Provention Bio, Inc. a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd., announced that the companies have entered into a strategic collaboration to develop and commercialize PRV-3279, a DART (bispecific antibody-based molecule) targeting the B cell surface proteins CD32B and CD79B, in Greater China (mainland China, Hong Kong, Macau and Taiwan). Provention Bio will retain all rights to PRV-3279 in the rest of the world.
This collaboration provides Provention Bio access to the second largest pharmaceutical market in the world via Huadong’s development, regulatory, and commercial capabilities. PRV-3279 represents the addition of an exciting autoimmune asset to Huadong’s growing autoimmunology portfolio. Provention Bio plans to begin a Phase 2a trial of PRV-3279 in systemic lupus erythematosus (SLE) in the second half of 2021 and expects a portion of such trial to be conducted in China.
“Huadong’s extensive development and commericalization experience in the Greater China region along with their strategic goal of being a leader in the autoimmune therapeutic space created the opportunity for a strong, strategic and mutually beneficial partnership between our two companies,” stated Ashleigh Palmer, CEO and co-founder of Provention Bio. “This collaboration is a reflection of PRV-3279’s potential to intercept and prevent life-altering and life-threatening autoimmune diseases and we look forward to working closely with Huadong to develop and commercialize PRV-3279 in Greater China as we simultaneously further the development of the program in the rest of the world.”
“Provention Bio is a well regarded biopharmaceutical company innovating to intercept and prevent serious autoimmune disorders. PRV-3279 has the potential to intercept SLE disease progression and improve the quality of life of people living with SLE,” added Liang Lu, Chairman of Huadong Medicine. “The SLE patient population is substantial in China, with very few treatment options. Leveraging Huadong’s clinical and regulatory capabilities, we will work closely with Provention Bio to accelerate the clinical development of PRV-3279 in Greater China, to benefit SLE patients as soon as possible.”
Under the terms of the agreement, Provention Bio will receive an upfront payment of $6 million, and up to $11.5 million in funding over the next three years to cover costs anticipated to be incurred by Provention Bio in connection with research, development and manufacturing activities. Provention Bio is eligible to receive additional milestone payments of up to $172 million if certain regulatory and commercial objectives are achieved. Provention Bio is also eligible to receive low-to-mid double digit royalties as a percentage net sales of PRV-3279 by Huadong in Greater China.
Huadong will be primarily responsible for development and commercialization of PRV-3279 in Greater China with the oversight of a joint steering committee comprised of individuals from both companies. Provention Bio will continue to be responsible for the development and commercialization of PRV-3279 in the United States and other geographies.