From Soup to MS Drug: One Fungus’s Journey – BusinessWeek

Tetsuro Fujita’s eureka moment about a Himalayan fungus came in 1985. As the scientist was driving over a bridge between Japan’s Shikoku and Honshu islands on his way to conduct research on traditional herbal remedies, Fujita was contemplating ways to keep patients’ immune systems from rejecting transplanted organs. He was particularly intrigued by the example of a parasitic fungus used in a Chinese medicinal soup. Known in Asia as “winter insect, summer plant,” the Cordyceps fungus invades an insect larva during winter, feeds on it for months, and then grows out of the host by summer. Fujita suddenly realized that the fungus must be suppressing the immune system of the insect larvae on which it grew to maturity.

His research on Cordyceps at Kyoto University eventually helped Japanese drugmaker Mitsubishi Tanabe Pharma produce Gilenya, a treatment for multiple sclerosis that Novartis #NVS# licensed and began selling in the U.S. in October. UBS #UBS# says annual sales of the medicine, the first pill to treat the autoimmune disease afflicting more than 2 million people worldwide, may exceed $5 billion annually by 2018. That would rank it among the 10 best-selling drugs worldwide, based on data from researcher IMS Health. Mitsubishi Tanabe will likely book royalties equivalent to 10 percent of sales, based on the median of estimates by four analysts surveyed by Bloomberg News.

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Novartis Gilenya MS Pill to Cost $48,000 a Year – Bloomberg

Talking about Novartis Gilenya MS Pill to Cost $48,000 a Year – Bloomberg

Novartis AG’s multiple sclerosis pill Gilenya will cost $4,000 a month in the U.S., according to a company spokesman.

Novartis has set a wholesale price at about $48,000 annually, Eric Althoff, a spokesman for the Basel, Switzerland- based company, said by e-mail. The company has programs to help patients with the cost of the drug, he said.

FDA weighs benefits, risks of Novartis MS pill

The Associated Press: FDA weighs benefits, risks of Novartis MS pill

Swiss drugmaker Novartis has asked the Food and Drug Administration to approve its drug Gilenia to treat patients with relapsed multiple sclerosis, which causes tremors and movement problems. The drug is a daily pill and would offer an alternative to older injectable drugs.

FDA reviewers said two studies of the drug “provide substantial evidence for an effect.”

However, FDA staff also noted a number of side effects with the drug, including eye disorders, heart problems and weakened lung function.

Serious side effects occurred in at least 8.5 percent of patients taking Novartis’ drug, compared with 5.8 percent of patients taking older multiple sclerosis drugs.

FDA reviewers complained that there was little data on the long-term effects of using Gilenia.