Wednesday, October 20, 2021

Fierce Pharma Asia—Gilead, Merck help India with COVID; BeiGene’s BTK win; Astellas’ gene therapy loss

Gilead Sciences and Merck offered help to local drugmakers with the production of their antiviral drugs. BeiGene claimed a head-to-head win for its BTK inhibitor Brukinsa against AbbVie and Johnson & Johnson’s Imbruvica in chronic lymphocytic leukemia. Astellas took a $540 million write-off as Audentes Therapeutics’ lead gene therapy remains in clinical halt. And more.

1. Gilead, Merck step in to help India’s drug manufacturers fight surging COVID-19 outbreak

Amid a devastating surge of COVID-19 cases in India, Gilead Sciences and Merck & Co. are offering help. Gilead will donate at least 450,000 vials of remdesivir to help ease the immediate need for treatment, and it’ll help its local partners boost production of the drug. Merck signed licensing agreements with five generic drugmakers in India for its antiviral candidate molnupiravir.

2. BeiGene’s Brukinsa turns in ‘near best case scenario’ against Imbruvica in key CLL trial: analyst

BeiGene’s Brukinsa beat AbbVie and Johnson & Johnson’s rival BTK inhibitor on tumor response rate by investigator assessment and irregular heartbeat side effects in a head-to-head phase 3 trial in relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Although the efficacy improvement didn’t meet statistical significance by independent review, one analyst views the results as “a near best-case scenario” for Brukinsa.

3. Astellas takes $540M impairment charge over Audentes’ gene therapy trial hold

Astellas took an impairment charge of JPY58.8 billion ($540 million) from its 2019 buy of Audentes Therapeutics because of an FDA clinical hold on the biotech’s lead gene therapy for a rare disorder called X-linked myotubular myopathy. The trial halt came last year after two children who had received a higher dose of the drug died.

4. Arrowhead, Takeda’s RNA-silencing med cuts scarring in rare liver disease

Arrowhead Pharmaceuticals’ RNA-silencing drug, ARO-AAT, reduced scarring and levels of a disease-causing protein in phase 2 trial patients with a rare, genetic liver disease linked to alpha-1 antitrypsin deficiency. Takeda signed on in October with $300 million upfront payment to co-develop and co-commercialize the drug.

5. Brii’s COVID antibody combo cleared for phase 3 as it targets high-risk patients to head off hospitalization

Brii Biosciences’ COVID-19 two-drug antibody combo, BRII-196 and BRII-198, recently failed in a study of hospitalized patients run by the National Institutes of Health. The company and the NIH now have the green light from an independent data monitoring committee to proceed with a late-stage study of the therapy in ambulatory care patients at high risk of disease progression after it met early safety and efficacy thresholds.

6. I-Mab’s IL-6 drug hits goal in ulcerative colitis phase 2

Biopharma companies have been trying to turn anti-IL-6 drugs against inflammatory bowel diseases for a long time without much success. I-Mab’s candidate olamkicept, at a high dose tested, showed early promise. It triggered more responses such as reducing rectal bleeding than placebo did in a phase 2 trial of ulcerative colitis.

7. SoftBank leads funding that could net up to $525M for Exscientia’s AI drug platform

SoftBank Vision Fund 2 led a $225 million series D round at Exscientia for developing an artificial intelligence-based drug design technology. The Japanese multinational investment shop also offers an additional $300 million in an equity commitment that Exscientia may tap at its discretion.

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