WESTMINSTER, Colo.—Allos Therapeutics, Inc. and MundipharmaInternational Corporation Limited have entered into a strategic collaborationagreement focused on the co-development of FOLOTYN. Under the terms of theagreement, Allos will retain full commercialization rights for FOLOTYN in theUnited States and Canada, and Mundipharma will hold exclusive rights tocommercialize FOLOTYN in all other countries.
"Mundipharma is delighted to partner with Allos in thedevelopment and commercialization of FOLOTYN and believes that it has worldwidepotential to become an important treatment alternative for patients," says ÅkeWikström, regional director Europe at Mundipharma International Limited."FOLOTYN represents a very meaningful addition to Mundipharma's oncologypipeline and reinforces our commitment to improving patients' quality of life."
Mundipharma will pay Allos an upfront payment of $50 millionunder the collaboration, as well as potential regulatory and commercialprogress- and sales-dependent milestone payments that could total up to $310.5million. Allos is entitled to receive tiered double-digit royalties as well,based on FOLOYTN's net sales within Mundipharma's licensed territories. Allos andMundipharma will fund development costs on a joint, 60:40 basis initially,which will change to a 50:50 basis pending the achievement of certainpre-defined milestones, such as approval of the Marketing AuthorizationApplication (MAA) in the European Union.
Mundipharma's development funding will support jointlyagreed-upon clinical development activities such as the Phase III studies ofFOLOTYN in previously undiagnosed peripheral T-cell lymphoma (PTCL) and incombination with bexarotene in relapsed or refractory cutaneous T-cell lymphoma(CTCL). Allos will supply FOLOTYN for Mundipharma's clinical and commercialuses, 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 havedemonstrated hematology/oncology development, regulatory and commercialcapabilities with recent major regulatory and commercial successes in bringingLevact (bendamustine) to market in Europe for non-Hodgkin lymphoma and otherblood cancers, as well as substantial resources to develop and commercializeFOLOTYN."
FOTOLYN is a folate analogue metabolic inhibitor, and is thefirst and only drug to be approved in the U.S. to treat patients with relapsedor refractory PTCL. PTCL is a biologically diverse group of aggressive bloodcancers, and is also being studied in other hematologic malignancies. Allosestimates that PTCL occurs in approximately 5,900 patients in the U.S. and6,000 to 7,000 patients in the top five European markets annually.
"Lymphoma arising from T-lymphocytes remains a devastatingdisease 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, andthis will allow us to work with hematologists to improve the treatment resultsby developing new and hopefully even more effective drug combinations."
Allos is in the process of securing regulatory approval tomarket FOLOTYN in the European Union for relapsed or refractory PTCL, and thecompany's MAA was accepted for review last December.
"Our twocompanies share a vision for bringing FOLOTYN to patients and believe thiscollaboration will maximize the development, commercialization and marketpotential of FOLOTYN in a variety of blood cancers," says Berns.
SOURCE: Allos Therapeutics press release