VIENNA, Austria, Dec. 19 Intercell today announced thatthe Company has transferred on an exclusive basis its pre-clinical Group BStreptococcus (GBS) vaccine program to Novartis. At the same time Intercellhas kept and received co-exclusive rights for the development of therapeuticantibodies against Group B Streptococcus and has in-licensed additional rightson GBS antibodies from Novartis. The GBS vaccine program was part of thevaccine portfolio for which Intercell had granted license options to Novartisunder a strategic partnership closed in 2007. This step will trigger arecognition of revenue from the upfront option fee received under thisstrategic partnership.
Furthermore, the collaboration with Sanofi Pasteur, to discover anddevelop a vaccine against an un-disclosed bacterial pathogen, has beenextended in order to define a vaccine candidate for development.
The collaboration with Wyeth to use Intercell's proprietary adjuvantIC31(R) in various bacterial vaccine targets, which are in pre-clinicaldevelopment, is progressing well. The collaboration runs under a non-exclusiveagreement signed in 2006.
"We are very pleased that all our technology partnerships are progressingvery well," states Gerd Zettlmeissl, Chief Executive Officer of Intercell."This demonstrates that our Antigen Identification Program, our adjuvantIC31(R) and Intercell's new patch technology are valuable assets of ourCompany. Given the richness of our pipeline we will even extend our portfolioof product development alliances where we expect new partnerships in the nearfuture," adds Zettlmeissl.
Intercell expects revenues and revenue recognition from existingtechnology partnerships to clearly exceed EUR 10m in the fourth quarter of2008.
About Group B Streptococcus
Intercell has identified and validated numerous antigens from Group BStreptococcus (GBS). The most promising antigens will be refined and used toprevent diseases in the most susceptible neonates (not yet born and newbornwith a weight of less than 1,000 g). In addition, antibodies will also begiven to neonates who already developed diseases caused by GBS. The vaccine iscurrently in pre-clinical development.
GBS causes infections of diverse kind in neonates (not yet born),newborns, pregnant women and elderly. An infection can result in lunginflammation (pneumonia), life-threatening systemic inflammatory responsesyndrome (sepsis) and brain and cerebrospinal fever (meningitis). Newborns areat especially high risk for infections and acquire the infection from theirinfected mothers, even though the mothers may be without symptoms.
Vaccines, based on antigens alone, are not always sufficient to providefull protection. Adjuvants are needed to educate the immune system torecognize and eliminate the pathogens efficiently.
IC31(R) is an adjuvant that induces T-cell and B-cell responses by using aunique synthetic formulation which combines the immunostimulating propertiesof an anti-microbial peptide, KLK, and an immunostimulatoryoligodeoxynucleotide, ODN1a. The two component solution can be simply mixedwith antigens; no conjugation is required.
Intercell currently uses IC31(R) in collaborations with a number of globalvaccine companies and biotech companies. These collaborations include amongstothers the development of a tuberculosis vaccine in Phase I clinical trials,which has been partnered with the Danish Statens Serum Institut and SanofiPasteur.
About Intercell's Antigen Identification Program (AIP(R))
The design and development of novel subunit vaccines is highly dependenton the identification and characterization of the proper antigens. ThroughAIP(R) we successfully have identified and refined a large number of antigensof numerous bacterial pathogens. The selected antibodies are derived frominfected or healthy exposed individuals and therefore directly mirror thepresence, accessibility and antigenicity of relevant proteins from theparticular microorganism in its human host. The most promising candidates arevalidated. AIP(R) has successfully been applied to identify a large number ofnovel antigens from numerous pathogenic organisms including S. aureus, S.epidermidis, S. pneumoniae, S. agalactiae, S. pyogenes, E. faecalis, K.pneumoniae, Borrelia spp., ETEC, Shigella, C. jejuni, non-typeable H.influenzae and M. catarrhalis. It has resulted in promising in-house productcandidates and generated strategic partnerships.
About Intercell's vaccine patch technology
Intercell's Vaccine Patch is a new and needle free delivery technologywhich can be used to:
The patch technology opens up a new way of vaccine delivery that is easierto administer, faster to deliver and can result in lower or fewer doses. Thepatch can boost cellular immunity to a diverse range of antigens andstimulates both B-cell and T-cell responses. It contains the heat labileenterotoxin from E. coli (LT), one of the most potent stimulators of theimmune system. When the patch is applied on the skin, immune stimulants aredelivered at the surface of the skin to Langerhans cells, a major component ofthe immune systems. The Langerhans cells, activated by the presence of theseimmune stimulants, take up the vaccine antigen and migrate to the regionaldraining lymph nodes. There, presentation to the immune system occurs,eliciting a robust immune response.
Compared with standard immunization via needles, the patch technology hassignificant benefits. It is easily administered, the antigen and adjuvant aredirectly delivered to the immune system through the natural defense pathway,which makes vaccination efficient and results in less side effects. The patchhas shown excellent local tolerability, it is stable at room temperature andstrong immune stimulants can be used since there is no systemic exposure.
At present, the Vaccine Patch is used in-house for the development of anovel Travelers' Diarrhea vaccine patch about to enter Phase III trials andthe Vaccine Enhancement Patch in the development of a pandemic Influenzavaccine patch. In addition, the technology is used in collaboration with Merck& Co., which uses it to conduct proof-of-principle pre-clinical studies.Intercell is seeking further collaborations with leading industry playersinterested in developing vaccines where fewer doses are desired, productlife-cycle management is needed or use in immune-compromised patients isrequired.
About Intercell AG
Intercell AG is a growing biotechnology company that designs and developsnovel vaccines for the prevention and treatment of infectious diseases withsubstantial unmet medical needs. Intercell's vaccine to prevent JapaneseEncephalitis is the company's first product on the market.
The Company's technology platforms include an antigen-discovery system,two proprietary adjuvants and a novel patch-based delivery system. Based onthese technologies, Intercell has strategic partnerships with a number ofglobal pharmaceutical companies, including Novartis, Merck & Co., Inc., Wyeth,Sanofi Pasteur, Kyowa Hakko Kirin and the Statens Serum Institut.
The Company's development pipeline includes Phase II vaccine programs forPseudomonas (in-house development) and S. aureus, which is being developedwith Merck & Co. Inc. The Company's novel Travelers' Diarrhea vaccine patchwill enter Phase III testing in 2009. Intercell is also in clinical trials ofa vaccine enhancement patch with injected pandemic influenza vaccines (oneshot plus patch). In addition, four other products focused on infectiousdiseases are in pre-clinical development.
Intercell is listed on the Vienna stock exchange under the symbol "ICLL".
For more information, please visit: http://www.intercell.com
This communication expressly or implicitly contains certainforward-looking statements concerning Intercell AG and its business. Suchstatements involve certain known and unknown risks, uncertainties and otherfactors which could cause the actual results, financial condition,performance or achievements of Intercell AG to be materially different fromany future results, performance or achievements expressed or implied by suchforward-looking statements. Intercell AG is providing this communication as ofthis date and does not undertake to update any forward-looking statementscontained herein as a result of new information, future events or otherwise.-- Enhance the effect of injected vaccines: Vaccine Enhancement Patch (VE Patch) -- Develop new vaccines which require transcutaneous administration because the antigen can not be delivered safely or efficiently through other routes of administration: Vaccine Patch