CEO: Sanofi may provide Genzyme with fill/finish long term

Veibacher made the remarks in a webcast discussing the $20bn (€14.8bn) deal in response to a query about whether Genzyme will be shifting fill finish work previously contracted to Hospira to Sanofi facilities.

“I think that would be premature to say​” said Veibacher, adding that “over time we will have a look at combining some of our fill/finish quantities…but I think at the start our principle objective​ is the same as Genzyme’s has been, that is we need to ensure stability of supply​.

He went on to reiterate that: “In the first instance we want to continue to execute on the plan Genzyme has outlined​” and said that work on integrating Sanofi and Genzyme was about to begin.

Outsourced manufacturing has played a key role in Genzyme’s plan with some fill and finish work previously carried out at its facility in Allston, Massachusetts, being contracted out to Hospira​..

The contract is scheduled to run until at least 2015 and covers the supply of a number of key Genzyme products including Cerezyme and Fabrazyme, the production of which is a key metric of the final value of the Sanofi takeover.

A Hospira spokesman told in-Pharmatechnologist that: “We are proceeding under the terms of the agreement and expect to continue forward with the agreement. We have not been approached with any requests for changes as a result of the merger.​

Sanofi gets FDA warning letter​

In other Sanofi news, BioPharm Insight​ reported on Monday that the French drugmaker received a warning letter from the US Food and Drug Administration citing "lax pharmacovigilance" related to the reporting of serious adverse events and the incomplete reporting of studies.

The newswire, which cited a person claiming knowledge of the situation, said the February 1 letter states that Sanofi “engaged in prohibited acts” by failing to comply with post marketing reporting requirements.

Sanofi did not respond to in-Pharmatechnologist.com’s request for confirmation of the warning letter.