Tokyo, Japan and Cambridge, UK, 6 March 2024 - Sosei Group Corporation ("Sosei Heptares" or "the Company"; TSE: 4565) announces that Formosa Pharmaceuticals, Inc. ("Formosa") has received approval from the US Food & Drug Administration ("FDA") for clobetasol propionate ophthalmic suspension 0.05% (APP13007), for the treatment of post-operative inflammation and pain following ocular surgery. The milestone has triggered a US$2.5 million payment to Sosei Heptares from Formosa.
APP13007 was originally designed and developed at Activus Pharma Inc. ("Activus"), formerly a wholly owned subsidiary of the Company. Activus was divested in August 2017 to Formosa, a wholly owned subsidiary of Formosa Laboratories, Inc., a leading manufacturer of Active Pharmaceutical Ingredients ("APIs") listed on the Taiwan Stock Exchange.
Activus was originally developing APP13007 by applying its patented proprietary APNT ("Activus Pure Nanoparticle Technology") to the steroid to create a novel nanoparticle formulation for treating post-operative inflammation of the eye. Since the divestment, Formosa has progressed the development of APP13007 and received FDA approval.
Under the terms of the sale to Formosa in 2017, Sosei Heptares is entitled to receive undisclosed milestone payments based on progression of Activus' pipeline as well as royalties from the commercialization of certain products should they reach the market.
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About Sosei Heptares
Sosei Heptares is a fully integrated, technology enabled pharmaceutical company focused on bringing life-changing medicines based on world-class science to patients globally. Our vision is to become one of Japan's global pharmaceutical champions.
Our global business combines our world-leading GPCR-targeted StaR® technology, structure-based drug design and early development capabilities in the UK with a highly experienced clinical development capability and a commercial operation in Japan.
We are leveraging these capabilities to generate and advance a broad and deep pipeline of novel medicines across multiple therapeutic areas, including neurology, immunology, gastroenterology and inflammatory diseases. We intend to develop these opportunities for patients in Japan and globally both internally and through our partnerships with global biopharmaceutical companies and emerging technology companies.
Sosei Heptares operates from key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea).
"Sosei Heptares" is the corporate brand and trademark of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). Sosei, Heptares, the logo and StaR® are trademarks of Sosei Group companies.
For more information, please visit https://soseiheptares.com/
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Enquiries:
Sosei Heptares - Media and Investor Relations
Kentaro Tahara, VP Investor Relations and Corporate Strategy
Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures
Maya Bennison, Communications Manager
+81 (0)3 5210 3399 | +44 (0)1223 949390 | IR@SoseiHeptares.com
MEDiSTRAVA Consulting (for International Media)
Mark Swallow, Frazer Hall, Erica Hollingsworth
+44 (0)203 928 6900 | SoseiHeptares@medistrava.com
Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Sosei Group Corporation's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
