Takeda has bought ex-China rights to a Hutchmed cancer drug in a deal potentially worth more than $1 billion. BeiGene's Brukinsa earned a key FDA approval in chronic lymphocytic leukemia. An Astellas gene therapy candidate has come off an FDA clinical hold. And more.
1. Takeda pledges up to $1.13B for rights to Hutchmed's cancer drug fruquintinib outside of China
Takeda has in-licensed ex-China rights to Hutchmed’s VEGFR inhibitor fruquintinib. The Japanese pharma offered $400 million upfront plus up to $730 million in potential milestone payments. The drug is also partnered with Eli Lilly in China, where it’s approved under the brand name Elunate for treating colorectal cancer. The deal followed a positive phase 3 readout last fall.
2. Look out, AbbVie and J&J. BeiGene's Brukinsa just scored a key leukemia nod to take on Imbruvica
After a short delay, BeiGene has won a much-anticipated FDA approval for Brukinsa in chronic lymphocytic leukemia or small lymphocytic lymphoma. Brukinsa’s head-to-head win against AbbVie and Johnson & Johnson’s first-to-market Imbruvica in previously treated disease has given SVB Securities analysts reason to believe that the newer BTK inhibitor could reach $3.6 billion in sales by 2030.
3. Astellas, after years of gene therapy woes, gets rare boost with FDA lifting of Pompe clinical hold
Astellas’ gene therapy efforts have hit a rough patch since the company's $3 billion acquisition of Audentes Therapeutics. In a reprieve, the FDA just lifted the clinical hold on a phase 1/2 study of the Japanese pharma’s Pompe disease gene therapy AT845. The temporary halt was put in place seven months ago after report of a nerve damage case.
4. Troubled Torrent plant in India gets FDA 'official action' letter
With an Official Action Indicated, the FDA is considering punishment on a Torrent Pharma manufacturing plant in Indrad, Gujarat, India. The FDA has already sent a Form 483, laying out three observations following a September inspection. Problems the agency observed include cleaning issues and lack of investigation of out-of-specification incidents.
In another Form 483 the FDA slapped on a drug manufacturer’s plant in Gujarat, India, the agency said Intas Pharmaceuticals’ employees shredded documents ahead of an inspection that started in November. The FDA noted altogether 11 citations, including a “cascade of failure” at Intas’ quality control unit.
6. Celebrity dermatologist Dr. Pimple Popper joins up with Sun Pharma's acne campaign
Sun Pharma, maker of the topical acne treatment Winlevi, has enlisted TV personality and dermatologist Dr. Sandra Lee—also known as Dr. Pimple Popper—to spotlight the role of hormones in acne. The “AH-ha! It’s Acne Hormones” campaign features a diverse group of people affected by the skin condition and includes patient Q&As with Lee.