В Индии будет создан дженерик "Совальди"
California-based drug-maker Gilead Sciences Inc is in discussions with a handful of local pharmaceutical companies to bring its much anticipated oral Hepatitis C drug Sovaldi (sofosbuvir) into India.
“We are going to give licence to Indian companies, so there will be Indian production of our hepatitis C product. We are in discussions right now. We hope to announce those in the next couple of months,” Gregg H Alton, Gilead’s Executive Vice- President, Corporate and Medical Affairs, told Business Line.
Gilead’s move comes at a time when the patent on sofosbuvir is being contested at the Kolkata patent office. The opposition was filed late last year by US-based legal group I-MAK (Initiative for Medicines, Access & Knowledge).
On how the drug would be priced, Alton said the imported and locally-made versions would be pegged lower than the current standard of care with existing generic products, estimated at $2,500 (around ₹1.5 lakh) for six months.
Gilead proposes to peg its imported branded product at about $2,000, he indicated, adding discussions were under way with patient-groups before the price is finalised. “We’ll be substantially less than that (current standards of care), and we’ll be more effective, less toxic and easier to use and without side-effects… We leave it up to the Indian companies to bring the price down – should they choose to do that,” he added.
You need three or more companies to compete against each other to truly get the cost down, and “so, we’ll be working probably with three-to-five different companies”, he said. In the US, Gilead’s drug is priced at $84,000 for 12 weeks.
Gilead’s soon-to-be sealed deal will include royalty payments and cover about 60 low and middle-income countries, he said, adding details were discussed during their latest visit to India.
Without getting into details on the patent case, Alton said: “We will defend the patents, but at the same time, we are going to be pushing very hard to enable generic production in India with multiple companies.”
By traditional timelines, it would take at least two years before the product is available in India, said Alton.
Clinical trials to test the drug on the local population have been approved and efforts are on to fast-track this process, he added.
About 15 sites have been identified to run Phase III trials on the drug, involving about 120 people.
Touted to be among “the biggest breakthroughs in medicine in the last 10 years”, Alton said the drug was launched in the US last December, and Gilead and its partners were working to bring it to India soon.