Bristol-Myers Squibb ($BMY) unveiled Phase III results that met the primary endpoint from an all-oral chronic hepatitis C combination trial that included Chinese patients, setting up a tight race for the first approval of a cutting-edge therapy in China.
|Bristol-Myers Squibb CEO Giovanni Caforio|
The BMS combination of daclatasvir (Daklinza) and asunaprevir (Sunvepra), long approved in Japan as well as South Korea and Taiwan, among Asian countries is aimed at genotype 1b, the most prevalent in China and seeks to replace the current standard regimen of interferon/ribavirin to treat hepatitis C (HCV) in China.
Other potential non-interferon-based treatments moving closer to approval in China, including Gilead Sciences' ($GILD) Sovaldi. Gilead is also in separate talks with China on pricing for Sovaldi (sofosbuvir) as the country stands outside of an access program by the U.S. drugmaker that relies heavily on manufacturing and sales licensing to mostly India-based companies.
As well, China's Ascletis Pharmaceuticals won approval in September to start a Phase II trial of danoprevir (ASC08) in Taiwan in combination with ASC16 (PPI-668) for an interferon-free HCV treatment that could also help put it in pole position in the Chinese market, where a separate clinical trial application rests with China FDA for review.
China FDA has accepted an approval filing for the candidate from BMS. But the review status of the application against other contenders or on its own was unavailable. A BMS spokesman said in an email to FiercePharmaAsia that "we do not have a firm timetable from China regulatory officials at this point."
The latest BMS trial results however build on data presented on Phase I work in November at the Liver Meeting conference in San Francisco.
"These results signal that the daclatasvir and asunaprevir regimen could provide a highly effective all-oral, interferon- and ribavirin-free treatment for many Chinese HCV patients with genotype 1b infection," Lai Wei, professor of Hepatology & Medicine and Director, Peking University Hepatology Institute, Chief, Department of Hepatology, Peking University People's Hospital, said in a press release.
"This is an important finding because the burden of HCV in China is extremely high, and newer direct-acting antivirals have yet to be introduced for any patients."
With tight competition in Japan, BMS has a lot riding on a first mover, or early entrant position into China in HCV.
To that end, the drug company backed a survey of 600 of China's estimated 13 million hepatitis C sufferers released in January that showed a lack of access to direct acting antiviral drugs that can cure at least 95% of them was among the key issues they face.
The survey, conducted jointly by China's Wu Jieping Medical Foundation and BMS, showed patients wanted increased access to the drugs and was willing to travel overseas to get them or use the Internet.
The Phase III pivotal study covered 159 patients who were interferon-ineligible and/or -intolerant and had genotype 1b, with the majority from Mainland China and 11% from South Korea and 9% from Taiwan.
The results, according to the press release, showed that 91% of patients achieved the primary endpoint of sustained virology response, with variations among subgroups such as those with or without cirrhosis showed some variation.
- here's the release