Abstract

European Biotech Model – Consolidation or disappointment?

U. Theuretzbacher
Center for Anti-Infective Agents - Vienna, Austria

Compared to the US, Europe still has fewer and smaller biotech companies with a smaller share of global investment. Recently, however, some large pharma companies spun off their antibiotics units, and the new biotech companies that are located in European countries have been established with strong drug candidates. In addition, a number of biotech companies focused on anti-infective research has emerged in recent years. They inlicensed from big pharma or have a more traditional biotech model, often based on university collaborations. Many of these companies are focusing on antiviral drugs, on vaccines or more unusual and innovative antibacterial approaches. This contributes to a growing pipeline in the anti-infective field in Europe. The countries with most activities in the anti-infective area are UK, Switzerland, Germany and France. The European regulatory agency EMEA is aware of the challenges in the context of continuing globalisation and is strengthening its collaboration with FDA. To facilitate the communication and collaboration between academia, biotech and big pharma, the International Society of Chemotherapy (ISC) that has its headquarter in Europe, is planning a web-based platform with freely available information about companies and their R&D programs in the anti-infective and anti-cancer field. This information will be confronted with the pronounced needs of clinicians.

Abstract

Clinical implications of tissue concentrations
U. Theuretzbacher
Center for Anti-Infective Agents-Vienna, Austria

Sufficient penetration of an antibiotic to the site of infection is a prerequisite for the successful treatment of patients. Since most bacterial infections occur in the interstitial fluid of tissues or in the cell-free fraction of body fluids, adequate free concentrations of the antibiotics should be present in these fluids. In severely ill patients the target site penetration of antibiotics may substantially differ from corresponding plasma drug levels due to an impaired local blood flow and transcapillary antibiotic transfer to the target site. Inadequate target site concentrations may markedly affect target site killing of bacteria and may cause therapeutic failure.

Abstract

Combating resistance with new drugs
Bad Bugs, No Drugs - Antibiotic drug development in the future

U. Theuretzbacher
Center for Anti-Infective Agents-Vienna, Austria

Antibiotic resistance is recognized worldwide as a major problem in the management of patients both in hospital settings and the community. In general, the medical community reacts by minimizing unnecessary antibiotic prescribing and by restricting the use of newer antibiotics which aim to reduce selection pressure for resistance. Established resistance is proving hard to displace. Therefore, there is an expressed need for new antibiotics. In spite of this obvious and highly visible medical need there is a global lack of new antibacterial scaffolds. Most of the large pharmaceutical companies have abandoned this area because these drugs simply are not as profitable as drugs that treat chronic conditions and lifestyle issues. Nevertheless, many biotech companies are working to develop new antibiotics, mostly relying on licensing or the outright purchase of late-stage experimental products from large drug companies. Some biotechnology companies have pursued a diverse choice of targets resulting in several novel classes of agents. The main issue for startups is the lack of funding because investors don't see an adequate financial payoff. This view is based on several factors: antimicrobials are usually used for short-course therapies, the large number of approved antimicrobials results in a high level of competition for newly developed agents, new antibiotics are typically held in reserve, and development of resistance makes antibiotics less profitable in the long term. However, there are encouraging research activities going on that involve three strategies, including modification of existing antibiotic structures, discovery of new target sites, and targeting resistance mechanisms. Examples of all these strategies are presented.

Abstract

European I.D. Drug Development Trends and Opportunities
U. Theuretzbacher
Center for Anti-Infective Agents-Vienna, Austria

There is a growing need for new, more powerful anti-infective drugs. Some big pharma abandoned this arena, but biotech companies could fill the gap.

European biotech, at an early stage in size of companies, revenues and product pipeline, has more companies than the US—Germany has the most in the EU, followed by the UK, France and Sweden. European companies working in anti-infectives either concentrate on developing vaccines, like Intercell in Austria; Innogenetics in Belgium; and Acambis, Cytos and Berna in Switzerland; or follow new drug discovery strategies like Arpida and Basilea in Switzerland; Axxima in Germany; Entomed in France; and Idenix and Arrow in UK. Vertex, a major antiviral player, is based in UK.

The EU seeks to improve European biotech’s potential through:

1. Comprehensive initiative to stimulate entrepreneurship and overcome issues of fragmentation, access to finance and intellectual property protection.

2. Sixth Framework Program 2003-2006 with objective to accelerate new drug development.

3. Broadening opportunities in the EU with 10 new countries, some with growing biotech activities, in May 2004.

Europe's biotech industry could catch up and increase potential opportunities for life science research, drug discovery technologies as well as R&D collaborations.