Pevion Fact Sheet Ju.. - Pevion Biotech AG
Pevion Fact Sheet Ju.. - Pevion Biotech AG
Pevion Fact Sheet Ju.. - Pevion Biotech AG
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<strong>Pevion</strong> at a glance<br />
Swiss, privately–owned,<br />
clinical stage vaccine<br />
development company<br />
Product pipeline focusing on<br />
major unmet medical needs<br />
Vaccine candidates based on<br />
clinically and commercially<br />
validated carrier & adjuvant<br />
technology (virosomes)<br />
Industrial partnerships<br />
established, one product<br />
successfully out-licensed<br />
Technology and product<br />
portfolio protected by<br />
extensive patent portfolio of<br />
11 patent families<br />
State-of-the-art, in-house<br />
development and scalable<br />
GMP process<br />
Experienced management,<br />
proven vaccine development<br />
and biotech expertise<br />
Company <strong>Fact</strong> <strong>Sheet</strong><br />
P E V I O N – B U I L T O N S O L I D G R O U N D<br />
<strong>Pevion</strong> <strong>Biotech</strong> <strong>AG</strong> is a Swiss company active in one of the fastest growing<br />
segments in the pharmaceutical industry: the vaccine market (C<strong>AG</strong>R approx.<br />
25%). The Company develops vaccines for unmet medical needs based on its<br />
clinically and commercially validated virosome technology, which functions<br />
both as carrier and adjuvant. Virosomes belong to the established class of VLP<br />
(virus-like particles) with successful products on the market such as Gardasil ®<br />
(marketed by Merck) or Engerix-B ® (marketed by GSK). Two virosome-based<br />
vaccines, Epaxal ® and Inflexal ® V (both marketed by Crucell Switzerland <strong>AG</strong>,<br />
now a Johnson & Johnson company) are licensed in over 40 countries, and<br />
more than 70 million doses of these vaccines have been commercially<br />
distributed, thereby providing a solid safety and efficacy track record.<br />
T O W A R D S N E W H O R I Z O N S<br />
Virosomes are particularly well suited for addressing new vaccine indications.<br />
They are a highly versatile toolbox-type system, allowing the use of difficult<br />
antigens and/or molecular targets (e.g. peptides, proteins). Of elementary<br />
importance, virosomes are the only VLP-based vaccines that are assembled in<br />
a tightly controlled process in vitro and are therefore independent from any<br />
host cell expression system. This results in products of well-defined<br />
composition and high purity, which is essential for developing effective and<br />
safe vaccines. <strong>Pevion</strong> has the in-house expertise and capability to develop its<br />
candidate vaccines according to industry standards, including a state-of-the-art<br />
and scalable GMP manufacturing process.<br />
S T R A T E G I C F O C U S<br />
J U L Y 2 0 1 1<br />
<strong>Pevion</strong>’s product pipeline focuses on innovative vaccines for unmet medical<br />
needs, which so far could not be addressed by any conventional treatment<br />
approach. Consequently, all candidates have first-in-class and/or best-in-class<br />
opportunities. While <strong>Pevion</strong>’s most advanced program, the malaria vaccine<br />
PEV3, has already been out-licensed successfully after completion of a Phase II<br />
study, the Company is now concentrating its efforts on its lead program PEV7,<br />
a therapeutic vaccine against recurrent vulvovaginal candidiasis (RVVC), an<br />
unrecognized but widespread and highly debilitating condition.<br />
Discovery Optimization Preclinical Phase I Phase II Phase III<br />
PEV7 i.m. Candida albicans (RVVC)<br />
PEV7 i.vag. Candida albicans (RVVC)<br />
PEV4 Respiratory syncytial virus (RSV)<br />
PEV6 Breast cancer (HER2)<br />
PEV3 Malaria - Product outlicensed<br />
HIV - Indication / technology outlicensed<br />
<strong>Pevion</strong> pipeline Q3 2011
Management Team<br />
Evert Kueppers CEO<br />
Christian Spyr Head of Clinical<br />
Development &<br />
Project Management<br />
Mario Amacker Head of Process<br />
Development &<br />
Manufacturing<br />
Christian Moser Head of Research<br />
Board of Directors<br />
Didier Hoch Chairman,<br />
Ex- Chairman of<br />
Sanofi Pasteur MSD<br />
Jean-Paul Prieels Ex-Senior VP R&D of<br />
GSK Biologicals<br />
Achim Kaufhold CMO Basilea<br />
Pharmaceutica<br />
Daniel Richner BZ Fund Managemt<br />
Daniel Erne CTO Bachem Hold<br />
Klaus Breiner BB <strong>Biotech</strong> Ventures<br />
<strong>Pevion</strong> <strong>Biotech</strong> <strong>AG</strong><br />
Worblentalstrasse 32<br />
3063 Ittigen<br />
Switzerland<br />
Phone +41 31 550 44 44<br />
Fax +41 31 550 44 45<br />
info@pevion.com<br />
www.pevion.com<br />
R E C E N T M I L E S T O N E S<br />
PEV7 therapeutic RVVC vaccine achieved positive Phase I interim results<br />
PEV4 RSV vaccine achieved preclinical proof-of-concept in two animal<br />
models: Mice and Cotton rats were protected against a live virus challenge,<br />
no pathological events were detected<br />
Licensee Mymetics announced positive Phase I trial results with virosomebased<br />
HIV vaccine<br />
Development of a mucosal galenic, freeze-dried version of virosomes<br />
enabling among others vaginal capsule formulation<br />
New Chairman with relevant vaccine development / launch experience<br />
New Board member with portfolio and vaccine development experience<br />
Strengthened management with experienced vaccine development<br />
specialist and biotech-proven CEO<br />
Additional CHF 10 million funding<br />
Partnership with US vaccine company<br />
S T R O N G T R A C K R E C O R D<br />
<strong>Pevion</strong>’s track record to date proves the company’s capability to translate its<br />
assets into successful product development and to generate added value for<br />
its shareholders.<br />
Products developed and manufactured by <strong>Pevion</strong> were tested in a total of 7<br />
Phase I and Phase II trials<br />
To date, 4 products demonstrated immunogenicity in human; 5 peptide<br />
and 2 protein antigens validated<br />
Excellent safety and tolerability in human, no failure ever<br />
PEV3 Malaria vaccine successfully out-licensed after Phase II<br />
Technology and product design out-licensed for HIV vaccine; now<br />
successful in clinical Phase I<br />
11x patent families, in-depth know how and trade secrets<br />
Platform improvements & new IP (freeze-dried formulation, mucosal<br />
galenic, immunostimulation)<br />
GMP compliance status granted by Swissmedic<br />
F I N A N C I A L S U M M A R Y<br />
<strong>Pevion</strong> was founded in 2002 by Bachem Holding and Berna <strong>Biotech</strong>, which<br />
provided a total of CHF 20 million as a start- up capital. Berna <strong>Biotech</strong> was<br />
acquired by Crucell N.V. (now a Johnson & Johnson subsidiary) in 2006. In<br />
August 2007, the Company closed a CHF 15 million series A financing round<br />
with new investors BZ Bank Aktiengesellschaft, BB <strong>Biotech</strong> Ventures and Core<br />
Capital Partners as well as the existing investor Bachem <strong>AG</strong>. Crucell was<br />
bought out in November 2007. In September 2010, <strong>Pevion</strong> secured additional<br />
CHF 10 million in financing from its current investors.<br />
C O N T A C T<br />
To request further information, please contact:<br />
<strong>Ju</strong>lian Wagner, PhD, Business Development<br />
info@pevion.com, Tel: +41 31 550 44 44