MINYANVILLE ORIGINAL Vertex Pharmaceuticals’
(NASDAQ:VRTX) combination therapy improved lung function in cystic fibrosis patients and appears to be safe, results of a company-sponsored study showed Thursday. The data support further study, moving the drugs closer to a possible approval.
“These study results are an exciting step for the cystic fibrosis community and we look forward to the start of this pivotal (study) program early next year,” lead researcher Michael P. Boyle of the Johns Hopkins Adult Cystic Fibrosis Center says in a statement.
Researchers disclosed mid-stage study results for the Vertex treatment Kalydeco combined with an experimental drug, VX-809, Thursday. While there was widespread optimism for good data from the study, shares jumped up and down in morning trading. The key takeaway was there were no bad surprises. The data was presented at a conference
of the Cystic Fibrosis Foundation in Orlando.
The stock rose 3% to $58.45 in midday trading Thursday. The shares climbed more than 76% this year, largely on hope for the combination therapy.
Vertex won US approval
in January to sell Kalydeco to a narrow group of cystic fibrosis patients with a particular genetic defect. Winning a broader approval of a combination therapy for the life-threatening disease would be a far bigger market opportunity. About 70,000 people worldwide have cystic fibrosis, including 30,000 in the US.
Analysts have estimated Kalydeco may be a multi-billion-dollar drug if approved for a broader patient population.
ISI Group analyst Mark Schoenebaum says the next big test for the stock will be in the first quarter of 2013 when he expects additional data will be disclosed about Kalydeco used in combination with another experimental drug, VX-661. Those additional results should give an even stronger indication of Kalydeco’s potential, he says. If efficacy is confirmed with additional data, expect the stock to continue to rally, the analyst says.
In May, shares of Vertex surged after the company disclosed positive results for its drug combination. (See Vertex Pharmaceuticals Soars on Cystic Fibrosis Drug Study
.) The company, which boasts an almost $13 billion market cap, has other investment catalysts: It sells a hepatitis C drug, Incivek, and is working on next-generation treatments for the liver-wasting virus. The company is led by CEO Jeffrey Leiden, a former Abbott Laboratories
Vertex hosts a webcast
at 6:30 p.m. ET Thursday to discuss the cystic fibrosis study.
No positions in stocks mentioned.
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