WESTMINSTER, Colo.--(BUSINESS WIRE)--Oct. 5, 2009--
Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that FOLOTYN™
(pralatrexate injection) is now available for commercial sale in the
United States. 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 peripheral T-cell
lymphoma (PTCL) on September 24, 2009. This indication is based on
overall response rate. Clinical benefit such as improvement in
progression free survival or overall survival has not been demonstrated.
For full prescribing information for FOLOTYN, visit www.folotyn.com.
FOLOTYN is the first and only drug approved by the FDA for this
indication and represents a new therapeutic option for patients with
relapsed or refractory PTCL.
Allos plans to market and sell FOLOTYN in the U.S. through its
commercial organization, which includes 25 sales specialists and will be
increased to approximately 50 in advance of the Company’s planned
full-scale commercial launch in January 2010. FOLOTYN is now available
to U.S. health care providers through their normal ordering process.
Allos is dedicated to patient access and has established a patient
assistance program named ASAP (Allos Support for Assisting Patients) to
provide reimbursement support. Commencing in October, more information
regarding ASAP will be available by calling the Hotline at 1-877-ASAP102
(272-7102), Monday to Friday, 8 am to 7 pm Central Time or by visiting www.getASAPinfo.com.
About Allos Therapeutics
Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company
committed to the development and commercialization of innovative
anti-cancer therapeutics. FOLOTYN is the first and only drug approved in
the U.S. for the treatment of patients with relapsed or refractory
peripheral T-cell lymphoma. Allos is also developing FOLOTYN in other
potential indications. Allos retains exclusive worldwide rights to
FOLOTYN for all indications. The Company is headquartered in
Westminster, CO. For additional information, please visit www.allos.com.
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 (1.0 -1.25 mg orally on
a daily basis) and receive vitamin B12 (1 mg intramuscularly
every 8-10 weeks) to potentially reduce treatment-related
hematological toxicity and mucositis.
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
modify dose.
Adverse Reactions:
The most common adverse reactions observed in PROPEL were mucositis
(70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most
common serious adverse events (>3%), regardless of causality, were
pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea
and thrombocytopenia. Forty-four percent of patients experienced a
serious adverse event while on study or within 30 days after their last
dose of FOLOTYN. Twenty-three percent of patients discontinued treatment
due to adverse reactions.
Drug Interactions:
Co-administration of drugs subject to renal clearance (e.g., probenecid,
NSAIDs, and trimethoprim/sulfamethaxazole) may result in delayed renal
clearance.
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.
For additional important safety information, please see the full prescribing
information for FOLOTYN at www.allos.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
the Company’s statements regarding the potential for FOLOTYN to offer an
important new treatment option for patients with relapsed or refractory
PTCL; the Company’s anticipated timeline and size of its sales force for
its planned full-scale commercial launch of FOLOTYN; 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 developing
adequate sales, marketing and distribution capabilities; the acceptance
of FOLOTYN in the marketplace; the status of reimbursement from third
party payers; the Company’s dependence on third party manufacturers; the
Company’s compliance with applicable regulatory requirements, including
the healthcare fraud and abuse laws and the Company’s post-marketing
requirements; and the Company’s access to capital to support its future
operations, including product development and commercialization plans
for FOLOTYN. 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 June 30, 2009, 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 trademarks of Allos
Therapeutics, Inc.
Source: Allos Therapeutics, Inc.
Allos Therapeutics, Inc.
Monique Greer, 720-540-5268
mgreer@allos.com
