Biotechnology

Sosei Heptares hails ‘transformational’ acquisition

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Sosei Group Corporation will acquire all the shares of Idorsia Pharmaceuticals Japan Ltd (IPJ) and Idorsia Pharmaceuticals Korea Co., Ltd (IPK).

The strategic transaction also includes the territorial rights of Japan and APAC, excluding China, to the pharmaceuticals range of the Idorsia portfolio, with the main product PIVLAZ (clazososentan) already commercially available and with sales growing rapidly 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 cash on hand from its balance sheet and JPY40 billion ($2 90 million) for seven years, unsecured corporate loans at low interest rates through Mizuho Bank.

Chris Cargill, president and CEO of Sosei Heptares, said: “Since the acquisition of drug discovery platform GPCR Heptares Therapeutics in 2015, we have patiently and diligently searched for the right opportunities to accelerate our mission of delivering 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 biopharmaceutical business in Japan, with increased commercial sales and new product launches expected 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, accelerates 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 an important next step for Sosei Heptares’ growth ambitions.

“We see tremendous potential to build a significant position in this market as an agile and lean participant, and at the same time now have full platform capabilities to become the development and commercialization partner of choice in the region. The business we acquired greatly complements our existing UK and Japanese operations and provides exciting opportunities and options to develop and commercialize our own portfolio, as well as partnered and future products licensed in Japan. We are confident that this transaction, which will be cash flow positive in its first year, will enable us to deliver significant value and benefits to all of our key stakeholders,” said Cargill.

Creating a new Japanese biopharmaceutical leader

Shinichi Tamura, chairman of Sosei Heptares, said: “Today is a historic day for the company and marks a step change in realizing our ambitious growth strategy. The addition of scalable first-rate development and commercial capabilities in Japan gives us greater control over our own destiny and enhances our ability to generate value for our shareholders. I want to congratulate Chris and his team on successfully completing this transaction. I also want to welcome Dr. Satoshi Tanaka and other members of the IPJ and IPK team at Sosei Heptares. I am confident that, by combining their expertise with our UK-based world-leading GPCR targeted discovery capabilities, we can create a new leader in the Japanese biopharma industry with the ability to bring transformative medicine to patients both in Japan and globally.”

Tanaka, president of IPJ, added: “My team and I are very excited about the opportunity to join forces with Sosei Heptares and build a competitive and lean pharmaceutical business in Japan and across other Asia-Pacific markets. With PIVLAZ having launched and Japan sales growing rapidly and daridorexant approaching J-NDA filing later this year, we have a strong foundation to grow, enhanced by access to the broad and ongoing pipeline of new candidates generated by the platform and Sosei Heptares’ world-leading GPCR-targeted drug design capabilities. Our team in Japan has a strong track record of delivering products to market, and with our shared strategic vision and integrated capabilities, we have a bright future ahead of us.”

Future Sosei Heptares pipeline products

Sosei Heptares noted the transaction securing and expanding future pipelines with two key products, PIVLAZ (clazososentan) and daridorexant; exclusive opt-in for cenerimod and lucerastat; and the right to elect up to five additional clinical stage programs from the Idorsia global channel.

PIVLAZ is a selective endothelin A receptor (ETA) antagonist indicated for the prevention of cerebral vasospasm, vasospasm-associated cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH).

In October 2022, daridorexant, a dual orexin receptor antagonist (DORA), achieved positive top-line phase 3 results in Japanese patients with insomnia. This successful trial paves the way for a potential regulatory filing in Japan by 2H 2023. Daridorexant is approved to treat insomnia in the US and Europe where it will continue to be marketed under the brand name QUVIVIQ by Idorsia.

Future prospects for Sosei Heptares

Following this transaction, Sosei Heptares said it will transform into a fully integrated biopharma business, and now has the broad and deep scale to accelerate its growth plans by delivering essential medicines to patients across all key markets starting with Japan. The newly expanded group now employs over 370 people across all locations.

The transaction is expected to be cash flow positive in the first full calendar year.

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