PRODUCT CO-DEVELOPMENT, CO-FINANCING AND GRANTS

Profit generated from our fee-for-service CRO business unit is to a large extent re-invested into our own drug development programs through the allocation of our skilled and experienced clinical research workforce in self-funded clinical research projects. As an end result, SMERUD will end up owning the results of clinical trial data and thus take a part of the value generation seen in successful drug development programs, while also taking a much larger risk of not finding any proof of efficacy of the drugs in question.

Since 2009, we have invested internal R&D time into a total of some 95 individual clinical research projects, of which about 20 are/were major co-development projects, with a total accumulated investment of approx. 100 mNOK (about 10 m€) in these self-financed R&D projects. We believe that it is in the long-term interest of the company to continue investing in co-development projects like these, and the firm is committed to continue to invest a huge percentage of our profit, and typically of our annual revenues into R&D projects. The SMERUD group is present as a fee-for-service consultancy in 8 European countries, whereas our self-financed R&D hubs are thus far only located in the UK (Manchester), Sweden (Uppsala), Germany (Mannheim) and Norway (Oslo).

SMERUD has developed an innovative business model in which we may partner with selected biotech companies. In such a co-development model, SMERUD invests a significant part of the clinical trial costs by providing our clinical trial services as in-kind contributions. Such co-development set-ups typically secure some of the investment needed for a clinical trial, generating a favorable investment case when seeking additional funds from venture capital, which again allows our biotech partners to spend their, often limited, cash more efficiently. 

As part of this co-financing and co-development strategy, SMERUD has achieved an unrivaled position in Europe as the consultancy, which not only successfully writes grant applications for clinical trials, but is also committed to being an active partner (beneficiary) within the consortia, with a dedication and responsibility in delivering the project as per agreed plans, and by taking a share of the risk associated with the innovation development. 

There are numerous grant opportunities for European-based innovative small-and-medium-sized enterprises (SMEs). Such programmes include Horizon 2020, now succeeded by Horizon Europe, as the main funding source for scientific research with in the European Union (EU). Specifically for SMEs within the biotech sector, there are now opportunities financed through the European Innovation Council (EIC), in particular the EIC Accelerator. Together with the EUROSTARS Programme, those remain important grant options to support the development of small projects and products pertaining to small and medium-sized European companies. 

SMERUD may assist both European and Non-European clients in obtaining funding through these programmes through actively participating as a partner as well as providing assistance and representation within Europe, and will be prepared to discuss potential collaborations and funding opportunities within Europe further with potential partners.

CURRENT R&D FOCUS

Our portfolio of clinical research projects has focused on therapeutic areas with which we have previous experience, and/or those for whom our R&D personnel have a particular expertise. Over these last 10 years, our main R&D programs have included rare disorders, nephrology, endocrinology, dermatology, oncology, lung diseases, psychiatry, and gastroenterology. We are currently capitalising on these investments, and are therefore open to evaluating new opportunities. 

For the 2022-2024 period, our primary R&D focus will be i.a. on the following areas:

• Rare diseases/orphan drugs: cystic fibrosis, phenylketonuria, MSUD, Stargardt’s disease
• Oncology: Breast and ovarian cancer
• Neonatology: extreme prematurity and prevention of its life-long complications
• Rheumatology: rheumatoid arthritis, polymyalgia rheumatica
• Dermatology: Psoriasis
• Companion diagnostics/biomarkers: oncology, gastroenterology, metabolic disorders