VALNEVA Signs $39.6 Million IXIARO (R) Supply Contract with US Government

2017-11-08 / @nasdaq

 

Valneva SE ("Valneva" or "the Company"), a fully integrated, commercial stage biotech company focused on developing innovative, life-saving vaccines, announces today the signing of a $39.6 million one year contract with the US Government's Department of Defense for the supply of its Japanese encephalitis (JE) vaccine IXIARO (R). The new agreement will supplement the initial contract Valneva signed with the US military in March 2016 as the maximum quantity of doses allowed in the precedent contract was reached earlier than expected.

Under the terms of the new agreement, Valneva will supply the IXIARO (R)doses to the Defense Logistics Agency (DLA), Supply Center of the US Department of Defense, over a one-year period for a value of $28.2 million guaranteed and up to $39.6 million. First deliveries are expected to commence in the coming weeks.

The increase in the US military demand follows an update of the US Navy medical guidance at the end of 2016 which made JE vaccination compulsory for all Navy personnel and DoD employees assigned to Japan or the Korean peninsula for over 30 days. At the time of this update, vaccination against Japanese encephalitis was already required for U.S Air Force personnel, US Army, and the Marine Corps so assigned.

Franck Grimaud, President and CBO of Valneva commented, "The US military has been using IXIARO (R) since 2010 and it has now become an established vaccine to protect the military personnel and their families stationed in Asia. We are extremely pleased to see that its usage is expanding, notably with the latest addition of the US Navy, and look forward to continuing working with the US government to fight this deadly disease."

IXIARO (R) is the only JE vaccine approved in the US. Valneva, which successfully established its own global marketing & distribution network in 2015, now markets and distributes IXIARO (R) directly to the US military.

About IXIARO (R)/JESPECT (R)

Valneva's Japanese encephalitis vaccine is indicated for active immunization for the prevention of Japanese encephalitis for adults 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 (R)and in Australia and New Zealand where it is marketed as JESPECT (R). It is the only vaccine being marketed to the U.S. military for Japanese encephalitis. IXIARO (R) is approved for use in individuals 2 months of age and older in the US and EU member states, Norway, Liechtenstein, Iceland, Singapore, Hong Kong and Israel. In all other licensed territories, IXIARO (R)/JESPECT (R) is indicated for use in persons 18 years of age and above.

About Japanese Encephalitis

Japanese Encephalitis (JE) 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 more than 3 billion inhabitants. In 2005, Japanese encephalitis 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 (R)/JESPECT (R) indicated for the prevention of Japanese encephalitis and DUKORAL (R) 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 (R) cell line and IC31 (R) adjuvant).

Valneva shares are tradable on Euronext-Paris, the Vienna stock exchange and Deutsche B??rse's electronic platform Xetra (R). 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, theability 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.


Share to Youtube Share to Facebook Facebook Share to Linkedin Share to Twitter Twitter Share to Tiktok