Roche boosts Tamiflu production; CDC cites signs of hoarding

Mar 16, 2006 (CIDRAP News) – Drug manufacturer Roche said today it is increasing its production capacity for the antiviral drug oseltamivir (Tamiflu) by a third this year and is keeping ahead of the demand from governments stockpiling the drug in preparation for a possible influenza pandemic.

The announcement came as US health officials reported an unusual spike in demand for flu antiviral drugs in New York City last October, probably reflecting people's attempts to build personal stockpiles amid publicity about the pandemic threat. The high demand came weeks before any seasonal flu outbreak.

Roche announced that with expansion of its own facilities and help from more than 15 partner companies, it will be able to produce up to 400 million treatment courses of oseltamivir by the end of this year, an increase of 100 million from last year.

"Roche's global network for the manufacture of Tamiflu will include several Roche sites and more than 15 external contractors located in 9 different countries around the world," the company said in a news release.

Roche well ahead of orders
Roche CEO William Burns said governmental orders and expected orders of oseltamivir over the past 2 years and stretching into 2007 total about 200 million treatments, according to an Agence France-Presse (AFP) report published today.

"We have a capacity well in excess of total government orders placed to date," he was quoted as saying. "There should be no holding back [on orders] in the belief that we do no have sufficient supply."

Burns warned that a shortage of orders could force Roche to reduce production in the future, AFP reported. "We can't be sitting here like a Walmart to the world, with stock in the warehouse," he said.

In the news release, Roche said it has chosen production partners "primarily on the basis of their ability to produce substantial quantities of the intermediates and finished materials in accordance with Roche's quality standards in a relatively short time frame."

The companies involved in production, the statement said, include Albemarle, Ampac Fine Chemical LLC, API Corp., Clariant, DSM, FIS, Martek Biosciences Corp., Novasep/Dynnamit Nobel, PHT International, PPG Industries, Sanofi Aventis, Shaanxi Jiahe Phytochem Co., and Siegfried Ltd.

Roche granted sublicenses last year to Hetero and Shanghai Pharmaceuticals for complete production of oseltamivir. In addition, the company is in final negations to grant a sublicense to another Chinese company, officials said.

The company said it has received and filled pandemic stockpile orders from more than 65 countries. According to the AFP report, the firm has donated 1.5 million treatment courses to the World Health Organization and will be delivering another 1.5 million within weeks. Another 2 million courses will be given for a stockpile in Asia later this year, the story said.

Evidence of hoarding in New York City
Meanwhile, the Centers for Disease Control and Prevention (CDC) reported today that sales of flu antivirals soared in New York City in the last week of October 2005, 7 weeks before any flu cases were confirmed in the area. The agency said the spike in sales probably signaled personal stockpiling by people worried about a flu pandemic.

The sales data came from New York state Medicaid records and from a retail pharmacy chain that reports certain prescription drug sales to the New York City Department of Health and Mental Hygiene, according to an article in the Mar 17 Morbidity and Mortality Weekly Report. About 34% of New York City residents receive Medicaid benefits, the article says.

The sales data show a major spike in the week of Oct 23 through 29. The pharmacy chain sold almost 1,000 prescriptions of the four available flu antivirals—oseltamivir, zanamivir, amantadine, and rimantadine. The Medicaid records showed close to 400 prescriptions for oseltamivir, zanamivir, and rimantadine. (Medicaid excluded amantadine from the flu category because it is also prescribed for Parkinson's disease.)

In previous years, strong sales of flu antivirals coincided with peaks in confirmed cases of flu, the CDC reports. But the October sales boom came 7 weeks before the first lab-confirmed flu cases in the New York area were reported in mid-December, the agency says.

The sales boom came amid heavy publicity about both avian and pandemic influenza. Romania, Russia, and China were reporting outbreaks in birds at the time, and the federal government was about to release its pandemic preparedness plan.

"Increased media attention to avian influenza in Asia and the resulting public concern might have produced the unprecedented demand for antiviral influenza medications in NYC before the start of the influenza season," the article says.

"These findings suggest that persons requested and/or their health-care providers prescribed antiviral influenza medications to create personal stockpiles for use in the event of an outbreak of avian influenza or an influenza pandemic."

The report notes that public health agencies and medical societies have discouraged healthcare providers from prescribing antiviral drugs for personal stockpiles, since global supplies are limited. But most of those recommendations were issued after the October sales spike, it says.

Oseltamivir treatment in Turkish patients
Oseltamivir and the other neuraminidase inhibitor, zanamivir (Relenza) are generally seen as the first line of defense if H5N1 avian flu evolves into a human pandemic strain, though there is no guarantee they would be effective.

According to today's AFP story, Roche officials reported that 17 H5N1 patients in Turkey who received early oseltamivir treatment survived, while four patients who were treated late died. Treatment recommendations say that flu patients must take the drug within the first 48 hours of illness to benefit from it.

See also:

Mar 16 Roche news release
http://www.roche.com/med-cor-2006-03-16

Mar 16 MMWR article "Increased antiviral medication sales before the 20506 influenza season—New York City"
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5510a3.htm

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