Allos Therapeutics and Mundipharma ink $360 million deal for Folotyn

USA-based Allos Therapeutics (Nasdaq: ALTH) and privately-held Mundipharma International have entered into a strategic collaboration to co-develop Folotyn (pralatrexate injection). Under the agreement, Allos retains full commercialization rights for the drug in the USA and Canada, with Mundipharma having exclusive rights to commercialize Folotyn in all other countries.

Under the terms of the deal, Allos will receive an upfront $50 million and potential regulatory and commercial progress- and sales-dependent milestone payments of up to $310.5 million. Allos is also entitled to receive tiered double-digit royalties based on net sales of Folotyn within Mundipharma’s licensed territories. Allos and Mundipharma will jointly fund development costs, initially on a 60:40 basis, which will change to a 50:50 basis if certain pre-defined milestones are achieved, including approval of the marketing authorization application, accepted in December 2010 and currently under review for Folotyn in the European Union.

Development funding by Mundipharma will support jointly agreed-upon clinical development activities, including, but not limited to, the planned Phase III studies of Folotyn in previously undiagnosed PTCL and in combination with bexarotene in relapsed or refractory cutaneous T-cell lymphoma (CTCL). Under a separate supply agreement with Mundipharma Medical, an affiliate of Mundipharma, Allos will supply Folotyn for Mundipharma’s clinical and commercial uses.