Indian drugmakers have a shot at bringing Gilead Sciences' ($GILD) hot new hepatitis C drug to their country. The California-based company is in talks with "a handful" of Indian pharmas to take Sovaldi (sofosbuvir) to that country and other developing nations at a fraction of the U.S. price.
"We are going to give license[s] to Indian companies, so there will be Indian production of our hepatitis C product," EVP Gregg Alton told Hindu Business Line. "We hope to announce those in the next couple of months."
Sovaldi would then be available to Indian patients at a cost lower than the current standard of care with generic products, Alton told the newspaper, which is about $2,500 for 6 months of treatment. Gilead is aiming for a price on Sovaldi of about $2,000 for a treatment course, he said. The U.S. sticker price is $84,000 for a 12-week cycle.
The talks come after a preemptive strike from patient advocates as Sovaldi won approval in the U.S. The legal group I-Mak--the Initiative for Medicines, Access & Knowledge--filed an official protest against IP protection for the drug with India's patent office. Médecins Sans Frontières backed the group's decision to contest the patent, saying Indian patients will need access to the breakthrough drug, particularly because so many patients in the country are coinfected with hepatitis C and HIV. I-Mak has said that, to be truly affordable, the price on Sovaldi would have to be less than $500.
Alton told Business Line that Gilead plans to defend its patents in India, but it will be "pushing very hard" to enable generic production in the country with "multiple" companies. "We'll be substantially less than [current standards of care]," he said, adding that its Indian partners would actually set the prices. "We leave it up to the Indian companies to bring the price down, should they choose to do that," he said.
That's why Gilead wants to make deals with three to five different domestic drugmakers, he said: to create enough competition among the companies to bring the cost down. The deal would cover about 60 low- and middle-income countries, and would include royalty payments to Gilead.
It won't be an overnight process. Sovaldi still has to make its way through late-stage trials, which have been approved by Indian authorities. Alton said Gilead is trying to speed up the process. Under the usual timeline, he said, it would be at least two years before the drug could make its debut in the Indian market.
With patent authorities in India increasingly balky about IP protections on Big Pharma drugs, several drugmakers have taken steps to make their products available at lower cost. Gilead itself just inked a deal with Mylan ($MYL), the U.S.-based generics maker expanding in India, to sell its newest HIV fighters there. Roche works with a local manufacturer on versions of its cancer drugs, sold under India-specific brand names. Patient advocates, however, say that even these discounted prices are often out of reach for Indian patients.
- check out the Business Line story
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