EIRGENIX SIGNS TRASTUZUMAB BIOSIMILAR LICENSE AGREEMENT WITH NOVARTIS SANDOZ

2019/04/30 – EirGenix, Inc. announced today that it has secured a license agreement with Sandoz AG, a Novartis division and a global leader in generic and biosimilar drug manufacturing. The signed license agreement grants Sandoz the exclusive rights to globally commercialize EirGenix's proposed trastuzumab biosimilar drug (EG12014) currently in Phase III development. EirGenix will maintain responsibility for development and manufacturing of the trastuzumab biosimilar, while Sandoz will maintain rights to commercialize the drug upon approval in all markets excluding China and Taiwan. Under the terms of the agreement, EirGenix will receive an upfront payment, milestone payments, and is entitled to receive profit share payments for sales in the agreed territories. The signing of this agreement is one of the most significant achievements for EirGenix's product development business since the company's establishment and represents an exciting moment for Taiwan's biotech industry.

Sandoz is a global leader in generic pharmaceuticals and biosimilars and a pioneer in the emerging field of prescription digital therapeutics. The company has a long history and extensive experience in the development and commercialization of biosimilar and cancer drugs in markets such as Europe and the United States. The collaboration between EirGenix and Sandoz will leverage the combined strength of EirGenix's R&D of biosimilar drugs, with Sandoz's substantial experience in global drug sales and advantages in market access. This collaboration will be conducive to EirGenix's market development and expansion in the pharmaceutical market and will be extremely positive for EirGenix's financial and business development as the collaboration will enhance the visibility and competitiveness of its products in the global market, which would thereby improve the company's overall operating scale and profitability. With the successful market entry of EG12014, HER2-positive breast cancer patients will benefit from more treatment options.

EG12014 (Trastuzumab biosimilar) has entered a global Phase 3 clinical trial (Study No.: EGC002) which has been to date approved to conduct such trial by ten regulatory authorities including the U.S. FDA, Taiwan TFDA, as well as the authorities in Russia, Belarus, Ukraine, South Africa, Georgia, South Korea, India and Chile. A total of 800 breast cancer patients will be enrolled for this Phase 3 clinical trial, and the primary endpoint analysis is expected to be completed in the second half of 2020 to support the product registration. According to Roche's 2018 annual report, Herceptin's global sales amounted to 6.982 billion Swiss Francs. Herceptin tops the list in drug spending by Taiwan's National Health Insurance, with an annual expenditure of nearly NT$3 billion.