Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced the
execution of a collaborative agreement with Idis, a UK-based global
company, to manage the named patient program for FOLOTYN™
(pralatrexate injection) outside of the United States. The U.S.
Food and Drug Administration (FDA) has granted accelerated approval
for FOLOTYN for the treatment of patients with relapsed or
refractory peripheral T-cell lymphoma (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. Allos retains exclusive worldwide rights to
develop and commercialize FOLOTYN in all indications. FOLOTYN has
been available to patients in the U.S. since October 2009, and is
expected to be available under the named patient program outside
the U.S. beginning in January 2010.
“We are pleased to partner with Idis, a recognized leader in
named patient programs, to provide access to FOLOTYN for patients
with relapsed or refractory peripheral T-cell lymphoma outside the
U.S.,” explained Paul L. Berns, president and chief executive
officer at Allos Therapeutics, Inc. “Importantly, this program will
allow a greater number of patients with relapsed or refractory PTCL
to potentially benefit from the use of FOLOTYN.”
A named patient program is a mechanism through which physicians
can legally and ethically prescribe investigational or approved
drugs for patients prior to their commercial launch. Under the
terms of the agreement, Idis will be the exclusive supplier of
FOLOTYN to health care providers outside of the U.S. on a named
patient basis.
Contact Information for Program
Licensed healthcare professionals outside the U.S. treating
patients with relapsed or refractory peripheral T-cell lymphoma
interested in FOLOTYN should contact Idis at:
Tel: +44 (0) 1932 824 123Fax: +44 (0) 1932 824 323Email:
customerservices@idispharma.com
About Idis
Idis is committed to addressing the unmet medical needs of
patients worldwide. Idis’ programs and services enable seriously
ill people, who have exhausted all treatment options, to obtain
access to pre-approved, pre-launch, or difficult-to-access
medicines that could prolong their lives.
With worldwide reach and market-specific regulatory expertise,
Idis partners with bio/pharmaceutical companies, pharmacists and
physicians around the world to provide medicines to patients
through expanded access programs. Idis’ comprehensive services for
developing and implementing successful expanded access programs
include: strategic counsel to companies on program development,
implementation and execution; support to healthcare professionals
for obtaining access and administering pre-approved drugs through
these programs; counsel on regulatory guidelines governing access
to pre-approved drugs; and valuable insight data. Idis also
develops and implements programs by which bio/pharmaceutical
companies can effectively manage mature brand strategies and offers
a range of strategic procurement solutions. For more information
please visit: www.idispharma.com.
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 exploring the potential of FOLOTYN in other
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.
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 potential for patients
outside the U.S. with relapsed or refractory PTCL to obtain access
to or potentially benefit from the use 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 the Company’s dependence on
Idis to manage the named patient program outside the U.S., Idis’
compliance with applicable regulatory requirements; the acceptance
of FOLOTYN in the marketplace; the status of reimbursement from
third party payers; and the Company’s dependence on third party
manufacturers. 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 September 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 is a trademark of Allos Therapeutics,
Inc.
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