Citigroup estimates that sales of migraine treatment Fremanezumab, which might be launched next year, could reach $2 billion annually.
After losing its exclusivity for Copaxone, Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) is taking one more step on the way to another best-selling drug. The company announced that it had submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for Fremanezumab, a drug for treatment of migraine headaches. The news was expected, but positive for the company's investors, who have experienced many disappointments in the recent past.
Among other things, the BLA is based on figures from the HALO clinical studies program, which included over 2,000 patients with chronic and acute migraines. The studies tested monthly and quarterly dosage regimes for Fremanezumab. Several months ago, Teva reported positive results in clinical studies of the drug in treatment of both chronic and acute migraine.
If everything goes as planned, the drug will be launched in the US in the second half of 2018. The market is competitive, but large for Teva. Citigroup estimated that peak sales of the drug would exceed $2 billion, although the company noted that Teva was submitting its BLA five months after a BLA submitted by Amgen and Novartis for a competing drug.
"This is a significant milestone for migraine sufferers," said Teva global R&D president and CSO Dr. Michael Hayden. "There have been few innovative treatments for migraine patients in the past 25 years. If Fremanezumab is approved, it will be among the first in a new cycle of migraine prevention drugs to enter the market. We're very proud about the progress that we have achieved in the Fremanezumab development program, and have great expectations for the potential of making this treatment available to millions of people all over the world who are living with the restrictive effects of migraines." Fremanezumab (previously called TEV-48125) came to Teva as part of its acquisition of Labrys in 2014 - the first acquisition led by former CEO Erez Vigodman.
Teva's share price has plummeted 53% since August, following the company's downwardly revised guidance, its major write-off of goodwill in its second quarter financial statements, and a cut in the company dividend.
After Teva's share had already begun to recover from its early September low, following the appointment of Kare Schultz as CEO, Mylan N.V. (Nasdaq: MYL; TASE: MYL) reported recently that it had obtained marketing approval for its generic version of Copaxone, putting Teva's share price into another tailspin. Teva's market cap is now $15 billion.
Teva's share price was up 0.2% in New York recently, after closing at a low point of $14.70 the previous day. Teva's share price has plummeted 53% since August, following the company's downwardly revised guidance, its major write-off of goodwill in its second quarter financial statements, and a cut in the company dividend.
After Teva's share had already begun to recover from its early September low, following the appointment of Kare Schultz as CEO, Mylan N.V. (Nasdaq: MYL; TASE: MYL) reported two weeks ago that it had obtained marketing approval for its generic version of Copaxone, putting Teva's share price into another tailspin. Teva's market cap is now $15 billion.
lN.V. (Nasdaq: MYL; TASE: MYL) reported two weeks ago that it had obtained marketing approval for its generic version of Copaxone, putting Teva's share price into another tailspin. Teva's market cap is now $15 billion.