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NEW YORK -- While few experts expect the bird flu to take wing in the United States in time to impact this year's cold and-flu season drastically, the federal government and the global pharmaceutical community continue to ramp up preparedness for a potential avian flu pandemic.

Late last month, the Food and Drug Administration announced the formation of a "rapid response team." Meanwhile, Roche, manufacturer of the highly popular antiviral Tamiflu, has agreed to license the formula to generics suppliers--provided they only manufacture stockpile reserves for use in the event of an actual pandemic, that is.

Roche reportedly is meeting with industry officials from Taiwan, which according to published reports, has replicated a Tamiflu equivalent in as little as 18 days and will be preparing to manufacture the generic antiviral with or without a license from Roche. However, country officials indicated they would prefer to operate with a Roche license.

In October, Roche made a relative about-face with regard to licensing generic production of Tamiflu. Just weeks ago, the company sought to block patent infringement of its top-selling prescription flu treatment. Now it is willing to entertain specific licensing arrangements for the generic production of Tamiflu explicitly for use in an emergency pandemic situation.

"For Tamiflu, the key need today is the rapid expansion of production capacity. Patients' needs in case of a pandemic remain our top priority. We have already significantly expanded production capacity internally and by working in close collaboration with other companies, and we will continue to do so," William Burns, chief executive officer of the Roche Pharma division, stated last month. "We are prepared to discuss all available options, including granting sublicenses, with any government or private company who approaches us to manufacture Tamiflu ... provided such groups can realistically produce substantial amounts of the medicine for emergency pandemic use, in accordance with appropriate quality specifications, safety and regulatory guidelines."

Already, India-based generics manufacturer Cipla reportedly has broken the Tamiflu code and is preparing production of the antiviral. And under the urging of Sens. Chuck Schumer, D-N.Y., and Lindsey Graham, R-S.C., Roche has agreed to meet with officials from Barr, Mylan, Ranbaxy and Teva.

Roche has graciously stepped up to the plate and has essentially agreed to share its technology and the rights to manufacture this drug with other companies who are willing to help out," Schumer told reporters with regard to the potential meeting.

"It has come a great distance in the best interests of the global public health, truly dedicating their efforts to protecting human life rather than focusing on their bottom line."

Roche s Canadian division has gone to such lengths as to limit distribution of Tamiflu in Canada, according to published reports, mirroring the company's position in Switzerland. According to a letter sent by Roche Canada to local pharmacies and obtained by a Canadian newspaper, the division has ceased distribution of Tamiflu until the flu season starts and will prioritize shipments to nursing homes and other direct care facilities when the flu season picks up in December. It also reported cases of Tamiflu hoarding north of the border. There have been reports that early demand for Tamiflu in the United States is unseasonably high, also suggesting individual stockpiling may be occurring here.

Morgan Stanley analyst David Moore has projected worldwide year-end 2005 Tamiflu sales at $1.1 billion, up from $330 million in sales in 2004. Next year, sales are projected to reach $1.2 billion.

Meanwhile, the FDA is working to make sure the United States is prepared. "While there is no current flu pandemic," the FDA stated, the new rapid response team "will help ensure an adequate supply of treatments, such as ... Tamiflu and other anti-influenza drugs, for stockpiling in the event there is an outbreak." The FDA has put procedures in place that could turn around a complete drug. application within six weeks to eight weeks and could streamline ample Tamiflu production within 12 months, if needed.

Currently, the U.S. government is reported to have enough Tamiflu in reserve to treat 4.3 million Americans.

"FDA has the best scientific minds working together to ensure we have enough Tamiflu and other medications and [that we can] quickly get it to doctors and patients," stated acting FDA commissioner Andrew von Eschenbach.

In the event of an avian flu outbreak, the FDA also is anticipating counterfeiting. "Currently, the agency is not aware of any counterfeit Tamiflu cases in the United States; however, there are initiatives in place to deter counterfeiters and parties who sell fraudulent or phony products," the agency stated.