On September 12, 2018 Novocure (NASDAQ:NVCR), a global oncology company developing a proprietary platform technology called Tumor Treating Fields, and Zai Lab (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, reported an exclusive license agreement for Tumor Treating Fields, including the brand name Optune, in Greater China and a global strategic development collaboration (Press release, NovoCure, SEPT 12, 2018, View Source [SID1234529407]). This agreement will enable Novocure to access the Chinese market and is intended to accelerate clinical trial enrollment. For Zai Lab, this agreement will add a complementary commercial stage oncology asset to its innovative pipeline.

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"The Zai Lab team is passionate about bringing innovative treatments to patients in need, a passion we share at Novocure," said Novocure’s Executive Chairman Bill Doyle. "We believe this collaboration supports our mission of making Tumor Treating Fields available to patients throughout the world and will accelerate the development of Tumor Treating Fields in indications beyond glioblastoma (GBM)."

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. Tumor Treating Fields is currently marketed under the brand name Optune in the U.S., the EU, Switzerland, Japan and certain other countries for the treatment of GBM and is in advanced clinical development for multiple solid tumor indications. Novocure reported trailing 12-month revenues from Optune of $217 million as of June 30, 2018, representing 60 percent year-over-year revenue growth Q2 2018 versus Q2 2017. While Optune is not yet approved for commercialization in China, the technology was included and recommended with Level 1 evidence as a treatment for GBM in China’s Glioma Treatment Guideline published in 2016.

"There are approximately 45,000 newly diagnosed GBM patients annually in China," said Lvhua Wang, Associate Director of China National Cancer Center and Vice President of China Society of Clinical Oncology. "Temozolomide is currently the only approved therapy for GBM in China so there are limited choices for one of the most deadly cancers. I am eagerly anticipating Tumor Treating Fields approval in China."

Novocure granted Zai Lab an exclusive license to commercialize Tumor Treating Fields in China, Hong Kong, Macau and Taiwan. Zai Lab will be responsible for regulatory submissions in Greater China and will work to establish Tumor Treating Fields as an oncology treatment in this territory.

Preclinical and clinical research demonstrated that Tumor Treating Fields’ mechanism of action affected fundamental aspects of cell division and may have broad applicability across a variety of solid tumors. In addition to GBM, Novocure and Zai Lab will collaborate on development activities for Tumor Treating Fields in multiple solid tumor indications, including Novocure’s ongoing phase 3 pivotal trials in non-small cell lung cancer (NSCLC) and pancreatic cancer, and a phase 3 pivotal trial in ovarian cancer planned to open later this year. In addition, Zai Lab will conduct a phase 2 pilot trial to investigate Tumor Treating Fields in gastric cancer in China. China has one of the highest incidence rates of gastric cancer in the world, with approximately 680,000 new cases annually. Gastric cancer is the second leading cause of cancer death in men and women in China.

"Optune has demonstrated strong efficacy in a very challenging and difficult to treat cancer, GBM," said Dr. Samantha Du, CEO of Zai Lab. "Optune was approved in Japan without the need for a local bridging trial and we hope for similar rapid development in China. In addition, Tumor Treating Fields has the potential to treat a variety of solid tumors, which we believe are complementary to Zai Lab’s existing late-stage oncology assets and represent strong commercial synergy for us."

Novocure will receive a $15 million upfront payment and is eligible to receive additional payments upon achievement of certain development, regulatory and commercial milestones. Novocure is also eligible to receive a royalty on net sales of the licensed products in Greater China ranging from 10 percent to the mid-teens.

China Renaissance served as sole financial advisor to Novocure for the transaction.