Friday, July 9, 2021

Fierce Pharma Asia—Takeda-CSL COVID fail; Daiichi Sankyo’s new 5-year plan; Legend-J&J CAR-T filing


Takeda and CSL closed their COVID-19 alliance after their plasma-derived therapy failed a phase 3 trial by the National Institutes of Health. Daiichi Sankyo laid out its five-year plan covering fiscal 2021 to 2025, featuring nearly $6 billion in sales from cancer drugs. Legend Biotech and Johnson & Johnson wrapped up a rolling submission of their BCMA CAR-T therapy to the FDA, with a possible decision for this year. And more.

1. Takeda, CSL pandemic plasma therapy fails phase 3, as COVID Alliance axed

Takeda and CSL Behring called it quits on an alliance established a year ago to develop a plasma-derived treatment for COVID-19. The anti-coronavirus antibody solution, dubbed CoVIg-19, failed a study run by the National Institute of Allergy and Infectious Diseases (NIAID), which tested it alongside Gilead Sciences’ remdesivir in hospitalized patients. Analyses remain ongoing, and the NIAID will publish full results soon.

2. Daiichi Sankyo outlines new 5-year plan, eyeing $6B sales from cancer drugs led by Enhertu (release, PDF)

Daiichi Sankyo came up with a new five-year business plan covering fiscal 2021 to 2025. The Japanese pharma aims to reach JPY 1.6 trillion ($14.6 billion) in revenues for fiscal 2025, compared with JPY 960 billion in the 2020 fiscal year ended in March. Of the total haul in fiscal 2025, it expects more than JPY 600 billion ($5.5 billion) from cancer drugs, led by AstraZeneca-partnered antibody-drug conjugate Enhertu. To get there, Daiichi plans to pour JPY 1.5 trillion into R&D over the period.

3. Legend Biotech, J&J finish off rolling submission for CAR-T hopeful, approach finish line

China’s Legend Biotech and partner Johnson & Johnson finished up a rolling submission to the FDA for their BCMA-targeted CAR-T therapy cilta-cel, teeing up a potential approval by the end of 2021. This comes just weeks after Bristol Myers Squibb and partner bluebird bio got a long overdue go-ahead for their rival drug Abecma in multiple myeloma.

4. ‘Very stressed’ Serum Institute asks government for $400M vaccine production boost

The Serum Institute of India may be the world’s largest vaccine producer by volume, but it too has hit a production bottleneck in making AstraZeneca’s COVID-19 vaccine. Saying its production capacity is “very stressed,” the Serum Institute is seeking $400 million from the Indian government to beef up output of the shot from about 70 million doses a month to more than 100 million by the end of May.

5. Sinovac aims to pump out 2B COVID-19 vaccine doses a year, courtesy of 3rd production line

Meanwhile, China’s Sinovac Biotech said it has built capacity to make 2 billion doses of its COVID-19 vaccine, CoronaVac, per year. The company just added a third production line that’s now operational. The shot boasts an emergency authorization or conditional approval in more than 30 countries, including a go-ahead doled out in February for use in the general public in China.

6. BeiGene’s massive biologics plant in China wins first commercial manufacturing nod

BeiGene has relied on Boehringer Ingelheim for manufacturing of its PD-1 inhibitor tislelizumab—until this week. Chinese authorities gave BeiGene a green light to start commercial manufacturing of the drug at the company’s own plant in Guangzhou. The plant boasts 8,000 liters of capacity, and the company expects to expand to 64,000 liters by the end of 2022.

7. Takeda’s rare disease med Natpara faces long road back to market as manufacturing issues multiply

Takeda has been offering its hypoparathyroidism drug Natpara through a special use program after fears of rubber particles in vials prompted a recall and put a halt to normal supply in 2019. But now, the company’s supply of the 100-mcg dose of the drug via the program has hit a delay. The hiccup “has further impacted our timelines” of bringing Natpara back to the U.S. market, the company said.

8. CDMO Ajinomoto to bring AstraZeneca fill-finish work to San Diego plant

Ajinomoto Bio-Pharma Services has signed on to help AstraZeneca with fill-finish work at its San Diego site. The CDMO has a new multipurpose filling line that’s expected to go online this summer, which will increase its capacity by 50% and will be able to produce syringes, vials and cartridges, a company spokeswoman said.

9. Chime Bio, flush with $190M, blueprints major biomanufacturing boost in China

Chinese CDMO Chime Biologics has raised $65 million. Together with a $125 million series A in early 2020, the money will help build the firm’s second plant in Wuhan, China, with the goal of 140,000 liters in capacity there. The company also penned a contract with local government a year ago to invest $900 million into its site.



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