Europe delays Merck & Co.'s HCV drug on back of CMO quality issues

By Dan Stanton contact

- Last updated on GMT

Image: iStock/Nuno André
Image: iStock/Nuno André

Related tags: European medicines agency, Hepatitis c

Inadequate record keeping at Merck & Co.’s contract manufacturer has delayed the European launch of its hepatitis C drug Zepatier (elbasvir and grazoprevir).

The oral hepatitis C virus (HCV) treatment was approved in the US back in January, but the drug may not be launched in Europe this year after the European Medicines Agency (EMA) pulled Merck up on regulatory issues at its third-party manufacturer.

CEO Roger Perlmutter said on his firm’s Q1 2016 conference call last week the unnamed contract manufacturing organisation (CMO) was hit for “issues largely related to inadequate record keeping and the need for improvement in their quality management systems,”​ and while Merck is “working assiduously with regulators to resolve these issues” ​the product may not arrive in Europe until next year.

“We continue to believe that EU approval can be achieved according to the midyear timeline that we previously disclosed. However, our European launch will be delayed until the fourth quarter or perhaps until the end of the first quarter of 2017, depending on how quickly these matters can be resolved.”

Zepatier is the latest in a new class of oral therapies which - along with Gilead’s Sovalsi and Harvoni, and AbbVie’s Viekira Pak and Technivie – offers a treatment option for HCV infections without requiring use of interferon.

For the first quarter, Merck – known as MSD outside North America – reported sales of $50m of the drug and EVP Adam Schechter said on the call the firm is really pleased with its progress.

“We're still early in the launch, but we have been working really hard to secure access. And we have conversations ongoing across all segments, many different customers,”​ he told investors.

“If you look at how we're approaching the marketplace, we really are focusing on having access, and it's important that we have parity with the competitors. So we're spending a lot of time trying to get access at parity across the different segments in the US so that there's physician and patient choice.”

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