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Study: Fluzone High-Dose works well in senior population

BY Michael Johnsen

SWIFTWATER, Pa. — Sanofi Pasteur, the vaccines division of Sanofi, released data from a new study examining the ability of its Fluzone High-Dose vaccine to provoke an immune response in elderly and younger adults, compared with a standard dose of Fluzone vaccine.

"The results further support the immunogenicity advantages of Fluzone High-Dose vaccine as compared to Fluzone vaccine, the standard dose comparator, in seniors 65 years of age and older," stated Peter Tsang, director clinical development, Sanofi Pasteur.

Fluzone High-Dose vaccine was licensed by the Food and Drug Administration in December 2009 for adults ages 65 years and older because the vaccine addressed an unmet medical need. People older than 65 years of age have the highest rates of hospitalization and death from influenza and its complications, despite having among the highest immunization rates against influenza. The immune response of people ages 65 years and older to the traditional flu shot is substantially lower than that of younger people. Thus, Fluzone High-Dose vaccine was developed to generate a more robust immune response in the senior population.

In the multicenter trial, 639 subjects between the ages of 65 and 96 were randomized to receive one standard dose of Fluzone vaccine or Fluzone High-Dose vaccine and 186 younger adults ages 18 through 49 years received Fluzone vaccine. Both influenza vaccines were formulated with the influenza virus strains for the 2007-2008 season and contained A/Solomon (H1N1), A/Wisconsin (H3N2) and B/Malaysia.

Hemagglutination Immunization antibody titers were measured before and 28 days post-vaccination.

Among those ages 65 years and older, statistically significantly higher antibody responses were induced by Fluzone High-Dose vaccine compared to Fluzone vaccine. Administration of Fluzone High-Dose vaccine in people over the age of 65 years enhanced the antibody response to levels similar to, and for some parameters higher than, those observed in younger adults receiving the standard dose of Fluzone vaccine.

The data were presented at the 49th Annual Meeting of the Infectious Diseases Society of America.


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Walgreens/Express Scripts dispute adding fuel to merger fire

BY Michael Johnsen

WHAT IT MEANS AND WHY IT’S IMPORTANT — It’s been another busy week on the Walgreens/Express Scripts front as an arbiter ruled against preliminary injunctive relief in time for the 2012 Medicare open enrollment period, which actually started last week. What’s more, other parties are beginning to weigh in on the dispute, notably in favor of Walgreens.

(THE NEWS: Preliminary injunctive relief denied in WAG/ESI dispute. For the full story, click here.)

Thomas Engels, VP public affairs of the Pharmacy Society of Wisconsin, wrote in to the Wisconsin daily, the Herald Times Reporter, expressing a thought that a lot of people have been thinking of late — if one of the largest pharmacy chains in the country can’t swallow Express Scripts’ reimbursement terms, what does that mean for small chains and independents that don’t have near the economies of scale enjoyed by Walgreens?

That becomes even a greater concern when you consider Express Scripts’ proposed merger with Medco. Groups like the National Community Pharmacists Association have been very vocal in opposing that merger, suggesting that the resulting mega-PBM would push many independents into early retirement.

And the Preserve Community Pharmacy Access NOW! coalition on Oct. 19 added its voice to that issue — charging that an ESI-Medco PBM would also mean increased healthcare costs and reduced access for patients. 

Taken together, the dispute around Walgreens’ refusal to accept Express Scripts’ proposed reimbursement rates and the number of groups and organizations climbing the closest mountain top to voice their opposition to that ESI-Medco merger, the Walgreens/ESI battle is serving to  fan the flames around the ESI-Medco merger and what that would mean for retail pharmacy. 

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BBU to acquire Sara Lee’s North American fresh bakery business

BY Allison Cerra

HORSHAM, Pa. — Bimbo Bakeries USA announced that its parent company, Grupo Bimbo, will acquire the North American fresh bakery business of Sara Lee.

As part of the transaction, BBU will have to divest certain Sara Lee brands in certain markets. These include: the Sara Lee and EarthGrains brands in California; the Holsum and Milano brands in central Pennsylvania; the EarthGrains and Mrs Bairds brands in Kansas City; the EarthGrains and Healthy Choice brands in Omaha and the EarthGrains brand in Oklahoma City.

The announcement comes after the deal was approved by the Department of Justice.

"This is an exciting day for the customers, consumers and associates of both businesses," BBU president Gary Prince said. "We will soon be able to begin the important work of creating the new BBU — a U.S. bakery business serving the highest quality products to every market in America and providing the best value to our customers and consumers."

The transaction is expected to close Nov. 5.

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