Global Briefs: Takeda, Sandoz, Astellas, Vir & More

A roundup of news from Takeda, Hutchmed, Torrent Pharmaceuticals, Sandoz, Astellas, Vir Biotechnology, Sanofi and CytoReason. Highlights below.  

* Takeda, Hutchmed in $1.13-Bn Licensing Pact for Cancer Drug   
* FDA Cites Torrent Pharmaceuticals’ Mfg Facility 
* Sandoz To Acquire Antifungal Drug from Astellas
* Vir Biotechnology Names Bayer Executive New CEO 
* Sanofi, CytoReason Partner for AI-Based Drug Discovery 

Takeda, Hutchmed in $1.13-Bn Licensing Pact for Cancer Drug 
Takeda has entered into an exclusive licensing agreement with Hutchmed, a Hong Kong-based bio/pharmaceutical company, for Hutchmed’s fruquintinib, a drug to treat refractory metastatic colorectal cancer (CRC), in a deal worth up to $1.13 billion ($400 million upfront and $730 million in milestone payments). 

Under the agreement, Takeda will receive an exclusive worldwide license to develop and commercialize fruquintinib in all indications and territories outside of mainland China, Hong Kong, and Macau. Approved in China in 2018, fruquintinib is an orally administered drug and has the potential to be used across subtypes of refractory metastatic CRC regardless of biomarker status. 

The US Food and Drug Administration (FDA) granted fast-track designation for fruquintinib for the treatment for metastatic CRC in 2020. In December 2022, Hutchmed initiated a rolling submission of a new drug application for fruquintinib with the FDA, which is planned to be completed in the first half of 2023. This will be followed by planned submission of a marketing authorization application to the European Medicines Agency and a new drug application to the Japan Pharmaceuticals and Medical Devices Agency. 

Under the agreement, Takeda will pay Hutchmed $400 million upfront and up to $730 million in additional potential payments for regulatory, development, and commercial sales milestones as well as royalties on net sales.  

The deal is subject to customary closing conditions, including completion of antitrust reviews.   

Source: Takeda 

FDA Cites Torrent Pharmaceuticals’ Mfg Facility 
The US Food and Drug Administration (FDA) has issued a communication to Torrent Pharmaceuticals, an Ahmedabad, India-based bio/pharmaceutical company, to classify a recent inspection at the company’s manufacturing facility in Indrad, Gujarat, India, as “Official Action Indicated,” which means regulatory and/or administrative actions are recommended. In September 2022, the FDA issued a Form 483 with three observations following inspection of the facility.  

The company says that inspection classification will not have an impact on existing supplies or revenues from this facility and that it will continue to cooperate with the FDA to resolve these issues.  

Source: Torrent Pharmaceuticals 

Sandoz To Acquire Antifungal Drug from Astellas 
Sandoz, the generics and biosimilars business of Novartis, has agreed to acquire from Astellas worldwide product rights for Mycamine (micafungin sodium, Funguard in Japan), a systemic antifungal agent. 

Mycamine is indicated for treating invasive candidiasis and espophageal candidiasis, which are currently both on the rise with a higher occurrence of associated hospital outbreaks, as well as prevention of candida and aspergillus infections in patients undergoing hematopoietic stem-cell transplantation. Mycamine had 2022 sales of JPY 18.9 billion ($135 million) for the year ending March 31, 2022.  

The deal is expected to closing in the first half of 2023, subject to standard conditions and regulatory approvals. 

Source: Novartis 

Vir Biotechnology Names Bayer Executive New CEO 
Vir Biotechnology, a San Francisco-based bio/pharmaceutical company, has named a Bayer executive, Marianne De Backer, Ph.D., currently Executive Vice President, Head of Pharmaceuticals Strategy, Business Development and Licensing/Open Innovation, and Member of the Executive Committee for Bayer Pharmaceuticals, as CEO,  effective April 3, 2023. She will also join Vir’s Board of Directors. She will succeed George Scangos, current CEO of Vir Biotechnology, who is retiring. Scangos joined Vir as CEO of Vir in January 2017 following his role as CEO of Biogen. Upon his retirement as Vir’s CEO, Dr. Scangos will serve in an advisory role to Dr. De Backer through June 2, 2023 and will continue providing strategic counsel to Vir as a member of the Board of Directors. 

Prior to joining Bayer, Dr. De Backer spent more than 20 years at the Johnson & Johnson family of companies, first as a scientist and scientific group leader, and later taking on roles of increasing responsibility and scope, including corporate development and international commercial positions. 

Dr. Scangos has served as Vir’s President and CEO, and as a member of the Board of Directors since January 2017. Prior to joining Vir, Dr. Scangos served as CEO and as a member of the Board of Biogen for six years. Previously, he was President and CEO of Exelixis, an Alameda, California-based bio/pharmaceutical company, for 14 years.   

Source: Vir Biotechnology 

Sanofi, CytoReason Partner for AI-Based Drug Discovery 
Sanofi and CytoReason, a Tel Aviv, Israel-based company developing computational disease models, have expanded their multiyear collaboration to include inflammatory bowel disease (IBD) using CytoReason’s artificial intelligence (AI) platform. The companies had previously initiated a project In 2021 to identify mechanistic insights for asthma endotypes. The expanded agreement will identify patient subtypes and pair them with IBD targets. Under the agreement, Sanofi will pay CytoReason an undisclosed multimillion dollar amount.  

Source: CytoReason