Collaboration Expands and Underlines Commitment to Biosimilars Portfolio and Focus on Women’s Health with Biosimilar Candidates for Osteoporosis and Breast Cancer
JERSEY CITY, NJ, June 13, 2022–(BUSINESS WIRE)–Organon (NYSE: OGN), a global women’s health company with deep expertise in the commercialization of biosimilars, today announced that it has entered into an agreement with Shanghai Henlius Biotech, Inc. (2696 .HK), whereby Organon will license the commercialization rights for biosimilar candidates referencing Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14). Organon will acquire exclusive worldwide marketing rights excluding China; including Hong Kong, Macau and Taiwan.
Pertuzumab is used for the treatment of certain patients with HER2+ breast cancer in combination with trastuzumab and chemotherapy. In the United States, 20% of people with breast cancer are HER2+. Denosumab is used for the treatment of certain osteoporosis patients at high risk of fracture and for the prevention of skeletal events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Osteoporosis affects more than 20% of women over 50 worldwide.
“Biosimilars are a key growth pillar for Organon, and this collaboration represents the successful execution of our strategy to expand our biosimilars portfolio by leveraging our strong global footprint and deep commercial expertise,” said Kevin Ali. , CEO of Organon. “With our experience in biosimilars and women’s health, our goal is to help more patients access treatments for breast cancer and osteoporosis, two areas that have a significant impact on women’s health. “
The agreement also includes an option to negotiate an exclusive license for the worldwide commercialization rights of a biosimilar candidate referencing Yervoy ® (ipilimumab, HLX13). Ipilimumab is used for the treatment of certain patients with unresectable or metastatic melanoma, as an add-on treatment for certain patients with cutaneous melanoma, certain patients with renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, cancer non-small cell lung, malignant pleural mesothelioma and esophageal cancer. Cancer.
The consideration for the transaction includes an upfront payment of $73 million as well as additional payments upon the achievement of certain development, regulatory and commercial milestones. Henlius will be responsible for the development and, if approved, will supply the products to Organon.
As noted during Organon’s first quarter conference call, to align with views expressed by the United States Securities and Exchange Commission, beginning in 2022, Organon will no longer exclude expenses for upfront and milestones related to collaborations and licensing agreements, or fees related to pre-approval assets obtained in transactions accounted for as asset acquisitions, from its non-GAAP results. Organon’s financial forecast does not assume an estimate of these expenses associated with business development not yet executed, and therefore the upfront payment of $73 million and approximately $30 million for milestones expected to be achieved in 2022 were not included in the full-year 2022 guidance provided by the Company on May 5, 2022. The Company does not plan to update its quarterly guidance based solely on these items.
About HLX11 (pertuzumab biosimilar candidate)
HLX11 (anti-HER2 domain II humanized monoclonal antibody injection) is a biosimilar candidate for pertuzumab and is being developed independently by Henlius. Pertuzumab is used in combination with trastuzumab and chemotherapy as neoadjuvant or adjuvant therapy for early HER2-positive breast cancer and in combination with trastuzumab and docetaxel in certain patients with locally recurrent metastatic or unresectable HER2-positive breast cancer . To date, HLX11 has met the primary endpoint of a Phase 1 clinical trial, showing pharmacokinetic and safety profiles similar to reference drugs from different sources.
About HLX14 (denosumab biosimilar candidate)
HLX14 (recombinant anti-RANKL human monoclonal antibody injection) is a biosimilar candidate for denosumab and is being developed independently by Henlius. Denosumab is used for a range of indications, including for the treatment of postmenopausal women with osteoporosis at high risk of fracture, certain patients with giant cell tumor of bone, and skeletal events in patients with multiple myeloma and in patients with solid bone metastases. tumors.
Organon is a global healthcare company created to focus on improving the health of women throughout their lives. Organon has a portfolio of over 60 drugs and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and a stable established drug franchise, Organon’s products are generating strong cash flow that will support investments in innovation and growth opportunities future in women’s health. In addition, Organon seeks opportunities to collaborate with biopharmaceutical innovators seeking to commercialize their products by leveraging its scale and presence in fast-growing international markets.
Organon has a global footprint with significant scale and geographic reach, world-class business capabilities and approximately 9,300 employees headquartered in Jersey City, New Jersey.
Henlius (2696.HK) is a global biopharmaceutical company whose vision is to deliver high-quality, affordable and innovative biologic medicines to patients worldwide, with a focus on oncology, autoimmune diseases and ophthalmic diseases. To date, 5 products have been launched in China, 1 in Europe, 13 indications approved worldwide and 2 New Drug Applications (NDAs) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high efficiency and innovation embedded throughout the product lifecycle, including R&D, manufacturing and commercialization. It has established global innovation centers and a Shanghai-based manufacturing facility certified by China and EU Good Manufacturing Practices (GMP).
Henlius has proactively built a diverse, high-quality product pipeline spanning over 20 innovative monoclonal antibodies (mAbs) and continued to explore immuno-oncology combination therapies with the proprietary HANSIZHUANG (anti-PD-1 mAb) as its backbone vertebral. Besides the launched products HANLIKANG (rituximab), the first biosimilar developed in China, HANQUYOU (trastuzumab, Zercepac® in Europe), the first biosimilar mAb developed in China approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI ( bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of solid tumors MSI-H and its NDA for the treatment of squamous non-small cell lung cancer and extensive small cell lung cancer (ES-SCLC ) is under review. Additionally, Henlius has conducted more than 20 clinical studies for 12 products and 10 combination therapies.
Organon Forward Looking Statement
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about the potential therapeutic benefits of HLX11 and HLX14 ; Organon’s ability to improve the lives of women; Henlius’ ability to bring high quality, affordable and innovative biologics to patients around the world; Henlius’ ability to advance the clinical development of HLX11 and HLX14; and the potential benefits of the Henlius License and Supply Agreement. Forward-looking statements may be identified by words such as “expects”, “intends”, “anticipates”, “plans”, “believes”, “seeks”, “estimates”, “will” or words with a similar meaning. These statements are based on the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the ongoing COVID-19 pandemic and the emergence of variant strains; the impact of pharmaceutical industry regulation and health care legislation in the United States and around the world; global trends toward health care cost containment; technological advances; new products and patents obtained by competitors; challenges inherent in developing new products, including obtaining regulatory approval; Organon’s ability to accurately predict its future financial results and performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties in developing and maintaining relationships with commercial counterparties; dependence on the effectiveness of Organon’s patents and other protections for innovative products; and exposure to litigation, including patent litigation, and/or regulatory actions.
Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Other factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission (“SEC”), including Organon’s Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent filings with the SEC, available on the SEC’s website (www.sec.gov).
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