WuXi PharmaTech said it will partner with Eli Lilly to develop, manufacture, and commercialize in China a Lilly-discovered once-daily oral experimental drug designed to address cardiovascular risk in patients with dyslipidemia. The value of the collaboration was not disclosed.
The drug candidate aims to reduce cardiovascular events in patients with elevated LDL cholesterol and triglycerides. According to WuXi, an estimated 276 million patients in China are affected by the conditions, including about 12 million patients who require drug treatment.
WuXi said yesterday it will oversee regulatory, development and manufacturing activities in China, which will be led and coordinated by WuXi's Product Development Service and Partnership Business Unit. WuXi also said it will manufacture the experimental treatment in China.
Lilly will be responsible for commercial activities, while both companies agreed to work toward bringing the experimental therapy to patients in China. Further financial terms of the collaboration were not disclosed.
An Investigational New Drug application will be filed in China by WuXi, and product development and registration will be carried out within China, the Chinese pharma said.
“This strategic collaboration will leverage the recently announced China regulatory reforms, which strongly encourage, support, and accelerate development and manufacture in China of highly innovative new medicines that target major unmet medical needs,” WuXi chairman and CEO Ge Li, Ph.D., said in a statement.
On August 18, China’s State Council announced the launch of reforms intended to improve its system of reviewing new drugs and medical devices. The reforms are aimed at increasing efficiency, resolving the China’s backlog of drug applications by the end of 2016, improving the quality of generic drugs, encouraging the development of innovative drugs and creating a more transparent review and approval process, the law firm Ropes & Gray said in an analysis.
“This unique collaboration is part of our 'In China, For China' strategy to leverage Lilly's leading technology and experience, and local partners' insight and expertise, to meet patient needs,” added Andrew Hodge, president of Lilly China.
According to Eli Lilly China’s LinkedIn page, the company bases nearly 4,000 employees in China. Lilly first expanded there in 1918, and established its first overseas representative office in Shanghai. After an absence, Lilly returned to China in 1993, and first partnered with WuXi in 2003 to provide a range of services from early compound screening to large-scale pharmaceutical intermediate manufacturing.
Lilly’s latest collaboration with WuXi comes nearly a month after the U.S. pharma giant disclosed that it was discontinuing development of its lead cardiology compound, the Phase III candidate evacetrapib, for high-risk atherosclerotic cardiovascular disease.
The decision followed a recommendation of the independent data monitoring committee for the Phase III ACCELERATE trial to terminate the pivotal study, citing what Lilly said were “periodic data reviews which suggested there was a low probability the study would achieve its primary endpoint based on results to date.” The company said October 12 it expects to take an up to $90 million pre-tax fourth-quarter charge to its R&D expense in connection with the termination.
The no-go on evacetrapib lowered the number of compounds with cardiovascular indications in Lilly’s pipeline to five, according to its website. None of the five are listed for dyslipidemia.