Roche Says Counterfeit Cancer Drug Avastin Being Investigated by U.S. FDA

Roche Holding AG (ROG) is working with U.S. authorities to determine the source of counterfeit Avastin, purchased by at least 19 medical practices in the U.S.

Roche and the Food and Drug Administration are seeking to prevent the fake cancer drug, which doesn’t include the active ingredient bevacizumab, from being distributed further, the company’s Genentech unit said in an e-mail late yesterday. The FDA notified the company about the issue in December, said Edward Lang, a spokesman for Roche’s South San Francisco, California-based unit.

“We’re working with the FDA, as well as with law enforcement authorities to aid in their investigation,” Lang said today in an interview. “We’ve analyzed some of the vials, we found no therapeutic protein there. So there’s no Avastin, there’s no generic form of Avastin.”

The labels on the counterfeit medicines aren’t all in English, and list Basel, Switzerland-based Roche as the manufacturer, unlike the real version of Avastin sold in the U.S. which lists Genentech, the FDA said in a statement.

The medical practices bought “unapproved cancer medicines” from Quality Specialty Products, a supplier based outside the U.S. whose products are distributed by Gainesboro, Tennessee-based Volunteer Distribution, the FDA said. No one answered at the telephone number listed for Volunteer Distribution in a local directory.

Clinic Locations

Most of the medical doctors and clinics that bought the fake medicines are in California, with two in Texas and one in Chicago, according to a list from the FDA.

The Beverly Hills Cancer Center was one of the practices that purchased drugs from Quality Specialty Products, which is also known as Montana Health Care Solutions, the FDA said. The center is checking its records to see if Avastin was included in its purchase from the supplier, Tracey Butler, the center’s director of operations, said in an e-mail.

“We believed that the drugs were legal and approved and only recently learned from the FDA that some of the drugs may have been counterfeit or unapproved,” Butler said. “To date, the center has identified no adverse effects for any of its patients who may have received drugs purchased from MHS.”

Avastin is approved for colon, lung, kidney and brain cancer in the U.S., as well as for breast cancer in Europe. Sales of the drug fell 18 percent last year to 5.29 billion Swiss francs ($5.73 billion) from 2010, according to data compiled by Bloomberg.

The agency said last month it was probing the sale of unapproved versions of Roche’s cancer drugs Rituxan and Herceptin, London-based AstraZeneca Plc (AZN)’s Faslodex for breast cancer and Thousand Oaks, California-based Amgen Inc. (AMGN)’s Neupogen, a drug used to reduce the risk of infection in chemotherapy patients.

To contact the reporters on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net; Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net; Reg Gale at rgale5@bloomberg.net

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