Allos Therapeutics, Inc. (NASDAQ: ALTH) and Mundipharma International
Corporation Limited (Mundipharma) has 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.
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
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.
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,
“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
FOLOTYN, a folate analogue metabolic inhibitor, was discovered by
Sloan-Kettering Institute for Cancer Research, SRI International and
Southern Research Institute and developed by Allos Therapeutics. In
September 2009, the U.S. Food and Drug Administration (FDA) granted
accelerated approval for FOLOTYN for use as a single agent for the
treatment of patients with relapsed or refractory PTCL. This indication
is based on overall response rate. Clinical benefit such as improvement
in progression-free survival or overall survival has not been
demonstrated. FOLOTYN has been available to patients in the U.S. since
October 2009. An updated analysis of data from PROPEL was published in
the March 20, 2011 issue of the Journal of Clinical Oncology.
FDA’s accelerated approval program allows the FDA to approve products
for cancer or other life-threatening diseases based on initial positive
clinical data. In connection with the accelerated approval, Allos is
required to conduct post-approval studies that are intended to verify
and describe the clinical benefit of FOLOTYN in patients with T-cell
lymphoma. In March 2011, Allos reached agreement with the FDA under its
Special Protocol Assessment (SPA) process for the design of Allos’ Phase
3 clinical trial of FOLOTYN in patients with previously undiagnosed
PTCL. The study will seek to enroll newly diagnosed patients with PTCL
who have achieved a response following initial treatment with a
Allos is also pursuing regulatory approval to market FOLOTYN in the
European Union for relapsed or refractory PTCL. Allos’ MAA was accepted
for review by the EMA in December 2010.
Conference Call Information
Allos will host a conference call today, May 10, 2011 at 4:30 p.m. ET,
to review its first quarter 2011 financial results and to discuss the
details of the collaboration with Mundipharma. Participants can access
the call at 1-877-941-1466 (U.S.) or +480-629-9724 (Canada and
international). To access the live audio webcast or the subsequent
archived recording, visit the “Investors - Presentations and Events”
section of the Allos website at www.allos.com.
Webcast and telephone replays of the conference call will be available
approximately two hours after the completion of the call. Callers can
access the replay by dialing 800-406-7325 (domestic) or 303-590-3030
(international). The passcode is 4438057#. The webcast will be recorded
and available for replay on Allos’ website until May 24, 2011.
About Peripheral T-Cell Lymphoma
T-cell lymphomas comprise a biologically diverse group of blood cancers
that account for approximately 10% to 15% of all cases of non-Hodgkin
lymphomas (NHL).1-3 Allos estimates the current annual
incidence of PTCL to be approximately 5,900 patients in the U.S. and
approximately 6,000-7,000 patients in the top five European markets. The
outcome of patients with PTCL is poor and the majority of patients
ultimately have refractory disease to a variety of agents, including
multi-agent chemotherapy with CHOP (cyclophosphamide, doxorubicin,
vincristine, and prednisone) or CHOP-like regimens. The 5-year overall
survival rate in these patients is 25% to 40%, depending on sub-type.4-5
About Allos Therapeutics
Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company
committed to the development and commercialization of innovative
anti-cancer therapeutics. Allos is currently focused on the development
and commercialization of FOLOTYN® (pralatrexate injection), a
folate analogue metabolic inhibitor. FOLOTYN is the first and only drug
approved in the U.S. for the treatment of patients with relapsed or
refractory PTCL. Allos is also developing FOLOTYN in other hematologic
malignancies and solid tumors. Allos is headquartered in Westminster,
CO. For additional information, please visit www.allos.com.
Mundipharma is one of the Purdue/Mundipharma/Napp independent associated
companies – privately owned companies and joint ventures covering the
world’s pharmaceutical markets. These companies worldwide are dedicated
to bringing to patients with severe and debilitating diseases the
benefits of novel treatment options in fields such haemato-oncology,
severe pain and respiratory disease. For more information, visit www.mundipharma.co.uk.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
FOLOTYN may suppress bone marrow function, manifested by
thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit
or modify dose for hematologic toxicities.
Mucositis may occur. If ≥Grade 2 mucositis is observed, omit or modify
dose. Patients should be instructed to take folic acid and receive
vitamin B12 to potentially reduce treatment-related
hematological toxicity and mucositis.
Fatal dermatologic reactions may occur. Dermatologic reactions may be
progressive and increase in severity with further treatment. Patients
with dermatologic reactions should be monitored closely, and if severe,
FOLOTYN should be withheld or discontinued.
Tumor lysis syndrome may occur. Monitor patients and treat if needed.
FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while
being treated with FOLOTYN and pregnant women should be informed of the
potential harm to the fetus.
Use caution and monitor patients when administering FOLOTYN to patients
with moderate to severe renal function impairment.
Elevated liver function test abnormalities may occur and require
monitoring. If liver function test abnormalities are ≥Grade 3, omit or
The most common adverse reactions were mucositis (70%), thrombocytopenia
(41%), nausea (40%), and fatigue (36%). The most common serious adverse
events are pyrexia, mucositis, sepsis, febrile neutropenia, dehydration,
dyspnea, and thrombocytopenia.
Use in Specific Patient Population
Nursing mothers should be advised to discontinue nursing or the drug,
taking into consideration the importance of the drug to the mother.
Co-administration of drugs subject to renal clearance (e.g., probenecid,
NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal
Please see FOLOTYN Full Prescribing Information at www.FOLOTYN.com.
Safe Harbor Statement
This press release contains forward-looking statements that are made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements include
statements regarding the status and prospects of our commercialization
of FOLOTYN for the treatment of patients with relapsed or refractory
PTCL; our Marketing Authorisation Application (MAA) for FOLOTYN in
Europe; our future product development and regulatory strategies,
including our intent to develop or seek regulatory approval for FOLOTYN
in additional indications; our strategic collaboration with Mundipharma,
including the parties intent to co-develop FOLOTYN in additional
indications and Mundipharma’s potential commercialization of FOLOTYN
outside the United States and Canada; and other statements that are
other than statements of historical facts. In some cases, you can
identify forward-looking statements by terminology such as “may,”
“will,” “should,” “expects,” “intends,” “plans,” “anticipates,”
“believes,” “estimates,” “predicts,” “projects,” “potential,”
“continue,” and other similar terminology or the negative of these
terms, but their absence does not mean that a particular statement is
not forward-looking. Such forward-looking statements are not guarantees
of future performance and are subject to risks and uncertainties that
may cause actual results to differ materially from those anticipated by
the forward-looking statements. Important factors that may cause actual
results to differ materially include, but are not limited to, the risks
and uncertainties associated with the commercialization of FOLOTYN; the
ability to expand the approved indications for FOLOTYN; that the design
of and data collected from the Company’s pivotal PROPEL trial may not be
adequate to demonstrate the safety and efficacy of FOLOTYN for the
treatment of patients with relapsed or refractory PTCL, or otherwise be
sufficient to support EMA approval; and risks and uncertainties relating
to the establishment, implementation and execution of the Company’s
strategic collaboration with Mundipharma, including the parties future
product development and commercialization strategies. Additional
information concerning these and other factors that may cause actual
results to differ materially from those anticipated in the
forward-looking statements is contained in the "Risk Factors" section of
the Company's Quarterly Report on Form 10-Q for the quarter ended March
31, 2011, and in the Company's other periodic reports and filings with
the Securities and Exchange Commission. The Company cautions investors
not to place undue reliance on the forward-looking statements contained
in this press release. All forward-looking statements are based on
information currently available to the Company on the date hereof, and
the Company undertakes no obligation to revise or update these
forward-looking statements to reflect events or circumstances after the
date of this presentation, except as required by law.
Note: The Allos logo and FOLOTYN name are registered trademarks of Allos
Sources: Allos Therapeutics, Inc. and Mundipharma International
Editor’s Note: This press release is also available under the Media
section of Allos Therapeutics’ website at www.allos.com
and at www.mundipharma.co.uk.
The Non-Hodgkin's Lymphoma Classification Project. A clinical
evaluation of the International Lymphoma Study Group classification
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Hennessy BT, Hanrahan EO, Daly PA. Non-Hodgkin lymphoma: an update
[review]. Lancet Oncol. 2004;5(6):341-353.
O'Leary HM, Savage KJ. Novel therapies in peripheral T-cell
lymphomas [review]. Curr Oncol Rep. 2008;134(5):202-207.
Savage KJ, Chhanabhai M, Gascoyne RD, et al. Characterization of
peripheral T-cell lymphomas in a single North American institution
by the WHO classification. Ann Oncol 2004;15(10):1467-75.
Savage KJ. Peripheral T-cell Lymphomas. Blood Rev. 2007; 21:201-216.