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23 Dec 2013

J&J Strikes a Deal to Manufacture Doxil Itself at Ben Venue Plant

Janssen Products, which has struggled to maintain supplies of its cancer drug Doxil since supplier Ben Venue Laboratories ran into FDA issues, may have landed on a way to help keep supplies available. The Johnson & Johnson unit has an agreement to lease part of Ben Venue's Bedford, OH, plant and take on manufacturing itself.


"We have reached an initial agreement to lease some parts of the plant, and steps are being taken to transition manufacturing," was about all that J&J spokeswoman Lisa Vaga would say Thursday, citing confidentiality agreements. "Although we've reached an initial agreement to lease the portions of Ben Venue's facility that produce Doxil, there are multiple steps required to transition manufacturing and any plans are subject to health authority approvals. I can't comment further because of confidentiality."


Vaga couldn't say what FDA thinks about the arrangement or whether it calls for using Ben Venue employees. Boehringer Ingelheim, which owns Ben Venue, said in October that the plant was no longer economically viable and that it would close at year end and its 1100 workers would be let go. Boehringer Ingelheim did not respond to requests for comment.


Vaga reiterated what the company has been saying for months: that Janssen has been in discussions with Ben Venue about various alternatives to ensure continued supplies into 2014 for Doxil, an older but very popular drug. It has said its talks with Ben Venue are one of several options being explored with FDA to keep Doxil accessible in the short and long term. It also has been working to get new suppliers approved to make the drug, but that has yet to happen.


Actually, J&J and Boehringer Ingelheim have been in more than just discussions. J&J sued the Boehringer Ingelheim unit, saying the company breached its 2009 agreement with J&J to make Doxil. J&J has been in court trying to get the German company to mediate its contract obligations.


Manufacturing and sterility problems at Ben Venue forced the contractor to suspend operations in November 2011 and later to sign a consent decree with FDA. But in October, the company threw in the towel on the facility. It said that while it had already invested $350 million in upgrades at the facility, it projected it would suffer $700 million in operating losses during the next 5 years to keep it open. It started laying off workers and said production would cease by the end of the year. It has the plant up for sale.


For its part, FDA has been working with J&J to keep Doxil supplies available. But in February 2012, FDA Commissioner Margaret Hamburg turned to India's Sun Pharma to import Lipodox, a Doxil substitute FDA had not approved. The company manufactured the injection at an FDA-approved facility in India. Earlier this year, FDA approved a generic version of Sun's drug for the US market to help ease the shortage.

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