FluoroPharma Enters Development and Commercialization Agreement for China and Canada
MONTCLAIR, NJ -- (Marketwired) -- 06/06/16 -- FluoroPharma Medical Inc. (OTCQB: FPMI) has entered an exclusive agreement with Sinotau USA Inc., a wholly owned subsidiary of Sinotau Pharmaceutical Group, a pharmaceutical enterprise with a focus on critical therapeutic areas. With this agreement, Sinotau will develop and commercialize FluoroPharma's proprietary cardiac imaging assets CardioPET and BFPET in China and Canada. These agents address two different aspects of cardiovascular disease (CVD) with Positron Emission Tomography (PET) imaging.
In exchange, FluoroPharma expects to earn significant revenue based on unit sales to Sinotau and royalties based on Sinotau's sales of both imaging agents. In addition to a $550,000 upfront payment to FluoroPharma, up to $1.4 million in development milestone payments have also been established.
CardioPET, the company's lead imaging asset, is a fatty acid analog that targets the heart's primary energy source, and promises to provide unique insight into cardiac physiology versus older technologies like SPECT. CardioPET has completed enrollment in a Phase II study in Europe, and will advance to additional clinical studies in the US.
BFPET, entering Phase II studies in the US, is a marker of mitochondrial membrane integrity and can be used to evaluate myocardial perfusion with all the potential benefits of Fluorine-18 PET imaging, such as higher image resolution fewer image artifacts.
"We are pleased to have reached agreement with such a well-established partner as Sinotau," said Thomas Tulip, Ph.D., President and Chief Executive Officer of FluoroPharma. "As cardiovascular disease prevalence continues to rise in China, Canada, and around the world, we believe these assets will play a major role in how heart disease is diagnosed and managed appropriately."
According to the World Health Organization, the death rate from cardiovascular disease in China is nearly double that of cancer, and across Asia it now exceeds the mortality rates for CVD in other developed countries.
"We are pleased to have a partnership that combines FluoroPharma's radiopharmaceutical assets with our extensive development, regulatory, sales, and marketing capabilities," commented Xu Xinsheng, Sinotau President and CEO. "Our goal is to offer novel radiopharmaceutical approaches to improve care and patient outcomes with the growing cardiovascular disease problem in China. Ultimately, we are focused on having an impact on the growing concern of cost implications and quality of care in such a large population."
As part of the agreement, Sinotau is responsible for the costs and conduct of clinical studies and regulatory applications to obtain approval by the China Food and Drug Administration (CFDA) and Health Canada. Upon approval, Sinotau will be primarily responsible for all CardioPET and BFPET sales, marketing, market access and medical affairs activities in China and Canada. FluoroPharma and Sinotau will jointly support certain pre-market planning activities with a joint commitment on clinical and market development programs pending CFDA and Health Canada approvals.
"This is the first of many important partnerships which we anticipate during the course of our clinical development," added Dr. Tulip. "The ongoing advance of CVD and the need for better and more efficient solutions in healthcare worldwide give us increased confidence in the inherent value of our portfolio, and our ability to deliver shareholder value as well."
