Needs of Global Start-up companies (Deliverable 2) GlobalStart wp1 Studies Deliverable 2 Needs of Global Start-up Companies Table of contents p
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- Pre-venture End 1997 – Early 2000 Foundation Early 2000 – Mid 2001
- Tech- nology platform Product Market
- Large tissue engineering platform
- Market introduction of ChondroSelect
- Finance Startcapital of 575 keur
- No international 2 nd round financing Technology grant IWT
- Staff Frank Luyten
- Networ-king Academic partnerships with univ of Leuven
- Industrial partnerships
- 1 (c) The internationalisation process Know-how / technology
- 2. The university – support for Globalstart companies
- 3. The regional infrastructure – support for Globalstart companies
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1 (a) Profile and background TiGenix is a biomedical firm company operating at the cutting edge in regenerative medicine. It focuses on the development of cellular therapy for the functional repair of musculoskeletal tissues. In 2000, the company has been founded as a spin-off of the KULeuven and the University of Gent by Professor Frank Luyten and Gil Beyen. Frank Luyten is the chairman of the Department of Rheumatology at the University Hospitals in Leuven. He is also the head of the Laboratory for Skeletal Development and Joint Disorders at the KULeuven. He spent 12 years in the US where he built up an extensive experience in rheumatology, repair of cartilage and bone defects. Gil Beyen holds a M.Sc. degree in Bio-Engineering and obtained an MBA at the University of Chicago. He has over 10 years of experience as consultant in the biotechnology, health care and pharmaceutical sector at Arthur D. Little where he still is a partner. When Prof Luyten returned to Belgium, he decided to set up a firm focused on tissue engineering and based on the “bench to bedside” principle: a close interaction between world-class science and the clinic. The market opportunities for engineered and regenerated tissue are substantial and increasing because of the ageing of the population. The discovery of a new family of more specific cartilage forming proteins by Prof Frank Luyten, resulted in potential novel tissue engineering protocols and potential patent applications. Recent advances in the understanding of precursor cell populations and the use of porous biodegradable synthetic polymers combined with tissue specific cells opened a broad range of potential new applications for tissue engineering, including the development of ‘biomaterials’, products integrating biology with materials science. First contacts with LRD were made end 1997. During the next year, a research laboratory was set up and end 1998, Gil Beyen was introduced by LRD staff to participate in the development of the business plan. From 1999 till 2000, the business plan was further updated and choices (focus) had to be made. It was decided to focus on osteoarthritis rather than rheumatoid arthritis as Prof Luyten had a lot of experience with artilage repair (US) and celltechnology, both important for the treatment of osteoarthritis. Moreover, the competition in the rheumatoid arthritis sector is very tough and the sector much oriented towards farmaceutical solutions. The original business plan was based on a multidisciplinary (systems biology, biomaterials and biosurgery) and very broad tissue engineering platform: joint surface defects, cartilage, bone, heart valves. Because of the long time horizons till full commercial breakthrough, it was essential to start up real business activity (and cash flow, even on a small scale) as soon of possible. This resulted in a dual business plan with focus on the short to medium term: making a success from the first product (ChondroSelect). In the meantime, experience is build up, knowledge of the market is acquired and the company also achieves some presence on the market. The technology is based on mature cells. The long term objectives of the companies are aiming at research for improvement of arthritis based on stemcell technology. As the speed of approval of new tissue engineering protocols and product will be crucial for the viability and the value of the company, clinical trials and regulations will require major attention from the management team. Nancy Veulemans, responsible for the clinical and regulatory affairs, is involved since the beginning of Tigenix’ and is one of the keypersons of the company. Ms. Veulemans holds a M.Sc. degree in Bio-Engineering and is currently managing director of 4C partner, a consultancy serving the pharmaceutical and biotech industry. Uptill today, TiGenix’ activities are still in line with the original business plan, although more oriented towards solutions as opposed to development oriented. The focus of the company is the development of solutions for repair and functional regeneration of damaged human tissue and in particular of damaged and osteoarthritic joints and has resulted in an R&D portfolio of chondral and osteochondral defects, osteoarthritis and others (bone, heart valves, muscle, etc) 1 (b) Major milestones
1 (c) The internationalisation process Know-how / technology From the beginning, TiGenix could build on the expertise of international caliber from research groups based at the universities of Leuven and Gent, and headed by professors (Prof. Luyten, Schacht and Flameng), who can be considered as world authorities in their specialization. Therefore, there was sufficient world class science and know-how available inhouse and there was no need for collaboration with other international research centres. Resources The management skills and business experience present at the foundation of TiGenix (Luyten, Beyen, Veulemans) did not require additional management from abroad. Market To be successful, the company needs to become an international world leader. Introduction of the product in the different markets appears to be quite complicated and time consuming. One needs to take into account different specific regulations about the introduction of innovative products, clinical trials, submittal of healths economics file for reimbursement, etc. In case of the European market, as long as there is no unified regulation, this means that every country needs to be individually approached. But, the company also needs to find the correct contact persons in the different countries, build up a network of clinical centres for the clinical trial, etc. Therefore Nancy Veulemans, responsible for clinical and regulatory affairs, is one of the keyperson of the spin-off company. In order to distribute its product in different markets, TiGenix will have to get involved in partnering with large pharma or biotech companies (via crosslicensing and joint venture agreements). Those companies will be responsible for part of the development of the products and most of the commercialization of it. 2. The university – support for Globalstart companies LRD introduced Gil Beyen to participate in the development of the business plan. Gil Beyen worked for more than 10 years as a consultant in the biotechnology, health care and pharmaceutical sector and therefore has some very valuable prior business experience for the company. According to Gil Beyen, the support capabilities of a TTO with respect to the internationalization process of spin-offs are limited. LRD has introduced the company with international financial groups. It also provided TiGenix with support for legal matters (negotiation of contracts, etc.). However, when it concerns very specific contracts or when it comes to finding the correct partners (lawyers, etc) abroad, coaching of the TTO is helpfull but not sufficient. 3. The regional infrastructure – support for Globalstart companies For the 2 round financing, some international capital was expected, however, it appeared to be very difficult / impossible to attract foreign money without a strong local lead (for ex. Capricorn). Hypertrust
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