Allos Therapeutics’ Marketing Authorisation Application (MAA) for FOLOTYN® Accepted for Review by European Medicines Agenc...
21 Dezembro 2010 - 11:00AM
Business Wire
Allos Therapeutics, Inc. (Nasdaq: ALTH) announced today that the
Company’s Marketing Authorisation Application (MAA), seeking
approval of FOLOTYN® (pralatrexate injection) for the treatment of
patients with relapsed or refractory peripheral T-cell lymphoma
(PTCL), has been accepted by the European Medicines Agency (EMA).
Acceptance of the MAA by the EMA indicates that the application is
complete and initiates the EMA’s regulatory review process. The MAA
is based on clinical data from the Company’s pivotal Phase 2 trial
known as PROPEL (Pralatrexate in patients with
Relapsed Or refractory PEripheral T-cell
Lymphoma).
“We are pleased to have achieved this important corporate
milestone,” said Paul Berns, president and chief executive officer
at Allos Therapeutics. “There are currently no agents approved by
the EMA for the treatment of patients with relapsed or refractory
peripheral T-cell lymphoma, which demonstrates the clear high unmet
need for new therapies to treat patients with this devastating
disease. We intend to enter into a strategic partnership for the
continued development and potential future commercialization of
FOLOTYN in Europe.”
Pralatrexate has orphan medicinal product designation in Europe
for the treatment of PTCL (nodal, other extranodal, and
leukaemic/disseminated). In the European Union (E.U.), orphan
medicinal product designation is conferred upon investigational
products for diseases that affect fewer than five in 10,000
patients. Products with orphan designation that are the first to be
approved for a specific indication, and continue to meet the
requirements for orphan designation, receive ten years of market
exclusivity in the E.U.
The U.S. Food and Drug Administration (FDA) granted accelerated
approval for FOLOTYN in September 2009 for use as a single agent
for the treatment of patients with relapsed or refractory PTCL.
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 lymphoma (NHL).1-3 The Company estimates the incidence
of newly diagnosed PTCL in the top five European markets in 2010 to
be approximately 6,000-7,000 patients, with an estimated
4,500-6,000 second-line PTCL patients. 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 FOLOTYN
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 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.
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 hematologic malignancies
and solid tumors. Allos retains exclusive worldwide rights to
FOLOTYN for all indications. Allos is headquartered in Westminster,
CO. For additional information, please visit 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 FOLOTYN
to be first agent approved by the EMA for the treatment of patients
with relapsed or refractory PTCL; the Company’s intent to enter
into a strategic partnership for the continued development and
potential future commercialization of FOLOTYN in Europe; 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, that
the design of and data collected from the 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; that the EMA may
disagree with the Company’s interpretations of data from
preclinical studies and clinical trials involving FOLOTYN,
including the PROPEL trial, or otherwise determine such data are
not sufficient to support approval; and that the Company may be
unable to negotiate a strategic partnership for the continued
development and potential future commercialization of FOLOTYN in
Europe on acceptable terms, or at all. 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, 2010, 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.
References:
1. The Non-Hodgkin's Lymphoma Classification Project. A clinical
evaluation of the International Lymphoma Study Group classification
of non-Hodgkin's lymphoma. Blood. 1997;89(11):3909-3908.2. Hennessy
BT, Hanrahan EO, Daly PA. Non-Hodgkin lymphoma: an update [review].
Lancet Oncol. 2004;5(6):341-353.3. O'Leary HM, Savage KJ. Novel
therapies in peripheral T-cell lymphomas [review]. Curr Oncol Rep.
2008;134(5):202-207.4. 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):1467-75.5. Savage KJ. Peripheral T-cell Lymphomas.
Blood Rev. 2007; 21:201-216.
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