GAITHERSBURG, Md.--(BUSINESS WIRE)--Valneva SE, a fully integrated commercial stage biotech company focused on developing innovative, lifesaving vaccines, today announced that its subsidiary Intercell USA, Inc. has formally changed its name to Valneva USA, Inc. (Valneva USA). Intercell USA was acquired by Valneva SE (Lyon, France) in May 2013 and has been operating as a fully owned subsidiary. Additionally, the company has taken control of full U.S. marketing and distribution rights for the IXIARO® vaccine, which is indicated for prevention of disease caused by Japanese Encephalitis, a mosquito-borne virus found in Asia that causes inflammation of the brain (encephalitis).
Charles Daily, General Manager, U.S., commented, “Japanese Encephalitis is a potentially devastating and deadly disease for travelers visiting Asia. In many countries where travelers are visiting, local individuals have been vaccinated starting at a very young age. Yet many travelers don’t seek preventative treatment with a vaccine, resulting in a lower immunization rate for U.S. travelers compared to certain European countries. By taking full control of IXIARO® and building out our commercial structure in the U.S., we intend to increase disease awareness and product access to doctors and travelers and improve immunization rates.”
Valneva has successfully established its own commercial infrastructure in key international travel markets over the past two years after it regained global distribution rights of IXIARO® in June 2015. The Company has been distributing the vaccine in the U.S. directly to its largest customer, the U.S. military, and in 2015 entered into an exclusive marketing and distribution agreement for the U.S. private market with a leading local distributor. With the recent expiration of this exclusivity, Valneva now has full commercial control of IXIARO® in the United States and is building a stronger commercialization structure through its subsidiary Valneva USA, Inc., with a new dedicated sales and marketing team, a broader distribution network, and improved packaging that is reduced in size by 30 percent to help with customer storage.
To learn more about how you can purchase IXIARO® please call 866-223-7118.
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.
IMPORTANT SAFETY INFORMATION
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO®, any other Japanese Encephalitis Virus vaccine, or any component of IXIARO®, including protamine sulfate, is a contraindication to administration of IXIARO®. Alternatively, because of uncertainty as to which component of the vaccine may be responsible, individuals with a history of severe allergic reaction to another Japanese Encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO® is considered.
IXIARO® contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. Appropriate medical care should be readily available in case of anaphylactic reaction.
Vaccination with IXIARO® may not protect all individuals.
Immunocompromised individuals may have a diminished immune response to IXIARO®.
In infants 2 months to <1 year of age, the most common injection site reaction was redness (>15%); the most common solicited systemic adverse reactions were fever (>20%), irritability (>15%), and diarrhea (>10%). In children 1 to <3 years of age, the most common solicited systemic adverse reaction was fever (>20%). In children 3 to <12 years of age, the most common solicited systemic adverse reaction was fever (>10%). In adolescents 12 to <18 years of age, the most common solicited injection site reactions were pain (15%) and tenderness (10%). In adults 18 years of age and older, the most common injection site reactions were pain (>25%) and tenderness (>25%); the most common solicited systemic adverse reactions were headache (>20%) and myalgia (>10%).
Healthcare practitioners are encouraged to report inadvertent use in pregnant women to Valneva at 844-349-4276 (8443-IXIARO).
Please see full Prescribing Information.
About Japanese Encephalitis
Japanese Encephalitis (JE) is a deadly infectious disease found mainly in Asia. About 68,000 cases of JE are estimated to occur in Asia each year, although the actual number of cases may be higher due to underreporting in rural areas. JE is fatal in approximately 30 percent of those who show symptoms, and leaves up to 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.1
According to the CDC2, the risk of JE is low for most travelers to Asia but can vary based on various factors, such as where a person spends time, when and for how long they are traveling and their activities. Travelers may have an increased risk of being exposed to mosquitos carrying the JE virus if they spend substantial time outdoors or in rural areas, especially at night; participate in active outdoor activities such as camping, hiking, biking, fishing or hunting, or sleep in accommodations without mosquito nets. The JE vaccine should be considered for such travelers, and is recommended for travelers visiting Asia for more than one month (for example, military members and their families, study abroad students or employees with extended work assignments).
About VALNEVA USA, Inc.
Valneva USA, is a subsidiary of Valneva SE, a global pure play vaccine company specialized in the development, manufacture and commercialization of innovative vaccines. The company’s mission is to protect people from infectious diseases through preventative medicine.
Valneva USA is focused on the marketing and distribution of Valneva’s vaccines, including IXIARO, in the United States. For more information, visit www.valneva.com.
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 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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1 Kumari, R and Joshi, PL, WHO South East Asia J Public Health. 2012 Oct-Dec;1(4):374-395.