UPDATE: Ben Venue To Exit Drug Contract Manufacturing Business
A Boehringer Ingelheim GmbH plant that has caused shortages in
drug supplies will exit the pharmaceutical contract-manufacturing
business, as it faces a Canadian ban on the importation of some of
Boehringer's Ben Venue Laboratories unit, which manufactures
injectable and inhaled drugs for major companies including Pfizer
Inc. (PFE) and Johnson & Johnson (JNJ), will exit the
contract-manufacturing business in a transition over the next
several years, spokesman Jason Kurtz said Friday. Ben Venue is
making the move to simplify its business model and focus on its
Bedford Laboratories generics business.
The move could compound recent drug shortages affecting numerous
manufacturers, which have forced some U.S. hospitals to ration or
restrict use of certain drugs, and sent patients on a hunt for
pharmacies with drugs in stock.
Ben Venue, which operates a plant in suburban Cleveland, will
work with its customers to minimize supply disruptions. Other
divisions of Germany's Boehringer Ingelheim will continue to
perform contract-manufacturing services, Kurtz said.
Canada's drug regulator, Health Canada, this week restricted
imports of certain drugs made at Ben Venue's Ohio plant after
identifying manufacturing deficiencies there, which the regulators
said could affect product quality, according to a notice posted
As a result, Health Canada only will allow the importation of 17
drugs treating serious or life-threatening conditions that are
manufactured at the Ben Venue plant, for which there are no
feasible alternatives. These include Pfizer's Torisel kidney-cancer
treatment; Velcade, a multiple-myeloma treatment co-marketed by
J&J and Takeda Pharmaceutical Co. (4502.TO, TKPYY); and
Bristol-Myers Squibb Co.'s (BMY) BiCNU cancer drug.
Health Canada said it hasn't identified any specific risk to
health as a result of the manufacturing deficiencies at Ben Venue's
The regulator didn't identify in its online notice which Ben
Venue-manufactured drugs won't be allowed into Canada; an agency
spokeswoman didn't immediately have that information.
In addition, European regulators have limited the import of
drugs made at Ben Venue's plant to certain medically necessary
products, said Ben Venue spokesman Kurtz.
Problems at the Ben Venue plant have contributed to a supply
shortage of J&J's Doxil treatment for ovarian cancer and
multiple myeloma. Ben Venue said in July that it was experiencing
manufacturing capacity restraints causing shortages for some
products, which forced J&J to advise doctors not to start new
patients on Doxil until the supply shortage could be resolved.
J&J spokeswoman Lisa Vaga said the company will transition
to another contract manufacturer, and that during the transition,
Ben Venue has committed to giving highest priority to ensuring
access to important drugs such as Doxil. J&J doesn't expect
Velcade supply in Canada to be affected.
Pfizer spokesman MacKay Jimeson said the company has been
working with Health Canada to obtain approval for another
manufacturer to supply an ingredient for Torisel, and that it's
monitoring the situation to ensure patients have access to the
A Bristol-Myers spokeswoman declined to comment.
A list of the Ben Venue-manufactured drugs that will be allowed
into Canada can be found here:
The trade publication Contract Pharma reported Ben Venue's
decision to exit the contract-manufacturing business Thursday.
-By Peter Loftus, Dow Jones Newswires; +1-215-982-5581;
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