On December 1, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, and Hikma Pharmaceuticals, a multi-national pharmaceutical company and leading licensing partner in the Middle East and North Africa ("MENA") region specializing in the development and commercialization of a broad range of high-quality medicines, reported that the companies have entered into an exclusive licensing agreement for the registration and commercialization of Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") and other types of cancer in MENA (Press release, Sesen Bio, DEC 1, 2020, View Source [SID1234572036]). 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 commercializing innovative products in the MENA region and a successful track record of serving patients worldwide. This partnership represents a further step in realizing the significant global opportunity for Vicineum."

"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."

Under the terms of the agreement, Sesen Bio granted Hikma an exclusive license to register and commercialize 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. Sesen Bio retains full development and commercialization rights for Vicineum for the treatment of NMIBC in the US and the rest of the world excluding Greater China and MENA.

Al-Tamimi and Hogan Lovells acted as legal advisors to Sesen Bio for this transaction.

About Vicineum
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. Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicineum for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

About Non-Muscle Invasive Bladder Cancer
Bladder cancer is the sixth most commonly diagnosed cancer in the United States, and approximately 80 percent of patients have non-muscle invasive bladder cancer (NMIBC). In NMIBC, cancer cells are in the lining of the bladder or have grown into the lumen of the bladder but have not spread into muscle or other tissue. NMIBC primarily affects men and is associated with carcinogen exposure. Initial treatment includes surgical resection; however, there is a high rate of recurrence and more than 60 percent of all patients diagnosed with NMIBC will receive bacillus Calmette-Guérin (BCG) immunotherapy. While BCG is effective in many patients, challenges with tolerability have been observed and many patients will experience recurrence of disease. If BCG is not effective or a patient can longer receive BCG, the recommended option for treatment is radical cystectomy, the complete removal of the bladder.