Company News: Curetis Enters into Distribution Agreement to Expand Commercial Activities into Greater China
– Exclusive Unyvero distribution agreement with Beijing Clear Biotech Co., Ltd. for Mainland China, Hong Kong and Taiwan
– Clinical trials for CFDA regulatory approval in preparation
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has signed an exclusive distribution agreement (the “Agreement”) for China, Hong Kong and Taiwan (collectively “Greater China”) with Beijing Clear Biotech Co. Ltd. The Agreement, effective from September 25, 2015, comprises the Unyvero Systems and P55 and i60 ITI Application Cartridges. Based in Beijing and founded in 2001, Beijing Clear Biotech is an experienced and prominent distributor of prime medical technology brands throughout Greater China. In the in vitro diagnostics market, Beijing Clear Biotech focuses on the distribution of point-of-care diagnostics, in particular European products and PCR devices.
Under the terms of the Agreement, Beijing Clear Biotech will conduct and fully fund all prospective multi-center clinical trials required for approval of the Unyvero System and its P55 and i60 ITI Application Cartridges by the China Food and Drug Administration (“CFDA”), including funding the systems and application cartridges required for the trials. Beijing Clear Biotech’s responsibilities also include leading the registration and approval process, inclusive of paying all fees, on behalf of Curetis. The anticipated CFDA license will be owned by Curetis. Curetis will pay Beijing Clear Biotech certain milestone payments upon clinical trial initiation and CFDA approval, respectively, and grant a commercial exclusivity for distribution in China, Hong Kong and Taiwan. Under the terms of the Agreement, Beijing Clear Biotech has agreed to certain minimum purchase numbers of Unyvero Systems as well as P55 and i60 ITI Application Cartridges per year.
Upon CFDA approval, Curetis will support commercialization through Chinese-language marketing materials and regular product training for the distributor’s sales force. Beijing Clear Biotech will be responsible for managing all local marketing and sales activities as well as handling storage and logistics support. Marketing in Taiwan will start earlier than in China and Hong Kong, as specific trials are not required for product registration there.
For the commercialization of the Unyvero i60 implant and tissue infection (“ITI”) Application Cartridge, Beijing Clear Biotech will partner with LandMover Medical Technologies Co. Ltd. (Beijing, China), the exclusive Chinese distributor of Heraeus Medical, one of the leading companies in the field of bone cement and biomaterials for elective orthopedic and trauma surgery. The i60 ITI Application Cartridge was co-developed by Curetis with Heraeus Medical to improve the management of patients with implant and tissue infections, including prosthetic joint and other orthopedic infections, to support an early and informed decision on the choice of antibiotic-supplemented bone cement in revision surgery.