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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

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