NEW YORK -- As many Chicken Little stories as there are about the potential for an avian flu pandemic, the apparent public concern is expected to have little impact on vaccine or antiviral sales for this season. "Unless human cases of avian flu appear in the United States, the effect overall [of all the avian flu news accounts] will be minimal," commented Gerald Kress, chief executive officer of Surveillance Data. "It will heighten awareness of influenza ... [consequently] you may have a slight increase in the number of people getting flu shots, but we really don't think it's going to have a major impact on that at all."
And while there have been reports of government stockpiling of such antivirals as Roche's Tamiflu or GlaxoSmithKline s Relenza, it currently is not being replicated by the industry.
Spokesmen for both CVS and Walgreens commented that consumer demand for antivirals is not out of the ordinary for this time of year. And, while chain drug's two largest retailers are not increasing inventory stock levels of the antivirals, they are monitoring the situation closely.
It s a little premature, noted Michael Polzin, Walgreens spokesman. There s been a lot of media hype, and the government is looking into preventative measures that could possibly be put into effect. But, at the same time, they're also making it clear that they have no reason to believe an outbreak will occur this winter, as opposed to next year or the next 50 years. It's all very precautionary at this point."
Still, Walgreens executives are watching carefully, Polzin said. "We. want to be an active participant in any planning measures," he said.
"Based on our conversations with [Roche], we're not anticipating a shortage," added CVS spokesman Michael DeAngelis, who also noted that the chain is keeping a close eye on potential avian flu developments.
Certainly, the U.S. government seems a bit more worried and has begun to stock up anti-flu medication in case the flight of avian flu arrives sooner than anticipated. "Thus far, the U.S. as 4.3 million treatment courses--two capsules a day for five days," Roche spokesman Terry Hurley told Drug Store News. "[U.S. Department of Health and Human Services] Secretary [Michael] Leavitt has announced plans to purchase 20 million treatment courses, and Roche continues to have discussions with them."
According to published reports, HHS also recently purchased $2.8 million worth of GlaxoSmithKline's Relenza.
Sales of Tamiflu are up 6.5 percent headed into the 2005-2006 flu season, according to IMS Health sales figures, reaching $83 million for the seven months ended in July. "We have seen an increase in prescriptions versus [the] same time last year, and off-season prescriptions are up," Hurley said--and all this before the flu season has begun.
GlaxoSmithKline, meanwhile, has invested $2 billion to expand the company's flu vaccine manufacturing capacity and to increase the production of the antiviral Relenza. Sales figures for Relenza were unavailable. "Currently, pandemic concerns have increased demand for, available supplies of Relenza, GlaxoSmithKline noted earlier this month.
ImmuneRegen BioSciences is testing Viprovex, an antiviral medicine that has been used to treat other strains of influenza in animal models.
And such companies as FlavoRx also are preparing for an increase in demand that avian flu may generate. FlavoRx is testing flavor-enhancing formulations in Thailand for the antiviral drugs that will be necessary for recovery if a pandemic hits, the company announced earlier this month.
The government is placing an emphasis on potential preventative measures, as well. Earlier this month, President George W. Bush met with several chief executives of pharmaceutical companies in the vaccine business to review preventative options in the event of a pandemic. "I'm not predicting an outbreak," the president said in a recent press conference. "I'm just suggesting ... that we better b-e thinking about [preparing for a potential pandemic]."
While the risk of bird-to-human transmission is minimal, there is a concern that the bug could mutate more quickly than anticipated, and that could put a real wrinkle in the current timeline for when a vaccine might be available. "The scientific community's biggest fear is that before a vaccine is available, the avian flu strain will mutate to where it can infect people more readily or become transmissible from person to person," stated ImmuneRegen chief executive officer Michael Wilhelm.
In a presentation to the American Health Information Community earlier this month, Leavitt reiterated his sense of urgency in finding a solution to a potential avian flu outbreak. "The virus is spreading rapidly among poultry," he said. "To date, more than 115 humans have been infected, and half of them have died. We have no pre-existing immunity to this deadly virus."
Leavitt is pushing for an early warning detection system in area emergency rooms to be put in place by the end of 2006.
As for vaccine development, Sanofi-Aventis is developing a pandemic influenza vaccine, with trials beginning in Norway this spring. Sanofi was awarded a $97 million contract last April from HHS to speed the production process for new cell-culture influenza vaccines. Sanofi hopes to initiate U.S. clinical trials next September. As part of the contract, Sanofi Pasteur will deliver a feasibility plan for constructing a U.S.-based and licensed cell-culture production plant for supplying up to 300 million influenza vaccine doses annually.
GlaxoSmithKline also has a prototype pandemic vaccine in development, H5N1, named for the chemical name of the deadly flu strain. The prototype uses an adjuvant, which may boost the body's immune response to the vaccine and allow for lower doses to be used, which would be essential for treating large populations in a pandemic. GlaxoSmithKline's clinical trials with the H5N1 flu strain are planned for 2006.
GSK is investing likewise in the development of new vaccine production technologies. It recently acquired a vaccine plant in Marietta, Pa., from Wyeth that will become a primary development and production center for tissue-culture technology used to create the next generation of flu vaccines, GS stated. Tissue-culture technology could eliminate dependence on chicken eggs, thereby increasing the efficiency and speed of manufacturing, which would be critical in a pandemic, the company added.
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