FiercePharmaAsia—Gilead's remdesivir licensing; Legend's $100M IPO; Takeda's blockbuster hopefuls

To boost supply, Gilead Sciences is allowing five generics makers to produce its COVID-19 treatment remdesivir. Chinese biotech Legend Biotech, known for its CAR-T partnership with Johnson & Johnson, is aiming for a $100 million Nasdaq IPO. Takeda touts 12 new drug launches that it hopes can collectively bring in $10 billion in peak sales. And more.

1. Gilead inks deals with generics makers to supply COVID-19 therapy remdesivir for 127 countries

Gilead Sciences has signed nonexclusive licensing deals with five generics makers operating in India and Pakistan to produce COVID-19 treatment remdesivir primarily for low- and lower-middle income countries. The partners are Cipla, Mylan, Ferozsons Laboratories, Hetero Labs and Jubilant Life Sciences. The licensees won’t pay royalties to Gilead until the pandemic is called off or until a second drug is approved.

2. J&J-backed CAR-T biotech Legend guns for $100M IPO but sees CRS death in early trial

Legend Biotech is looking to raise $100 million in a Nasdaq IPO. The company, a spinoff from Chinese CDMO Genscript, plans to fund a pipeline spearheaded by a Johnson & Johnson-partnered anti-BCMA CAR-T therapy dubbed LCAR-B38M (JNJ-4528). According to phase 1b results (PDF) updated at the American Society of Clinical Oncology (ASCO) virtual event, the drug completely cleared signs of cancer in 86% of 29 previously heavily treated multiple myeloma patients at a median follow-up of 11.5 months.

3. Takeda touts blockbuster hopefuls, dials up cost-saving target from Shire deal

Takeda is looking to launch 12 new drugs by 2024, which by its estimates could collectively generate $10 billion in peak sales. These include the latest addition, CoVIg, a plasma-based COVID-19 therapy the Japanese pharma is working to advance into a clinical trial as early as July. Meanwhile, the company also raised its annual cost-savings target for the Shire buyout to $2.3 billion from the previous $2 billion.

4. BeiGene's new BTK drug Brukinsa falls short as PD-1 tislelizumab shines in busy quarter

BeiGene’s BTK inhibitor Brukinsa—a competitor to Johnson & Johnson’s Imbruvica and AstraZeneca’s Calquence—only sold $720,000 in its first full quarter on the market, way below consensus estimates of around $7 million. SVB Leerink analyst Andrew Berens suspected the lackluster performance stemmed from low off-label use in chronic lymphocytic leukemia. But the Chinese biotech’s sales of PD-1 drug tislelizumab in China pleasantly surprised industry watchers.

5. ASCO: Pfizer, Astellas show Xtandi helps early prostate cancer patients live longer

Adding Pfizer and Astellas’ Xtandi to androgen deprivation therapy cut nonmetastatic castration-resistant prostate cancer (nmCRPC) patients’ risk of death by 27%, data from ASCO showed. The drug was approved in nmCRPC in mid-2018 and has since then taken over 50% of new patient share within the novel hormone therapy class, Andy Schmeltz, Pfizer’s oncology unit head, said.

6. Thermo Fisher, WuXi and Mayo Clinic to develop open-platform COVID-19 antibody test

Thermo Fisher is developing a COVID-19 antibody test through an ongoing collaboration with WuXi Diagnostics and the Mayo Clinic. The ELISA test will be available on an open instrument platform following clinical evaluation at the Mayo Clinic and a regulatory green light.

7. Dr. Reddy's Laboratories recalls bottles of generic Nexium on quality concerns

Dr. Reddy’s Laboratories has voluntarily recalled 1,752 bottles of generic esomeprazole made at its facility in Bachupally, India, after tested lots showed discoloration and contained brown pellets, according to the FDA. It followed a recall of 40,592 bottles of the same product back in February 2019.

8. China, Iran hackers fingered for targeting COVID-19 vaccine R&D: reports

The U.S. government is reportedly planning to accuse hackers linked to the Chinese government for attempting to steal research knowledge around COVID-19 vaccines and treatments. And an Iranian hacker group was implicated in an attack on Gilead in a scheme to compromise the biotech’s email accounts.

9. China's Kangmei Pharma fined $84.5K for $4.2B securities fraud (Bloomberg)

Kangmei Pharmaceutical was fined CNY 600,000 ($84,500) by China’s securities regulator for having overstated its cash position by nearly CNY 30 billion ($4.2 billion). Six executives, including the company’s former chairman, are now banned from participating in the securities market for at least 10 years. The fine is the maximum allowed under China’s old securities law before a new version came into effect in March.

10. Cadila shutters Indian ingredients plant after 26 workers test positive for COVID-19: report

Cadila Pharmaceuticals recently shut down an API plant in Dholka, Ahmedabad, India, after 26 employees tested positive for COVID-19. Another 95 suspected close contacts were put under quarantine as the drugmaker began sanitizing the site.