#Taiwan #Taipei #Sandoz #EirGenix #EG1206A

EirGenix Strengthens its Position in Biosimilars with New Agreement

In a noteworthy development, EirGenix Inc. (TWSE: 6589) has signed a second global exclusive licensing agreement with Sandoz AG, a leader in the biosimilars market. This agreement will facilitate the commercialization of EirGenix's innovative breast cancer biosimilar, EG1206A, which is a biosimilar for Pertuzumab, often marketed as Roche's Perjeta®. This strategic partnership aims to enhance the availability of EG1206A in various international markets, excluding Taiwan, Mainland China, South Korea, and a few Southeast Asian countries.

EirGenix will benefit significantly from this deal, with potential earnings of up to USD 152 million from upfront and milestone payments. Furthermore, EirGenix stands to gain a share of profits post-launch depending on EG1206A's market performance. Their responsibilities will span from product development to manufacturing and supply, ensuring a comprehensive approach towards bringing this vital medication to market.

The journey of EG1206A marks an important milestone in EirGenix's endeavors in biosimilar development. The product has recently completed its pharmacokinetic clinical study, obtaining positive feedback from regulatory bodies such as the FDA and the European Medicines Agency (EMA). This validation allows EirGenix to bypass extensive Phase III comparative efficacy trials, expediting EG1206A's entrance into the market.

Market Potential and Future Directions

Breast cancer continues to be a formidable health issue globally, with an estimated 2.3 million new cases reported annually. Among these, 20% are classified as HER2-positive, making them prime candidates for targeted therapies like the Trastuzumab and Pertuzumab combination. The global market for such therapies is projected to expand, particularly highlighted by studies suggesting that the combination of Pertuzumab with Trastuzumab deruxtecan (Enhertu®) could set a new benchmark in first-line treatments for HER2-positive metastatic breast cancer. This heightened demand presents a lucrative opportunity for EG1206A to capture market share, further bolstered by Roche's reported sales of Perjeta® reaching CHF 3.62 billion (approximately USD 4 billion).

EirGenix's partnership with Sandoz, previously marked by a licensing agreement for another biosimilar (EG12014 for Trastuzumab), underscores their growing collaborative ties. EG12014 has already gained approval from the European Commission and is currently undergoing review for a Biologics License Application (BLA) in the U.S.

Sandoz's reputation as a pioneer in affordable medications positions it as an ideal partner for EirGenix. With a workforce exceeding 20,000 and a portfolio of roughly 1,300 products, they are well-equipped to ensure that critical medicines reach the patients who need them most. The company's long history is resplendent with innovations, including the world’s first oral penicillin and the first biosimilar, positioning it to navigate the complexities of the pharmaceutical landscape efficiently.

EirGenix's Future in the Biosimilar Sector

The landscape for biosimilars is becoming increasingly favorable as regulatory changes inspire more efficient pathways for drug development. EirGenix is strategically prepared to accelerate the development of its pipeline, which includes four HER2-targeted antibody programs in addition to its CDMO services for other biosimilar projects. As global demand for biosimilars surges, EirGenix's advanced technical proficiencies, coupled with its expansive manufacturing capabilities, have made it a focal point for collaboration with international pharmaceutical firms.

Recently, EirGenix is witnessing enhanced utilization of its two commercial production lines located in Zhubei, affirming its growth trajectory and operational success. With the launch of EG1206A positioned as a key milestone, EirGenix aims to solidify its role as a prominent player in the global biosimilar landscape, contributing to better treatment options for patients suffering from HER2-positive breast cancer.

This latest licensing agreement marks a pivotal moment in EirGenix's journey and underscores its commitment to advancing cancer care through innovative biosimilar solutions.