With a new FDA approval for Enhertu, AstraZeneca and Daiichi Sankyo are heaping pressure on Roche and Seagen. As Biogen terminates its Aduhelm marketing efforts, the focus has shifted to its second Alzheimer's disease candidate, led by Eisai. In back-to-back rejections, China-developed cancer drugs from Hutchmed and a partnership between Junshi Biosciences and Coherus BioSciences hit a wall at the FDA. And more.
1. Move over, Roche: AstraZeneca and Daiichi's Enhertu snags FDA nod for earlier breast cancer use
AstraZeneca and Daiichi Sankyo have received a quick FDA nod to move Enhertu into HER2-positive breast cancer after one prior anti-HER2 therapy. The nod comes after the drug trounced Roche’s rival antibody-drug conjugate Kadcyla in a phase 3 trial. Enhertu’s second-line nod now also pressures Seagen’s Tukysa.
2. Biogen shoves Aduhelm to the side. It's time for lecanemab
Biogen CEO Michel Vountasos is stepping down, and the company is essentially chopping its Aduhelm sales team. It’s now shifting focus to its second Alzheimer’s disease candidate, lecanemab, where Eisai leads the charge. The pair now aims to finish lecanemab’s rolling submission for an accelerated approval by June and file for a full nod with data from the confirmatory Clarity AD study in the first quarter of 2023.
3. FDA snubs another China-made cancer drug, foiling Hutchmed's first shot at US market
The FDA has rejected Hutchmed’s surufatinib, a neuroendocrine tumor therapy marketed in China under the brand name Sulanda. The reason is in the same vein as the FDA’s recent rebuff of Eli Lilly and Innovent Biologics’ PD-1 inhibitor Tyvyt: Instead of China-only pivotal trials and a small U.S. bridging study, the agency wants a multiregional trial that reflects U.S. patient populations and medical practice.
4. FDA spurns Coherus and Junshi's China-made PD-1 cancer drug
The FDA also turned down Junshi Biosciences and U.S. partner Coherus BioSciences’ China-developed PD-1 inhibitor Tuoyi in nasopharyngeal carcinoma, but for a different reason. The FDA is asking for a quality process change that the companies think is “readily addressable.” Tuoyi’s application also has China-only data, but the pair said the FDA noted it warrants “regulatory flexibility.”
5. Amid BeiGene's global expansion push, CEO Oyler scores 16% pay raise to $16.7M
BeiGene CEO John Oyler got $16.75 million in 2021 compensation, which was 16% larger than his pay package in 2020. He nabbed a combined $15 million in share and option awards. His cash incentive pay, tied to BeiGene’s business performance, came to $919,000 and his salary was $740,000.
6. BeiGene CEO touts 'strategic asset' in flagship US site and a fix to stock delisting risk
Meanwhile, BeiGene has broken ground on its flagship U.S. manufacturing and clinical R&D center in New Jersey. CEO John Oyler said the biologics site offers a “strategic asset” as the company nears an FDA nod for Novartis-partnered PD-1 drug tislelizumab. Besides, Oyler believes BeiGene has resolved a recent stock delisting risk by shifting its auditor to the U.S.
7. All Takeda wants for its billion-dollar gene therapy spending spree is functional cures
Since March 2020, Takeda has signed multiple gene therapy deals that the company estimates could altogether worth over $9 billion. The goal is to add technological pieces to build the final product. In an interview with Fierce Biotech, Madhu Natarajan, head of Takeda’s Rare Disease Drug Discovery unit, talked about the company’s gene therapy plan and how it chooses biotech partners.
8. GlaxoSmithKline trade secret theft case strikes down Swiss scientist, its 5th target, in conviction
In the latest development of a trade secret theft case involving a Chinese biotech stealing from GlaxoSmithKline, a Chinese citizen and former scientist at the Friedrich Miescher Institute for Biomedical Research in Switzerland has been convicted. The conviction followed guilty pleas by four other people.
9. Teva settlement prevents Lupin from launching its Austedo generic until 2033
Lupin has settled an Austedo generic suit with Teva, agreeing not to launch its version of Teva’s tardive dyskinesia drug in the U.S. before April 2033. Teva’s other case against another Indian drugmaker, Aurobindo, remains unresolved. Austedo is one of the few innovative drugs that Teva counts on for growth.
Other News of Note:
10. Jazz flexes deal chops, paying Sumitomo $50M for ex-Asia rights to early-phase narcolepsy prospect
12. Asia-Pacific CRO Novotech makes US play with NCGS acquisition
13. Celltrion tacks on a 3rd Class I recall for unauthorized use of rapid COVID tests