Curetis, Beijing
Clear Biotech Expand Strategic Collaboration for Unyvero in Greater
China
-
Exclusive
Unyvero A50 distribution agreement extended to eight
years
-
Significant
further contractual minimum purchase commitments by Beijing Clear
Biotech for additional contract years
-
Good progress
in regulatory process for gaining market access for Unyvero A50 in
China
Amsterdam, the
Netherlands, Holzgerlingen, Germany, and San Diego, USA, October
11, 2018, 09:00 am CET - Curetis N.V. (the "Company" and, together with its subsidiaries, "Curetis"), a developer of next-level molecular
diagnostic solutions, today announced that it has significantly
expanded its strategic collaboration with Beijing Clear Biotech
(BCB) for the exclusive distribution of the Unyvero A50 Platform
and Unyvero A50 Application Cartridges in Greater China.
The parties have amended their
exclusive international distribution agreement (the "Agreement"),
originally signed in September 2015, to expand the term of the
Agreement from five to eight years from the first regulatory
approval in China. The amended agreement has also expanded the
total commitment of BCB for cumulative minimum purchases to more
than 360 Unyvero A50 Systems from 260 Systems previously and over
1.5 million Unyvero Application A50 Cartridges from about 550,000
Cartridges previously for the duration of the Agreement. This
minimum commitment would indicate potential revenues to Curetis of
over EUR 30 million annually in years six to eight of
commercialization in China in addition to potential cumulative
revenues of more than EUR 60 million for years one to five of
commercialization in China as agreed upon previously.
Further, the parties agreed to
waive certain milestone payments otherwise payable by Curetis to
BCB for the initiation of clinical trial sites and the future
regulatory approvals by the China Food and Drug Administration
(CFDA) for the Unyvero A50 System and the first two Unyvero A50
Application Cartridges. These waivers represent a total saving to
Curetis of EUR 600,000 over the next one to three years.
BCB has made significant progress
in preparing the CFDA submission for approval of the Unyvero A50
System and the Unyvero HPN Application Cartridge. For example, BCB
has successfully completed the analytical validation of the Unyvero
HPN Application Cartridge under the auspices of the Beijing
Institute of Medical Technologies with all 40 assays of the HPN
panel now cleared for clinical trials in China. Further, BCB has
successfully completed a first clinical evaluation with
approximately 500 patient samples at the Sino-Japanese Friendship
Hospital in Beijing, China, generating a data set that will become
a further element in the submission to the CFDA. The parties also
intend to use the comprehensive data from Curetis' U.S. FDA trial
for the Unyvero LRT Application Cartridge to bolster the submission
of data to the CFDA to potentially accelerate market access in
China. The use of foreign data in submissions to the CFDA became
possible after October 2017 when a respective new regulation was
issued by the Chinese government.
The Company expects that BCB will
initiate clinical trials in China, which may be required to support
the final submission for CFDA approval, swiftly after feedback from
the CFDA on the regulatory pathway and the data requirements for a
final submission. Assuming a final submission in 2019 and a CFDA
approval were obtained in late 2019 or early 2020, Curetis
anticipates that it would generate initial revenues from commercial
sales in China starting in 2020.
"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 Dr. Achim Plum, Chief Business Officer
of Curetis. "The expansion of a strategic collaboration with BCB is
timely as we believe we are making very good progress with the
preparation of a submission for the approval of the Unyvero A50
System and HPN Application Cartridge in China. We are also excited
about the prospect of accelerating access to this strategically
important market by potentially leveraging our comprehensive data
set from our U.S. FDA trial in a submission to the CFDA."
About Curetis
Curetis N.V.'s (Euronext: CURE)
goal is to become a leading provider of innovative solutions for
molecular microbiology diagnostics designed to address the global
challenge of detecting severe infectious diseases and identifying
antibiotic resistances in hospitalized patients.
Curetis' Unyvero System is a
versatile, fast and highly automated molecular diagnostic platform
for easy-to-use, cartridge-based solutions for the comprehensive
and rapid detection of pathogens and antimicrobial resistance
markers in a range of severe infectious disease indications.
Results are available within hours, a process that can take days or
even weeks if performed with standard diagnostic procedures,
thereby facilitating improved patient outcomes, stringent
antibiotic stewardship and health-economic benefits. Unyvero in
vitro diagnostic (IVD) products are marketed in Europe, the Middle
East, Asia and the U.S.
Curetis' wholly owned subsidiary
Ares Genetics GmbH is developing next-generation solutions for
infectious disease diagnostics and therapeutics. The ARES
Technology Platform combines what the Company believes to be the
most comprehensive database worldwide on the genetics of
antimicrobial resistances, ARESdb, with
advanced bioinformatics and artificial intelligence.
For further information, please
visit www.curetis.com and www.ares-genetics.com.
About Beijing Clear
Biotech
Founded in 2001 in Beijing, Beijing Clear Biotech
Co., Ltd ("Beijing Clear Biotech") is a privately held distributor
of POCT products in China with a particularly strong geographic
focus on north China. Beijing Clear is known for its industrial
expertise and marketing experience in the POCT segment and sells
POCT devices and supplies to hospitals, physician office
laboratories and other primary care settings.
Legal Disclaimer
This document constitutes neither
an offer to buy nor to subscribe securities and neither this
document nor any part of it should form the basis of any investment
decision in Curetis.
The information contained in this
press release has been carefully prepared. However, Curetis bears
and assumes no liability of whatever kind for the correctness and
completeness of the information provided herein. Curetis does not
assume an obligation of whatever kind to update or correct
information contained in this press release whether as a result of
new information, future events or for other reasons.
This press release includes
statements that are, or may be deemed to be, "forward-looking
statements". These forward-looking statements can be identified by
the use of forward-looking terminology, including the terms
"believes", "estimates", "anticipates", "expects", "intends",
"may", "will", or "should", and include statements Curetis makes
concerning the intended results of its strategy. By their nature,
forward-looking statements involve risks and uncertainties and
readers are cautioned that any such forward-looking statements are
not guarantees of future performance. Curetis' actual results may
differ materially from those predicted by the forward-looking
statements. Curetis undertakes no obligation to publicly update or
revise forward-looking statements, except as may be required by
law.
Contact Details
Curetis GmbH
Max-Eyth-Str. 42
71088 Holzgerlingen, Germany
Tel. +49 7031 49195-10
pr@curetis.com or ir@curetis.com
www.curetis.com
International Media &
Investor Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68
U.S. Media & Investor
Inquiries
The Ruth Group
Lee Roth
lroth@theruthgroup.com
Tel. +1 646 536 7012
20181011_Curetis_PR_EN_Expansion
China Corporation