Sumitomo and Roivant put flesh on bones of $3bn R&D deal

Six weeks after Sumitomo Dainippon Pharma agreed a $3 billion deal to license a host of drug candidates developed by companies in Vivek Ramaswamy’s Roivant group, the detail of the transaction has been revealed.

The Japanese drugmaker is taking over Roivant’s stake in five of its subsidiaries, with an option on six more until 2024.

With the deal formally signed yesterday, Sumitomo will now start the process of rolling the acquisitions into a new as-yet unnamed company that will be headed up by ex-Genentech executive Myrtle Potter, who has been operating chair of Roivant since July 2018.

The five companies are women’s health specialist Myovant, urology company Urovant, Enzyvant and Altavant in the rare disease category, and Spirovant, a newly-unveiled company focused on developing innovative gene therapies for cystic fibrosis (CF).

Along with the $3 billion upfront fee to kick off the alliance, Sumitomo will also provide a $350 million loan facility to Myovant to help fund the launch of its late-stage candidate for uterine fibroids – relugolix – if it gets approved for marketing, plus a $200 million loan to Urovant for its overactive bladder drug vibegron.

If Sumitomo takes the option on the other six, it will have effectively bolted on a ready-made pipeline consisting of more than 25 clinical programmes, with multiple potential launches in the 2020 to 2022 timeframe.

The big reveal in the new announcement is Spirovant, which has two gene therapies in development for CF, both designed to deliver a functional copy of the CFTR gene to the cells lining the airways and developed at University of Iowa Center for Gene Therapy.

SPIRO-2101 is based on an adeno-associated virus (AAV) vector, while SPIRO-2102 uses a lentiviral vector, and both have been shown to restore CFTR function in animal models of CF.

The Japanese company desperately needs new products to bring to market as it prepares for the loss of patent protection to Latuda (lurasidone), a $1.6 billion drug for schizophrenia and bipolar depression that is facing a generics hit in 2023.

It has also suffered some recent pipeline setbacks including the failure of napabucasin (BBI608) in a phase 3 pancreatic cancer trial, and a mid-stage study of SanBio-partnered stem cell therapy for stroke.

“This strategic alliance allows us to not only acquire potential blockbusters and innovative health technology platforms…but it will also enable us to deepen our relationship with Roivant, a company that possesses an innovative business model and underlying culture,” commented Sumitomo’s president and chief executive Hiroshi Nomura.

“We expect this relationship will contribute significantly to the establishment of a position as a ‘global specialised player’ which we aspire to be by 2033,” he added.