Merck is trying to determine the reasons behind the surprise decline of Gardasil in China. Eisai and Biogen's Leqembi was rejected by European authorities amid a continued slow sales ramp. Lawmakers behind the BIOSECURE Act are trying to block drugmakers from working with certain Chinese clinical trial sites. And more.
1. Merck mystified by sudden 'step down' in Gardasil sales in China
Merck’s Gardasil suddenly slowed down in China. The HPV vaccine franchise has been a big growth driver for Merck’s overall business, having recently helped the company surpass AstraZeneca to become the biggest global pharma in China by sales. And the company’s 9% stock price declined after the news spoke to the vaccine’s importance. Merck is working with its local partner Zhifei Biological Products to understand the situation, and it already has a few theories.
2. Eisai, Biogen's Alzheimer's med Leqembi turned down in Europe—but analyst says it's merely a 'delay'
Biogen retains biosimilars as Eisai-partnered Leqembi plows ahead amid business pivot
Eisai and Biogen’s Leqembi continued its slow ramp, with second-quarter sales reaching $40 million, including $30 million from the U.S. The drug’s expansion efforts hit a snag as regulators at the European Medicines Agency declined to recommend the anti-amyloid drug, citing a “small” benefit and ARIA as a safety concern. Meanwhile, an extended study showed Leqembi’s benefit in cutting average cognitive declines appeared to widen to 31% over three years, compared with 27% in the original 18-month study.
3. Congress targeting trials at Chinese military hospitals and in Xinjiang Uyghur Autonomous Region (Biocentury)
The House Select Committee on the Chinese Communist Party, the driving force behind the draft BIOSECURE Act, has set its eyes on the next target in its crackdown against China. Lawmakers are looking for ways to block drugs seeking U.S. approvals from being tested at facilities associated with the Chinese army, including those that serve civilian patients, Biocentury reports, citing people familiar with the matter.
4. With BIOSECURE Act looming, WuXi AppTec shows declining revenue
As the draft BIOSECURE Act threatens to push WuXi AppTec out of the U.S. market, the CRO giant’s business has so far remained relatively stable. The company’s U.S. sales, which accounted for 62% of the firm’s total, only fell by 1% in the first half of 2024. As the bill moves forward, WuXi spent $360,000 on lobbying efforts in the second quarter, more than tripling the $100,000 it spent in the fourth quarter of 2023.
5. Takeda's Entyvio holds onto IBD market share despite threat from AbbVie's Skyrizi
Takeda takes $140M charge on failed epilepsy drug, while touting continued FDA potential
Despite the entry of newer inflammatory bowel disease therapies such as AbbVie’s Skyrizi, Takeda’s Entyvio still grew sales by 7.6% during the three months ended in June, reaching $1.5 billion. The company took an impairment charge of about $143 million tied to the Ovid Therapeutics-partnered epilepsy med soticlestat’s recent phase 3 flop. Meanwhile, the Japanese pharma will take full U.S. control of depression drug Trintellix as its long-time partner Lundbeck wants to reallocate resources. The drug will lose U.S. patent protection at the end of 2026.
6. Otsuka pays $800M for Jnana Therapeutics and its clinical-stage PKU drug
The dealmaking streak among Japanese pharmas continues. Otsuka is acquiring Jnana Therapeutics for $800 million, plus up to $325 million in milestones, to obtain a clinical-stage oral phenylketonuria (PKU) drug coded JNT-517, an allosteric small-molecule inhibitor of SLC6A19. A registrational study for the med is planned for next year.
7. Kyowa Kirin looks to cut small molecule research and manufacturing jobs, slims down in Asia
Kyowa Kirin is making some major adjustments to its business. The Japanese pharma is planning “a significant reduction” in small molecule research activities as it focuses on biologics. It’s also looking to trim some manufacturing jobs. In two separate deals, Kyowa will divest its Chinese operations to WinHealth Pharma and transfer rights to seven established brands in certain Asian markets to DKSH Holding.
8. Instil refills pipeline in $2B biobucks deal with China's ImmuneOnco for 2 cancer assets
After Akeso and Summit Therapeutics’ positive readout for their PD-1xVEGF bispecific ivonescimab against Merck’s Keytruda in a Chinese phase 3 trial, Instil Bio has agreed to pay Shanghai biotech ImmuneOnco Biopharmaceuticals $50 million in upfront and near-term payments, plus up to $2 billion in potential milestones, for two assets, including a PD-L1xVEGF bispecific.
Other News of Note:
9. After tense standoff, AstraZeneca and Daiichi's Enhertu turned away by NICE on pricing grounds
10. Chasing Pfizer and Lilly, Sun Pharma wins FDA nod for alopecia areata med Leqselvi
11. South Korea regulator hits GSK for problems with asthma, acne drugs: report
12. Ideaya, eyeing drug combos, bags option on Biocytogen bispecific ADC in $400M deal
13. In Eisai, Medidata finds its first big buyer for new clinical trial management platform