The licensing agreement provides Hikma with exclusive rights to commercialise and distribute Vicineum in the MENA region for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”) and other types of cancer.
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive NMIBC. In December 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review.
“At Hikma, we believe that partnerships with innovative pharma companies are a key contributor to the success of our business. We are very pleased to enter into an exclusive partnership with Sesen given their expertise in NMIBC and the strong clinical profile of Vicineum,” said Mazen Darwazah, Hikma’s Executive Vice Chairman and President of MENA. “As a company whose mission is to put better health within reach every day, we regard being the partner of choice to Sesen in MENA as a key collaboration that augments Hikma’s biotechnology and oncology portfolio to deliver on our strategy of bringing innovative products to patients in the region. Vicineum™ - our first innovative fusion protein - is a highly differentiated product candidate and is positioned to make a meaningful impact on the lives of bladder cancer patients.”
“Sesen is committed to saving and improving the lives of patients, and Hikma is an ideal partner to deliver Vicineum to patients with NMIBC in the MENA region,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “As we continue to work toward regulatory approval in the US and Europe, we also continue to execute partnerships outside of the US as part of our mission to deliver this important medicine to patients around the world. Hikma has strong expertise in commercialising innovative products in the MENA region and and a successful track record of serving patients world-wide. This partnership represents a further step in realizing the significant global opportunity for Vicineum.”
Under the terms of the agreement, Sesen Bio granted Hikma an exclusive license to register and commercialise Vicineum in all 19 MENA markets in an arrangement anticipated to deliver equal value share to both parties. Financial terms of the agreement are confidential and include an upfront payment to Sesen Bio, sales related milestone payments and royalties on net sales in the region for the term of the agreement.