Date: 20-Jan-2020

Astellas cell therapy deal Takeda's €398M tax bill Lilly-shared PD-1 in NSCLC

Astellas Pharma is partnering up with Adaptimmune Therapeutics in a deal worth nearly $900 million to develop off-the-shelf T-cell therapies. Takeda is appealing a surprising €398 million tax bill from Irish authorities over a breakup fee AbbVie paid Shire in 2014. Tyvyt, the PD-1 inhibitor Innovent Biologics developed and shares with Eli Lilly, passed a phase 3 China trial in first-line non-small cell lung cancer. And more. 1. Astellas teams with Adaptimmune to create CAR-T, TCR therapies Astellas subsidiary Universal Cells teamed up with Adaptimmune to develop CAR-T and TCR therapies. Adaptimmune will choose up to three targets outside the scope of its other projects. Astellas will pay $50 million upfront and $7.5 million a year in research funding through the end of phase 1, plus milestones that could take the deal value toward $900 million. 2. Shire surprises Takeda with €398M tax bill on long-ago AbbVie breakup fee Irish authorities demanded that Takeda cough up an additional €398 million ($443 million) in tax over a $1.64 billion breakup fee AbbVie paid Shire way back in 2014 after terminating their $55 billion merger. Takeda said it appealed the ruling, arguing legal advice it has received suggests the payment isn’t taxable in Ireland. The surprising demand comes as Takeda is trying to pare down its debt load. 3. Innovent's Lilly-shared PD-1 Tyvyt hits goal in front-line NSCLC trial in China (release) After becoming the first PD-1 to land national reimbursement in China, Innovent Biologics’ Eli Lilly-partnered Tyvyt has posted a key trial win. Used in tandem with Lilly’s Alimta and platinum chemo, Tyvyt hit the goal of a China phase 3 in newly diagnosed nonsquamous non-small cell lung cancer. The trial showed Tyvyt delivered a significant benefit in delaying the time to cancer progression or death. Based on the positive interim analysis, the pair said it will soon start discussions with local authorities. 4. New FibroGen CEO Conterno cut his post-Lilly 'vacation' short. Why? Roxadustat FibroGen and partner AstraZeneca’s winning China national coverage for roxadustat in both dialysis-dependent and nondialysis-dependent anemia patients with chronic kidney disease invited talk of a potential spinoff for FibroGen’s local operation. But executives said they’re not considering that option this year, according to SVB Leerink analysts. The company might eventually still pursue that path, though. 5. Otsuka's Avanir unit plots 140 layoffs in wake of $116M Nuedexta settlement Avanir Pharmaceuticals, which Otsuka picked up in 2014 for $3.5 billion, plans to lay off 140 employees in California. The job cuts come fresh off a $116 million settlement with the federal government around dubious marketing of Nuedexta, a drug approved for the uncontrollable crying or laughing that can accompany certain neurological conditions. 6. WuXi Biologics taking over Bayer plant, giving it a jump on its global expansion plans WuXi Biologics will take on a long-term lease for a Bayer finished drug plant in Leverkusen, Germany. The Chinese CDMO won’t hire the two dozen employees that currently wok there but will buy its equipment. The employees will transfer to other Bayer sites, the company said. Bayer said the plant “shall serve as a back-up site for final product manufacturing of Kovaltry.” 7. PPD sets out $1B IPO plans as it launches new China labs As PPD plans for its return to the public markets, the CRO giant says it’s also boosting its operations in China. In 2020, it plans to open a multifunctional lab in China “offering bioanalytical, biomarker and vaccine sciences services,” and it’s adding the country to its site conduct and patient enrollment solutions. Ding Ming has been named vice president and general manager of PPD’s China operations. 8. Celltrion CEO says China is next move on its game board for biosimilar production: report South Korea’s biosimilar maker Celltrion intends to build in China a plant capable of producing 120,000 liters so it can cash in on that market, Chairman Seo Jung-jin announced at the annual J.P. Morgan Healthcare Conference in San Francisco, the Yonhap News Agency reported. 9. Charles River pens Takeda early-stage drugs deal Charles River Laboratories and Takeda struck a deal around the Japanese pharma’s four core therapeutic areas—oncology, gastroenterology, neuroscience and rare disease. The CRO will offer its drug discovery expertise to help move early programs toward preclinical candidate status. 10. FDA wrath falls on Chinese OTC maker of children's drugs China’s Huaian Zongheng Bio-Tech has been hit with the FDA’s first warning letter of 2020. The agency says the company ships over-the-counter drug products, many of them for children, to the U.S. without testing ingredients or retaining samples of the finished products to see whether they meet standards.