FiercePharmaAsia—Gilead’s remdesivir trial flop; India’s reduced production; Samsung’s Herceptin copy
Numbers from a Chinese COVID-19 study showed Gilead’s remdesivir failed to show efficacy, but the company and analysts disagree, citing the fact that it wasn’t fully enrolled. A lockdown in India is threatening drug output at a key manufacturing hub housing facilities operated by Sun Pharma and Dr. Reddy’s, among others. Samsung Bioepis has rolled out a Herceptin biosimilar in the U.S. at a 15% discount, although its partner Merck & Co. is on track to leave the business. And more.
A leaked document accidentally posted by the World Health Organization showed Gilead Sciences’ remdesivir failed to improve serious COVID-19 patients’ symptoms or clear out the virus in their blood in a Chinese study that was terminated early. However, Evercore ISI analyst Umer Raffat pointed out the lack of detailed data in patients that started early, while Jefferies analyst Michael Yee sided with Gilead in noting that the study is not powered to reach a conclusion because of insufficient enrollment.
Baddi, Himachal Pradesh, is a key hub of drug manufacturing in India. But many facilities there have shut down or reduced capacity since the regional lockdown in mid-April, The Economic Times reported. At least one of the shuttered sites belongs to top generics maker Sun Pharma. Others operated by Dr. Reddy’s, Abbott Laboratories and Cadila are reportedly operating at or below 35% of capacity.
Samsung Bioepis said Ontruzant, its biosimilar of Roche’s blockbuster HER2 breast cancer drug Herceptin, has been launched in the U.S. The copycat is priced at $1,325 for the 150-mg vial and $3,709 for the 420-mg multidose vial, representing a 15% discount to the original drug’s list price. That’s a higher tag than Pfizer put on its version, Trazimera, which is priced at a 22% discount. Merck & Co. should be in charge of commercializing Ontruzant, but the Big Pharma is currently in the process of spinning off its biosim business alongside women’s health.
China’s Sinovac won local regulatory clearance to start a clinical trial of its inactivated COVID-19 vaccine. To prepare for a potential manufacturing scale-up, the company has secured access to more than 70,000 square meters of land sourced by the Beijing government, according to Reuters. The site will produce multiple vaccines with one plant devoted to the coronavirus shot if it wins approval.
Scientists at the Duke-NUS Medical School in Sinapore are exploring the possibility of CAR/TCR-T cell therapies against COVID-19. Previously, a team there generated TCR-T cells that can go after SARS, another coronavirus that caused a deadly 2002 outbreak. Those cells displayed a functional profile similar to that of SARS-specific memory CD8 T cells from people who recovered from SARS-CoV infection.
Fosun Pharma said it won Emergency Use Authorization from the FDA for its COVID-19 RT-PCR nucleic acid diagnostic kit. The test has medical device clearance in China and CE certification in the EU. According to the Chinese company, the kit can process 96 samples within two hours. The company also has PCR hepatitis B virus diagnostic reagents.