Hepatitis C is a big problem in China, but a new generation of safer, more effective drugs still aren't available there. Now, with regulators finally promising action on those meds, Gilead Sciences ($GILD) is pressing the accelerator.
The U.S. company has been at the forefront of developing next-gen hep C treatments, but it has yet to launch its blockbuster meds Sovaldi and Harvoni there, three years after entering the market in the west.
Now, the company has hired a new general manager to build its Chinese operations and accelerate its launch plans, reports Bloomberg. The U.S. pharma company has appointed former Roche Shanghai vice president Rogers Luo to help it launch both hep C and hep B drugs "over the next few years."
Gilead is already making massive sales of Sovaldi and Harvoni in the U.S., Europe and Japan, thanks to shorter treatment duration, fewer side effects and greater cure rates than older cocktails based on the injectable interferon. Now that a million people in established markets have already been treated and growth is beginning to slow, the company is turning to new markets--and China represents an enticing prospect.
The country is in the midst of something of a hepatitis C epidemic and is among the countries with the highest prevalence of the disease worldwide. With around 30 million hep C cases, the virus is now the fourth most commonly reported infectious disease in China, according to an epidemiological study reported last year.
Interferon remains only option for many people there, but the China Food and Drug Administration (CFDA) wants to change that. In April, it said directly acting antivirals for hep C such as Sovaldi would get quicker passage through the regulatory review process.
Gilead is in a race to market in China with other companies that have developed non-interferon hep C therapies, including AbbVie ($ABBV), Merck & Co. ($MRK) and Bristol-Myers Squibb ($BMY), as well as China's own Ascletis Pharma. The drugmakers are in the process of running trials in China, while negotiating with the Chinese government on pricing and access deals.
Aside from lengthy regulatory review times that are pretty much the norm in China, the country lies outside an access deal set up by Gilead to supply cheaper Sovaldi to low-income countries via licensing deals with several Indian generic manufacturers. Middle-income countries such as China and Russia don't qualify, leaving them in limbo until Gilead decides on a path to market.
When asked about its plans for China on a recent conference call, Gilead's chief operating officer Kevin Young did not reveal much, other than to say the company intends to launch its hep C drugs there in a "very modest, very focused way, very efficient way."
In the meantime patients are being forced to turn to online sources for the new generation of hep C drugs, putting them at risk of buying substandard and counterfeit versions.
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