Sosei Group Corporation is set to acquire all shares of Idorsia Pharmaceuticals Japan Ltd (IPJ) and Idorsia Pharmaceuticals Korea Co., Ltd (IPK).
The strategic transaction also includes the Japan and APAC territory rights, with the exception of China, to a pipeline of medicines from Idorsia’s portfolio, with lead product PIVLAZ (clazosentan) already commercially available and with fast-growing sales in Japan following a successful launch in April 2022. Sosei Heptares will fully finance the transaction, which is valued at approximately JPY65 billion ($470 million), through a combination of JPY25 billion ($180 million) of existing cash from its balance sheet and a new JPY40 billion ($290 million) seven-year, low-rate unsecured corporate loan through Mizuho Bank.
Chris Cargill, president and CEO of Sosei Heptares, said: “Since the acquisition of the Heptares Therapeutics GPCR drug discovery platform in 2015, we have patiently and diligently searched for the right opportunity to accelerate our mission to deliver life-changing new medicines to patients in Japan and globally. This fully funded transaction is truly transformational and achieves one of our key strategic objectives, establishing the company as a fully integrated Japan-focused biopharmaceutical business, with growing commercial sales and an expected new product launch next year. The addition of a highly experienced clinical development and entrepreneurial commercial team in Japan led by Dr. Satoshi Tanaka, one of the country’s most successful drug developers in recent times, fast-tracks our vision to become one of Japan’s global biopharmaceutical champions.”
Cargill added that the Japanese pharmaceutical market, given its size, large aging population and attractive clinical development and regulatory environment is the key next step for Sosei Heptares’ growth ambitions.
“We see fantastic potential to build a significant position in this market as an agile and lean participant, and at the same time now have the full platform capabilities to be a development and commercialization partner of choice in the territory. The businesses we are acquiring are highly complementary to our existing UK and Japan operations and provide exciting opportunities and optionality to develop and commercialize our own portfolio, as well as partnered and future in-licensed products in Japan. We are confident that this transaction, which will be cash-flow positive in year one, will allow us to deliver significant value and benefits to all our key stakeholders,” Cargill said.
Creating new Japanese biopharma leader
Shinichi Tamura, chairman of Sosei Heptares, said: “Today is an historic day for the company and marks a step change in delivering on our ambitious growth strategy. The addition of a first-rate, scalable development and commercial capability in Japan provides us with greater control of our own destiny and enhances our ability to generate value for our shareholders. I would like to congratulate Chris and his team for successfully concluding this transaction. I would also like to welcome Dr. Satoshi Tanaka and the other members of the IPJ and IPK teams to Sosei Heptares. I am confident that, by combining their expertise with our world-leading GPCR-targeted discovery capabilities based in the U.K., we can create a new leader in the Japanese biopharma industry with the ability to bring transformative medicines to patients both in Japan and globally.”
Tanaka, president of IPJ, added: “My team and I are thrilled by the opportunity to join Sosei Heptares and build a competitive and lean pharma business in Japan and across other Asia-Pacific markets. With PIVLAZ already launched and Japan sales growing fast and daridorexant nearing J-NDA filing later this year, we have a strong foundation from which to grow, enhanced by access to an extensive and sustainable pipeline of novel candidates generated by Sosei Heptares’ world-leading GPCR-targeted drug design platform and capabilities. Our team in Japan has a strong track record for delivering products to market, and with our shared strategic vision and integrated capabilities we have an exciting future ahead of us.”
Sosei Heptares future pipeline products
Sosei Heptares noted the transaction secures and expands its future pipeline with two major products, PIVLAZ (clazosentan) and daridorexant; exclusive opt-ins for cenerimod and lucerastat; and selected rights to up to five additional clinical-stage programs from Idorsia’s global pipeline.
PIVLAZ is a selective endothelin A (ETA) receptor antagonist indicated for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH).
In October 2022, daridorexant, a dual orexin receptor antagonist (DORA), achieved positive phase 3 top-line results in Japanese patients with insomnia. This successful trial paves the way for a potential regulatory submission in Japan in 2H 2023. Daridorexant is approved for treating insomnia in the US and Europe where it will continue to be marketed under the brand name QUVIVIQ by Idorsia.
Future outlook for Sosei Heptares
Following this transaction, Sosei Heptares said it will be transformed into a fully-integrated biopharma business, and now has the breadth and depth of scale to accelerate its growth plans delivering important medicines to patients across key markets starting with Japan. The newly enlarged group now employs more than 370 people across all locations.
The transaction is expected to be cash flow positive in the first full calendar year.