NEW YORK (GenomeWeb) – Curetis announced today that it has extended an exclusive distribution agreement with Beijing Clear Biotech (BCB), expanding it from five years to eight years following the first Chinese regulatory approval.
The strategic collaboration covers distribution of the Curetis Unyvero A50 platform and assay cartridges in China.
The amendment to the original 2015 agreement also expands BCB’s minimum purchases of A50 systems from 260 to 360, and increases the number of cartridges from 550,000 to 1.5 million. In a statement, Curetis noted this commitment would increase potential revenue in China by €30 million ($34.7 million) in years six to eight of the agreement, in addition to an estimated €60 million for the original five-year agreement.
The firms also agreed to waive milestone payments by Curetis to BCB for the initiation of clinical trial sites as well as future CFDA approvals for the Unyvero A50 System and the first two test cartridges, representing a savings to Curetis of €600,000 over the next one to three years.
“With the amendment of our strategic agreement with BCB, we further limit our short-term cash exposure in gaining market access to China, while creating a much more attractive medium- to longer-term business prospect for our partner and ourselves,” said Achim Plum, Curetis’ chief business officer.
In its progression toward CFDA submission, BCB has completed analytical validation of an assay cartridge for pneumonia in hospitalized patients, called HPN, at the Beijing Institute of Medical Technologies, and all 40 assays of the HPN panel are now cleared for clinical trials in China, Curetis said. BCB has also completed a first clinical evaluation, and the firms further intend to use data from Curetis’ US Food and Drug Administration trial for the Unyvero lower respiratory tract infection assay in the CFDA submission in order to accelerate market access in China.
The use of foreign data in submissions to the CFDA became possible after October 2017, when a new regulation was issued by the Chinese government, Curetis noted.
The company anticipates generating initial revenues from commercial sales in China starting in 2020 after a final CFDA submission in 2019 and approval in late 2019 or early 2020.