WESTMINSTER, Colo.--(BUSINESS WIRE)--Nov. 30, 2009--
Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that the United
States Patent and Trademark Office has issued a patent for the use of
FOLOTYN™ (pralatrexate injection) for the treatment of T-cell lymphoma.
U.S. Patent No. 7,622,470 was issued to Memorial-Sloan Kettering Cancer
Center, SRI International and Southern Research Institute, and expires
on November 24, 2025. Allos holds an exclusive worldwide license from
these institutions to develop and market FOLOTYN for all indications.
“We are pleased to add this important patent to our intellectual
property portfolio for FOLOTYN,” said Marc H. Graboyes, senior vice
president, general counsel of Allos Therapeutics. “Patent protection is
an essential component of our product life cycle management strategy,
and this patent further strengthens the FOLOTYN franchise.”
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 peripheral T-cell lymphoma. Allos is also developing FOLOTYN
in other potential indications. Allos retains exclusive worldwide rights
to FOLOTYN for all indications. Allos 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.
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
