Sandoz announced the signing of a global license agreement to commercialize a proposed biosimilar of oncology medicine pertuzumab.
The agreement with EirGenix Inc. is milestone-based for a total consideration of up to $152M, including an upfront payment and further potential incentives dependent upon market performance. The reference medicine market is worth an estimated $4.1B in global sales, and pertuzumab will join the deep Sandoz pipeline with the strategic objective to capitalize on a projected ~$300B biosimilar market opportunity over the next 10 years.
Under the terms of the agreement, Sandoz has exclusive worldwide commercial rights to a biosimilar of pertuzumab, excluding certain countries in Asia*, while EirGenix Inc. will be responsible for development, manufacturing and supply. The medicine has already completed a human pharmacokinetic similarity clinical study.
Richard Saynor, CEO of Sandoz, said: “According to the latest estimates, up to 2.3 million patients worldwide are diagnosed with breast cancer each year and, of these cases, approximately 15% to 20% are HER2-positive breast cancer.
“This agreement underscores our commitment to expand patient access, as well as support healthcare systems by offering high quality and more affordable treatment options. It also enhances our biosimilar oncology portfolio and complements our pipeline, given that the combination of pertuzumab and trastuzumab represents the standard of care in this field.”
The reference medicine Perjeta®** is a humanized IgG1 monoclonal antibody that is used in combination with other therapies, including trastuzumab, to treat HER2-positive early breast cancer and HER2-positive metastatic or locally recurrent unresectable breast cancer.
The agreement strengthens the collaboration between Sandoz and EirGenix Inc, with an existing agreement already in place for worldwide commercialization*** of the proposed biosimilar trastuzumab, in both 150 mg and 420 mg forms. Studies also show that a combination of pertuzumab and trastuzumab deruxtecan could become a new first-line standard for HER2-positive metastatic breast cancer6, with a biosimilar of trastuzumab deruxtecan currently in the Sandoz pipeline.
* Countries out of scope: Taiwan, China, Macau, Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines and Japan
** Perjeta® is a registered trademark of Roche
*** Under this agreement, Sandoz holds the right to commercialize the medicine globally except in Russia, China, Taiwan, Australia, and some other Asian and South American countries
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