Allos Therapeutics, Inc. (Nasdaq: ALTH) announced today that the
Agreement and Plan of Merger and Reorganization (“the Merger
Agreement”) entered into by and among Allos, AMAG and Alamo
Acquisition Sub, Inc. on July 19, 2011, as amended on August 8,
2011, has been terminated. The Merger Agreement was terminated
following the October 21, 2011, special meeting of AMAG
stockholders at which AMAG's stockholders voted against the
issuance of shares of AMAG common stock to Allos’ stockholders in
the proposed merger. Separately, a majority of Allos’ stockholders
voted in favor of the adoption of the Merger Agreement at a special
meeting of Allos stockholders also held on October 21, 2011.
“The Board and shareholders of Allos supported the proposed
merger with AMAG based on the strategic rationale, anticipated
operating synergies and potential for future growth of the core
brands. With the termination of the merger agreement, we will
remain focused on growing U.S. sales of FOLOTYN for relapsed or
refractory PTCL, as well as pursuing future label expansion
opportunities in T-cell lymphoma and regulatory approval in the EU,
which may occur in early 2012,” commented Paul L. Berns, President
and Chief Executive Officer of Allos. “We ended the third quarter
with no debt and $100.4 million in cash and investments, which
based on our historical sales levels for the first nine months of
2011, we believe will be sufficient to fund our operations through
early 2014. Achievement of growth in U.S. sales and/or potential
milestone payments and royalties associated with regulatory
approval of FOLOTYN in the EU would further extend our cash
resources.”
Conference Call Information
Allos will host a conference call to review its third quarter
2011 financial results on November 3, 2011, at 8:30 a.m. ET.
Participants can access the call at 1-877-941-2927 (U.S.) or
+480-629-9725 (Canada and international). To access the live audio
webcast or the subsequent archived recording, visit the “Investors
- Presentations and Events” section of the Allos website at
www.allos.com. Webcast and telephone replays of the conference call
will be available approximately two hours after the completion of
the call. Callers can access the replay by dialing 800-406-7325
(domestic) or 303-590-3030 (international). The passcode is
4438057#. The webcast will be recorded and available for replay on
Allos’ website until November 17, 2011.
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. 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 greater-than or equal to 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 greater-than
or equal to 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.
Forward-Looking Statements
This communication contains forward-looking statements that are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. 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, are intended to identify such
forward-looking statements, 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. These statements are not guarantees of future
performance, involve risks, uncertainties and assumptions that are
difficult to predict, and are based upon assumptions as to future
events that may not prove accurate. The following factors, among
others, could cause actual results to differ materially from those
described in the forward-looking statements: risks and
uncertainties associated with the commercialization of FOLOTYN; the
Company's compliance with applicable regulatory requirements,
including the healthcare fraud and abuse laws and the Company's
post-marketing requirements; risks and uncertainties relating to
the establishment, implementation and execution of the Company's
strategic collaboration with Mundipharma, including the parties
future product development and commercialization strategies; that
the Company may lack the financial resources and access to capital
to support its future operations, including its product development
and commercialization plans for FOLOTYN; disruptions to the
business of Allos as a result of the pendency of the merger with
AMAG, the termination of the Merger Agreement and the failure to
consummate the merger; and other economic, business, competitive,
and/or regulatory factors affecting the business of Allos
generally, including those set forth in the filings of Allos with
the SEC, especially in the “Risk Factors” section of Allos’
Quarterly Report on Form 10-Q for the quarter ended June 30, 2011
filed with the SEC on August 4, 2011 and in Allos’ other periodic
reports and filings with the SEC. Allos cautions investors not to
place undue reliance on the forward-looking statements contained
herein. All forward-looking statements are based on information
currently available to Allos on the date hereof, and Allos
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.
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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