Article preview from "The Pink Sheet" November 3, 2010
The pandemic influenza situation is leaving the biopharmaceutical industry in a healthy state - with early reports of vaccine sales having notable impact on manufacturers' bottom lines, revitalization for waning antiviral products and accelerated pathways for novel products. Read on...
H1N1 Vaccine Update: Big Sales To Come In Fourth Quarter, Mfrs. Say
The pandemic influenza situation is leaving the biopharmaceutical industry in a healthy state - with early reports of vaccine sales having notable impact on manufacturers' bottom lines, revitalization for waning antiviral products and accelerated pathways for novel products.
The full impact of flu vaccine sales is still emerging. AstraZeneca is the only vaccine maker to have reported direct sales for the third quarter, and the recent round of third-quarter sales and earnings calls brought news that most H1N1 vaccine sales revenue will be realized in the fourth quarter of 2009 and first of 2010. But increased demand for the seasonal vaccine and accelerating production of H1N1 vaccines are indicators that both types of products will be quite lucrative for the companies involved.
The pandemic also means better positioning of antivirals. Worldwide stockpile efforts are giving GlaxoSmithKline's Relenza (zanamivir) a stronger showing against the market leader, Roche's Tamiflu (oseltamivir), and unmet need prompted FDA to allow BioCryst's investigational I.V. antiviral peramivir to the market through an emergency use authorization.
Shortage Should Be Short, HHS' Sebelius Says
Lower-than-anticipated virus yields to date, and glitches in the additional production lines that were put in place to deal with the pandemic, have resulted in a slower than anticipated release of the H1N1 vaccine supply. But despite general concerns for the public and public health officials' handling the shortage, the process is going fairly smoothly on the industry side.
The sharp up-tick in production was the major theme of an Oct. 28 media call with Department of Health and Human Services Secretary Kathleen Sebelius. "The growth rate is really now much more robust as companies change to other strains that we're growing at a faster pace," - meaning coming months should bring hefty returns to the four companies with FDA-approved H1N1 vaccines: AstraZeneca, Novartis, Sanofi Aventis and CSL Behring.
AstraZeneca is the only firm that has not been held back by low-yield strain issues: its subsidiary MedImmune produces the only live-attenuated vaccine.
During the Oct. 28 call, Sebelius along with Department of Homeland Security Secretary Janet Napolitano acknowledged the public's frustration with the vaccine shortage while reiterating the agencies' good-news talking points: that the virus has not mutated; that the approved products are safe, effective, and in most cases require only one dose of vaccine rather than two; and that though the virus itself is novel, the production process is not - the products were approved by the same strain change process by which FDA clears new strains of the seasonal vaccine each year.
Though production has gone more slowly than anyone would have liked, the supply to states is steadily growing, with 150,000 sites now ready to receive the vaccine, and, as of Oct. 28, 23.2 million doses available, 9 million of which were produced in the last week. All 50 states and territories have placed an order, and the doses are allocated on a per capita basis.
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