Update on Phase II/III Clinical Trial of Investigational Staphylococcus aureus Vaccine, V710
WHITEHOUSE STATION, N.J. & VIENNA--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Intercell AG (VSE: ICLL) today announced that following a pre-specified interim analysis from the Phase II/III clinical trial evaluating V710, an investigational vaccine for the prevention of Staphylococcus aureus (S. aureus) infection, the independent Data Monitoring Committee (DMC) recommended suspension of enrollment. Although the trial did not meet the pre-specified futility criteria, the DMC nonetheless recommended suspension of enrollment pending further analyses of the benefit/risk profile of the vaccine candidate. Merck and Intercell plan to provide a further update when analyses have been completed.
About S. aureus
S. aureus is a leading cause of hospital-acquired infections. In addition to bloodstream infections with a mortality rate of up to 35 percent, infections of bone, heart and other inner organs can often lead to serious health complications and death. Today, approximately 50 percent of S. aureus strains isolated in hospitals worldwide are resistant to multiple antibiotics, rendering staphylococcal disease management increasingly difficult and challenging.
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.
About Intercell AG
Intercell AG is an innovative biotechnology company that develops novel vaccines for the prevention and treatment of infectious diseases with substantial unmet medical needs. Intercell's vaccine to prevent Japanese Encephalitis is the Company's first product on the market.
The Company's technology platform includes an antigen-discovery system and human anti-infective monoclonal antibody discovery system, adjuvants and a novel patch-based delivery system (Vaccine Patch, Vaccine Enhancement Patch). Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including GSK, Novartis, Sanofi-Aventis, and Romark.
The Company's pipeline of investigational products includes a Pseudomonas aeruginosa vaccine candidate (Phase II), a vaccine to prevent Pandemic Influenza combining our Vaccine Enhancement Patch with an injected vaccine (Phase I/II), a vaccine candidate for Pneumococcus (Phase I) as well as a therapeutic vaccine against Hepatitis C (Phase II). A vaccine candidate against infections with Clostridium difficile has entered Phase I clinical trials in 2010. In addition, further vaccine and antibody products targeting infectious diseases are in pre-clinical development.
Intercell is listed on the Vienna stock exchange under the symbol "ICLL" (U.S. level one ADR symbol "INRLY").
For more information, please visit: www.intercell.com.
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The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
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