Doxil May Disappear From Market as Plant Closes

Nick Mulcahy

October 15, 2013

The only company in the world that manufactures Doxil, the branded version of doxorubicin hydrochloride liposome injection, will close its production facility in Bedford, Ohio, before the end of this year, according to news reports.

Ben Venue Laboratories announced the closure earlier this month, citing manufacturing problems, as reported by Crain's Cleveland Business.

Doxil is administered intravenously and is most commonly used in patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

The drug is also indicated, in combination with bortezomib, for the treatment of patients with multiple myeloma.

Doxil is a liposomal injection form of doxorubicin, but the workhorse cancer drug is also available as a lyophilized powder (Adriamycin). Both forms have been in short supply in the United States for an extended period of time.

Ben Venue Laboratories, which specializes in making injectable drugs, currently manufactures Doxil for Johnson & Johnson, which owns the product.

Johnson & Johnson is reportedly suing Ben Venue for breach of contract. "We have taken action to ensure Ben Venue meets its contractual obligations to manufacture Doxil," said Lisa Vaga, a spokesperson for Johnson & Johnson, in an email to Medscape Medical News.

The possible disappearance of Doxil from the market will be eased by the availability of a generic version of doxorubicin hydrochloride liposomal injection, which was approved by US Food and Drug Administration (FDA) earlier this year. The generic product, which is available in 20 mg and 450 mg vials, is manufactured by Sun Pharma Global FZE in India, and was approved in a priority review aimed at helping to alleviate drug shortages.

Nevertheless, with the possibility that there will be 1 less source of doxorubicin, some healthcare professionals are worrying about a subsequent shortage of the generic version. "Once the supply of one goes down, it greatly impacts the amount available of the next agent," Jan Kover, RPh, a pharmacy specialist for oncology at MetroHealth System in Cleveland, told Crain's.

Johnson & Johnson is seeking a new manufacturer for Doxil. "We continue our discussions with Ben Venue about various alternatives to ensure continued supplies of Doxil into 2014," said Vaga, on behalf of Johnson & Johnson.

The closure of the Ben Venue factory will have a widespread impact on the generic injectables market, according to another report.

"If you had asked me 2 months ago how long we thought it would be before we would see real improvement in the number of ongoing and active drug shortages, I would have told you it was going to be about 2 years," said Erin Fox, PharmD, director of the drug information service at the University of Utah Pharmacy Services in Salt Lake City, in a report published October 11 in the Cancer Letter, an industry newsletter.

That time period now doubles or triples, she said.

"I think we are closer to maybe 4 to 6 years out, because Ben Venue was such a significant manufacturer and such a large provider of these injectable products," said Dr. Fox. "I think we'll see some improvements, but unless we see a very large company commit to making a large number of these drugs that are in short supply, we aren't going to see real improvement any time soon."

A Lot of Other Cancer Drugs Out of Stock

Ben Venue will cease operations because of "systemic manufacturing challenges," according to a company statement issued on October 3. It notes that the company, which is owned by Boehringer Ingelheim, has invested more than $350 million in their plant, but that more changes are needed. An estimated $700 million in operating losses are expected over the next 5 years.

The company suspended production in 2011 because of manufacturing issues, and has worked with the FDA and other global regulatory agencies to remediate problems. Production at the factory has been off and on since that time.


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