■ New R&D hub will be based at U.S. subsidiary, Helsinn Therapeutics (U.S.), Inc. (HTU) and will support clinical work across Helsinn Group’s diversified pipeline of innovative oncology assets and augments the Group’s global R&D organization
■ Initial work will focus on development of a fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor for oncology indications

Lugano, Switzerland, May 25, 2022 – Helsinn Group (“Helsinn”), a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track-record of commercial execution, today announces the establishment of a new dedicated R&D hub at its U.S. subsidiary, Helsinn Therapeutics (U.S.), Inc. (HTU), that augments Helsinn Group’s global R&D organization.

As a result of the updated licensing agreement with BridgeBio Pharma Inc. announced in March 2022, Helsinn is creating a new R&D hub as part of its U.S. subsidiary in order to support a significant expected increase in clinical activities for developing the FGFR tyrosine kinase inhibitor for oncology.

Bringing this R&D expertise into HTU through this new hub complements the global R&D organization and is the next step in Helsinn’s strategy of creating a differentiated pipeline of highly innovative oncology assets and transforming Helsinn from a leading cancer supportive care company to a Fully Integrated Targeted Therapy company. Over the next five years, Helsinn intends to continue investing approximately 35 percent of the revenues from its commercial engine of supportive care and cancer therapeutic products into targeted therapeutics R&D.

Dr. Giorgio Calderari, Helsinn Group CEO & Board Member, said: “The implementation of Helsinn’s strategy continues at pace and we are excited to announce the enlarging of our global R&D organization by establishing a new hub in the U.S. as part of HTU. With the infigratinib development work for oncology transferring to Helsinn from BridgeBio and the anticipated future additions to our pipeline, this is the perfect time to ramp up our R&D capabilities and establish a center that will support the whole Group’s R&D capabilities. This is an important strategic milestone for the global Helsinn brand and will allow us to double down on our mission to improve the lives of cancer patients, driven by our values of respect, integrity and quality.”

Dr. Sergio Cantoreggi, Helsinn Group Chief Scientific Officer and Group Head of R&D, said: “By establishing this new R&D hub and enlarging our scientific expertise in the US, Helsinn is now perfectly positioned to develop products for patients with unmet needs in the largest global oncology market. This has been a highly exciting period for the Helsinn Group, and we are looking forward to welcoming many new colleagues to the Helsinn family in the weeks and months ahead.”

Key pillars of the full FITT strategy include:

• Developing a FGFR tyrosine kinase inhibitor commercially available in the US and approved in Canada and Australia for the treatment of patients with previously-treated locally advanced or metastatic cholangiocarcinoma (CCA) with an FGFR2 fusion or rearrangement. Phase III studies in first-line cholangiocarcinoma and adjuvant urothelial cancer are currently ongoing.
• As part of the non-exclusive framework agreement with BridgeBio, initiating a preclinical program to co-develop and co-commercialize a glutathione peroxidase 4 (GPX4) inhibitor.
• Studying a rearranged during transfection (RET) tyrosine kinase. Currently in a Phase I/II trial, the product candidate originates from a global co-development and co-commercialization agreement signed with Taiho Pharmaceutical Co., Ltd. in 2017. The parties will continue to jointly pursue preclinical, clinical and chemistry, manufacturing and controls (CMC) development for this product. The agreement is designed to reach as many patients as possible around the world through Helsinn’s own commercial infrastructures or valued partners.
• Actively seeking new opportunities to be in-licensed or acquired.

Helsinn continues to market its commercial portfolio of existing products for certain cancers, chemotherapy-induced nausea and vomiting, and dermo-oncology, through its subsidiaries HTU in the U.S. and Helsinn Pharmaceuticals (Beijing) Co., Ltd. in China, as well as through its worldwide partnerships in more than 190 countries. Manufacturing continues to be supported by Helsinn Birex Pharmaceuticals Ltd. in Ireland.

About the Helsinn Group
Helsinn is a fully integrated, global biopharma company headquartered in Lugano, Switzerland. It is focused on improving the lives of cancer patients all over the world with a leading position in cancer supportive care and an innovative pipeline of cancer therapeutics. Helsinn is a third-generation family-owned company, that since 1976 has been focused on improving the lives of patients, guided by core values of respect, integrity and quality. It operates a unique licensing business model with integrated drug development and manufacturing capabilities. Helsinn has a commercial presence in 190 countries either directly, with operating subsidiaries in the U.S. and China, or via its network of long-standing trusted partners. Helsinn also has a fully integrated supply chain and product development through its subsidiary in Ireland,
Helsinn Birex Pharmaceuticals Ltd.

Helsinn Group plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do, which is reinforced in the company’s strategic plan by a commitment to sustainable growth.

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Helsinn Group Media Contact:
Paola Bonvicini
Group Head of Communication
Lugano, Switzerland
Tel: +41 (0) 91 985 21 21
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