De distributiedeal van vandaag laat zien dat ze overal kansen zien om op korte termijn inkomsten te genereren want net als bij de Chinese deal (zie hieronder - oud nieuws) is er ook nu een minimale afnamen afgesproken.
Amsterdam, the Netherlands, and Holzgerlingen, Germany, February 04, 2019, 08:00 am
CET - Curetis N.V. (the "Company" and, together with its subsidiaries, "Curetis"), a developer
of next-level molecular diagnostic solutions, today announced that Beijing Clear Biotech (BCB)
has filed for regulatory approval of the Unyvero A50 HPN Application Cartridge for pneumonia
with the Chinese National Medical Products Administration (NMPA; formerly Chinese Food
and Drug Administration). BCB is Curetis’ exclusive distribution partner for the Unyvero A50
platform and product line in Greater China and has filed the submission to the NMPA in the
name and on behalf of Curetis.
The submission is based on comprehensive data from Curetis’ U.S.-FDA trial as well as from
European CE-IVD validation studies comprising data sets from close to 1,400 patient samples
in total, combined with analytical validation data of the Unyvero HPN Application Cartridge that
were generated under the auspices of the Beijing Institute of Medical Technologies. The use
of foreign data in submissions to the newly formed NMPA became possible in October 2017
when a respective new regulation was issued by the Chinese government.
BCB has already generated clinical data from several hundred patient samples at a Chinese
hospital and further intends to collect additional clinical data on the performance of Unyvero
HPN in China under appropriate protocols to augment the submission, if required, and to
support future market access and adoption in Greater China.
Assuming a potential regulatory approval by NMPA in late 2019 or early 2020, Curetis
anticipates initial revenues from commercial sales through BCB in China starting in 2020.
In the light of the progress made toward gaining market access in China, BCB and Curetis in
October 2018 expanded their exclusive distribution agreement from five to eight years post
NMPA approval with total minimum purchasing commitments by BCB that may generate more
than EUR 150 million in revenues for Curetis over the entire duration of the contract, i.e. an
increase by about EUR 90 million compared to the original agreement between the parties.
“The filing for our Unyvero A50 System and our HPN pneumonia panel by our partner BCB is
an important milestone in our strategic approach to the Chinese market,” said Dr. Achim Plum,
Chief Business Officer of Curetis. “With pneumonia being a major health threat in China and a
leading cause of death particularly in children, we believe that Unyvero, once approved, can
support ongoing public health initiatives to improve rapid diagnosis and treatment of this often
fatal disease.”