A Chinese company has started mass producing a generic to Gilead's remdesivir as the drug shows promise against the novel coronavirus, triggering new patent confusion. Daiichi Sankyo's U.S. chief said its AstraZeneca-partnered antibody-drug conjugate could potentially reach $18 million in its first quarter on the market. With an initial nod in small cell lung cancer, Roche's Tecentriq has become the seventh PD-1/L1 inhibitor approved in China. And more.
In the latest twist to the patent confusion around Gilead Sciences’ anti-coronavirus hopeful remdesivir amid the ongoing outbreak, Chinese drugmaker BrightGene said it has successfully copied the experimental drug. It has mass produced remdesivir's active ingredient and is turning it into finished doses. But the company did say its final marketing requires a license from Gilead, the patent holder.
After an extremely early FDA nod for Enhertu, Daiichi Sankyo and partner AstraZeneca have quickly trained their dedicated sales teams and treated the first commercial patient on Jan. 2. Now, Daiichi’s U.S. chief Ken Keller said the company expects a potential $18 million sales during the first quarter, and the pair’s looking to expand its use into other indications from late-line HER2-positive breast cancer.
Roche earned a Chinese nod for Tecentriq, following AstraZeneca’s Imfinzi as the second PD-L1 inhibitor approved in the country. The initial indication is in combination with chemo for newly diagnosed patients with extensive-stage small cell lung cancer. Among all seven PD-1/L1s approved in China so far, Imfinzi's the first to enter this field in China.
Meanwhile, Chinese authorities just accepted a new application for a Tecentriq-Avastin combo in first-line liver cancer. According to data updated at the European Association for the Study of the Liver meeting last week, the combo pared down the risk of death by 56% compared with Bayer’s Nexavar in a cohort of Chinese patients in the phase 3 IMbrave150 study.
The ongoing coronavirus outbreak may have mixed implications for U.S. biopharma companies, Moody’s said in a recent report. Branded drugmakers may see decreased demand for their innovative drugs in China as local resources are channeled toward combating the new disease. As for generic players, their dependence on China-produced active pharmaceutical ingredients may increase the risk of supply disruption if the outbreak drags on.
Meanwhile, the quarantine and partial travel lockdown is causing disruptions to drug R&D as China is a key region for clinical trial sites. There are around 500 clinical studies with a site in the city of Wuhan, the epicenter of the outbreak, according to Reuters. CRO dMed also said it’s been unable to send staff to monitor trial sites.
Dr. Reddy’s has spent nearly five years trying to meet the FDA’s criteria for an important API plant in India, but a new Form 483 suggests it still hasn’t done enough. The five-observation letter for its Unit VI API plant in Srikakulam District lambasted the plant’s investigations of out-of-specification tests.
India’s Wockhardt is selling a plant in Baddi and a portfolio of 62 products to Dr. Reddy’s for INR 1,850 crore ($260 million). The business had sales of about INR 377 crore ($53 million) for the nine months that ended Dec. 31, accounting for about 15% of its revenues during the period. All related employees will join the new owner.