Just days after Gilead COO John Milligan told investors to expect negotiations for its hep C franchise to unfold very quickly in Europe, Germany has said it has a deal to buy Sovaldi at €41,000 for a 12-week course. That is deeply discounted from the initial price of €56,500 with which the company started.
Merck's not the only big player in the hepatitis C competition to face losing bragging rights to the FDA's "breakthrough" drug designation for a late-stage program. It turns out that Bristol-Myers Squibb, another laggard in the race to hatch new therapies for the virus, also finds its daclatasvir on the FDA's chopping block.
Gilead Sciences might have expected a hepatitis C patent challenge in India. But in Europe? Not so much. But that's exactly what Gilead is getting. After losing its bid for a new Indian patent covering its blockbuster treatment Sovaldi, Gilead is now threatened with a similar action at the European Patent Office in Munich.
Now that AbbVie has followed up on Gilead's game-changing combo with its own directly competitive hep C cocktail, Merck's late-stage player in the field doesn't look quite as revolutionary as it once did. With a new drug application being prepped for a near-term filing, the FDA has decided to drop its breakthrough therapy designation for Merck, possibly slowing the Big Pharma's marketing timeline a bit.
Gilead Sciences racked up another point in the pricing battle with its hep C rival AbbVie as UnitedHealth Group chose Harvoni as its preferred hepatitis C treatment over AbbVie's Viekira Pak, weeks after Gilead scored deals with three insurers to make Harvoni the primary option for patients.
SINGAPORE-- Undeterred by its loss of a new patent bid for its Sovaldi (sofosbuvir) hepatitis C drug in India, Gilead Sciences put together package deals with 8 of the country's generics makers to add an experimental drug to a deal for low-cost copies in 91 poor countries around the world. Meanwhile, Gilead said Sovaldi won marketing approval this month in India and it's off and running in that country.
Gilead Sciences reportedly inked its first hepatitis C discount deals in Germany, and it's announcing a new offer to bring a Sovaldi follow-up to India even before it's approved in the U.S.
Merck will stop selling Victrelis in the U.S. by the end of this year. The company cites "advances in treatment practices"--namely, the new all-oral drug cocktails offered by Gilead and AbbVie--and the shrinking demand they've caused.
The hepatitis C market is breaking new ground all over the place. As payers put the squeeze on Gilead Sciences and AbbVie for discounts in the U.S., England's National Health Service is delaying a broad rollout of Gilead's blockbuster Sovaldi till July, citing the drug's high cost--an unprecedented move on a treatment already blessed by the country's cost-effectiveness watchdogs.
AbbVie has won European Commission approval for its oral hepatitis C cocktail, offering some positive news after some disappointments for the U.S. drugmaker in recent months. It also sets the stage for the drugmaker to take its marketing battle with Gilead Sciences to another continent.