Oasmia Pharmaceutical has given Abbott Animal Health exclusive, nearly-worldwide license and distribution rights to its two leading animal cancer drug candidates, expanding a 3-1/2-year-old collaboration between the companies.
In return, the unit of Abbott Laboratories agreed to pay Oasmia an undisclosed up-front payment, plus payments of up to $21.5 million tied to various undisclosed product development and sales milestones for Paccal® Vet and Doxophos® Vet. Oasmia will also receive tiered royalties on net sales should either or both of the drugs are commercialized.
“We will now have one world-class partner for essentially the entire global canine oncology market,” Julian Aleksov, Oasmia's CEO, said in a statement Monday. “We believe that there is great future market potential in developing countries as medical innovation allows dedicated owners to treat emerging health issues in their beloved companion animals.”
Oasmia said it will continue to fund research, development, and manufacture of Paccal Vet, a formulation of the company’s solubility-improving excipient XR-17 and the anticancer drug paclitaxel for nonresectable Grade II and III mast cell tumors in dogs not receiving previous therapy except corticosteroids; and Doxophos Vet, a formulation of XR-17 and doxorubicin for lymphoma in dogs
Doxophos Vet has entered clinical trials; Paccal Vet has concluded them, and is pursuing FDA marketing authorization. Both drugs have FDA minor use/minor species designations and are based on the company’s nanotechnologically produced micellar platform. Oasmia retains rights to both drugs in Russia and the Commonwealth of Independent States, and to Doxophos Vet in Japan.
In Europe, Oasmia has said it plans to resubmit a marketing application for Paccal Vet in 2013, with additional data not included in its initial application, which the company withdrew following concerns about the drug’s potential risks raised by the European Medicines Agency’s veterinary medical products committee.
Under their original agreement, announced in July 2009, Oasmia granted Abbott exclusive rights to distribute Paccal Vet for veterinary use in the U.S. and Canada, as well as responsibility for sales and marketing. Oasmia retained clinical development, manufacturing, and registration rights.
At the time, the original agreement with Oasmia added oncology to Abbott Animal Health’s research and product lines of diabetes, anesthesia, wound care, pain management, and fluid therapy.