Takeda is preparing for the patent loss of its third-largest product but called it quits on a rare disease therapy. Sun Pharma and Aurobindo Pharma received new Form 483s for their manufacturing facilities. Eisai has wrapped up the FDA rolling submission of its second Alzheimer's disease candidate and is hoping for a better rollout than Aduhelm. And more.
1. Takeda, bracing for Vyvanse patent loss, makes strides on debt goal and pivots its focus to launches
Takeda scraps dream of getting rare disease drug to market in latest setback to Wave 1 pipeline
Since the Shire megamerger, Takeda has successfully lowered its debt to earnings ratio to 2.8x, drawing closer to its target of 2x by fiscal year 2023. The Japanese pharma now feels urgency to grow revenue because its third-largest product, ADHD therapy Vyvanse, is heading toward a patent cliff in August 2023. Just as the company counts on new drugs to fill the gap, it has capped a rare disease candidate, TAK-609, for Hunter syndrome, years after a phase 2/3 flop.
2. Sun Pharma facility dinged with notice of deficiencies after visit from FDA inspectors
Sun Pharma's Halol manufacturing facility is under FDA scrutiny—again. The agency has served the plant a Form 483 with 10 observations, the Indian pharma disclosed. Troubles at the Halol facility go way back. The FDA escalated a Form 483 to a warning letter against the facility in 2015. After a short reprieve in 2018, the site received another Form 483 in 2019.
3. Aurobindo Pharma slapped with Form 483 as FDA inspectors cite 6 findings
Another Indian drugmaker also got a Form 483 this week. Aurobindo Pharma said its oral drug manufacturing facility in Jedcherla, Hyderabad, dubbed Unit VII, was dinged with six observations. This comes just months after a warning letter the FDA slapped on the company’s Doultabad, Telangana, facility, dubbed Unit I.
4. Eisai wraps filing for Biogen-partnered Aduhelm follow-up, hoping to regain 'credibility and trust'
Eisai has wrapped a rolling submission of its Biogen-partnered Alzheimer’s disease candidate lecanemab to the FDA. The pair hopes this medicine holds more promise than the ill-fated Aduhelm. “Gaining credibility and trust from the public is critically important,” Ivan Cheung, Eisai’s U.S. chairman and global president of neurology, said in an interview with Fierce Biotech.
5. Ready to go to FDA, can Hengrui's China-made PD-1 liver cancer immunotherapy change the tides?
Jiangsu Hengrui Medicine plans to talk to the FDA about a potential filing of its PD-1 inhibitor camrelizumab. The drug’s combination with Hengrui’s VEGFR inhibitor apatinib, also known as rivoceranib, topped Bayer’s Nexavar in a global phase 3 trial of newly diagnosed liver cancer. The development follows two recent FDA rejections of China-developed PD-1s this year.
6. Bayer's pharma business feels the pain from Xarelto generics in China
Bayer’s star heart med Xarelto was included last year in China’s price-cutting scheme targeting off-patent drugs, and the company is feeling the pain. Sales of the anticoagulant were halved in China in the first quarter, dragging its global sales down by 5% year over year to 1.09 billion euros during the three months, Bayer pharma chief Stefan Olerich said.
7. Merck KGaA warns of volatile 2022 thanks to war in Ukraine and fresh COVID lockdowns in China
Merck KGaA warns that Russia’s invasion of Ukraine and China’s COVID-19 lockdowns are creating uncertainty for its business. The German company is taking several mitigation steps to cope with the situation. It will rely on higher stockpiles for critical raw materials, adjust pricing on a case-by-case basis and leverage more e-commerce and production sides outside of lockdown-affected areas.
Otsuka’s Taiho Pharmaceutical is paying $275 million upfront to take back some licensing rights to a lung cancer med called CLN-081 from partner Cullinan Oncology as the drug nears a pivotal phase 2 trial. Taiho signed away ex-Japan rights over three years ago and is not reclaiming global rights except for the U.S. and China.