Funding

SECTION I: ESTIMATION OF COSTS

 

1

Taking into account the rest of the cost evaluation please provide an overall estimation of the total costs for full deployment/production of the R & D result.
… in terms of IPR protection
2012:  € 40002014: € 80000

 

 

…in terms of product development
Completing the R&D activity:  € 240 000Product development: € 220 000

 

 

…in terms of mass production
€ 580 000 

 

… in terms of marketing
€ 350 000

 

 

2

Based on the above assessment as well as the marketing information please provide the correct estimation of the price for R&D product in correlation with costs

Year 1

Year 2

Year 3

Year 4

Year 5

Fixed costs

€ 130 000

€ 130 000

€ 200 000

€ 200 000

€ 200 000

Personnel

€ 40 000

€ 40 000

€ 60 000

€ 120 000

€ 150 000

Other running costs

€ 90 000

€ 90 000

€ 140 000

€ 450 000

€ 3 150 000

Marketing costs

€ 50 000

€ 100 000

€ 200 000

TOTAL EXPECTED COSTS

€ 260 000

€ 260 000

€ 450 000

€ 870 000

€ 3 700 000

Price per Unit

115 EUR

Type of Unit

Monthly supply of medicine

Number of Units

1000

10000

50000

TOTAL Expected Revenues

€ 0

€ 0

€ 115 000

€ 1 150 000

€ 5 750 000

CASH FLOW REQUIRED (REVENUES-COSTS)

-€ 260 000

-€ 260 000

-€ 335 000

€ 280 000

€ 2 050 000

TOTAL CAPITAL required for five years

-€ 855 000

 

SECTION 2: QUALITATIVE FACTORS

 

3

Dimension of identified target groups
Millions of patients worldwide suffer of muscular dystrophy.

 

4

Evaluation of financial Risks for R&D result
The 855 thousand Euro investments cover the product development of the R&D result and the initial expenses of the first phase of mass production. The competitive advantage is that the product is unique in the market. To use the benefit of this advantage it is necessary to run up the sales quite quickly, so the fast availability of the market is very important. Otherwise the cash flow can be negative for more than five years, so the investment won’t be enough. From the same reason the time of the approval of the product is critical too. It has to be reached until the end of the third year.

 

 

SECTION 3: IDENTIFICATION OF FINANCING SOURCES

After evaluating all the above mentioned criteria, please tick the best financing source for the achievement of R&D result (i.e. own capitals, banking credits, venture capital, business angels, etc)

 

1. European Funding

Define relevance of the product with the following potential funding sources and comment

  1. 1.  

2.

 

2. National Funding

  1. 1.  New Széchenyi Plan:  GOP-2011-1.3.1/C for completing the R&D activity

2. New Széchenyi Plan: GOP-2011-2.1.1/B (Komplex technology development for SME-s)  (Max HUF 100 million- Intensity of subsidy: 35%)

 

3. Private funding

  1. 1.  Venture capital

 

 

4. Other

 

 

SECTION 3: FINAL EVALUATION

It is requested a final evaluation considering the funding opportunities you believe most suitable for the exploitation of the R&D result, considering the possibility of the creation of a spin-off, further research, in particular, a cost/benefit analysis and a financial projection for the R&D result, type of collaboration identified (i.e. Licensing Agreement, Technical Cooperation, Joint Venture, Manufacturing Agreement, Commercial Agreement with Technical Assistance, Creation of a spin-off, Joint further development)…

Genetic diseases, including muscular dystrophies are rarely curable directly. Muscular dystrophy can restrict the flexibility and mobility of joints. Up to now the different therapies of muscular dystrophies relies on classical treatment, assistive devices that can improve quality and sometimes length of life of patients with muscular dystrophy. The R&D result is based on eradicating of the initial step of muscle dystrophy by inhibition of the proteolytic cleavage of bulk muscle proteins actin and myosin, which in turn provides substrates for the main proteolytic pathways, calpain, lysosomal and the ubiquitin-26S proteasome.

This R&D achievement therefore very promising. The present state of R&D activity requires an initial investment or subsidy to complete the development of the product. One version of the product can be a nutraceutical supplement. This product can reach the market in the fourth year and with an average pharmaceutical-level product plant, the mass production can be solved.

There can be other solutions too for implementing the R&D result. In case of a registered medicine the procedure of the approval and licensing (i.e.: FDA approval)takes at least five years. So in this valorization plan we did not take into consideration this option. Another possibility is to contract with a pharmaceutical company for licensing agreement. In this case the investment for finalizing the development is a bit less – according to the calculation of the project owner it can be € 460 thosand) and after the third year the IPR can be sold for the company.

 

 

 

 

 

Decision of evaluation (Please keep only the appropriate)

  • The R&D has a high potential of exploitation

 

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