CYTK. All three are Zacks Rank #1 (Strong Buy) stocks.
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