Boehringer Ingelheim (BI) has warned that latest efforts to ensure continued Doxil production at Ben Venue's troubled sterile injectables plant in Bedford, Ohio must still be approved.
Last week the US contract manufacturing organisation (CMO) confirmed that Johnson & Johnson (J&J) subsidiary Janssen has filed its plan to lease space and produce Doxil at the plant with the US District Court for the Northern District of Ohio.
This was confirmed by a BI spokeswoman who told in-Pharmatechnologist.com today that: “We’ve reached an initial agreement with J&J to lease the portions of the Ben Venue facility that produce Doxil.”
This was echoed by J&J spokeswoman Lisa Vaga who told us that: "The lease agreement has been designed to help ensure continuity of supply while we continue to transition to alternate long-term manufacturers."
The decision appears to bring to an end a dispute between J&J and BI that was prompted by the German drugmaker’s announcement that it planned to close the Bedford facility by the end of 2013 after a number of quality problems .
J&J, for which Ben Venue had produced Doxil since 2009, said the closure may result in shortages and filed a lawsuit against the CMO designed to force it to produce the remaining 67 batches of the drug that it had been contracted to make.
However, while the plans to lease space at the site to Janssen affiliate Alza may solve this issue, supplies of J&J brand Doxil may still be limited for the short term as switching production is a complex process according to the BI spokeswoman.
“It is also important to note that multiple steps are required to transition manufacturing, and any plans are subject to health authority approvals.
“This is just one option we continue to pursue in conjunction with the U.S. Food and Drug Administration to keep this therapy accessible for patients, in both the short- and long-term” she told this publication.
Any delays to Alza’s Doxil production will be welcomed by firms like Sun Pharma and Hikma, which have both benefited from J&Js supply problems.
Whether or not BI wants to sell the Bedford facility – as was suggested in a Reuters report in December - is still unclear.
When asked, the BI spokeswoman told us the firm has engaged Merrill Lynch to try to find a buyer for the Bedford Laboratories business – which is part of Ben Venue – but did not comment on the plant itself.