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Janssen says 'alternative manufacturing' will restore doxil supplies; Ben Venue gets consent decree

By Dan Stanton , 24-Jan-2013
Last updated the 24-Jan-2013 at 14:22 GMT

Doxil shortage over with new CMO approach
Doxil shortage over with new CMO approach

Janssen says an alternative manufacturing approach will restore Doxil supplies, days after Ben Venue Laboratories’ (BVL) entered into consent decree with FDA.

The statement follows an official letter  sent two weeks ago to healthcare professionals informing them of the latest developments with Doxil.

Janssen said a “collaboration between Ben Venue Laboratories (BVL) and another supplier to complete the end-to-end production of Doxil” had addressed the shortage of the drug.

He explained that the process had not been officially approved by the FDA but instead had “undergone a full Janssen internal review to ensure that it meets quality and safety standards.”

Lisa Vaga, spokesman for Jansen’s parent company J&J, told In-Pharmatechnologist.com: “There continues to be full and unrestricted access to DOXIL, and we’ve been working closely with the US FDA to ensure ongoing supply.”

Vaga confirmed the new approach to manufacture was “consistent with the provisions of the BVL consent decree” and that Janssen would continue “working closely with our suppliers and the FDA.”

Doxil is presently being supplied by JOM Pharmaceutical Services, J&J’s in-house service provider. Janssen did not offer further details of the additional CMO working with them and BVL.

Vaga said: “we continue to advance in our long-term transition to other manufacturers, which is currently progressing against expected milestones.”

Consent decree

Earlier this week Bedford, Ohio BVL announced it was to enter into a consent decree with the US Food and Drug Administration (FDA) over continuing issues relating to current Good Manufacturing Practice.

Though banning manufacture of certain drugs, the decree states that BVL – a manufacturing arm of German company Boehringer-Ingelheim – “is permitted to continue to manufacture and distribute more than one hundred important drugs that are essential for patient care.” 

Boehringer-Ingelheim offered no further comment on the press release to Outsourcing-Pharma.com.

Drug Drought Stemming from BVL’s Problems

The stipulation is part of the FDA’s approach in avoiding drug shortages arising from BVL’s long-term GMP issues.

In 2011, an assessment of the plant by drug regulator Health Canada led to restrictions of drugs being imported into Canada. A 483 published by the FDA  pulled up 48 quality concerns later in the year leading to a suspension of manufacturing  which only restarted, in limited capacity, in October 2012.

On top of BVL’s woes the European Medicine’s Agency (EMA) ordered the recall a number of cancer drugs  manufactured at the facilities. One drug which avoided the recall was Doxil - marketed in Europe as Caelyx – which was already in a state of shortage due to being exclusively manufactured and supplied by Ben Venue.

Doxil, marketed by J&J’s Janssen Products unit, is an intravenous therapy which is used to treat patients with ovarian cancer that has progressed or recurred after platinum-based chemotherapy. There is no generic version of Doxil and this coupled with manufacturing issues augmented the shortage.

During the shortage, Janssen sent letters  to its healthcare providers explaining that due to the proprietary drug delivery method and the complexity of manufacture, Doxil was produced by a contract organisation.

In regular updates  Janssen President Rob Bazemore explained that the intermittent supply had “been caused, in part, by unplanned downtime due to equipment failures at [its] independent specialty manufacturer.”

Sales results at J&J have also been negatively affected due to the lack of the drug.

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