Allos, Mundipharma enter strategic collaboration to co-develop FOLOTYN

May 11 2011

Allos Therapeutics, Inc. (NASDAQ: ALTH) and Mundipharma International Corporation Limited (Mundipharma) today jointly announced that the companies have entered into a strategic collaboration agreement to co-develop FOLOTYN^® (pralatrexate injection). Under the agreement, Allos retains full commercialization rights for FOLOTYN in the United States and Canada, with Mundipharma having exclusive rights to commercialize FOLOTYN in all other countries.

“Mundipharma is delighted to partner with Allos in the development and commercialisation of FOLOTYN and believes that it has worldwide potential to become an important treatment alternative for patients”

FOLOTYN, a folate analogue metabolic inhibitor, is the first and only drug approved in the United States for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), a biologically diverse group of aggressive blood cancers, and is being studied in a number of other hematologic malignancies. Allos is pursuing regulatory approval to market FOLOTYN in the European Union for relapsed or refractory PTCL. Allos' Marketing Authorisation Application (MAA) was accepted for review by the European Medicines Agency (EMA) in December 2010.

Under the collaboration, Allos will receive an upfront payment of $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 MAA currently under review to market 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 3 studies of FOLOTYN in previously undiagnosed PTCL and in combination with bexarotene in relapsed or refractory cutaneous T-cell lymphoma (CTCL). Pursuant to a separate supply agreement with Mundipharma Medical Company, an affiliate of Mundipharma, Allos will supply FOLOTYN for Mundipharma's clinical and commercial uses.

"Mundipharma is an ideal global partner. 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," said Paul L. Berns, president and chief executive officer of Allos Therapeutics, Inc. "We are currently seeking regulatory approval to market FOLOTYN in Europe for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. 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."

"Mundipharma is delighted to partner with Allos in the development and commercialisation of FOLOTYN and believes that it has worldwide potential to become an important treatment alternative for patients," commented 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."

"Lymphoma arising from T-lymphocytes remains a devastating disease and new treatments are urgently needed. FOLOTYN, if approved, may be in many countries the first drug to treat this cancer and this will allow us to work with haematologists to improve the treatment results by developing new and hopefully even more effective drug combinations," added Dr. Thomas Mehrling, director of European Oncology at Mundipharma International Limited.