Valneva Expands its Commercial
Operations and Establishes US Infrastructure
Lyon (France), November 30, 2017 - Valneva SE, a
fully integrated commercial stage biotech company focused on
developing innovative, lifesaving vaccines, today announces further
expansion of its global commercial infrastructure with Valneva USA.
The fully-owned commercial subsidiary will take direct control of
sales and marketing of IXIARO® in the U.S. private market with the
aim of accelerating sales growth of the vaccine.
Franck Grimaud, President & CBO of Valneva,
commented, "Japanese encephalitis is a potentially devastating and
deadly disease for travelers visiting Asia; yet many travelers
don't seek prevention with a vaccine, especially in the U.S. By
giving focus through a dedicated sales & marketing team, we
expect to drive further penetration and sales."
The U.S. private market represented 20% of the
€53.2 million of IXIARO® revenues Valneva reported in 2016.
Valneva has successfully established its own
commercial infrastructure in key travel markets over the past two
years after it regained global distribution rights of its Japanese
encephalitis vaccine IXIARO® in June 2015. The Company has been
distributing the vaccine directly to its largest customer, the U.S.
Military, and in 2015 entered into an exclusive marketing and
distribution agreement for the US private market with a leading
local distributor. Valneva is regaining full commercial control of
IXIARO® on December 4, 2017, allowing the Company to build a
stronger commercialization structure through its subsidiary Valneva
USA, Inc.
About IXIARO®/JESPECT®
Valneva's Japanese Encephalitis vaccine is
indicated for active immunization for the prevention of the disease
for people who travel to, or live in, endemic areas. It has
received marketing approval in the U.S., Europe, Canada, Hong Kong,
Singapore, and Israel under the trade name IXIARO® and in Australia
and New Zealand where it is marketed as JESPECT®. It is the only
vaccine available to the U.S. military for Japanese Encephalitis.
IXIARO® is approved for use in individuals two months of age and
older in the U.S. and EU member states, Norway, Liechtenstein,
Iceland, Singapore, Hong Kong, and Israel. In all other licensed
territories, IXIARO®/JESPECT® is indicated for use in persons 18
years of age and above.
About Japanese Encephalitis
Japanese encephalitis is a deadly infectious
disease found mainly in Asia. About 70,000 cases of JE are
estimated to occur in Asia each year, although the actual number of
cases is likely much higher due to underreporting in rural areas.
JE is fatal in approximately 30 percent of those who show symptoms,
and leaves half of survivors with permanent brain damage. The
disease is endemic in Southeast Asia, India and China, a region
with a population of more than three billion. In 2005, JE killed
more than 1,200 children in only one month during an epidemic
outbreak in Uttar Pradesh, India, and Nepal.
About Valneva SE
Valneva is a fully integrated, commercial stage
biotech company focused on developing innovative life-saving
vaccines.
Valneva's portfolio includes two commercial
vaccines for travelers: IXIARO®/JESPECT® indicated for the
prevention of Japanese encephalitis and DUKORAL® indicated for the
prevention of cholera and, in some countries, prevention of
diarrhea caused by ETEC. The Company has proprietary vaccines in
development including a unique vaccine against Lyme disease. A
variety of partnerships with leading pharmaceutical companies
complement the Company's value proposition and include vaccines
being developed using Valneva's innovative and validated technology
platforms (EB66® cell line and IC31® adjuvant).
Valneva shares are tradable on Euronext-Paris,
the Vienna stock exchange and Deutsche Börse's electronic platform
Xetra®. The Company has operations in France, Austria, Great
Britain, Sweden, Canada and the US with over 400 employees. More
information is available at www.valneva.com.
Valneva Investor and
Media Contacts Laetitia Bachelot Fontaine Global Head of
Investor Relations & Corporate Communications T +33 (0)2 2807
1419 M +33 (0)6 4516 7099 investors@valneva.com |
Nina Waibel
Corporate Communications Specialist T +43 1206 201 149 M +43
6768 455 6719 Communications@valneva.com |
Forward-Looking Statements
This press release contains certain
forward-looking statements relating to the business of Valneva,
including with respect to the progress, timing and completion of
research, development and clinical trials for product candidates,
the ability to manufacture, market, commercialize and achieve
market acceptance for product candidates, the ability to protect
intellectual property and operate the business without infringing
on the intellectual property rights of others, estimates for future
performance and estimates regarding anticipated operating losses,
future revenues, capital requirements and needs for additional
financing. In addition, even if the actual results or development
of Valneva are consistent with the forward-looking statements
contained in this press release, those results or developments of
Valneva may not be indicative of their in the future. In some
cases, you can identify forward-looking statements by words such as
"could," "should," "may," "expects," "anticipates," "believes,"
"intends," "estimates," "aims," "targets," or similar words. These
forward-looking statements are based largely on the current
expectations of Valneva as of the date of this press release and
are subject to a number of known and unknown risks and
uncertainties and other factors that may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievement expressed or implied by
these forward-looking statements. In particular, the expectations
of Valneva could be affected by, among other things, uncertainties
involved in the development and manufacture of vaccines, unexpected
clinical trial results, unexpected regulatory actions or delays,
competition in general, currency fluctuations, the impact of the
global and European credit crisis, and the ability to obtain or
maintain patent or other proprietary intellectual property
protection. In light of these risks and uncertainties, there can be
no assurance that the forward-looking statements made during this
presentation will in fact be realized. Valneva is providing the
information in these materials as of this press release, and
disclaim any intention or obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events, or otherwise.
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