Building Biotech Businesses

The biotech industry in Ireland has grown substantially during the past decade, and yet more growth is on the horizon. This is due in part to the groundwork laid during the past 10 years by various organizations and agencies in Ireland, and to the considerable increase in investments in Irish biotech research and development (R&D). Irish biotechnology in the near future stands to benefit from financial support available from Science Foundation Ireland, Enterprise Ireland, the Higher Education Authority, the Health Research Board, the European Union and others. Indeed, the combined potential funding from these organizations totals more than €1 billion. With these resources at its fingertips, Ireland is poised to create an extraordinary high-tech research and industrial base in the biotechnology sector.

In February 2002, Enterprise Ireland (EI) — the Irish development agency focused on accelerating the development of world-class Irish companies that are market focused and innovation driven — published its Building Biotech Businesses strategy. The strategy is now fully operational and is contributing significantly to the development of Ireland's entrepreneurial-led biotechnology industry. The strategy has a number of key elements, including applied research funding, commercialization and technology transfer, international networks, bioincubation, venture capital, and fast-track company growth.

Applied Research Funding

EI's commitment to funding and commercializing high-quality applied research has led to the establishment of a range of supports brought together under its Commercialization Fund. The fund consists of 3 elements: proof of concept, technology development, and business development. Funding is provided on a competitive basis to researchers in all institutes and colleges, for projects leading to technologies of commercial interest to existing companies in Ireland or having the potential to be the basis for new Irish business.

Commercialization and Technology Transfer

Enterprise Ireland's Biotechnology Directorate (EI Bio) focuses on technology transfer and campus-based activities. It forms a crucial link in the commercialization chain by connecting those who conduct the research, and the entrepreneurs, industrialists, and companies who apply the fruits of that research.

So that EI Bio is best placed to commercialize the results of Irish biotech research, it has located staff as close as possible to where the research happens. A number of biotech commercialization specialists and biotech project officers are embedded at selected campus technology transfer offices. EI Bio commercialization specialists are assigned to Dublin City University, Trinity College, Dublin, University College Cork, University College Dublin, National University of Ireland in Galway, University of Limerick, and Royal College of Surgeons in Ireland. EI Bio also continues to forge strong new relationships with other campuses involved in biotechnology.

In 2004 EI Bio added the TechMate module to its web portal at www.biotechnologyireland.com. TechMate showcases the latest life sciences and food technologies that have been developed in Irish universities and research institutes and are now available for licensing, collaboration, and business development. Companies can also submit requests for the technology or expertise they require. In addition, TechMate showcases technologies from the National Institutes of Health in the US and has links to sources of European technologies. EI Bio also runs Next Wave technology showcase events to highlight the applications and commercial potential of emerging technologies. For more information about this exciting tool, visit www.biotechnologyireland.com/techmate

Paul Roben, Ph.D., is director of Enterprise Ireland's Biotechnology Directorate. In October 2005, to take this leadership position, Roben returned from San Diego. Earlier in his career, he had worked with the Scripps Research Institute specializing in antibody phage display. Roben has a broad background in the development of commercial opportunities from research activities and has successfully negotiated licensing deals and collaborations with academic and commercial entities. He led the molecular biology department at NovaDx International, Inc, and at Corvas International, Inc, he led the molecular biology section of the vascular targeting group. In addition, in 1999 he founded Target Protein Technologies, Inc.

Roben recently noted, "The environment for starting and growing innovative biotechnology companies in Ireland is excellent. Enterprise Ireland is focused on market and industry demands, and we are working proactively with the Irish biotech sector, Irish universities, and research institutes to bring emerging high-quality technologies to market."

International Networks

In association with the Irish BioIndustry Association, EI Bio is working on a project to stimulate bioindustry-relevant research at Irish universities. This program brings leading scientists and business managers from industry together with leading university researchers. The businesses involved include: Elan Corporation PLC, Wyeth, Biotrin International Ltd, Deerac Fluidics, Luxcel Biosciences, BioClin Research Laboratories, Omega Research, and Life Scientific. Meanwhile, academicians from 6 universities bring expertise in sensors, microfluidics, microelectronics, biodiagnostics, and process engineering. The project aims to solve generic biological problems faced by the Irish bioindustry. Phase 1 of the project involves investigating quantitative point-of-care test systems and in-line and at-line bioprocess monitoring.

In addition, Enterprise Ireland is tapping into the Irish Diaspora as a means of attracting entrepreneurs, as well as scientists who have developed international experience. EI was instrumental in establishing networks in the US (Biolink USA-Ireland) and in the UK (TechLink UK-Ireland), and it also supports the network for biotech professionals within Ireland (BioConnect Ireland).

BioLink USA-Ireland now has more than 700 members. Chapters have been established in 10 locations throughout the US. The newest chapter was formed in April 2005 in Chicago. BioLink members contribute to the growth of the biotechnology sector in Ireland as mentors, company founders, scientific advisors, and board members.

Many Irish professionals living in the UK and working in biotech, nanotech, or pharma have joined TechLink UK-Ireland. They are interested in the advancement of these sectors in Ireland, and in developing their own careers through networking.

BioConnect Ireland hosts networking meetings attended by academics, industry, venture capital, government, and service providers. These events provide an opportunity to network, discuss issues relevant to the sector, and learn from expert speakers.

BioIncubation

One of the Building Biotech Businesses strategy's early objectives, central to creating the proper support infrastructure for a fledgling biotechnology industry, was to ensure an adequate supply of wet lab incubators to support the development of early-stage companies. On-campus bioincubation space has now doubled. Enterprise Ireland has provided financial support for the conversion of 6 existing buildings into bioincubators that provide laboratory and office space for 20 start-up companies. The facilities are located at Dublin City University, National University of Ireland in Galway, St. James's Hospital, Trinity College, Dublin, University College Cork, and University College Dublin. The facilities are available to a range of clients, including university spinoffs, company spinoffs, entrepreneurs from overseas, expatriate entrepreneurs, and foreign companies that wish to relocate to Ireland. The bioincubators provide professional research and commercialization services; access to financial, legal, and marketing advice; and help for start-up companies seeking to establish themselves.

Feargal O'Morain is director of science, innovation, and corporate support services, for Enterprise Ireland. Speaking of the bioincubation program, he recently observed, "Specialized bioincubators will provide the appropriate business and scientific support needed for new companies to survive and grow. Increased funding for research in life sciences will result in increased commercial capitalization of basic and applied research in Ireland in the next decade. The bioincubators will provide a launch pad for innovative new ideas and products, which are the future for our knowledge-based economy. This is a central objective of Enterprise Ireland's biotechnology strategy, Building Biotech Businesses."

The first tenant for the Trinity College, Dublin bioincubator was IdentiGEN Ltd, a company that has developed the world's first DNA-based traceability system for meat (TraceBack™). This development grew from research initially carried out at the Institute of Genetics at Trinity College, Dublin. Using IdentiGEN's system to assure consumers of the source of their meat, Irish supermarket chain Superquinn saw an 11% increase in beef sales. The Irish and UK Food Control Agencies have also selected IdentiGEN's DNA-testing technology for high-profile studies. IdentiGEN's tests were shown to be the only ones sufficiently sensitive to consistently detect low amounts of target-DNA in certain processed food samples. For more information about the bioincubation aspect of EI's Building Biotech Businesses strategy, visit www.biotechnologyireland.com/incubate.

Venture Capital

Since 2001, EI has invested 19% of its €133 million seed and venture capital funds in life sciences. EI has also been successful in stimulating the emergence of the private sector seed and venture capital environment.

Fast Track Company Growth

EI has worked successfully with numerous Irish companies as part of its Building Biotech Businesses program. The company profiles in the following section illustrate this success.

COMPANY PROFILES

ALIMENTARY HEALTH LIMITED

Alimentary Health Limited, based in Cork, specializes in the development of human therapeutic products derived from probiotic bacteria. The probiotic strains are being developed to treat irritable bowel syndrome, inflammatory bowel disease, and Crohn's disease/ulcerative colitis.

To assist the start-up of Alimentary Health, EI Bio licensed technology into the company. Following this, Enterprise Ireland invested start-up funds by way of grant and equity. The company has been invited to participate in overseas missions to the US and more recently, has been approved for an innovation partnership grant.

Contact details: Dr. Barry Kiely, CEO, Alimentary Health Ltd, Simla Villa, Passage West, County Cork, Ireland, +353.021.477.4715, bkiely@alimentaryhealth.ie.

BIOCLIN RESEARCH LABORATORIES

BioClin Research Laboratories is Ireland's leading good laboratory practice certified, US Food and Drug Administration (FDA) audited, independent contract research laboratory.

BioClin's services include:

• Bioanlysis

• Method development/validation

• High-volume sample analysis (small molecules, proteins, peptides, and biomarkets)

• Analytical services

• Pharmacokinetic analysis and integrated study management

BioClin's scientific expertise and extensive experience is internationally recognized. Its state-of-the-art equipment includes mass spectrometry, chromatography, immunochemistry, capillary electrophoresis, and the Watson™ LIMS system. BioClin provides flexible and personalized services to all clients.

EI has supported the company through feasibility and mentor programs, and has invested funds by way of grant and equity. In addition BioClin is working with EI's UK office under the business acceleration program to generate new market leads. It has also participated in EI-sponsored missions and trade fairs in the UK, Europe, and North America.

Contact details: Amanda Byrne, Business Development, BioClin Research Laboratories, Monksland Industrial Estate, Athlone, County Westmeath, Ireland, +353.0. 90.648.0400, info@bioclinlabs.com.

BIOTRIN INTERNATIONAL LTD

Biotrin International Ltd is a diagnostics company that specializes in providing a range of novel and proprietary tests for the clinician and the research scientist. The company has two distinct business units: Infectious diseases, which provides tests for the detection of new and emerging viruses; and biomarkers, which includes a range of novel, proprietary biomarkers to assess organ and tissue damage.

Biotrin International owns subsidiaries in France and Germany and is an FDA- registered site, with compliance to the International Standards Organization 13485 standard, the Canadian Medical Devices Conformity Assessment System, and the EU 98/79/EC in vitro diagnostic medical devices directive.

Enterprise Ireland has been assisting the development of Biotrin since the early 1990s. Funding and grant equity have been provided for feasibility studies, capital equipment purchase, and participation in overseas trade missions organized by EI in Europe, Asia, North America, and Australia. Product development, business consultancy, and market research projects have also been supported.

Contact details: Dr. Cormac Kilty, CEO, Biotrin Holdings PLC, 93 The Rise, Mount Merrion, County Dublin, Ireland, +353.0.1.283.1166, ckilty@biotrin.ie.

GENABLE TECHNOLOGIES

Genable Technologies is a specialty biotech company spun out of Trinity College, Dublin. Genable has developed a platform technology known as GeneXchange, which is protected by patent. The system involves a single RNA cut/replacement therapy, and the company aims to provide unique solutions to various disease states caused by genetic mutation. Genable intends to target and treat diseases such as retinitis pigmentosa, osteogenesis imperfecta/brittle bone disease, and Huntington's disease. The techniques may also be applicable in certain kinds of cancer treatment.

Enterprise Ireland helped fund the feasibility study which led to the start-up of Genable Technologies. In addition, EI included Genable in its mentor program and has invested in Genable by way of preference shares to allow the company to conduct further R&D.

Contact: Dr. Jane Farrar, CSO, Genable Technologies, Smurfit Institute of Genetics, Trinity College, Dublin 2, Ireland, +353.0.1.608.2482, gjfarrar@tcd.ie.

EIRX THERAPEUTICS PLC

EiRx Therapeutics PLC is a specialist provider of pre-clinical therapeutics to the pharmaceutical industry. Its core technologies include its proprietary apoptosis target discovery platform, ALIBI™, which incorporates apoptosis biology, genomics, and bioinformatics. This is complemented by its patented rapid-throughput target validation system. EiRx has recently commenced an in-house intelligent drug discovery screening program to identify potential anticancer therapeutics. Its drug targets, including kinases, G-protein-coupled receptors, and enzymes, represent a continually growing pipeline that is advancing at different stages through screening, leading discovery, and pre-clinical development. EiRx has also begun an anticancer therapeutic screening program. In addition, the company is pursuing preclinical studies with a range of anticancer compounds and provides contract research services.

Enterprise Ireland has supported the company through its feasibility program and invested funds by way of grant and equity to promote R&D activity and assist company expansion. EiRx has participated in a number of EI-sponsored missions in the US and Europe.

Contact Details: Finbar Murphy, CEO, EiRx Therapeutics PLC, 2800 Cork Airport Business Park, Cork, Ireland, +353.0.21.432.0847, f.murphy@eirx.com.

MERRION BIOPHARMA, LTD

Merrion BioPharma, Ltd, is a drug delivery company with a strong research pipeline of targeting technologies addressing the oral administration of vaccines and the uptake of drugs across the blood brain barrier. Merrion aims to continue the development of these technologies and to apply its products to both the life cycle management of existing drugs and the development of new drugs. Merrion's technology platforms are cutting-edge, differentiated, and protected by patents. Merrion has a strong senior management team with extensive international industry experience, as well as state-of-the-art laboratory facilities and common good manufacturing practices manufacturing capability.

Merrion Biopharma has been supported financially at a very early stage in its development through preference share investment. Enterprise Ireland's overseas network is providing business development support throughout Europe, the UK, and the US.

Contact Details: John Lynch, Managing Director, Merrion BioPharma, Ltd, Trinity College, Dublin, 3rd Floor, Biotechnology Building, Dublin 2, Ireland, +353.0.1.672.9272, jlynch@merrionpharma.com.

OPSONA THERAPEUTICS LTD

Opsona Therapeutics Ltd is a new biotechnology company focused on the development of drugs and vaccines for autoimmune and inflammatory diseases, including psoriasis, rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease. The company has emerged from research conducted at Trinity College, Dublin by a highly respected team of scientists. Two lead candidate drugs have been identified for progression through trials. The company intends to create a pipeline of products to emerge over time.

EI Bio has worked for a number of years with the academic founders on their patenting, research, and commercialization strategies. In addition, EI Bio and EI's High Potential Start-Up department have worked closely with the company from the pre-start-up phase. EI has invested in the company through a feasibility grant and the purchase of shares. Opsona is also working with EI overseas offices to identify potential partners.

Contact: Dr Mark Heffernan, CEO, Opsona Therapeutics Ltd, Innovation Center, Trinity College, Dublin 2, Ireland, +353.0.87.643.4766, heffernan@opsona.com.

CONCLUSION

Dick Lenehan, manager of EI's High Potential Start-Up department, recently noted, "Enterprise Ireland's Building Biotech Businesses is a dynamic strategy, based on best international practice, to sustain a world-class biotech business environment in Ireland, by ensuring that the support infrastructure, funding environment, and access to international business networks are in line with the needs of researchers, entrepreneurs, and businesses developing world-class companies."

He continued, "The biotechnology industry is fast-moving, international, and highly dynamic. The Enterprise Ireland strategy is likewise dynamic, in line with the needs of biotech business developing in a fast-moving business and scientific environment."

Enterprise Ireland's Building Biotech Businesses strategy is clearly fulfilling its mission of helping grow and develop Ireland's entrepreneurial-led biotechnology and life sciences industries. Building Biotech Businesses will continue to encourage creation of new commercially focused biotech companies in Ireland, to nurture early-stage biotech companies, and to target foreign biotech entrepreneurs and early-stage companies with potential to locate in Ireland. It will also continue to fast-track biotech company development, and to encourage private-sector seed and venture capital in Ireland. The EI biotech team is now in place and is integrating its resources to deliver on the goals of this strategy — goals which, together with other progressive EI initiatives, will all play key roles in biotech sector development in Ireland now, and in years to come.