Taiwan-based contract development and manufacturing organisation EirGenix Inc (TWSE:6589) announced on Wednesday that it has signed a second global exclusive licensing agreement with Sandoz AG (SIX:SDZ) (OTCQX:SDZNY), a Swiss company that focuses on generic pharmaceuticals and biosimilars.

This agreement covers the commercialisation of Sandoz's independently developed breast cancer biosimilar, EG1206A (Pertuzumab Biosimilar to Roche Perjeta), covering all territories except Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, and Japan.

The new agreement further strengthens the two companies' collaborative development of the HER2 biosimilar product.

EirGenix will receive a total up to USD152m of upfront and milestone payments. EirGenix will also be entitled to a profit share once the product is launched in the licensed territory, plus potential sales incentives based on market performance. EirGenix will be responsible for product development, manufacturing, and supply.

EG1206A has completed its pharmacokinetic (PK) clinical study, and last month received positive feedback from both the US FDA and the European Medicines Agency (EMA), confirming that the product qualifies for an abbreviated development pathway, allowing for the waiver of Phase III comparative efficacy trials.