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-- Oslo, Norway /Bethesda, USA, and Bubendorf/Basel, Switzerland, January 28, 2009 - Bachem (SWX: BANB) and Bionor Immuno.
Bionor Immuno, a biotech company specializing in peptide-based vaccine research, announced today the conclusion of an agreement for the development and supply of active pharmaceutical ingredients and finished dosage forms for Bionor Immuno's peptide-based vaccine development projects. According to the agreement, Bachem supplies the active ingredients for Bionor Immuno's lead product, Vacc-4x, an HIV-vaccine based on a "cocktail" of four peptides, as well as finished dosage forms for the clinical trial program.
Vacc-4x is in a phase IIb multinational clinical trial in the United States and Europe that researchers hope will offer HIV patients a break from daily antiretroviral treatment.
Rolf Nyfeler, CEO of Bachem, commented: "We are excited about the collaboration with Bionor Immuno because the lead project could be the first peptide cocktail vaccine to be approved. Seeing a peptide vaccine registered by authorities would be of high strategic importance as we share the conviction of attractive business opportunities in this field."
Birger Sørensen, President and CEO of Bionor Immuno, stated: "Since we are now recruiting for the Vacc-4x clinical program, it is important for us to have a supply partner as capable and reliable as Bachem. They will provide us with the active ingredients and finished dosage forms for the clinical trials and can guarantee timely supply and sufficient quantities from either of their production sites in Switzerland or the US. This advantage allows us to focus on advancing our products in clinical development and get them on the market as soon as possible."
Prior to the conclusion of the agreement, Bachem supplied Bionor Immuno with the peptide cocktail for Vacc-4x and, through Bachem's Clinalfa brand, has provided sterile finished dosage forms for intradermal application for clinical trials. In order to meet Bionor Immuno's requirements, both of Bachem's major production sites, in Bubendorf, Switzerland, as well as in Torrance, CA, USA, are prepared to provide the active ingredient. The agreement includes Bionor Immuno's further development projects which are currently in the preclinical research stage.
About the Vacc-4x Clinical Trial
Bionor Immuno currently is recruiting volunteers in the U.S. and in Europe to participate in a Phase IIB clinical trial for its lead HIV therapeutic candidate Vacc-4x. Vacc-4x is being studied for its sustainable therapeutic value in well controlled, HIV positive patients, who, after a series of inoculations with the investigational agent, are able to maintain viral suppression and robust T-Cell counts in absence of their daily anti-retroviral (ART) regimen. Data in earlier clinical trials have shown patients who received Vacc-4x were able to go an average of 31 months off anti-retroviral therapy before restarting a standard ART regimen.
For the full appreciation of these unique data, it should be noted that previous experience has shown that in studies not using Vacc-4x, ART usually could not be interrupted for more than 3 to 4 months. Patients, medical professionals, and researchers seeking more information on the trial should visit http://clinicaltrials.gov/ct2/show/NCT00659789?term=vacc-4x&rank=1
About Vacc-4x
Vacc-4x is an HIV-1 immunotherapeutic vaccine comprised of synthetic peptides corresponding to conserved domains on the major core HIV-1 p24 capsid protein. Safety and tolerability have been confirmed in HIV-1-infected subjects following intradermal immunization schedules with mild to moderate adverse events. As a therapeutic vaccination, it evoked strong, dose-dependent immune responses, with CD4+ and CD8+ T-cell proliferative responses and lower viral loads following a 14-week combination antiretroviral treatment (CART)-free period. Moreover, approximately 1.5 years after completing the immunization, a significant number of patients had not returned to antiretroviral treatment. Vacc-4x is currently undergoing phase II clinical trials as a therapeutic vaccine for the treatment of HIV infection. Current management of HIV infection includes anti-retroviral therapy (ART). Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods.
About Bachem
Bachem is an independent, technology-based, public biochemicals company providing full service to the pharma and biotech industries. Bachem is specialized in the process of development and manufacturing of peptides and complex organic molecules as active pharmaceutical ingredients (APIs), as well as innovative biochemicals for research purposes. With headquarters in Bubendorf, Switzerland, and affiliates in Europe and the US, Bachem works on a global scale and holds a leading position in the field of peptides.
About Bionor Immuno
Bionor Immuno AS is an innovative biotech company developing synthetic peptide vaccines that stimulate cell-mediated immunity. Previous efforts made to use T-cell stimulation for vaccines have been notoriously unsuccessful and this is also the reason why such vaccines are not on the market today. Bionor Immuno carefully designs synthetic (modified) peptides with improved efficacy and safety profiles. Among the diseases targeted are chronic infections caused by HIV, Hepatitis C (HCV), Human Papilloma Virus (HPV) and Influenza. Bionor Immuno's platform technology is universally applicable and makes it possible to extend the range of projects to include vaccines targeting cancer.
For further questions, please contact:
Bionor Immuno Inc.
Jeff Hackman
Sr. Vice President, Commercial and Business Development
+1-301-571-9395
jhackman@bionorimmuno.com
www.bionorimmuno.com
For Bionor Immuno
David Sheon
+1-202-470-2880
Bachem Holding AG
Michael Hüsler, CFO
Tel.: +41 61 935 2333 Fax: +41 61 935 2324
ir@bachem.com
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