Ben Venue restarts production; Janssen says Doxil available soon

17-Oct-2012 - Last updated on 24-Oct-2012 at 13:23 GMT

US CMO Ben Venue has restarted 'limited drug manufacturing' at its plant in Bedford, Ohio, but does not expect to start shipping product for several months.

The contract manufacturing organisation (CMO) - a unit of German drugmaker Boehringer Ingelheim - said the move followed progress in corrective actions taken at the plant, which has been off line since last November after the FDA and EMA voiced concerns over quality.

The shutdown resulted in significant drug shortages, saw customers shift production to other CMOs and prompted the US Food and Drug Administration (FDA) to introduce a requirement that drugmakers notify it of potential shortages when only one supplier is involved.

Ben Venue said it has "invested more than $300 million to upgrade our facilities, making necessary improvements and changes to our processes to resolve the manufacturing-related issues that resulted in our voluntary shutdown last year."

Doxil supplies

Working with other contractors seems to be part of this resolution process. At the time of the shutdown Ben Venue was the only US supplier of the ovarian cancer treatment Doxil, which resulted in significant shortages.

However, earlier this week J&J's Janssen Products unit - which sells Doxil - announced that it was releasing a batch of the drug after "working diligently to restore a reliable supply... and confident these efforts will ensure consistent availability."

Janssen's president, Robert Bazemore, said:"The solution includes product from an innovative collaboration between Ben Venue and another supplier to complete end-to-end production" he said, adding that "this approach is under expedited review by the FDA, and we are confident we'll be able to ensure a continuous supply of Doxil to the marketplace."

The other CMO that Ben Venue is working with to restore Doxil supplies has not been named.