Aratana Therapeutics, Inc. a pet therapeutics company focussed on licencing, developing and commercialising innovative biopharmaceutical products for cats, dogs and other companion animals, has entered into an exclusive licence agreement with Vet-Stem, Inc., for its novel, allogeneic stem cell therapy technology.
Under the agreement, Aratana obtains exclusive rights to commercialise Vet-Stem’s allogeneic stem cells in the United States, which if approved, will be the first FDA-regulated, “off the shelf” regenerative cell therapy for the treatment of osteoarthritis in dogs.
Vet-Stem pioneered the use of adipose tissue as a source for stem cells in veterinary regenerative medicine, but to date has offered only autologous stem cell therapy as a service (adipose tissue, also known as fat tissue, is harvested from the patient from which stem cells are isolated then reintroduced into the same patient). The positive experience using adipose-derived stem cells in this way is strong, with thousands of veterinarians utilising the service since its introduction in 2004. Although excess doses can be frozen and banked, they can be used only as a future therapy for the original donor patient.
Vet-Stem has now developed a technology platform for producing allogeneic stem cell therapies, where a single donor sample can be used to generate a large bank of doses that can be stored and used to treat multiple patients. Aratana has licenced this allogeneic therapy, which will be tested for safety and efficacy in randomised, placebo-controlled dogs with osteoarthritis and submitted to the FDA for approval.
Steven St. Peter, managing director, president & chief executive officer of Aratana Therapeutics, stated, “As we continue to build our pipeline, we have made a clear strategic investment in the high-need area of pain management for our pets. We therefore are pleased to expand our pain franchise further by adding an allogeneic, regenerative cell therapy product, which in addition to its aim of reducing the pain of osteoarthritis, has the potential to impact the progression of the disease, and to promote tissue regeneration. We will examine this phenomenon in planned studies, which could result in product labelling that specifies disease- modifying properties.”
Robert J. Harman, D.V.M., M.P.V.M., founder and chief executive officer of Vet-Stem, stated, “Aratana is the ideal commercial partner for our regenerative cell therapy for osteoarthritis, based upon their deep expertise in pain and the overall quality of their pet heath organisation. We look forward to accelerating development of what we believe to be an effective and potentially disease-modifying therapy, and to offering a more streamlined therapeutic option for veterinarians and their patients.”
Aratana and Vet-Stem expect to initiate a blinded, multi-centre, placebo-controlled, dose confirmation study later this month. Aratana does not expect US FDA approval before 2016.
Dr. St. Peter concluded, “The advantages of a product-based stem cell therapy versus the current service-based model include the potential for lower overall treatment costs for osteoarthritis, higher market penetration, the benefit of scheduled campaign manufacturing, and for patients and their owners, no need for surgery to harvest tissue.”
Under the terms of the agreement, Aratana will have an exclusive licence to develop and commercialise products in the US., based upon Vet-Stem Technology for the treatment of pain and inflammation of canine osteoarthritis. Vet-Stem will continue to be responsible for the ongoing development of its allogeneic stem cell technology. Aratana will pay $500,000 upon signing of the licence as a reimbursement to Vet-Stem for a portion of its past development expenses and will be responsible for funding future budgeted development. Aratana will also pay up to $4.5 million in success-based development and regulatory milestones, as well as tiered royalties upon potential commercialisation of the stem cell therapy, based on potential sales. Aratana will also have the exclusive right to negotiate expansion of the agreement to include the European Union countries during the calendar year of 2014.
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