ANNUAL REPORT - Pevion Biotech AG
ANNUAL REPORT - Pevion Biotech AG
ANNUAL REPORT - Pevion Biotech AG
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HIGHLIGHTS IN 2005<br />
2005 <strong>ANNUAL</strong> <strong>REPORT</strong><br />
� Important steps forward in clinical development<br />
<strong>Pevion</strong> <strong>Biotech</strong>’s lead product, a multi-component malaria vaccine<br />
candidate, entered clinical Phase II. Positive interim results concerning<br />
immunogenicity and safety were announced in December 2005.<br />
� Achievements in product development<br />
In 2005 two projects reached preclinical status and are ready to enter a<br />
clinical phase I trial. One project aims for the development of a breast<br />
cancer vaccine, a collaboration with Bio Life Science, Vienna, and another<br />
project involves the HCV therapeutic vaccine candidate, representing <strong>Pevion</strong><br />
<strong>Biotech</strong>’s approach for a multi-epitope and personalized therapeutic<br />
regimen.<br />
� New vaccine candidate in the pipeline<br />
To strengthen <strong>Pevion</strong> <strong>Biotech</strong>’s pipeline, a diphtheria/tetanus vaccine was<br />
integrated into <strong>Pevion</strong> <strong>Biotech</strong>’s development plan. The vaccine candidate<br />
will be a premium booster vaccine for adults and have a considerably higher<br />
safety profile than conventional applications currently available in the<br />
market.<br />
� Increased stability for virosome vaccines<br />
In 2005 a new virosome-manufacturing process called lyophilization was<br />
established. This process is a groundbreaking innovation for virosome<br />
technology. It improves the stability and the formulation of pharmaceutically<br />
active substances.<br />
� GMP certificate for manufacturing<br />
<strong>Pevion</strong> <strong>Biotech</strong>’s quality system was approved by the national registration<br />
authority Swissmedic, and the certificate of GMP Compliance of a<br />
manufacturer was issued. It certifies that <strong>Pevion</strong> <strong>Biotech</strong> is authorized to<br />
manufacture up to Phase III clinical trial products in collaboration with Berna<br />
Crucell.<br />
� Newly established strategic collaborations<br />
<strong>Pevion</strong> <strong>Biotech</strong>’s virosome carrier/adjuvant technology platform provided<br />
the basis for a number of strategic alliances with international biotechnology<br />
companies, including Innogenetics (INNX; Ghent Belgium) and Mymetics<br />
(MYMX; NYC, NY).<br />
Additionally, <strong>Pevion</strong> <strong>Biotech</strong> signed an option agreement for an exclusive<br />
license with Vivalis SA. The license grants a more favorable production<br />
process of Hemagglutinin, an important component of <strong>Pevion</strong> <strong>Biotech</strong>’s<br />
virosome technology.<br />
� Intellectual property<br />
<strong>Pevion</strong> <strong>Biotech</strong> further extended its patent portfolio by filing two<br />
applications covering specific aspects of its virosome carrier. The IP portfolio<br />
grew in 2005 to eleven patent applications. Additionally, the company has<br />
exclusive licenses for four patent families with more than 90 granted patents.<br />
In 2005 the company became registered owner of the trademarks “<strong>Pevion</strong>”,<br />
“<strong>Pevion</strong> <strong>Biotech</strong>”, “PeviPRO TM” , “PeviTER TM ” and “Pevi TM ” in Switzerland, the<br />
United States and the European Union.<br />
<strong>Pevion</strong> <strong>Biotech</strong>_Annual Report2005_01_01_04_004 4/13