Pharma in brief

24 October 2005 00:01  [Source: ICB Americas]

Avian flu vaccine en route

Nobilon International, the vaccines arm of Akzo Nobel, in conjunction with the Organon, the human healthcare business of Akzo, is developing a vaccine against the H5N1 strain of the avian flu virus. Nobilon was recently licensed to manufacture flu vaccines for use in clinical testing at its facility in Boxmeer, the Netherlands. Clinical trials for the H5N1 vaccine are scheduled to begin next year.

“The current situation in Europe highlights the urgent need for a human vaccine against this potentially lethal infection,” says Toon Wilderbeek, Akzo’s board member responsible for pharma. “In partnership with Organon, Nobilon is working as quickly as possible to develop a pure, safe and efficacious human H5N1 vaccine of consistent quality.”

The vaccine facility in Boxmeer uses cell culture technology rather than chicken eggs, which will facilitate scale-up of vaccines production in the event of a pandemic, according to the company.

Serono pleads guilty in Marketing of aids drug

Swiss pharmaceutical major Serono has reached an agreement with the US Department of Justice over the fraudulent marketing and sale of its AIDS drug Serostim. The company has pleaded guilty to two counts of criminal conspiracy and will pay over $704 million—the largest settlement in history related to the Medicaid program, says the DoJ. According to the DoJ, Serono artificially increased the market for Serostim and offered kick-backs to doctors in return for prescribing the drug, profiting more than $90 million from the illegal activity. The company had taken a $725 million provision in April to cover the settlement, which it says will be sufficient to cover all related costs.

Pargluva approvable

Bristol-Myers Squibb Company and Merck & Co. Inc. have received an Approvable letter from the Food and Drug Administration for Pargluva, an oral treatment for type 2 diabetes. The agency asked the companies for more safety information about the cardiovascular safety profile of the drug.

Ranbaxy challenges patent on astrazeneca’s Nexium

Indian generic drug maker Ranbaxy Pharmaceuticals Inc. has filed an abbreviated new drug application with the FDA to make a generic version of AstraZeneca’s antiulcerant drug Nexium, challenging patents set to expire in 2018. Nexium, a follow-on version of Prilosec, had global sales of $3.88 billion in 2004.

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