TRENTON, N.J. (AP) — Johnson & Johnson is making more headway in restoring supplies of a crucial cancer drug unavailable to many patients since the contract manufacturer producing it, Ben Venue Laboratories, shut down a year ago due to serious contamination and other quality problems at its Ohio factory.
Access to Doxil, or Caelyx as it's called in the European Union and some other places, had been limited to existing patients since last fall amid dwindling supply. The drug treats advanced breast and ovarian cancers, the bone marrow cancer multiple myeloma and Kaposi's sarcoma, a blood vessel cancer. For many patients, it was the only effective option.
A J&J spokeswoman said Wednesday that new stock of Caelyx is now available to at least some new patients in Europe. That's after the European Medicines Agency approved an arrangement under which Ben Venue will do the initial manufacturing steps and another company will then handle sterile packaging of the injected drug into vials.
Doctors in European Union countries are being notified to use a new Internet-based ordering and reservation system for Caelyx.
"We're now slowly building up stock and we are organizing access via this online portal ... on a first-come, first-served basis," Satu Glawe, a spokeswoman for J&J's Janssen Pharmaceuticals Inc. unit, said Wednesday.
Preference will go to EU patients currently taking the drug, then to new patients without other options and finally to other new patients, she said. The company will resume supply in other countries after getting approvals there.
A week ago, Janssen ended its rationing of Doxil, known chemically as doxorubicin hydrochloride, for American patients. The company hopes to soon have approval from the Food and Drug Administration for a manufacturer to handle sterile vial filling in the U.S. for Doxil produced by Ben Venue, which makes sterile injectable drugs at its Bedford, Ohio, complex.
A subsidiary of German drugmaker Boehringer Ingelheim, Ben Venue said on Oct. 16 it had resume limiting manufacturing at the Ohio plant, where it's investing more than $300 million in upgrades. Still, most products it makes there won't be available for several more months.
The Ben Venue supply problem comes amid more than three dozen recalls by Johnson & Johnson since September 2009 for products it manufactures, from Tylenol and other nonprescription drugs to prescription medicines, contact lenses and defective hip implants.
Among the most recent recalls is one from August — just announced recently — involving three brands of staplers used in hemorrhoid and rectal surgery. According to the FDA, the devices can misfire, causing incomplete staple formation that can result in death, severe pain, bleeding, infection and damage to or blockage of the rectal canal.
Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma
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