Allos Therapeutics, Inc. (NASDAQ: ALTH) announced today that
following its request for re-examination, the European Medicines
Agency’s Committee For Medicinal Products for Human Use (CHMP)
confirmed its previous negative opinion on the marketing
authorisation application (MAA) for FOLOTYN® (pralatrexate
injection) as a treatment for patients with peripheral T-cell
lymphoma (PTCL) whose disease has progressed after at least one
prior systemic therapy. Allos intends to review the CHMP opinion
and evaluate its potential options for continuing to pursue
regulatory approval of FOLOTYN in Europe for this indication.
“We are very disappointed with the CHMP opinion on the MAA for
FOLOTYN in Europe,” said Charles Morris, MB ChB, MRCP, chief
medical officer at Allos Therapeutics. “We will continue to work
closely with our partner Mundipharma to pursue regulatory approval
to market FOLOTYN for relapsed or refractory PTCL in other
countries, and to evaluate our options for bringing FOLOTYN to
patients who could benefit from it in Europe. We also remain fully
committed to advancing the FOLOTYN development program in
hematologic malignancies, including first-line PTCL and relapsed or
refractory cutaneous T-cell lymphoma.”
In May 2011, Allos entered into a strategic collaboration
agreement with Mundipharma International Corporation Limited
(Mundipharma), pursuant to which the parties agreed to collaborate
in the development of FOLOTYN according to a mutually agreed-upon
development plan. Under the agreement, Allos retains full
commercialization rights for FOLOTYN in the United States and
Canada, with Mundipharma having exclusive rights to commercialize
FOLOTYN in all other countries. To date, Mundipharma has submitted
applications seeking regulatory approval of FOLOTYN for patients
with relapsed or refractory PTCL in Australia, S. Korea and
Switzerland. The parties' joint development funding supports
mutually agreed-upon clinical development activities including, but
not limited to, the ongoing and planned Phase 3 registration
studies of FOLOTYN in patients with previously undiagnosed PTCL and
in patients with relapsed or refractory cutaneous T-cell lymphoma,
or CTCL.
Pralatrexate has orphan medicinal product designation in Europe
for the treatment of PTCL (nodal, other extranodal, and
leukaemic/disseminated). In the 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 up to ten years of market exclusivity in the
E.U.
For further details about the CHMP opinion on FOLOTYN, please
visit the EMA website www.ema.europa.eu/ema.
About FOLOTYN
FOLOTYN® (pralatrexate injection), a folate analogue metabolic
inhibitor, was discovered by Memorial Sloan-Kettering Cancer
Center, SRI International and Southern Research Institute and
developed by Allos Therapeutics. In September 2009, 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 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 Peripheral T-Cell Lymphoma
Peripheral T-cell lymphomas are a biologically diverse group of
aggressive, mature T and NK (natural killer) cell non-Hodgkin
lymphomas with similar outcomes, which include PTCL-NOS (PTCL not
otherwise specified), AITL (angioimmunoblastic T-cell lymphoma),
and ALCL (anaplastic large-cell lymphoma).1 The prognosis for
patients with PTCL is generally poor for most subtypes.2
T-cell lymphomas account for approximately 10% to 15% of all
cases of non-Hodgkin lymphomas (NHL).1-3 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 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
approved in the U.S. for the treatment of patients with relapsed or
refractory PTCL.
On April 5, 2012, Allos announced that it had entered into a
definitive merger agreement with Spectrum Pharmaceuticals, Inc. On
April 13, 2012, Spectrum commenced a tender offer to purchase all
of the outstanding shares of common stock of Allos.
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 and
receive vitamin B12 to potentially reduce treatment-related
hematological toxicity and mucositis.
Fatal dermatologic reactions may occur. Dermatologic reactions
may be progressive and increase in severity with further treatment.
Patients with dermatologic reactions should be monitored closely,
and if severe, FOLOTYN should be withheld or discontinued.
Tumor lysis syndrome may occur. Monitor patients and treat if
needed.
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 were mucositis (70%),
thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most
common serious adverse events are pyrexia, mucositis, sepsis,
febrile neutropenia, dehydration, dyspnea, and
thrombocytopenia.
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.
Drug Interactions
Co-administration of drugs subject to renal clearance (e.g.,
probenecid, NSAIDs, and trimethoprim/sulfamethoxazole) may result
in delayed renal clearance.
Please see FOLOTYN Full Prescribing Information at
www.FOLOTYN.com.
Additional Information about the Transaction and Where to
Find It
This press release is for informational purposes only and does
not constitute an offer to purchase or a solicitation of an offer
to sell any securities of Allos Therapeutics, Inc. The tender offer
is being made pursuant to a tender offer statement on Schedule TO
(including the offer to purchase, letter of transmittal and other
related tender offer materials) that was filed by Sapphire
Acquisition Sub, Inc. (“Merger Sub”),
a wholly owned subsidiary of Spectrum Pharmaceuticals, Inc.
(“Spectrum” or “Parent”), with the Securities and Exchange
Commission (the “SEC”) on April 13,
2012. In addition, on April 13, 2012, Allos filed a
Solicitation/Recommendation Statement on Schedule 14D-9 with the
SEC with respect to the tender offer. Investors are able to obtain
the tender statement on Schedule TO, the offer to purchase, the
Solicitation/Recommendation Statement of Allos on Schedule 14D-9,
the proxy statement, if applicable, and related materials with
respect to the tender offer and the merger, free of charge at the
website of the SEC at www.sec.gov, from the information agent and
dealer manager named in the tender offer materials. Investors may
also obtain, at no charge, the documents filed with or furnished to
the SEC by Allos under the “Investors” section of Allos’ website at
www.allos.com. Investors are advised to read these documents when
they become available, including the Solicitation/Recommendation
Statement of Allos and any amendments thereto, as well as any other
documents relating to the tender offer and the merger that are
filed with the SEC, carefully and in their entirety prior to making
any decisions with respect to whether to tender their shares into
the tender offer because they contain important information,
including the terms and conditions of the tender offer.
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 future
development of FOLOTYN for the treatment of patients with
peripheral T-cell lymphoma or any other type of cancer 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
pace of subject enrollment in the ongoing and planned Phase 3
trials may be slower than expected, that the Phase 3 trials may not
successfully meet safety and efficacy endpoints or that the data
from the trials may not support the continued marketing of FOLOTYN,
and the risk that the Company may lack the financial resources and
access to capital to fund future clinical trials for FOLOTYN; and
risks and uncertainties relating to the Company’s strategic
collaboration with Mundipharma, including the parties’ future
product development, regulatory and commercialization strategies.
Such forward-looking statements also include the ability of the
Company, Parent and Merger Sub to complete the transactions
contemplated by the Agreement and Plan of Merger dated as of April
4, 2012 by and among Allos, Spectrum and Merger Sub (the
“Merger Agreement”), including the
parties’ ability to satisfy the conditions to the consummation of
the tender offer and the other conditions set forth in the Merger
Agreement and the possibility of any termination of the Merger
Agreement. Actual results may differ materially from current
expectations because of risks associated with uncertainties as to
the timing of the tender offer and the subsequent merger;
uncertainties as to how many of the Company’s stockholders will
tender their shares of common stock in the tender offer; the risk
that competing offers or acquisition proposals will be made; the
possibility that various conditions to the consummation of the
offer or the merger may not be satisfied or waived, including that
a governmental entity may prohibit, delay or refuse to grant
approval for the consummation of the offer or the merger; the
effects of disruption from the transactions on the Company’s
business and the fact that the announcement and pendency of the
transactions may make it more difficult to establish or maintain
relationships with employees, suppliers and other business
partners; and the risk that shareholder litigation in connection
with the tender offer or the merger may result in significant costs
of defense, indemnification and liability. 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 Annual Report on Form 10-K for the year ended December
31, 2011, 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 press
release, except as required by law.
Note: The Allos logo and FOLOTYN name are registered trademarks
of 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.
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024