Manufacturing issues are likely to delay the approval of fremanezumab but Teva remains confident its migraine drug will launch this year.
Teva Pharmaceutical Industries’ monoclonal antibody (mAb) candidate fremanezumab is under regulatory review as a preventive treatment for chronic migraine.
The US Food and Drug Administration (FDA) has assigned fremanezumab a Prescription Drug User Fee Act (PDUFA) action date mid-June, but the firm announced yesterday it expects a delay on the decision due to manufacturing issues.
“There’s not much doubt about the efficacy of this class, it’s very efficacious. It’s a huge improvement in the health situation for people with chronic migraine,” said Teva CEO Kåre Schultz on a call to discuss Q1 financials.
“The only issue we still have outstanding is the fact that our API source Celltrion has had a warning letter.”
Celltrion makes the active pharmaceutical ingredient (API) for fremanezumab at its facility in Incheon, Korea. Schultz told investors Teva “had a surprise, a negative surprise” when the FDA issue the manufacturer a warning letter in January.
The FDA’s issues lie with Celltrion’s finished pharmaceutical manufacturing practices and not API production, Teva has said. Schultz therefore remained confident fremanezumab can be approved and launched later this year.
“We have been in discussions with FDA on this, and based on those discussions we are expecting to see an inspection of [Celltrion’s] plant in the coming months. And of course, we’re expecting that we will be able to have our partner meet the demands from FDA. Based on that, we are expecting to see an approval and launch before the end of this year.”
Schultz added that without a secondary API manufacturing source Teva is “assuming and expecting that Celltrion will get in good shape in terms of GMP compliance,” though added it has no reason to believe otherwise.
“You could say my assessment is based on mine and some of my colleagues and external experts’ assessment of the outstanding issues mentioned in the 483 and then the activities undertaken by our partner Celltrion to remedy all these different deficiencies and make sure that they have a good state of GMP compliance.”
The warning letter caused Teva a headache earlier this year, being the main reason for the FDA to reject biosimilar versions of Rituxan (rituximab) and Herceptin (trastuzumab) made at the site in April. Teva inked a North American commercialization partnership with Celltrion for the two biosimilars in 2016.
Teva added fremanezumab – formerly known as LBR-101 – to its pipeline through the acquisition of Labrys Biologics in 2014, worth a potential US$835 million (€700 million).
Teva has also filed fremanezumab in Europe but Schultz said this is proceeding without any problems.