Teva Pharmaceutical’s bid to bring a new migraine drug to the market faces a possible delay due to manufacturing problems found with one of the company’s partners, and observers are skeptical about whether Teva will be able to get it over the finish line.
The FDA was set to issue a decision about Teva’s (NYSE: TEVA) injectable migraine drug, fremanezumab, by June 16. But the Israel-based drug maker disclosed Thursday that Celltrion, the manufacturer of the active ingredient for the drug, received an FDA warning letter about unspecified issues at a site in South Korea where it makes the drug for Teva. In numerous previous instances, the FDA has cited manufacturing problems when rejecting a drug or device. In these cases, the regulator typically says it cannot reconsider the application until those problems are fixed. Celltrion is the sole source of the ingredient for fremanezumab so Teva can’t easily switch to another manufacturer.
In its announcement of 2017 fourth quarter and full year financial results, Teva said the warning to Celltrion will likely delay FDA approval of the Teva drug. But the company added that it is talking with the FDA “in an effort to maintain our priority date for the approval of fremanezumab.”
Teva’s fremanezumab, a biological drug, is part of a new class of migraine drugs that block a protein, calcitonin gene-related peptide (CGRP), thought to play a role in the transmission of pain. In clinical trials by Teva and other companies, patients treated with these drugs reported a reduction in the frequency of their migraine headaches. Competitors Amgen (NYSE: AMGN) and Eli Lilly (NYSE: LLY) also await FDA decisions for their CGRP migraine drugs, and others in the pipeline are not far behind.
Evercore ISI analyst Umer Raffat spoke with Teva about the FDA warning letter. In a research note, he wrote that the company said the FDA’s concerns cover a part of the Celltrion facility unrelated to where Teva’s sterile drugs are packaged. Teva is using that distinction to try to persuade the FDA that its migraine drug is unaffected by the manufacturing issue, Raffat added. The company told Raffat that if the FDA delays a decision, that delay could last between six and 18 months. The company also told Raffat that it has also begun searching for another manufacturer.
Still, Raffat said he does not believe the Teva drug will be approved, because the federal law governing the FDA defines a drug or device as “adulterated” if the facilities used to make, process, or package it do not meet current good manufacturing practices (CGMP). At best, he said an approval decision will be delayed until the first half of next year.
The likely delay for Teva’s migraine drug is the latest in a series of setbacks for the drug maker. Late last year, the company announced it would lay off one fourth of its workforce—approximately 14,000 people—as part of a restructuring intended to save $3 billion by the end of 2019. Teva, which mainly makes generic drugs, has faced pricing pressure from the launch of products from competitors, making some of its own products unprofitable.