Intercell and Biological E. Ltd. announce successful completion of investigational Japanese Encephalitis vaccine pivotal Phase II/III study in India
» Positive results from first pivotal immunogenicity Phase II/III trial in endemic region to prevent Japanese Encephalitis (JE) in children » Primary study endpoint of non?inferiority of Biological E’s investigational vaccine compared with an inactivated JE comparator vaccine was met » Important development step towards a modern, cell culture?derived product in endemic countries – licensure submission to Indian DCGI expected shortly
Vienna (Austria)/Hyderabad (India), September 16, 2011 – Intercell AG and its partner Biological E. Ltd. today announced the successful completion of a pediatric Phase II/III study for the vaccine to protect children from Japanese Encephalitis (JE). Analysis of the pivotal Phase III safety and immunogenicity data showed positive results and that the study met its primary endpoint.
The clinical study was designed to compare the immunogenicity and safety of Biological E’s investigational cell culture?derived vaccine with the mouse brain derived vaccine produced by the Korean Green Cross Corporation, Korea, in a multicentre, open label, parallel, randomised Phase II/III study design. The study, conducted across 8 study sites in India and including 456 randomized subjects, was designed to lead to licensure in India. The vaccine is manufactured in India by Biological E and is based on Intercell?s technology, which was successfully used to gain product licensure of the adult vaccine in Europe, the United States, Canada, Hong Kong (IXIARO®) and Australia (JESPECT®).
?We are very pleased to have reached this important milestone in our collaboration with Biological E. which moves us one step closer towards being able to provide a vaccine to protect children living in endemic areas threatened by this terrible disease. The successful completion of this Phase II/III study is a major step towards making our modern cell culturederived product available in Asia, and supports our global territory expansion ?, states Thomas Lingelbach, Chief Executive Officer of Intercell AG.
Dr. Vijay Kumar Datla, Chairman and Managing Director of Biological E. Limited added: “We are excited about the successful completion of our Phase II/III clinical study which should enable us to offer this novel and safe vaccine to combat Japanese Encephalitis not only in India but also across Asia. There is an urgent need to respond to the JE epidemic throughout India and Asia where large?scale immunization is of high importance. Through our strategic partnership with Intercell, licensure of this modern JE vaccine will allow us to ensure the vaccine reaches those who need it most.” Page 2 of 4 In March 2011, an independent data and safety monitoring board evaluated data from 160 subjects having completed their day 7 visit and concluded that the safety assessment was favorable, thus allowing the study to proceed into Phase III.
In 2005, Intercell and Biological E. signed a contract for the development, manufacturing, marketing and distribution in India and the Indian subcontinent of Intercell?s Japanese Encephalitis vaccine. The vaccine?s further regulatory approval route for other Asian territories is expected through the World Health Organization – Novartis will be responsible for the marketing and distribution in these regions. Following the approval and launch of Intercell?s vaccine against Japanese Encephalitis for adult travelers and military personnel in Europe, the USA and Australia, the development of a vaccine to protect children in endemic areas from Japanese Encephalitis has been a major goal of the Company.
About Japanese Encephalitis Japanese Encephalitis (JE) is a deadly infectious disease found mainly in Asia.
Approximately 30,000 to 50,000 cases of JE are reported in Asia each year, and the actual number of cases are 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, a region with more than 3 billion inhabitants. Only within 1 month in the year 2005, Japanese Encephalitis killed more than 1,200 children during an epidemic outbreak in Uttar Pradesh, India, and Nepal.
About Biological E. Ltd.
Established in 1953, Biological E. Ltd. (BE) has been a leading vaccine and pharmaceutical company based out of Hyderabad, India. The company produces a range of critical vaccines and has been an active partner with the National Immunization Programs of various countries. The company continues to invest in large scale cGMP facilities in order to increase its capacities and product range to offer vaccines/biologics on a global basis including US FDA and EMEA markets. In addition to its pipeline of vaccines and biologics, the company has entered into a number of strategic collaborations with leading biotech companies and research institutes for joint R&D projects. Biological E. is a privately held company and run by professionals with significant experience in global biopharmaceutical business.
For more information please visit: www.biologicale.com About Intercell AG Intercell AG is a vaccine?biotechnology company with the clear vision to develop and commercialize novel immunomodulatory biologicals to prevent disease and reduce suffering across the world.
Page 3 of 4 Intercell’s vaccine to prevent Japanese Encephalitis (JE) is the Company’s first product on the market.
The Company’s technology base includes novel platforms, such as the patch?based delivery system and the proprietary human monoclonal antibody discovery system eMabs®, in addition to well?established technologies upon which Intercell has entered into strategic partnerships with a number of leading pharmaceutical companies, including GSK, Novartis, Merck & Co., Inc., and sanofi?aventis.
The Company’s pipeline of investigational products includes a development program for the pediatric use of Intercell’s JE?Vaccine IXIARO® in endemic markets (in collaboration with Biological E.) and non?endemic markets. Furthermore, the portfolio comprises different product candidates in clinical trials: a Pseudomonas aeruginosa vaccine candidate (Phase II/III) partnered with Novartis, a vaccine to prevent Pandemic Influenza by combining the Company’s Vaccine Enhancement Patch with an injected vaccine (Phase I), a combination treatment approach for Hepatitis C (Phase II) partnered with Romark, a vaccine candidate against infections with C. difficile (Phase I) as well as partnered vaccine programs using the Company’s IC31® adjuvant, e.g. in a Tuberculosis vaccine candidate.
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 Contact Intercell AG Corporate Communications Campus Vienna Biocenter 3, A?1030 Vienna P: +43?1?20620?1222 Mail to: email@example.com Biological E. Ltd Corporate Communications 18/3 Azamabad, Hyderabad 7 AP India Mail to: firstname.lastname@example.org This communication expressly or implicitly contains certain forward?looking statements concerning Intercell AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, Page 4 of 4 performance or achievements of Intercell AG to be materially different from any future results, performance or achievements expressed or implied by such forward?looking statements. Intercell AG is providing this communication as of this date and does not undertake to update any forward?looking statements contained herein as a result of new information, future events or otherwise.
Posted: September 2011