Allos Therapeutics could see up to $360.5 million under a collaboration with Mundipharma to co-develop Folotyn® (pralatrexate injection). The drug is reportedly the first and only therapy approved in the U.S. for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Under the agreement, Allos would receive $50 million up front payment, followed by payments of up to $310.5 million that hinge on regulatory and commercial progress and sales-dependent milestones.
Allos retains full commercialization rights in the U.S. and Canada, while Mundipharma has exclusive rights to commercialize Folotyn in all other countries. The deal entitles Allos to receive tiered double-digit royalties based on net sales of Folotyn within Mundipharma’s licensed territories. Under a separate supply agreement with a Mundipharma affiliate, Mundipharma Medical Co., Allos will supply Folotyn for Mundipharma’s clinical and commercial uses.
Allos and Mundipharma will jointly fund development costs, initially on a 60:40 basis, which will change to a 50:50 basis if milestones are achieved, including approval of the MAA covering the relapsed or refractory PTCL indication, which is now under review.
The two companies say development funding by Mundipharma will also support jointly agreed-upon clinical development activities including but not limited to planned Phase III studies in previously undiagnosed PTCL and in combination with bexarotene in relapsed or refractory cutaneous T-cell lymphoma (CTCL).
In March Allos reached an agreement with the FDA for the design of the Phase III trial in previously undiagnosed PTCL. The study will seek to enroll newly diagnosed patients with PTCL who have achieved a response following initial treatment with CHOP chemotherapy.
“Folotyn, if approved, may be in many countries the first drug to treat this cancer, and this will allow us to work with hematologists to improve the treatment results by developing new and hopefully even more effective drug combinations,” notes Thomas Mehrling, M.D., Mundipharma’s director of European oncology.
Folotyn, a folate analogue metabolic inhibitor, is also being studied in a number of other hematologic malignancies. It has been available to patients in the U.S. since October 2009, a month after the FDA granted accelerated approval for the drug for use as a single agent for relapsed or refractory PTCL, based on overall response rate. Clinical benefits such as improvement in progression-free survival or overall survival has not been demonstrated.
Paul L. Berns, Allos’ president and CEO, notes that Mundipharma has demonstrated its hematology/oncology development, regulatory, and commercial capabilities by bringing Levact® to market in Europe for non-Hodgkin lymphoma and other blood cancers.
In December, Mundipharma extended through 2012 an R&D funding collaboration with another cancer drug developer. Mundipharma agreed to pay Infinity Pharmaceuticals an additional $110 million for 2012, on top of the $85 million it previously committed to for this year, toward IPI-926 for a broad range of cancers. After 2012, Mundipharma says, an additional payment will occur after Infinity's end-of-Phase II meeting with the FDA pertaining to an ongoing study of IPI-926 in patients with pancreatic cancer.