Ben Venue lengthens remediation timeline

Ben Venue Labs is extending the timeline for remediation at an Ohio plant—and along with it the expected availability of some critical drugs currently in short supply. The company made the announcement late last month.

Timeline extensions are common in major plant remediation efforts (Genzyme and Johnson & Johnson ($JNJ) are two examples). One reason is that an internal assessment of the scope of GMP issues—typically a first step in remediation—continues after the manufacturer has announced its shutdown or newly constrained production. Problems inevitably are larger than first anticipated, when executives may still hold a glimmer of optimism.

Ben Venue, which has continued limited production of some of the more critical drugs it manufactures for such pharma companies as J&J, said in the announcement that it can no longer simultaneously "continue to manufacture and remediate," under the scrutiny of the FDA and other drug regulators.  Instead, the company will focus solely on its manufacturing issues.

Top of the list appears to be the North facility, one of several plants at the Bedford, OH, site. Several sterile injectables that are in short supply are manufactured there, according to the statement. Among them is J&J cancer drug Doxil, the shortage of which has led to 1,000 wait-listed patients, reports Dow Jones.

The North facility needs "major reconstruction" that may stretch 9 months. "We anticipate that no products manufactured in the North facility will be available...before the fourth quarter of 2012," the statement said.

J&J said it will pursue "other options" to bring Doxil back to patients, "including shifting production to another supplier," according to Dow Jones.

Not all of Ben Venue's clients are in the same bind, however. Millennium CEO Deborah Dunsire said regulators' concerns last fall were enough for her transfer Ben Venue's share of the manufacturing of cancer drug Velcade to the two other suppliers she uses, according to Mass High Tech. The upshot: no interruption in supply, despite recalls in the U.S and Europe.

- see the Dow Jones story (sub. req.)
- here's the announcement
- see the Millennium story

Related Articles:
J&J releases Doxil batch; Ben Venue troubles detailed in FDA report
Europe issues 2nd recall of drugs made by Ben Venue
Theravance MRSA drug a victim of Ben Venue shutdown
Genzyme reports batch disposal; lengthens remediation time
J&J quantifies manufacturing woes in financials

Suggested Articles

Recipharm has been building its capabilities in sterile injectable and inhalation drugs. Now it is buying a CDMO that manufactures devices for both.

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.

GSK expects Shingrix supplies to rise slightly in 2020, but the real "step change" will come in 2024 with a brand-new manufacturing facility.