Monday, October 7, 2013

Ben Venue shutdown will cause Doxil drug shortage, but similar cancer drugs available

In the wake of the news that Bedford-based drug manufacturer Ben Venue Laboratories Inc. will permanently shut down its operations by the end of the year, physicians are once again faced with likely shortages of a crucial cancer drug, starting this month.
Unlike previous shortages, however, this one will be less painful because of the availability of a generic version of the drug, which the FDA approved last February.
Even before news of the closing, Janssen Products, a pharmaceuticals unit of Johnson & Johnson, sent out a letter dated Sept. 25, warning that the supply of their drug Doxil was running low.
The injectable chemotherapy drug is used to treat women with advanced or recurring ovarian cancer, and patients with other cancers.

Don’t start treating new patients with the drug in the foreseeable future, said the letter, which didn’t mention Ben Venue, nor its owner, Boehringer Ingelheim, by name.
Instead, physicians and providers were told to contact drug company Sun Pharma about getting a supply of the generic version of Doxil that the company makes.
Sun Pharma is the India-based company that the FDA turned to in February 2012 for Lipodox, a drug equivalent to Doxil that was supposed to be a short-term solution to the Doxil shortage (and shortage of other drugs) created after Ben Venue temporarily suspended its drug manufacturing and distribution operations in November 2011.

Local physicians say they anticipate being able to get Doxil in the short-term, and more of it than 20 months ago, the last time they were told of a shortage.

"Fortunately, when we were kind of broadsided with this a year and a half ago, [we]  began to make contingency plans on the chance that something like this was going to happen again," said Dr. Steven Waggoner, division chief of gynecological oncology at University Hospitals Case Medical Center.
Upon hearing the news of Ben Venue's pending closure, UH convened a task force that went through the roster of patients taking Doxil.

"At the moment, the pharmacist assures us that we have well over two months' supply," Waggoner said.

Even though Lipodox and a generic form of Doxil are also available, Dr. Robert DeBernardo, a gynecological oncologist at the Cleveland Clinic, says he prefers treating patients with the brand-name Doxil; he put his patients back on it about a year ago when a second supplier in the United States began making the drug.

DeBernardo also agreed that the shortage of available drugs won't be nearly as acute, but any supply of Doxil the Clinic gets won't be enough to treat everyone who needs it.

"It would be terrible if Doxil went away," he said. "It’s going to negatively impact the care that we can give women."
Johnson & Johnson is using an alternate approach it has used in the past to try not to let that happen, with certain areas of Ben Venue being used for production while another supplier finishes up the rest of the manufacturing process.

That “alternative manufacturing process,” mentioned in eight other letters the company sent this year has not received FDA approval, but has “undergone a full Janssen internal review to ensure that it meets quality and safety standards.”

Johnson & Johnson is also focusing on working on getting other companies up to speed to take over completely once Ben Venue’s production goes off line for good.

“That takes some time,” said Johnson & Johnson spokeswoman Lisa Vaga. Issues such as site preparation, transfer of technology, equipment and process validation and, finally, a review and approval by the FDA all must take place, she said.

The company is pursuing multiple suppliers; citing confidentially agreements, Vaga would not name any of the potential suppliers.

The lawsuit that Johnson & Johnson filed against Boehringer Ingelheim and Ben Venue in September was “taken to make sure they meet their contractual obligations” to supply Doxil, Vaga said.
To that end, Boehringer Ingelheim spokeswoman Marjorie Moeling said in an email that it is “exploring strategic options" to try to continue supplying patients with the drugs manufactured at Ben Venue on a long-term basis.
“In the meantime, Bedford [Labs, a division of Ben Venue] will continue to market the company’s portfolio of available products, including those medicines manufactured by Ben Venue prior to ceasing production.”

Waggoner of UH said he's not so sure that will happen, at least with Doxil.

Other pharmaceutical companies are conducting clinical trials with other Doxil-like drugs, he said. Having another company step up to make the Doxil brand is a huge undertaking -- and probably not profitable, given the competition, he said.
"I don't anticipate new Doxil being made in, perhaps, forever," he said. 

http://www.cleveland.com/healthfit/index.ssf/2013/10/ben_venue_shutdown_will_cause_doxil_drug_shortage_but_similar_cancer_drugs_available.html

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