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Curetis, Beijing Clear Biotech Expand Strategic Collaboration for Unyvero in Greater China

Curetis /
Curetis, Beijing Clear Biotech Expand Strategic Collaboration for Unyvero in
Greater China
. Processed and transmitted by West Corporation.
The issuer is solely responsible for the content of this announcement.






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:
http://hugin.info/171382/R/2220166/868621.pdf



This announcement is distributed by West Corporation on behalf of West Corporation clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Curetis via GlobeNewswire



 
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