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Karolinska Development
is supported by the European
Union through the “Technology
Transfer Pilot Project”

karolinska development

Karolinska Development aims to create value for patients, researchers, investors and society by developing innovations from world class science into products that can be sold or out-licensed with high returns. The business model is to: SELECT the most commercially attractive medical innovations; DEVELOP innovations to the stage where the greatest return on investment can be achieved; and COMMERCIALIZE the innovations through the sale of companies or out-licensing of products.


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Select

Karolinska Development has developed a well-structured selection process to identify the most commercially attractive medical innovations screened by KIAB. Pharmaceutical development is a high-risk enterprise. In most cases, development projects fail because of side effects or insufficient efficacy. Successful selection of innovations is fundamental to Karolinska Development’s business model, which makes the inflow of new projects crucial. One key to success lies in selecting those innovations that can be developed from scientific findings to products and have significant commercial potential. To date, over 1,300 projects have been screened by KIAB.

To be accepted for screening, an innovation must:

  • meet a significant medical need and exhibit major international commercial potential;
  • be based on a unique technology originating from prominentresearch; and
  • have secured, or have the potential to secure solid intellectual property rights.

After initial selection, projects go through a validation period, which is financed by Karolinska Development. Once certain milestones have been achieved, Karolinska Development may invest according to a predetermined formula. Karolinska Development’s goal is to invest in up to five projects annually.

Develop

The portfolio companies are often founded together with the innovators and are initially operated as virtual companies with few or no employees. During the first six to twelve months, the companies normally have minimal fixed costs and technological development is outsourced.

The innovator, who is often employed at an academic institution, normally participates as a board member and scientific advisor. The CEO of a portfolio company cooperates closely with a representative of Karolinska Development, who in most cases is also a board member of the company. The companies are capitalized to reach their next milestone, usually within a period of six to eighteen months. Development projects are continuously monitored, and those that do not meet their stipulated targets are discontinued. In the first three to four years, a portfolio company’s operating expenses are often limited to a few million Swedish kronor per year, which cover the cost of external studies and the salary of the staff. In subsequent years, Karolinska Development and other investors play an important role recruiting key expertise to the companies

Commercialize

Karolinska Development intends to realize value by exiting portfolio companies or through out-licensing of projects. Such transactions (especially out-licensing) are often structured as single upfront payments followed by payments based on predetermined milestones and royalties on sales. Although Karolinska Development has a flexible exit strategy, pharmaceutical products are, for two reasons, preferably exited at Phase II. First a successful Phase II study indicates that the pharmaceutical has an effect on patients, which is an important value-enhancing factor when negotiating out-licensing or sales. Secondly, finalizing product development and undertaking Phase III clinical trials frequently requires very large patient populations. In many cases this requires much greater resources than those available at Karolinska Development but these can be found in established pharmaceutical companies. Several licensing deals were closed in 2011 involving projects with a similar focus and development phase to Karolinska Development's projects.

 

Number of licensing agreements for drug candidates through Phase II

 

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Large pharmaceutical companies have shown steadily growing interest in investing in innovations from outside companies.

Source: MedTrack