November 7, 2022
ORGANON CANADA LAUNCHES AYBINTIO®, A BIOSIMILAR OF THE REFERENCE BIOLOGIC AVASTIN*, PROVIDING A NEW OPTION AT A REDUCED COST FOR CANADIANS LIVING WITH CERTAIN AGGRESSIVE FORMS OF CANCER
Kirkland, Quebec, November 7, 2022 – Organon (NYSE: OGN), a global women’s health company, is announcing the launch and product availability of AYBINTIO®, a biosimilar of Avastin*, providing a new treatment option for adult Canadian patients affected with certain aggressive forms of cancers, including metastatic colorectal cancer (mCRC), locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), platinum-sensitive recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer, platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal and malignant glioma (WHO Grade IV) – glioblastoma.1
“Organon Canada is committed to expanding its biosimilar portfolio to help strengthen our healthcare system and support patients in need,” said Michael Casia, President and Managing Director, Organon Canada. “The impact of COVID-19 continues to put pressure and strain on our healthcare system across Canada. The adoption of biosimilars that are available at a reduced cost, such as AYBINTIO®, can help alleviate these burdens.”
With the company’s experience in biosimilars, the launch of AYBINTIO® represents Organon Canada’s first entry in Oncology.
Continued advancement and availability of biosimilars provides patients impacted by aggressive cancers more affordable and alternative treatment options. Some of these cancers include non-small cell lung cancers; lung cancer, which is the leading cause of cancer death in both women and men,2 and colorectal cancer, which is expected to be the fourth most diagnosed cancer, excluding non-melanoma skin cancer, in Canada in 2022. Colorectal cancer is the second leading cause of death from cancer in men and the third leading cause of cancer death in women.3 In addition, approximately 3,000 Canadian women will be diagnosed with ovarian cancer in 2022, and over half (1,950) will die from it.4
“More affordable and alternative treatments are undeniably needed to support patients across Canada,” said Dr. Sandeep Sehdev, Medical Oncologist, Ottawa Hospital Cancer Centre. “These highly regulated biologic medicines have the potential to improve patient care by increasing patient access to therapies.”
AYBINTIO® was developed and manufactured by Organon’s collaborator Samsung Bioepis which also developed and manufactured its other biosimilars portfolio including HADLIMA®, RENFLEXIS® and BRENZYS®.
Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking 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 commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.
Forward-Looking Statement of Organon & Co., Jersey City, N.J., USA
Except for historical information herein, this news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about management’s expectations about Organon’s future financial performance and prospects. Forward-looking statements may be identified by words such as “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’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 emergence of variant strains; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict its future financial results and performance; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the Securities and Exchange Commission (SEC), including its registration statement on Form 10, available at the SEC’s Internet site (www.sec.gov).
References: 1. AYBINTIO® Product Monograph. Organon Canada. November 30, 2021. https://www.organon.com/canada-en/aybintio-pm_e. 2. Government of Canada. Lung Cancer. Available at https://www.canada.ca/en/public-health/services/chronic-diseases/cancer/lung-cancer.html. Accessed on September 14, 2022. 3. Canadian Cancer Society. Colorectal Cancer Statistics. Available at https://cancer.ca/en/cancer-information/cancer-types/colorectal/statistics. Accessed on September 8, 2022. 4. Canadian Cancer Society. Ovarian Cancer Statistic. https://cancer.ca/en/cancer-information/cancer-types/ovarian/statistics. Accessed on October 5, 2022.
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