Welcome to this week's FiercePharmaAsia report, which includes stories about Merck's $5.8 billion deal for half of Eisai's Lenvima, a $90 million series A pulled off by Juno and WuXi AppTec's Chinese CAR-T joint venture, a novel HIV drug developed by Taiwan's TaiMed Biologics and manufactured by WuXi Biologics and more.
After nabbing a 50% share of AstraZeneca’s Lynparza, Merck has signed a similar deal for Eisai’s Lenvima. Through the potential $5.76 billion pact, Merck will get half of Lenvima’s sales. The Lenvima-Keytruda combo already has an FDA “breakthrough” designation in kidney cancer, and the pair is looking to explore its potential in 11 other indications.
JW Therapeutics, a Chinese CAR-T firm formed by Juno Therapeutics (now owned by Celgene) and WuXi AppTec, just pulled off a $90 million series A. They hope to move a CD19-directed clinical candidate for B-cell malignancies further. The biotech could go up against a long list of CAR-T players in China, including a joint venture by Fosun and Kite Pharma.
The FDA has approved Taiwanese company TaiMed Biologics’ Trogarzo, the first HIV therapy with a novel mechanism of action in more than 10 years. It’s used in combination with other antiretrovirals in drug-resistant HIV-1 patients. The med is manufactured by WuXi Biologics, which became the first and is still the only Chinese company to have a plant receive FDA clearance to make biological products.
Japan has taken further actions to cut the prices of top-selling meds. Opdivo's price, which had been halved last year, will be slashed by another 23.8% starting in April. Merck’s Keytruda will get a 11.2% cut. The cuts come as Japan is changing the frequency of drug price checks from every other year to every year.
Daiichi Sankyo is cutting 280 jobs from its commercial operations across the U.S. as it streamlines its business to fit its current U.S. portfolio and begins to “prepare for its upcoming oncology pipeline.” The Japanese company went through another round of downsizing that cut 1,200 jobs in the U.S. in April 2016.
Eisai and partner Purdue announced positive topline results from a phase 2 trial on sleep and wake regulation medication lemborexant. The drug was pitted against zolpidem and a dummy in the study, which the pair said had hit its primary and key secondary endpoints.
In an unusual round for a British biotech startup, South Korean and Chinese investors put £9 million behind cancer vaccine developer Oxford Vacmedix. The Asia-dominated round is actually in line with the company’s strategy. It has entered the Chinese market with a subsidiary in Hong Kong and an R&D center on the Chinese mainland. Korea is next on its agenda.
MedGenome, which focuses its genetic diagnostics business in India, has topped up its series C round from $30 million to $40 million. The company, best known for its noninvasive prenatal screening services, plans to expand into second- and third-tier cities in the country.
An FDA inspection at a sterile formulations plant of Aurobindo’s ended with a Form 483. The company said none of the nine observations are related to data integrity or repeated problems. It was reported that the issues cited could lead to product contamination.
The FDA issued a warning letter to Chinese OTC drugmaker Zhejiang Ludao Technology. The company was cited for lacking basic controls to prevent data manipulation. A previous test on a batch of spray made by the manufacturer found nearly twice the amount of active ingredient than was labeled.