JERUSALEM Teva Pharmaceutical Industries Ltd said on Wednesday its experimental drug to prevent migraines cleared another late-stage study, setting it on course for U.S regulatory approval and launch in the second half of 2018.
The drug's success would be a much needed boost for Teva, Israel's biggest company and the world's largest generic drugmaker. Analysts have estimated it could generate at least $1 billion in sales annually.
Teva's stock price has plummeted over the past few months after a series of costly acquisitions and delayed drug launches, while its best-selling multiple sclerosis drug Copaxone faces new generic competition.
The new migraine treatment, fremanezumab, significantly reduced the amount of headaches suffered by patients during a phase III trial in episodic migraine prevention using both monthly and quarterly doses, Teva said.
Teva also released positive results for the drug treating less-prevalent chronic migraines a week ago.
"Teva plans to submit a Biologics License Application to the U.S. Food and Drug Administration for fremanezumab later this year in both episodic and chronic migraine with anticipated approval and launch in the second half of 2018," it said.
Its shares, which hit a decade low last month, were up 0.6 percent in early trading in New York on Wednesday.
Teva as well as companies such as Amgen Inc, Eli Lilly Co and Alder BioPharmaceuticals Inc are developing similar drugs to target calcitonin gene-related peptide, or CGRP, a protein involved in pain-signalling during migraine.
The lack of effective medicines and the sheer number of patients guarantee that each company's drug, if approved, will eventually generate at least $1 billion in sales, analysts have forecast.
This could help to offset an expected blow to Teva which faces new generic competition to Copaxone.
About 40 million Americans suffer from migraine - intense headache characterized by throbbing pain and sensitivity to light and nausea. The condition, which can last for days, is incurable.
(Reporting by Ari Rabinovitch. Editing by Jane Merriman)