Vertex Pharmaceutica
VRTX
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Vertex Pharmaceuticals : Corporate News Blog - Vertex Pharma Announces Approval from the FDA For KALYDECO in More Than 600 Patients Suffering from Cystic Fibrosis

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08/03/2017 | 01:10 pm

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LONDON, UK / ACCESSWIRE / August 3, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) ("Vertex"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=VRTX. The Company announced on August 01, 2017, that the US Food and Drug Administration (FDA) has approved the KALYDECO (ivacaftor) for use in more than 600 people suffering from cystic fibrosis (CF) ages 2 and older who have one of the five residual function mutations, that result in a splicing defect in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Cystic Fibrosis is a rare, life-threatening genetic disease affecting about 75,000 people in North America, Europe, and Australia. For immediate access to our complimentary reports, including today's coverage, register for free now at:

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The Announcement

This announcement from Vertex follows the Phase-3 clinical data for ivacaftor in these mutations and follows the FDA's approval of ivacaftor in May 2017 for 23 other residual function mutations, which was based on analysis of in vitro data. The Company announced that based on the FDA's approval, it has increased its guidance for 2017, where KALYDECO product revenues are expected to be in the range of $770 million to $800 million. The Company's guidance range for total CF product revenues in 2017 now stands at a range of $1.87 billion to $2.1 billion, which includes ORKAMBI guidance range of $1.1 billion to $1.3 billion.

Cystic Fibrosis

CF is caused by defective or missing CF transmembrane conductance regulator (CFTR) proteins resulting from mutations in the CFTR gene. The defective or missing proteins result in poor flow of salts and water into or out of cells for a number of crucial organs, including the lungs. The five mutations covered under today's approval (2789+5G?>A, 3272-26A?>G, 3849+10kbC?>T, 711+3A?>G, and E831X) cause CF, and result in moderate loss of chloride transport.

People, with these mutations, usually experience progressive lung function decline and other complications of the disease. All of the mutations (as indicated above) were evaluated as a part of the Phase-3 EXPAND study, in which the KALYDECO monotherapy arm, met its primary efficacy endpoint and was generally well-tolerated. KALYDECO now stands approved in the US to treat people with CF ages 2 and older, who have one of 38 ivacaftor-responsive mutations in the CFTR gene.

Ivacaftor (KALYDECO)

Ivacaftor is the first medicine to treat the underlying cause of Cystic Fibrosis in people with specific mutations in the CFTR gene. Also known as CFTR potentiator, the KALYDECO is an oral medicine designed to keep CFTR proteins at the cell surface open longer to improve the transport of salt and water across the cell membrane. It eventually helps hydrate and clear mucus from the airways.

The ivacaftor is available as 150 mg tablets for adult and pediatric patients, age 6 years or older, and is taken with fat-containing food. It is also available in 50 mg and 75 mg versions in pediatric patients aged 2 to less than 6 years and are administered with fat-containing soft-food or liquid.

Phase-3 Results

On March 28, 2017, the Company announced the results from Phase-3 studies of the tezacaftor/ ivacaftor combination treatment that showed statistically significant improvements in lung function (percent predicted forced expiratory volume in one second, or ppFEV1) in people with CF ages 12 and older who have certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The 24-week EVOLVE study evaluated the combination treatment in people who have two copies of the F508del mutation. The study eventually met its primary end-point with a mean absolute improvement in ppFEV1 through 24 weeks of 4.0% from baseline compared to placebo (p < 0.0001).

Company Growth Prospects

The Company recently announced its Q2 FY17 results on July 26, 2017. Vertex reported net Q2 FY17 revenues of $514 million from cystic fibrosis products, $324 million for ORKAMBI, and $190 million for KALYDECO. The Company also announced that its pipeline of investigational CF medicines continues to progress and expand the support its goal of treating all people with CF.

Last Close Stock Review

Vertex Pharma's share price finished yesterday's trading session at $157.55, rising 2.84%. A total volume of 1.78 million shares have exchanged hands. The Company's stock price soared 32.34% in the last three months, 82.69% in the past six months, and 58.92% in the previous twelve months. Additionally, the stock skyrocketed 113.86% since the start of the year. Shares of the Company have a PE ratio of 150.91 and currently have a market cap of $39.76 billion.

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