Helsinn Launches Fully Integrated Targeted Therapy (FITT) Strategy and Announces Leadership and Structural Changes

Helsinn Launches Fully Integrated Targeted Therapy (FITT) Strategy and Announces Leadership and Structural Changes

• Strategy focuses on developing and commercializing a differentiated pipeline of highly innovative oncology assets addressing unmet needs
• Helsinn intends to reinvest approximately 35% of revenues from existing commercial engine of cancer therapeutic and supportive care products into targeted therapeutics R&D in the next 5 years
  • Riccardo Braglia appointed Executive Chairman and Gabriele Edoardo Braglia appointed to the Board of Directors. Gabriele Braglia, current Chairman and Founder, named Honorary Chairman
  • Giorgio Calderari, current Group General Manager, appointed Chief Executive Officer
  • Siddharth Kaul appointed as new Member of the Board of Directors
  • New simplified group structure following the launch of HAS Healthcare Advanced Synthesis as an independent business

Lugano, Switzerland, January 13, 2021 – 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 launch of its Fully Integrated Targeted Therapy (FITT) Strategy and Board and management changes.

FITT Strategy

Helsinn’s FITT strategy will focus on developing a differentiated pipeline of highly innovative oncology assets addressing unmet needs, transforming Helsinn from a leading cancer supportive care company to a fully integrated targeted therapy company. In addition to this, as previously announced, Helsinn has also entered into a non-exclusive framework agreement with BridgeBio Pharma, Inc. (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, to identify and potentially co-develop and co-commercialize preclinical precision oncology therapies. Helsinn intends to continue to invest approximately 35 percent of its revenues from its commercial engine of supportive care and cancer therapeutics products into targeted therapeutics research and development over the next five years.

The key pillars of the FITT strategy include:

• A fibroblast growth factor receptor (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) harboring an FGFR2 fusion or rearrangement. In March 2021, Helsinn Group entered a strategic collaboration with QED Therapeutics, an affiliate of BridgeBio, to co-develop and co-commercialize this product in oncology indications worldwide except in China, Hong Kong and Macau.
• A RET tyrosine kinase inhibitor currently in a Phase I/II trial that Helsinn believes has the potential for fast-track approval. This product candidate originates from a global co-development and co-commercialization agreement signed with Taiho Pharmaceutical Co., Ltd. in 2017, and the parties will continue to pursue together all preclinical, clinical and chemistry, manufacturing and controls (CMC) developments. This alliance also includes efforts to reach as many patients as possible around the world through their own commercial infrastructures or through valued partners.
• As part of the non-exclusive framework agreement with BridgeBio a first preclinical program has been initiated to co-develop and co-commercialize a potentially first-in-class GPX4 inhibitor.
  • Proactive targeting of new opportunities to be in-licensed or acquired.

In line with the refined strategy, Helsinn will continue to market its commercial portfolio of cancer supportive care and cancer therapeutic products for people in need that are undergoing treatment for cancer, chemotherapy-induced nausea and vomiting and dermo-oncology, through its subsidiaries Helsinn Therapeutics (U.S.), Inc. in the US and Helsinn Pharmaceuticals (Beijing) Co., Ltd. in China as well as through its worldwide partnerships in more than 190 countries around the world. Manufacturing will continue to be supported by Helsinn Birex Pharmaceuticals Ltd. in Ireland.

In addition to a shift in focus, the strategy evolution involves the simplification of the Helsinn Group, and as part of this HAS Healthcare Advanced Synthesis SA, previously Helsinn’s full-service contract manufacturing subsidiary, will be launched as an independent business separate from the Helsinn Group structure, together with the 3B Future Health Fund SA, SICAR, Luxembourg. These combined changes will enable Helsinn to be fully focused on building out its targeted oncology pipeline.

Board and Management Team changes

In order to focus on strategic growth across Helsinn and the wider portfolio of businesses, Riccardo Braglia has been appointed Executive Chairman of Helsinn. Gabriele Braglia, prior Chairman and Founder, has been named Honorary Chairman. In addition, Riccardo Braglia’s eldest son, Gabriele Edoardo Braglia, has joined Helsinn’s Board of Directors. Gabriele owns an MSC Degree in Healthcare Management from City University London and has over 3 years of healthcare and pharmaceutical consulting experience, prior to joining Helsinn in 2021.

In line with these changes, the operational leadership of the Group will be fully taken over by Giorgio Calderari, who has been appointed CEO. Mr. Calderari has been working in Helsinn for the last 36 years, including the last 12 years as Group General Manager, contributing to the development and commercialization of several new drugs and shaping Helsinn into its current structure. He is also Chairman of the Ticino Pharmaceutical association and member of the Board of Directors of BIOSplus and of the University of Applied Sciences and Arts. Giorgio has a PhD in Chemistry from the Federal Institute of Technology (ETH) in Zurich.

In addition, Helsinn is pleased to announce that Siddharth Kaul has been appointed as a new Member of the Board of Directors. Mr. Kaul has 37 years of experience in the consumer products and healthcare industries with P&G and Novartis, and more recently as Chief Financial Officer Pharma in the EU and the US and Group Treasurer and Head of Business Planning & Analysis of Novartis. Mr. Kaul will bring a wealth of expertise, a significant asset which will strengthen the organization.

Riccardo Braglia, Helsinn Group Executive Chairman commented: “This is an extremely momentous time for Helsinn as we initiate our FITT Strategy and shift our focus to the development of potentially transformative oncology therapeutics. Delivering vital cancer supportive care products to patients is still very close to our hearts, and we will continue to do so in conjunction with our strategy evolution. I would like to thank my father Gabriele, who founded and led the Helsinn group for 40 years and I am honored to succeed him and steer Helsinn through the next step in its journey from the position of Executive Chairman as we focus our efforts on developing next generation targeted therapies. I also wish to thank Giorgio Calderari for his many years of service at the Helsinn Group so far and I am delighted that he has accepted the role of Chief Executive Officer. Giorgio has my full support as he assumes the responsibility of leading a dynamic management team of professionals and as we execute on the FITT strategy.

Alongside these changes, we are augmenting our Board with two new appointments, and I am delighted to welcome and work with Mr. Siddharth Kaul as well as my eldest son, Gabriele Edoardo Braglia.”

Giorgio Calderari, Helsinn Group CEO & Board Member, added: “Being part of the Helsinn journey together with Riccardo and the Braglia family for more than 30 years, it is now an honor for me to be appointed as Chief Executive Officer. We are truly excited to be focusing on targeted therapies and on Helsinn’s future prospects as we focus our efforts to be at the forefront of innovative cancer therapeutics. As part of our strategic evolution, we will remain fully committed to supplying our marketed supportive cancer care and cancer therapeutic products to patients in need and this will also support the development of our fully integrated targeted therapies as we continue to reinvest approximately 35 percent of our revenues in R&D”.

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.

To learn more about Helsinn Group please visit www.helsinn.com

For more information:
Helsinn Group Media Contact:
Paola Bonvicini
Group Head of Communication
Lugano, Switzerland
Tel: +41 (0) 91 985 21 21
Email: Info-hhc@helsinn.com
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