Teva's Migraine Candidate TEV-48125 Positive In Phase III

Teva Pharmaceutical Industries Limited (NYSE:TEVA) announced positive top-line results from a phase III study (HALO), evaluating its pipeline candidate, fremanezumab (TEV-48125) for prevention of chronic migraine (CM). The study met both its primary and secondary end points.

The company will report another top-line data from HALO study in episodic migraine (EM) in the coming weeks.

Notbly, fremanezumab became a part of Teva’s pipeline following the Jul 2014 acquisition of Labrys Biologics.

Shares of Teva have underperformed the Zacks classified Medical-Generic Drugs industry so far this year. The stock has lost 23.2%, compared to broader industry’s fall of 8.4%.



The multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group, multi-dose phase III study (n=1130) evaluated the efficacy and safety of four doses of fremanezumab as compared to placebo in adults with episodic and chronic migraine.

Patients randomized to one of three treatment arms, were subcutaneously given fremanezumab once a month for two months (quarterly dose regimen), either in high (675mg) or low doses (225 mg, monthly dose regimen). The study met all primary endpoints in both monthly and quarterly dosing regimens and demonstrated statistically significant reduction in the number of monthly headache days compared to a placebo. The study also met its secondary endpoints and showed significant improvement over placebo.

Strikingly, fremanezumab is also in phase III clinical study to evaluate its safety and efficacy in treating chronic and episodic cluster headaches. The study was initiated in Feb 2016.

According to the press release issued by the company, approximately 38 million people suffer from migraine in the U.S. Among them, prevention is appropriate for 40% of the patients but only 13% are currently receiving therapy. Hence, there remains a significant unmet medical need for treatments designed specifically to heal migraines.

Zacks Rank & Key Picks

Teva currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in healthcare sector include VIVUS, Inc. (NASDAQ:VVUS) , Bayer (DE:BAYGN) AG (OTC:BAYRY) and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) . While VIVUS flaunts a Zacks Rank #1 (Strong Buy), Bayer and Regeneron carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s loss per share estimates lessened from 50 cents to 39 cents for 2017 in the last 30 days. The company posted positive earnings surprises in all four trailing quarters, with average beat of 233.69%.

Regeneron’s earnings per share estimates increased from $10.17 to $10.52 for 2017 and from $10.90 to $12.10, over the last 30 days. The company posted positive earnings surprises in two of four trailing quarters with average beat of 0.45%.

Bayer’s earnings per share estimates increased from $8.36 to $8.85 for 2017 and from $8.88 to $9.53 for 2018, over last 30 days. The company posted positive earnings surprises in three of four trailing quarters with an average beat of 10.25%.

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