Seeking to offset early Copaxone sales declines, Teva swept up NuPathe a few years ago to get its hands on the only migraine patch approved in the U.S. But in less than a year after launch, the FDA has laid out concerns about "serious" adverse events including burning and scarring.
Teva's Zecuity is now under the radar as a "large number" of users have reported those problems plus severe redness, pain, skin discoloration, blistering and cracked skin, the FDA reported. The patch first hit the market last September.
In a statement, a Teva spokesperson said the FDA's decision was made "as a precautionary measure," and that "there is nothing more important to us than the health and safety of those who use our products."
"Patient wellbeing is at the heart of everything we do," the statement said. "Teva is working closely with the FDA on the investigation."
The development marks a headache for Teva, which bought Zecuity developer NuPathe in early 2014 for about $114 million, eclipsing Endo’s $105 million offer. At that time, the generics giant was looking to grow sales in the face of an earlier-than-expected patent loss for its megablockbuster multiple sclerosis drug Copaxone. That patent loss is still having repurcussions at the Israeli generics giant, with Q1 2016 results that fell short of expectations.
The investigation may also upset NuPathe investors, who stand to gain from tiered Zecuity sales milestones set up through the Teva deal.
Powered by a battery, Zecuity administers sumatriptan through a single-use device placed around a patient’s upper arm or thigh.
Though the patch has been FDA-approved since 2013 from NuPathe’s efforts, Teva didn’t get the product on the market in the U.S. until the second half of 2015. In promoting the product, the Israeli generics giant cited a study finding that Zecuity outperformed a nonmedicated patch in reducing headache pain and cutting light/sound sensitivity.
The FDA alert comes as Teva works to close a $41 billion deal to buy Allergan’s generics business, a price which some investors and investment bankers called into question this week because market dynamics have changed since the agreement.
- here's the FDA alert
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