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EirGenix and Sandoz Extend Collaboration with New Licensing Agreement

EirGenix Inc., a biotechnology company based in Taiwan, has recently announced a significant step in its partnership with Sandoz AG, a global leader in biosimilars. On November 12, EirGenix revealed the signing of a second exclusive global licensing agreement with Sandoz for the commercialization of its second biosimilar, EG1206A, aimed at treating HER2-positive breast cancer.

The Details of the Agreement

This licensing agreement covers numerous international territories, excluding Taiwan, mainland China, Macao, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, and Japan. This expansion marks a crucial enhancement of the cooperation between the two firms, which initially forged a partnership over another biosimilar asset, EG12014, related to trastuzumab. Within the new deal, EirGenix stands to receive up to $152 million in initial payments and milestone-related funds.

Upon the launch of EG1206A in licensed territories, EirGenix will also earn a share of the profits along with potential sales incentives based on market performance. Notably, the company is tasked with the development, manufacturing, and supply of the biosimilar.

Positive Clinical Developments

In terms of product development, EG1206A has completed its pharmacokinetic clinical study, recently garnering favorable feedback from the FDA in the United States and the European Medicines Agency (EMA). Such endorsements confirm that the product could benefit from a shortened development process, which may exempt it from requiring Phase III efficacy trials. This is a significant milestone for EirGenix in its ongoing push towards developing effective biosimilars.

The cooperation between EirGenix and Sandoz not only strengthens their relationship but also emphasizes their aligned goals in producing effective treatment options for patients suffering from breast cancer. Approximately 2.3 million individuals worldwide are impacted by breast cancer, with an estimated 20% diagnosed with HER2-positive disease. Current therapy for these patients often involves combination treatments with trastuzumab and pertuzumab, demonstrating a growing demand for effective biosimilars like EG1206A.

The Market Potential of EG1206A

With the emergence of new therapies, such as the combination of pertuzumab with trastuzumab deruxtecan (Enhertu), the market for HER2-positive breast cancer treatments is poised for expansion. As per Roche's 2024 annual report, worldwide sales of Perjeta® reached around 4 billion dollars, highlighting the lucrative potential for EirGenix’s EG1206A in the global market.

Sandoz, founded in 1886 and headquartered in Basel, Switzerland, has a legacy of innovation, being recognized for introducing the first oral penicillin and the first biosimilar globally. Their mission focuses on enhancing patient access to high-quality medications, which resonates with EirGenix’s aspirations of providing affordable therapeutic options.

EirGenix's Commitment to Innovation

EirGenix has leveraged reverse engineering technologies to successfully develop several biosimilar products. This recent agreement underscores their competitiveness, technical excellence, and global outreach capability. With an increase in demand for biosimilars, EirGenix is expediting the development of several HER2-targeting antibody programs along with broadening its CDMO services for further biosimilar projects. The company’s two commercial production lines in Zhubei have played a vital role in their rapid progress, solidifying EirGenix's position as a key player in the biosimilar landscape.

As the global appetite for biosimilar research and production continues to grow, EirGenix is on track to maintain its trajectory of strong growth while making meaningful contributions to the field of oncology.