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Feasibility study for registration of medicine RIGVIR with the European Medicine Agency

Periodic Reporting for period 1 - RIGVIR (Feasibility study for registration of medicine RIGVIR with the European Medicine Agency)

Reporting period: 2016-08-01 to 2017-01-31

The Project and accomplished Feasibility study was aimed to ascertain framework for the registration process for medicine RIGVIR® in European Medicine Agency (further in text EMA) and development of Briefing document that fulfils EMA requirements. The special approach was needed as the medicine is already in use (registered in three countries) but existing bases of documents and proof of clinical trials are not sufficient for existing requirements.

The main target for the Company is to register Rigvir® and commercialize within the European Union.
The society would benefit on following aspects:

Financial: In case Rigvir® would have EMA registration, it would be a welcome addition to the available treatments that would not only help patients to survive and increase their quality of life, but also it would bring a significant financial relief for government budgets, since the melanoma treatment is widely compensated by the government. In case of only 15% market share (currently 75% of market share in Latvia) would generate savings of EUR 1 billion. Melanoma patients, insurance companies, and government could expect a reduction in expenses of 13% if Rigvir® enters the market.

Survival and quality of life: According to approved guidelines the existing treatment possibilities (interferon, anti-PD1, anti-CLTA4, BRAF/MEK) are therapies with significant side effects – pain, fatigue, diarrhea, nausea and vomiting and other. These side effects significantly influence the patients feeling and quality of life. The Rigvir is unique as it has proven its clinical efficacy and does not cause significant side effects. The patients’ life prolongs and quality of life does not deteriorate.

The overall objectives that were described and researched during the Study was following:
• Develop cooperation with Contact Research Organizations (further in text CRO). The main tasks were: prepare a list pf potentional CRO partners, to start negations and sign confidential disclosure agreement (further in text CDA); to agree on clinical trial protocols and receive initial quotes.
• Development of briefing document. The Study included tasks to find out the EMA requirements, cooperate with experienced outsourced consultants in order to develop the briefing document.

All tasks were successfully accomplished and Briefing document was submitted in EMA for scientific advice.
The Project involved accomplishment on several Tasks:
Task 1: To Gather a team of specialists and preparation of the road map.
Description: The Project Manager (PM) gathered the team of experts for set tasks. The Road map was developed and approved. The Road map gives information on project members and detailed tasks and responsibilities.
Status: Accomplished

Task 2: To select CROs (Contract research organization), develop a clinical trial protocol and obtain quotes.
Description: Number of respectable and international CROs were selected and list of potential partners was created. The confidential disclosure agreement were prepared and signed with all selected candidates. The initial quotes were received from all candidates. Detailed information of selection criteria and summary of quotes are revealed in Feasibility Report.
Status: Accomplished

Task 3. To prepare a Briefing document ahead of the Scientific Advice meeting with EMA.
Description: The briefing document is the main document that requires EMA. A briefing document is a document that introduces with the medicine under development, and the Company's description and position. The document should be prepared using a template from EMA and it is usually 50 to 100 pages. During the Project the PM developed the Briefing document. The company involved outsourced consultants, translators and statisticians (actuary) in development process.
The Briefing document consists of 101 page and includes information on background of the product, quality development, non-clinical development, clinical development, regulatory status, description on company’s positions and quality background information. The document encloses 8 annexes.
Status: Accomplished

Task 4. Submit for Scientific / Regulatory Advice to EMA.
Description: As the Briefing document’s 1st version was accomplished the pre-submission meeting with EMA representatives was organized on 17 January 2017. During the pre-submission meeting EMA representatives point out issues to be solved and paragraphs to be supplemented. The final version of Briefing document was submitted in EMA on 31 January 2017.
Status: Accomplished

Task 5. The preparation of the feasibility report.
Description: The Feasibility Report (further in text - the Report) was created. The Report gives detailed information:
o Proposals of Clinical trial protocols from CROs;
o Main information of Briefing Document and its development process;
o Recommendations and advice given by the EMA representatives.
o Conclusions and action plan for future in order to reach the target of the Project.
The Feasibility report consists of 10 pages and 6 annexes.
Status: Accomplished

The Project was successfully accomplished and all needed tasks were done. The next steps in order to go forward registration process are:
1. The PM should resubmit proposals for CROs and get quotes and business proposals. During the Feasibility study and development process of the Briefing document initial assumptions about clinical trials were changed.
2. The final scientific advice from EMA should be received and detailed action plan should be developed.
The Company provides new treatment for cancer compared to existing treatment possibilities. Rigvir is a live, not genetically modified and non-pathogenic virus with immunomodulating activities. It is approved and used as a treatment in Latvia since 2004, in Georgia since 2015 and in Armenia since 2016. The registration in EMA would give opportunity for EU citizens to use medicine that has little side effects and owe immunomodulation activity. These are invaluable advantages and help to prolong life and improve the quality of life for millions of Europeans. Malignant melanoma is considered to be one of the most dangerous and aggressive types of human cancers. Melanoma comprises only 4% of all skin cancers but is responsible for 80% of skin-cancer related deaths. On a yearly basis 100 000 new cases of melanoma are diagnosed in Europe and more than 22 000 European citizens lose their lives to the disease every year.
Moreover the Rigvir is 5-20 times less expensive than other medicine. This advantage will decrease expenditure of government, private funds and insurance companies for melanoma treatment.
Mechanism of action of Rigvir