The work performed during the reporting period of VetBiomat is as follows:
1 Confirmation of market size for osteoarthritis products for horses and dogs
Analyses to confirm the market size for drugs for the treatment of osteoarthritis were undertaken. Estimates of both dog and horse populations were verified. In addition, prevalence of the disease was obtained from KOLs and research papers. Combining these data, estimates for the market size for the new product were obtained for the new business plan.
2 Detection of commercial barriers
From contacts with regulatory agencies (see 4 below), it became clear early on during the project that the new product would be a veterinary medicinal product, and thus, the focus on the commercial barriers was oriented to the market of veterinary drugs. The main commercial barrier is the need for the product to obtain “Marketing Authorization” or a similar term that varies between regions, and that requires the preparation of a dossier with all the information on the drug, including manufacturing details, indications, and results from preclinical and clinical trials. After careful analysis of presented data, the agencies will grant Marketing Authorization to the drug for the requested indications. Once a veterinary medicinal drug has been authorized in a country/region, commercialization of the product has to be done according to the legislation in the country/region.
3 Intellectual property protection for new product/FtO
A FtO analysis on the product was subcontracted to a well-known industrial property and patents law firm in Spain, Garrigues. Actually, this law firm had drafted and worked on obtaining the patent of the active substance HR007, and knew well the subject, the product and the area. The FtO analysis indicated that the new product for intra-articular inoculation in veterinary medicine based on HR007 would be free to be commercialized and that it would not interfere with previous patents.
With all this information and data, the first deliverable of the project was prepared.
“D1. REPORT ON MARKET SIZE, COMMERCIAL BARRIERS AND FTO FOR THE NEW PRODUCT FOR ANIMALS”
4 Regulatory consultations with European Medicines Agency (EMA)
Both Spanish and European regulatory agencies were contacted. Clear advice as to what type of product is the new intra-articular treatment for dogs and horses (a veterinary medicinal drug) and how to proceed with many regulatory aspects were obtained. Also, during this period, registration of the company ArtinVet Innovative Therapies, in the European Medicines Agency Small and Medium Enterprise Office was obtained. Inclusion of ArtinVet in this registry will means that fees for obtaining Marketing Authorization will be significantly reduced, and extensive help will be offered to the company. EMA´s SME Office is oriented to help SMEs satisfy regulatory requirements and potentiate drug registration by SMEs in Europe.
In addition to the information obtained from the regulatory agencies, during the coaching sessions funded by the Horizon 2020 SME I-1program, a COACH from EASME that had very strong regulatory experience in obtaining Marketing Authorization of veterinary medicinal products, as well as great business experience in veterinary medicine companies was selected. The COACH helped with improving the product registration and commercialization roadmap as well as with key business development aspects for the new product.
Completion of this task resulted in the elaboration of a “Strategic Drug Development Planning” which is the second deliverable of the project.
D2. ROAD MAP FOR REGISTRATION AND COMMERCIALIZATION AUTHORIZATION OF THE PRODUCT
5 Updated Business Plan
Using the Business Model Canvas, a new updated business plan for the innovative intra-articular regenerative medicine product for osteoarthritis in dogs and horses was drafted.
Completion of this business plan, will finalize the third deliverable from the project VetBiomat.
“D3. UPDATED COMPLETE BUSINESS PLAN FOR THE INNOVATIVE INTRA-ARTICULAR PRODUCT”
