Allos, Mundipharma to collaborate on FOLOTYN development
WESTMINSTER, Colo.—Allos Therapeutics, Inc. and Mundipharma International Corporation Limited have entered into a strategic collaboration agreement focused on the co-development of FOLOTYN. Under the terms of the agreement, Allos will retain full commercialization rights for FOLOTYN in the United States and Canada, and Mundipharma will hold exclusive rights to commercialize FOLOTYN in all other countries.
"Mundipharma is delighted to partner with Allos in the development and commercialization of FOLOTYN and believes that it has worldwide potential to become an important treatment alternative for patients," says Åke Wikström, regional director Europe at Mundipharma International Limited. "FOLOTYN represents a very meaningful addition to Mundipharma's oncology pipeline and reinforces our commitment to improving patients' quality of life."
Mundipharma will pay Allos an upfront payment of $50 million under the collaboration, as well as potential regulatory and commercial progress- and sales-dependent milestone payments that could total up to $310.5 million. Allos is entitled to receive tiered double-digit royalties as well, based on FOLOYTN's net sales within Mundipharma's licensed territories. Allos and Mundipharma will fund development costs on a joint, 60:40 basis initially, which will change to a 50:50 basis pending the achievement of certain pre-defined milestones, such as approval of the Marketing Authorization Application (MAA) in the European Union.
Mundipharma's development funding will support jointly agreed-upon clinical development activities such as the Phase III studies of FOLOTYN in previously undiagnosed peripheral T-cell lymphoma (PTCL) and in combination with bexarotene in relapsed or refractory cutaneous T-cell lymphoma (CTCL). Allos will supply FOLOTYN for Mundipharma's clinical and commercial uses, pursuant to a separate supply agreement with Mundipharma Medical Company.
"Mundipharma is an ideal global partner," says Paul Berns, president and chief executive officer of Allos Therapeutics, Inc. "They have demonstrated hematology/oncology development, regulatory and commercial capabilities with recent major regulatory and commercial successes in bringing Levact (bendamustine) to market in Europe for non-Hodgkin lymphoma and other blood cancers, as well as substantial resources to develop and commercialize FOLOTYN."
FOTOLYN is a folate analogue metabolic inhibitor, and is the first and only drug to be approved in the U.S. to treat patients with relapsed or refractory PTCL. PTCL is a biologically diverse group of aggressive blood cancers, and is also being studied in other hematologic malignancies. Allos estimates that PTCL occurs in approximately 5,900 patients in the U.S. and 6,000 to 7,000 patients in the top five European markets annually.
"Lymphoma arising from T-lymphocytes remains a devastating disease and new treatments are urgently needed," says Dr. Thomas Mehrling, director of European Oncology at Mundipharma International Limited. "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."
Allos is in the process of securing regulatory approval to market FOLOTYN in the European Union for relapsed or refractory PTCL, and the company's MAA was accepted for review last December.
"Our two companies share a vision for bringing FOLOTYN to patients and believe this collaboration will maximize the development, commercialization and market potential of FOLOTYN in a variety of blood cancers," says Berns.
SOURCE: Allos Therapeutics press release