Biotech Values

[DewDiligence]

NVS’ Malaria NDA Is Mostly About Vouchers

[This is my own headline, not the one from Reuters.]

http://www.reuters.com/article/marketsNews/idINN0334690820081203

›Wed Dec 3, 2008 5:50pm EST
By Susan Heavey

SILVER SPRING, Md., Dec 3 (Reuters) - Swiss drugmaker Novartis AG's widely-used malaria drug, Coartem, appears safe and effective for use in the United States, a U.S. advisory panel overwhelmingly said on Wednesday.

Although of limited U.S. application, the company could get a more profitable prize in the form of a special Food and Drug Administration voucher allowing it to receive a speedier review for any other experimental drug.

Malaria, found mostly in warm, developing areas, is not a big problem in the United States, where about 1,500 cases are reported each year. As many as 500 million cases occur worldwide, U.S. government estimates show.

While a number of outside advisers on the U.S. Food and Drug Administration's panel expressed concern about the lack of data on how the drug would work in the U.S. population, the severity of malaria outweighed those reservations, they said.

"We do have an immediate need for this drug," said panel member Martin Wolfe, a professor at two medical schools in Washington.

Novartis is seeking FDA approval to market Coartem in the United States. The drug is already used to treat millions of malaria patients in other countries, mostly those in Africa and Asia where the mosquito-borne disease is prevalent.

The FDA will weigh the panel's recommendation before making its final decision, expected to come by Dec. 26.

…Novartis has said FDA approval could benefit Americans who travel abroad to areas with high malaria rates, as well as visitors to the United States who come from such areas.

But Merrill Goozner, head of the Center for Science in the Public Interest's Integrity in Science Project, said that, even if the drugmaker charged 100 times Coartem's global price for its U.S. version, it would reap less than half a million dollars.

But the company could get a profitable prize in the form of a special FDA voucher that would allow Novartis to receive a speedier 6-month review for any other experimental drug rather than a typical review that can take 10 months or longer.

That could allow a potentially more profitable medicine to reach the U.S. market sooner. The company could also sell the voucher to another drugmaker, fetching millions, Goozner said.

"It will have market value," he told the panel.

Congress granted such vouchers for new drugs that treat tropical diseases in a 2007 law. After the meeting, FDA officials said the agency would decide whether to give Novartis a voucher when it makes its approval decision.

Novartis denied it was seeking U.S. approval just for the voucher, saying it began the process in 2006 before the law.

"Those two decisions are completely unrelated," said Mathias Hukkelhoven, the company's senior vice president for global regulatory affairs. Coartem is generally provided at cost for needy countries at an average of 80 cents per day, company spokesman Peter Shelby said.

Other malaria treatments are already approved in the United States, including GlaxoSmithKline Plc's Malarone, but Coartem is the first artemisinin-based combination therapy (ACT) to be considered.

ACTs are considered the standard of care, and Coartem is the drug of choice for the World Health Organization, Novartis told the panel. Coartem also provides another option when drug-resistance with other medications is a problem, it said.

While Coartem has been approved elsewhere since 1998, panelists said there is not enough data on its use in children, pregnant or lactating women, the elderly or the obese.

Panel members were particularly concerned about children, who in clinical trials experienced vomiting, diarrhea, cough and other side effects, and said they needed more study.

"To me, it's a big hole," said panelist Archana Chatterjee, a pediatrician at Creighton University School of Medicine in Nebraska.

If the FDA approved the drug, it should require Novartis to collect additional data on those populations as well as possible drug interactions, the panel said.‹