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Advanced material for the regeneration of joints in veterinary medicine

Periodic Reporting for period 1 - VETBIOMAT (Advanced material for the regeneration of joints in veterinary medicine)

Reporting period: 2015-02-01 to 2015-07-31

In VetBiomat, a Horizon 2020 SME Instrument Phase I funded project, a technical and market feasibility study on an innovative regenerative medicine treatment for osteoarthritis (OA) in horses and dogs was undertaken. The new product, HR007-ANIOA, is based on a new advanced material rich in sulfated and non-sulfated glycosaminoglycans from a natural origin.

Market size of products for the treatment of osteoarthritis in dogs and horses was estimated and results indicated that there is large and increasing potential market for an effective drug for the treatment of chronic and acute degeneration of the cartilage in dogs and horses. Key opinion leaders in the field confirmed the high prevalence of the disease in both species. Although disease prevalence appears to be higher in horses than dogs, and treatment with intra-articular products is more widespread in horses, due to the size of the dog population, a product for dogs could provide higher sales for ArtinVet.

Commercial barriers and competing products were also analyzed. In most countries, no similar competing product administered through the same route is currently authorized and available to veterinary practitioners. Furthermore, almost all commercially intra-articular products are authorized only for horses, and among these, formulations including only hyaluronic acid are predominant. An important potential competitor based only on chondroitin sulfate is now being administered intra-muscularly. HR007-ANIOA, due to its rich mix in various glycosaminoglycans and specific properties, could be a very successful competing product.

A freedom to operate analysis confirmed that HR007-ANIOA is protected by a patent and will not interfere with other patents. Multiple contacts with the Spanish Medicines and Medical Devices Agency (AEMPS), the European Medicines Agency (EMA) and regulatory experts, including the COACH sessions organized by EASME and funded by the European Commission under the grant agreement, have provided a detailed gap analysis which has served as the basis for preparing a thorough roadmap for obtaining marketing authorization of this veterinary medical product.

The successful completion of Phase 1 of VetBiomat has yielded an updated, improved and detailed business plan for development of the new regenerative medicine HR007-ANIOA for horses and dogs. This business plan will be the basis for requesting funding under Phase 2 of the SEM Instrument to further develop this drug.
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
Final results are that ArtinVet has a detailed and realistic roadmap to obtaining Marketing Authorization in Europe for the new regenerative medicine based treatment for osteoarthritis in dogs and/or horses. Also, clear financial needs and timeline for product commercialization have been obtained. The new business plan will also help determine which species to focus on first. The socio-economic impact of commercializing the new product will be that animals, dogs and/or horses with acute or chronic degenerative disease of the joints will be treated with an effective drug that permits cartilage regeneration and improve their well-being.

As far as wider societal implication of the action, it is worth it mentioning that once the new drug for OA in animals is in the market, Histocell, a Spanish SME and the parent company of ArtinVet, or another human pharmaceutical company, in view of the positive results of the treatment of animals with the HR007-based drug, will undertake the development of a similar drug for humans, improving the health of many human patients suffering from joint problems associated with cartilage degeneration.
ArtinVet´s Website I+D VetBiomat Info