Regulatory Filings • Mar 26, 2013
Regulatory Filings
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Press Release
Nantes & Lyon (France) – Vivalis (NYSE Euronext : VLS) is pleased to announce the following press release distributed by GSK detailing their continued efforts with the Texas A&M University System (TAMUS) for the development of an EB66® cell culture based influenza vaccine funded by the U.S. Department of Health and Human Services (HHS). Under this program, the HHS has approved the development of a \$91 million influenza vaccine manufacturing facility to be located in Bryant-College Station, Texas.
A full copy of the GSK press release is presented herein.
GlaxoSmithKline plc (GSK) and The Texas A&M University System announced today that the U.S. Department of Health and Human Services (DHHS) has approved the establishment of a \$91 million influenza-vaccines manufacturing facility as the anchor of the Center for Innovation in Advanced Development and Manufacturing (CIADM) in Bryan-College Station, Texas.
The announcement was hosted by Governor Rick Perry at the Texas State Capitol, and was attended by a number of dignitaries including Texas A&M System Chancellor John Sharp, Dr. Robin Robinson, DHHS Deputy Assistant Secretary and Director of the Biomedical Advanced Research and Development Authority (BARDA), and Antoon Loomans, Senior Vice President, GSK Vaccines.
"Today's announcement is a huge win for Texas and for the nation," Governor Perry said. "The Texas A&M Center, anchored by this facility, is expected to bring more than \$41 billion in expenditures within the State of Texas over the next 25 years, and will add more than 6,800 direct and related jobs to Texas."
The TAMUS influenza vaccines manufacturing center will afford GSK the capabilities to eventually manufacture influenza vaccine based on a proprietary cell-culture line, 1EB66®. Most existing influenza vaccine is manufactured using fertilized chicken eggs. The cell-culture process will supplement the vaccine supply from eggs, and facilitate a rapid national vaccine response in the event of a pandemic.
1 *EB66® exclusively licensed from Vivalis by GSK Biologicals S.A. for the field of Influenza and sublicensed use at the Texas A&M Center for Innovation in Advanced Development and Manufacturing (CIADM).
GSK Vaccines produces 30 vaccines worldwide, eleven of which are licensed by the FDA. The Texas A&M-GSK venture will complement and support the company's existing influenza vaccines operations, based in Quebec, Canada, and Dresden, Germany. GSK's operations hub in Marietta, Pennsylvania will package, inspect and distribute influenza vaccine manufactured at the Texas A&M Center. In 2012, GSK provided more than 20 million flu shots for the U.S. market and recently became the first major U.S. vaccines provider to gain FDA-approval for a broader-protection, four-strain (quadrivalent) influenza vaccine shot that will be available in time for the 2013-14 flu season.
"GSK is privileged to deepen our commitment to U.S. public health, as part of this unprecedented publicprivate collaboration to protect against pandemics and bio-threats," noted Loomans. "In Texas A&M we have found a partner with a rich tradition of service, and with pioneering technologies that will benefit the entire pharmaceutical industry in making vaccines available and accessible to all in need."
One of only three CIADMs to be developed in the U.S., the Texas A&M Center is at the vanguard of U.S. pandemic-preparedness efforts and represents unprecedented public-health collaboration among state and federal governments, academia and private industry. Once constructed and operational, the Center's influenza manufacturing facility will be able to supply 50 million doses of pandemic influenza vaccine within four months of an outbreak. BARDA conceived the public-private formula to assure a strong biosecurity product development and manufacturing base on U.S. soil, ensuring that the nation would have rapid access to vaccines and therapeutics in the advent of influenza pandemics, or chemical, biological, radiological, and nuclear attacks.
"We are honored to welcome GSK to Texas A&M as a key partner in the Center for Innovation," said Sharp. "GSK's dedication to public service is well-aligned with the Texas A&M tradition of serving the nation and defining its future through research and scholarship. Equally important is the cultural and philosophical match between GSK and the A&M System, as reflected by GSK's desire to collaborate with academia and the U.S. government, and their ongoing commitment to helping address global health scourges such as pandemic influenza and malaria."
The Texas A&M Center for Innovation is lead by Dr. Brett Giroir, Vice Chancellor for Strategic Initiatives at the Texas A&M System, and a core team of A&M experts in biotechnology, infectious diseases, facilities planning and construction, federal acquisitions/contracting, and government affairs. The partnership with GSK was founded on a long, collaborative relationship between Texas A&M and the Wallonia Region of Belgium, with specific planning for this project beginning in the spring of 2010.
"GSK's decision to partner with Texas A&M and bring their vaccine manufacturing to our state is a testament to the investments that the A&M System and the State of Texas have made in the people, infrastructure and technologies, much of which came from critical state programs such as the Emerging Technology Fund," Giroir said. "GSK brings unequaled influenza vaccine development, manufacturing, and regulatory expertise to our Center. Equally important, GSK brings its cell based influenza vaccine development program, which we have assessed to be the most promising near term influenza vaccine technology to improve upon current egg based vaccines."
The Texas A&M Center for Innovation represents the largest commitment of a global biopharmaceutical company to partner within Texas, and will be an important catalyst to the future growth of this industry within the State.
Efforts highlighted in this release have been funded in whole or in part with Federal Funds from the DHHS/ASPR/BARDA, under contract numbers HHSO100200600011C, HHSO100200700029C and HHSO100201200002I.
The A&M System is one of the largest systems of higher education in the nation, with a budget of \$3.5 billion. Through a statewide network of 11 universities, seven state agencies and a comprehensive health science center, the A&M System educates more than 120,000 students and makes more than 22 million additional educational contacts through service and outreach programs each year. Externally funded research expenditures exceed \$780 million and help drive the state's economy.
Texas A&M University System 979-458-6023 [email protected]
The Texas A&M Center for Innovation in Advance Development and Manufacturing (CIADM) is one of three centers established in June, 2012 by the US Department of Health and Human Services to enhance the nation's emergency preparedness against emerging infectious diseases, including pandemic influenza, and chemical, biological, radiological and nuclear threats. The Center is founded on an initial \$285.6 million investment, including a \$176.6 million contribution from the US Department of Health and Human Services, with the remainder cost-shared by commercial and academic proposal partners.
The Center will perform research and advanced development to accelerate vaccines and other medical products through pre-clinical and clinical development and produce these products in cases of pandemics or other national emergencies. Through these activities, the Center will address a recognized shortcoming in preparedness and response to known and unknown threats, and will improve our nation's ability to protect the health of its citizens in emergency situations.
With GSK and other partners, TAMUS also will utilize CIADM capabilities to develop and transition platform technologies to accelerate new treatments for conditions as diverse as cancer and cardiovascular disease.
979-458-6052 [email protected]
GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://us.gsk.com/
| US Media Inquiries: | Rob Perry | +1 4074924616 | (Philadelphia) |
|---|---|---|---|
| Sarah Alspach | +1 202 715 1048 | (Washington, DC) | |
| Analyst/Investor Inquiries: | |||
| Sally Ferguson | +44 (0) 20 8047 5543 | (London) | |
| Lucy Budd | +44 (0) 20 8047 2248 | (London) | |
| Tom Curry | + 1 215 751 5419 | (Philadelphia) | |
| Gary Davies | + 44 (0) 20 8047 5503 (London) | ||
| James Dodwell | + 44 (0) 20 8047 2406 (London) | ||
| Jeff McLaughlin | + 1 215 751 7002 | (Philadelphia) | |
| Ziba Shamsi | + 44 (0) 20 8047 3289 | (London) |
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.
March 7, 2013 - VIVALIS SA (NYSE Euronext: VLS) and Intercell AG (VSE: ICLL) announced that the Extraordinary General Meeting of both companies approved the proposed merger of equals between Intercell AG and Vivalis SA to create Valneva SE. The merger should be effective in May 2013
Vivalis (NYSE-Euronext: VLS) is a biopharmaceutical company that provides innovative cell-based solutions to the pharmaceutical industry for the manufacture of vaccines and recombinant proteins, and develops monoclonal antibodies for the prevention and treatment of pathologies with unmet medical needs. Vivalis' expertise and intellectual property are leveraged in two main areas:
Vivalis offers research and commercial licenses for its EB66® cell line, derived from duck embryonic stem cells, to pharmaceutical and biotechnology companies for the production of therapeutic and prophylactic viral vaccines, virosomes, VLPs and recombinant proteins, with a focus on monoclonal antibodies having enhanced cytotoxic activity. Clinical trials of EB66 ® produced vaccines are currently on-going in the USA and Japan. Through these programs, Vivalis receives upfront payments, clinical stage milestone payments, and royalties on licensees' net sales.
Customized solutions for the discovery, development and production of rare, fully human monoclonal antibodies are offered by Vivalis. Through these programs, Vivalis receives payments associated with the funding of discovery phase, upfront payments, clinical stage milestone payments, and royalties on net sales of licensed antibodies that are commercially developed and sold by our clients.
Based in Nantes and Lyon (France) and in Toyama (Japan), Vivalis was founded in 1999 by the Grimaud Group (ca. 1,700 employees), one of the worldwide leaders in animal genetic selection. Vivalis has
established more than 30 partnerships and licenses with world leaders in this sector, including Sanofi Pasteur, GlaxoSmithKline, Transgene, Zoetis, Kaketsuken, Kitasato Daiichi Sankyo Vaccine, Merial, Merck Animal Health and SAFC Biosciences. Vivalis is a member of the French ATLANTIC BIOTHERAPIES and LYON BIOPOLE bio-clusters and a member of the Japanese HOKURIKU INNOVATION CLUSTER FOR HEALTH SCIENCE in Toyama. nd clusters Euronext
VIVALIS
Listed on Euronext Paris – Compartment B of NYSE Eur Reuters: VLS.PA – Bloomberg: VLS FP Included in NYSE Euronext's SBF 250, CAC Small 90 and Next Biotech indexes
This document contains forward-looking statements and comments on the company's objectives and strategies. No guarantee can be given to any of the events anticipated by the forward contained in this document, which are subject to inheren company's Document E, changes in economic conditions, the financial markets or the markets in which the company operates. looking inherent risks, including risk factors described in the forward-looking statements t
Franck Grimaud, CEO Email: [email protected] NewCap
Financial communications agency Axelle Vuillermet / PierreLaurent Tel.: +33 (0) 1 44 71 94 91 Email: [email protected]
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