Allos Therapeutics Announces Issuance of U.S. Patent for FOLOTYN
01 December 2009 - 12:00AM
Business Wire
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.
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