Plant-made GREEn Kit

Project Information

Pgreek

Grant agreement ID: 698871

DOI

10.3030/698871

Project closed

EC signature date 9 September 2015

Start date 1 October 2015

End date 31 May 2016

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

Officina Biotecnologica S.R.L.
Italy

Periodic Reporting for period 1 - Pgreek (Plant-made GREEn Kit)

Reporting period: 2015-10-01 to 2016-05-31

Summary of the context and overall objectives of the project

In the present final report a five-years business plan for the commercialization of an innovative diagnostic kit for Sjogren’s syndrome (SjS) is presented.
The kit will enable clinicians to perform a definitive diagnosis of SjS, an autoimmune disease with an high incidence in the general population. The product rely on a disruptive technology based on nanomaterials produced in plants, namely plant virus-based particles, characterised by superior performance in ELISA tests compared to actual diagnostic systems.
We first analysed the market in order to identify target markets and the strategies to be implemented by the company to enter the EU and US markets.

The envisaged strategy that resulted from our analysis is: (1) to enter the domestic Italian market by using sales agents (first year); (2) enter the principal EU markets (UK, Germany, France and Spain) by commercial partnership with target distributors (second year); (3) set-up licensing agreements in the US with diagnostic US companies (third to fifth year).
During the envisaged timeframe we will set-up academic partnership in UK in order to develop a robust clinical evidence of our product.
We defined a pricing strategy based on a cost-plus analysis, resulting in a cost per kit of 300€. Considering the market strategy previously described we predict to reach the break-even point by the second year with revenues in the third year of €3,211,115, in the fourth year of €7,057,000 and in the fifth year of €11,960,218. The definitive company employment structure on the fifth year will rely on the presence of 10 people with different roles.

The product is currently covered by a patent filed in Italy in 2015; our IP strategy is to extend the patent in all EU members, US, Japan, Mexico, Russia, Australia and South Africa.
We analysed the regulation for the diagnostic sector in EU and US and defined the following strategy to comply with it.
For EU commercialization we need to CE label our product after the approval of national health authorities while in US the procedure is more complex and is based on specific product validation by FDA.
Eventually, we identified potential developments of our technology by the application of our innovative platform for the diagnosis of other diseases.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the period covered by the project, a fully comprehensive technical report was produced in which different topics were analysed.
First of all a complete market study was performed in which after identifying four main market targets (Italy, Germany, UK and US), the corresponding market structure for our product was evaluated.
Furthermore, we analysed the reference normative both in US and EU.
We then develop an Operating Plan, a Marketing Strategy, a Financial Plan and the Funding Model for setting-up our business.
In the last section of the Technical Report we described all the future developments we envisaged for our business.
We designed a logo for our product, attached to this session.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

OFB would like to create benefits for SjS-suspected patients and for public and private healthcare systems globally.

Since the symptoms of Sjögren’s disease so closely mimic those of many other diseases, receiving a definitive diagnosis is very difficult. Most sufferers work through many specialists over a period of several years (4 on average) at very high costs before a definitive diagnosis is reached. There are often cases of misdiagnosis and lost workdays due to the illness.
In Italy, the complete diagnostic workup also includes antibody measurements by sera analysis, ultrasound and scintigraphy. In most cases patients can obtain a definitive diagnoses only through invasive and irreversible techniques such as biopsy of the salivary glands. These diagnostic techniques sometimes cause side effects such as anesthetic allergies, bleeding, infection, and reduction or loss of sensitivity in the case of accidental injury of the trigeminal or facial nerve.
In addition to the physical discomfort, the difficulty in arriving at a definitive diagnosis, for the majority of patients, means destabilizing their psychological framework leading to a perception of social exclusion. Testimonies of people living with SjS, made known through the association A.N.I.Ma.SS. have given us an insight into the suffering linked to years of hardship and pain caused by this disease.
Moreover, scientific studies have also shown that SjS patients have a 40 times higher probability of contracting cancer especially if SjS is not treated in its early stages.
The social objectives can be summarized as follows:
- definitive diagnosis with a simple blood test allows the doctor to recommend a specific treatment for the patient thus reducing clinical manifestations related to the syndrome;
- reduce the cost that the public and private healthcare must support with the current diagnostic process.
The benefits related to the ability to make an accurate and early diagnosis of SjS are both for the individual patient and for the public/private health systems.
First, the benefits are related to a consequent decrease of unnecessarily visits currently carried out that, in most cases lead to further complication of the clinical framework.
This will be a long-term economic advantage for the health system.

Annex1_technical Report

Logo of the Pi-greek Kit