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annual report 2008 - Pevion Biotech AG

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<strong>2008</strong> ANNUAL REPORT 4<br />

H I G H L I G H T S 2 0 0 8<br />

<strong>Pevion</strong> <strong>Biotech</strong> moved to Ittigen<br />

<strong>Pevion</strong>_<strong>Biotech</strong>_<strong>annual</strong>_<strong>report</strong>_<strong>2008</strong>_final.docx<br />

<strong>2008</strong> A N N U A L R E P O R T<br />

In July <strong>2008</strong> <strong>Pevion</strong> <strong>Biotech</strong> moved to new premises in Ittigen/Bern which<br />

were rebuilt for <strong>Pevion</strong> <strong>Biotech</strong>'s purposes. <strong>Pevion</strong> <strong>Biotech</strong> was fully<br />

operational after one week.<br />

Mymetics Corporation Acquires Preventive Malaria Vaccine from<br />

<strong>Pevion</strong> <strong>Biotech</strong> <strong>AG</strong> (Switzerland)<br />

Mymetics Corporation, a vaccine development company, made the<br />

acquisition of a preventive malaria vaccine from <strong>Pevion</strong> <strong>Biotech</strong>. The <strong>Pevion</strong><br />

<strong>Biotech</strong> vaccine has successfully completed human clinical trial phases I and<br />

IIa in Switzerland and in the UK.<br />

Successful Swissmedic Inspection<br />

The Swiss Agency for Therapeutic Products, Swissmedic, conducted its third<br />

regulatory inspection at <strong>Pevion</strong> <strong>Biotech</strong>. The company passed it successfully<br />

and was awarded an extension of the manufacturing license for<br />

investigational medicinal products. The Certificate of GMP Compliance<br />

states that the required level for good practices in the manufacture of<br />

pharmaceutical products and active pharmaceutical ingredients according to<br />

valid Swiss regulations has been met. These regulations are in accordance<br />

with the requirements for good practices in the manufacture and quality<br />

control of the Pharmaceutical Inspection Convention/Co-operation Scheme<br />

(PIC/S) and the directives of the European Commission.<br />

Breast Cancer Clinical Phase I – Interim results<br />

The Phase I study was started in November 2006 to give information about<br />

the safety and immunogenicity of the virosome-based breast cancer vaccine<br />

candidate. Preliminary data from the first group of patients receiving the low<br />

dose of the vaccine show that the vaccine is safe and well-tolerated.<br />

Furthermore, from the immunological data gained it can be concluded that<br />

the formulation is immunogenic and has led to a seroconversion in eight out<br />

of nine patients.<br />

<strong>Pevion</strong> <strong>Biotech</strong> Signs Cooperation Agreement with ISS<br />

<strong>Pevion</strong> licensed an antigen (SAP2) for its vaccine against candidiasis from the<br />

Istituto Superiore di Sanità (ISS). The vaccine candidate is being developed<br />

to treat and prevent Candida infections and even chronic vulvovaginitis.

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