GPX4 inhibitor(Helsinn Birex Pharmaceuticals Ltd)

- The potentially first-in-class inhibitor designed to target glutathione peroxidase 4 (GPX4) has the potential to impact approximately 500,000 cancer patients with unmet therapeutic needs - BridgeBio and Helsinn have also established a non-exclusive framework agreement to identify and potentially co-develop and co-commercialize additional small molecule targeted oncology therapies - This framework agreement leverages BridgeBio’s drug discovery expertise and Helsinn’s clinical development and commercial capabilities - The BridgeBio and Helsinn collaboration builds on the $2.45 billion USD global license and collaboration agreement signed in March 2021 for development of BridgeBio’s FGFR inhibitor infigratinib in oncology indications PALO ALTO, Calif. and LUGANO, Switzerland, Nov. 19, 2021 (GLOBE NEWSWIRE) -- BridgeBio LLC (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, and Helsinn Group, a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track record of commercial execution, announced they have entered into a strategic collaboration to co-develop and co-commercialize a potentially first-in-class inhibitor designed to target glutathione peroxidase 4 (GPX4) with the hope of providing an effective new therapy for patients with difficult-to-treat tumors. The joint collaboration for BridgeBio’s GPX4 inhibitor was established as part of a new non-exclusive collaboration framework between BridgeBio and Helsinn that allows the companies to propose co-development and co-commercialization opportunities for preclinical precision oncology programs. Under the terms of the non-exclusive agreement, BridgeBio and Helsinn will have the option to collaborate on preclinical oncology programs that are identified from time to time by either party. The agreement is designed to magnify the ability of both companies to identify small oncology interventions that may have greater potential to help patients in combination with larger investigational therapies. For each program that the parties agree to pursue, they will share global development responsibilities under an agreed cost split. Helsinn will have exclusive manufacturing and commercial rights to the programs under the agreement, with BridgeBio receiving a profit share on U.S. sales and tiered royalties on ex-U.S. sales. The first program under the framework collaboration agreement that the parties will pursue is GPX4, a potentially first-in-class inhibitor that may be an effective new therapy for certain cancer patients. GPX4 is an enzyme that is often elevated in cancer tissue and associated with a worse prognosis for patients. GPX4 neutralizes toxic free radicals at the lipid membrane, protecting cells from death by ferroptosis. The GPX4 inhibitor is being developed to induce ferroptosis in cancer cells with the potential to impact approximately 500,000 patients in need of a therapeutic option. The safety and efficacy of GPX4 has not yet been established by any health authority world-wide. “We are excited to expand our collaboration with Helsinn to develop and potentially commercialize our GPX4 program. Our hope is that together we can move even more swiftly to advance this potential precision oncology therapy for cancer patients living with severe unmet medical needs,” said BridgeBio’s chairman of oncology, Frank McCormick, Ph.D., F.R.S., D.Sc. (Hon). Riccardo Braglia, vice chairman and CEO at Helsinn Group, commented: “This non-exclusive pipeline agreement with BridgeBio has the potential to be transformational for Helsinn because BridgeBio’s world class drug discovery platform can augment our innovative oncology pipeline. It also affords Helsinn the opportunity to identify and offer potential programs on which the parties could collaborate. BridgeBio’s deep expertise in drug hunting and early preclinical development combined with Helsinn’s drug development and global commercial platform can facilitate an ongoing cadence of moving novel therapies into clinical development with the potential to meaningfully improve the lives of patients with cancer. We’re delighted to get started with our first program, GPX4, and look forward to updating the market on this and additional programs in due course.” The non-exclusive framework agreement builds on an earlier global collaboration and licensing agreement that BridgeBio and Helsinn Group’s affiliates, Helsinn Healthcare S.A. and Helsinn Therapeutics (U.S.), Inc., entered into in March 2021. Under that agreement, Helsinn Therapeutics is jointly responsible for further development and commercialization activities for infigratinib, a small molecule kinase inhibitor of FGFR, in oncology and all other indications except for skeletal dysplasias (including achondroplasia) in the United States and other regions (excluding China, Hong Kong, and Macau), sharing profits and losses on an equal basis. This includes exclusive commercialization rights for infigratinib in Canada, where Health Canada recently approved TRUSELTIQ™ (infigratinib) under the Notice of Compliance with Conditions (NOC/c) policy, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with a FGFR2 fusion or other rearrangement. Helsinn will fund the majority of ongoing and future research and development related to infigratinib in oncology in the foregoing territory. BridgeBio will be eligible for tiered royalties as a percentage of adjusted net sales, and potential payments totaling up to $2.45 billion USD in the aggregate. BridgeBio previously entered a strategic collaboration with LianBio for development and commercialization of infigratinib in oncology indications in China, Hong Kong and Macau. About BridgeBio Pharma, Inc. BridgeBio Pharma, Inc. (BridgeBio) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company’s first two approved therapies. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn and Twitter. 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 innovative pipeline of cancer therapeutics. Helsinn is 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 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 BridgeBio Pharma, Inc. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with such safe harbor provisions. These forward-looking statements include statements relating to expectations, plans and prospects regarding clinical development plans, clinical and therapeutic potential, regulatory status and commercial strategy for BridgeBio’s novel glutathione peroxidase 4 (GPX4) inhibitor, including, but not limited to: the ability of BridgeBio and Helsinn to jointly develop and commercialize a potentially first-in-class inhibitor designed to target GPX4 to provide an effective new therapy for patients with difficult-to-treat tumors, the ability of BridgeBio’s GPX4 inhibitor to be a first-class inhibitor and to induce ferroptosis in cancer cells, the size of the patient population BridgeBio’s GPX4 inhibitor may be able to impact, the success of the non-exclusive framework between BridgeBio and Helsinn to allow the companies to propose additional co-development and co-commercialization collaborations for other preclinical precision oncology programs, the ability of the agreement to magnify the ability of both companies to identify small oncology interventions that may have greater potential to help patients in combination with larger investigational therapies, the belief that the combination of BridgeBio’s early preclinical development and Helsinn’s global commercial platform will help to accelerate the identification and development of this therapeutic option for patients, the timing and cadence of updating the market on GPX4 and additional programs, potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, and the timing of these events, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales; the fact that the U.S. Food and Drug Administration or such other regulatory agencies may not agree with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of the various collaborations between BridgeBio and Helsinn, potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, and those risks set forth in the Risk Factors section of BridgeBio’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and our other SEC filings. Moreover, BridgeBio and Helsinn operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio’s management as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. BridgeBio Media Contact: Grace Rauh grace.rauh@bridgebio.com (917) 232-5478 BridgeBio Investor Contact: Katherine Yau katherine.yau@bridgebio.com (516) 554-5989 Helsinn Group Media Contact: Paola Bonvicini Group Head of Communication Info-hhc@helsinn.com +41 (0) 91 985 21 21