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.