Updated on 11 September 2013
Mayne Pharma will supply HPPI withSUBA-Itraconazole for use in clinical trials and for future exclusive commercial supply following FDA approval
Singapore: Australian drug giant Maybe Pharma Group has announced its signing of an exclusive supply and license agreement with US-based HedgePath Pharmaceuticals (HPPI) to pursue clinical development, registration and commercialization of Mayne Pharma's patented formulation of itraconazole, known as SUBA- Itraconazole, for treatment of a variety of cancers in the US.
As part of the agreement, Mayne Pharma expects to appoint one representative to the HPPI Board. Although the agreement is effective immediately, it remains subject to certain conditions being achieved, as detailed in the current report on Form 8-K that HPPI filed with the US Securities and Exchange Commission on September 10, 2013. Subject to meeting these conditions and in return for granting HPPI exclusive US rights, Mayne Pharma is expected to acquire an equity stake in HPPI of between 30-to-45 percent.
Under the terms of the agreement, Mayne Pharma will supply HPPI with SUBA-Itraconazole for use in clinical trials and for future exclusive commercial supply following the US FDA approval.
Mayne Pharma and HPPI are collaborating through a joint development program for SUBA-Itraconazole in oncology, with the initial areas of investigation being selected indications in prostate, lung and skin cancer.
In the US, there are more than two million new cases of these three cancers reported annually and the pharmaceutical market size to treat these diseases exceeds $5 billion and forecast to grow more than five percent per annum over the coming decade.