Affiris and Onepharm listed as promising European biotech companies

This analysis of five biopharmaceutical companies, selected from a pool of 67 European start-ups, is offered by LifeScience-consulting as an exclusive for readers of Partnering News to fuel conversations at BIO-Europe Spring 2008 in Madrid.

Prepared by Ferfoglia Fabio, PhD., an analyst with Lifescience-online, the report provides an analysis of companies having at least one therapeutic in clinical development and with less than five years since their foundation.

· Affiris GmbH: the Alzheimer's vaccine

· Cellerix SL: adult stem cells therapeutics

· Moberg Derma AB: Skin disease

· Novexel: Antibacterial and antifungal agents

· Onepharm: Small molecule drugs to treat viral diseases Mainly,these are companies with an independent status that are not subsidiaries of major firms, thus representing a more interesting target for investments, writes Dr. Fabio.

The main goal of this study is to identify and highlight very active European healthcare start-ups that have the potential to become global players in their market.

The outstanding level of research and development and the innovative technologies adopted to address severe and incurable diseases with unmet medical needs were among the major criteria considered in the selection. In addition, the market size and its potential related to each specific area of application were also critical in the companies' choice.

Among the numerous European healthcare start-ups having an interesting pipeline of products in development, only the ones that announced advances in clinical trials or achievement of milestones in the past twelve months through international press releases have been taken into consideration.

Affiris GmbH: the Alzheimer's vaccine

In the area of vaccine technologies the Austrian based Biotech Company AFFiRiS develops an innovative approach for the design of vaccine-based therapeutics to treat severe and life threatening diseases such as Alzheimer's disease (AD) and Atherosclerosis. Awarded in November 2007 of a European patent for the Alzheimer's vaccine, Affiris has secured exclusive rights to develop its vaccine.

AD is a chronic and progressive neurodegenerative disorder that causes an irreversible loss of memory and other mental abilities and ultimately leads to death. In addition to generalized brain deterioration, it also affects the immune system increasing the susceptibility of patients for infectious diseases which represent the most frequent cause of death in AD. The etiology of the disease is not completely understood but the formation of amyloid plaques in the brain has been associated with the neuronal degeneration. There is currently no cure for AD and, furthermore, no treatment has been proven successful to slow down the progression of the disease.

A number of international healthcare companies are exploring the potential of vaccines to treat AD. However, because of the ubiquitous nature of the disease-causing protein (beta-amyloid), potential autoimmune reactions represent major obstacles that need to be bypassed. In principle, a functional and safe vaccine would allow the immune system to discriminate between two types of beta-amyloid proteins, the one on the brain cells membrane (non-toxic) and the one in the brain fluid which is responsible for the formation of beta-amyloid plaques.

Affiris uses its proprietary technology Affitopes to generate synthetic peptides that mimic the structure of natural epitopes of human disease-causing proteins. Affitope-vaccines are capable of inducing a therapeutic immune response without the side effects normally observed upon vaccination with the more conventional epitope-based compounds. The Alzheimer's vaccine developed by Affiris is expected to trigger an immune response in patients selectively against the toxic beta-amyloid protein (main component of the amyloid plaques). The healthy amyloid precursor protein (APP) which is a transmembrane component of the brain cells necessary for normal brain cell function would not be recognized. AFFITOPE AD-01, the first Affiris vaccine, is currently undergoing Phase I clinical trials to asses its tolerability.

Affiris has already protected all peptide sequences that can be used to attack the toxic beta-amyloid proteins. Moreover, in February 2008, the company obtained an additional European patent for an innovative approach to treat AD. Based on its proprietary AFFITOME technology, the method consists in dialysing the blood of AD's patients to reduce the concentration of beta-amyloid proteins in the brain.

PROFILE : Affiris GmbH

Year of Foundation: 2003 Registered Office: Campus Vienna Biocenter 2 Viehmarktgasse 2A - Vienna, 1030 - Austria Business Model: R&D

Sector: Biotechnology Subsector: Nervous System Management: Walter Schmidt, PhD (CEO); Richard Westmoreland (CFO); Frank Mattner, PhD (CSO)

Web site:

Pipeline: Affitope AD-01 / Central Nervous System / Phase I

Investors: Mig Verwaltungs AG (major investor); Austria Wirtschaftsservice Gesellschaft mbH (AWS); Österreichische Forschungsförderungsgesellschaft (FFG); Wirtschaftsförderungsfond (WWFF); Zentrum für Innovation und Technologie (ZIT); Prof. Dr. Max L. Birnstiel (Business Angel)

Onepharm: Small molecule drugs to treat viral diseases

Seasonal influenza affects each year 5-15% of the population with upper respiratory tract infections.

Influenza can represent a serious problem for very young and old individuals and for people already affected by chronic diseases such as lung diseases, diabetes, cancer, and cardiovascular problems.

With three to five million cases and 250 000 to 500 000 deaths occurring every year worldwide in developed countries, influenza has a considerable economic weight.

Onepharm is a young biotech company developing novel antiviral and anti-inflammatory compounds with a special focus on the screening of new interesting molecules. The company develops the drug until Phase II and constantly searches partnerships with established pharmaceutical companies to carry out Phase III, registration and product launch. Small molecules active in viral respiratory tract diseases such as the common cold, influenza, bird flu, and SARS represent the main interest of the Onepharm.

The company was co-founded in 2005 by its management and Green Hills Biotechnology, a biopharmaceutical company specialized in virology that develops and commercialize innovative products offering cost-effective treatment against viral infectious diseases and cancer. Green Hills transferred their expertise and corresponding patents into Onepharm and became a founding partner and shareholder.

Since the end of 2006, Onepharm attracted additional funds of more than 2 million euros. In June 2007, the company finalized a capital increase with private investors and received funding of over 3.5 million euros from Austrian private investors, Austria Wirtschaftsservice and the Research Promotion Agency. Finally, in October 2007 the company successfully concluded an exclusive cooperation agreement with the Japanese pharmaceutical company Minophagen. Under this agreement Onepharm obtained exclusive access to the whole preclinical and clinical data package, as well as to the Minophagen's market products for influenza.

The lead compound OPM-3001, isolated from a medicinal plant, is currently in Phase I and should enter into clinical Phase 2 during the flu season 2008/2009. OPM-3001 represents an innovative remedy with a strong combined antiviral and anti-inflammatory activity and has the potential to become a suitable treatment option for viral diseases with pandemic potential. In addition, Onepharm aims to expand its portfolio of therapeutics for the treatment of different viral respiratory tract diseases and a number of additional compounds is currently under investigation.

PROFILE : Onepharm

Year of Foundation: 2005 Registered Office: Veterinärplatz 1, Building IA - Wien, 1210 - Austria Business Model: R&D

Sector: Drug Development Subsector: Infectious Diseases Management: Bernhard Küenburg (CEO); Oliver Szolar (CSO)

Web site:

Pipeline: OPM-1001 / Anti-Infective / Preclinical OPM-3001 / Anti-Infective / Phase I

Investors: Austria Wirtschafts Service (AWS); Forschungs Förderungs Gesellschaft (FFG); Zentrum für Innovation und Technologie (ZIT); Private investors

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