Spectrum Pharmaceuticals and Allos Therapeutics Announce That FTC Clears Transaction; Tender Offer for Shares of Allos Common Stock To Expire at 5pm Eastern Time on September 4, 2012
Spectrum intends to accept for payment shares of Allos common
stock on September 4, 2012
HENDERSON, Nev. & WESTMINSTER, Colo.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI) (Spectrum) and Allos
Therapeutics, Inc. (NasdaqGS: ALTH) (Allos) today announced that the
Federal Trade Commission terminated the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended,
relating to the previously announced pending acquisition of all
outstanding shares of common stock of Allos by Spectrum.
As previously disclosed, Spectrum has commenced a tender offer to
purchase all of the outstanding shares of common stock of Allos for
$1.82 per share in cash, without interest and less any applicable
Spectrum intends to accept for payment shares of Allos common stock
validly tendered and not withdrawn prior to the scheduled tender offer
expiration at 5:00 p.m., Eastern time, on Tuesday, September 4, 2012.
The consummation of the tender offer is conditioned upon the tender of a
majority of the outstanding shares of Allos common stock, as well as
other conditions that are specified in the Schedule TO filed with the
Securities and Exchange Commission on April 13, 2012.
"This acquisition is a transformational step for Spectrum, building upon
our desire to add value for our shareholders and increasing our ability
to meet the needs of cancer patients," stated Rajesh C. Shrotriya, M.D.,
Chairman, President and Chief Executive Officer of Spectrum
Pharmaceuticals, Inc. "Key to the acquisition is the diversification of
our portfolio of marketed products by adding Allos' FOLOTYN, which
targets the same physicians as our ZEVALIN product."
Dr. Shrotriya added, "We see a number of synergies between the two
companies, which could result in significant savings. Our top priority
continues to be to create an environment that nurtures talent and allows
us to excel and enhance our presence in oncology markets where our
products are making a difference. We are excited about the prospect of
combining the two companies and in welcoming our new Allos colleagues to
the Spectrum team."
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on
acquiring, developing, and commercializing drug products, with a primary
focus in oncology and hematology. Spectrum currently markets two
oncology drugs ─ FUSILEV® (levoleucovorin) for Injection in the U.S. and
ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which
the Company has worldwide marketing rights. Spectrum's strong track
record in in-licensing and acquiring differentiated drugs, and expertise
in clinical development have generated a robust, diversified, and
growing pipeline of product candidates in advanced-stage Phase 2 and
Phase 3 studies. More information on Spectrum is available at www.sppirx.com.
About Allos Therapeutics, Inc.
Allos Therapeutics 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 analog metabolic inhibitor. FOLOTYN is approved in the U.S. 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 is also developing
FOLOTYN in other hematologic malignancies and solid tumors. Allos is
headquartered in Westminster, Colorado. For more information, please
visit Allos' website at www.allos.com.
About ZEVALIN® and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan) injection for intravenous use is
indicated for the treatment of patients with relapsed or refractory,
low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). ZEVALIN is
also indicated for the treatment of patients with previously untreated
follicular non-Hodgkin's Lymphoma who achieve a partial or complete
response to first-line chemotherapy.
ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN
therapeutic regimen consists of two components: rituximab, and
Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN builds on
the combined effect of a targeted biologic monoclonal antibody augmented
with the therapeutic effects of a beta-emitting radioisotope.
Important ZEVALIN® Safety Information
Deaths have occurred within 24 hours of rituximab infusion, an essential
component of the ZEVALIN therapeutic regimen. These fatalities were
associated with hypoxia, pulmonary infiltrates, acute respiratory
distress syndrome, myocardial infarction, ventricular fibrillation, or
cardiogenic shock. Most (80%) fatalities occurred with the first
rituximab infusion. ZEVALIN administration can result in severe and
prolonged cytopenias in most patients. Severe cutaneous and
mucocutaneous reactions, some fatal, can occur with the ZEVALIN
Please see full Prescribing Information, including BOXED WARNINGS, for
ZEVALIN and rituximab. Full prescribing information for ZEVALIN can be
found at www.ZEVALIN.com.
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. An updated analysis of data from PROPEL, the pivotal
study of FOLOTYN in patients with relapsed or refractory PTCL, was
published in the March 20, 2011 issue of the Journal of Clinical
Oncology. FOLOTYN has patent protection through 2017 and potentially
through July 2022, assuming a five-year patent term extension through
the Hatch-Waxman Act. Please see full Prescribing Information for
FOLOTYN at www.FOLOTYN.com.
Important FOLOTYN® 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.
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.
Co-administration of drugs subject to renal clearance (e.g., probenecid,
NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal
Please see FOLOTYN® Full Prescribing Information at www.FOLOTYN.com.
This press release may contain forward-looking statements regarding
future events of Spectrum Pharmaceuticals and Allos Therapeutics that
involve risks and uncertainties that could cause actual results to
differ materially. These statements are based on management's current
beliefs and expectations. Such forward-looking statements include
statements relating to the ability of Spectrum Pharmaceuticals and Allos
Therapeutics to complete the transactions contemplated by the Agreement
and Plan of Merger dated as of April 4, 2012 (the "Merger Agreement"),
including Spectrum Pharmaceuticals' and Allos Therapeutics' ability to
satisfy the conditions to the consummation of the tender offer and the
other conditions set forth in the Merger Agreement, the possibility of
any termination of the Merger Agreement, and, if the transaction is
completed, the success and strategic fit of the proposed combination of
Spectrum Pharmaceuticals and Allos Therapeutics, the anticipated market
and projected sales for FOLOTYN® and the
synergies for Spectrum Pharmaceuticals and Allos Therapeutics. The
forward-looking statements contained in this document are subject to
risks and uncertainties which may cause actual results to differ
materially from the forward-looking statements. 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 Allos' 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 risk that stockholder
litigation in connection with the tender offer or the merger may result
in significant costs of defense, indemnification and liability; the
possibility that the combined companies may not obtain synergies or
perform as expected and the possibility that the anticipated market and
projected sales for FOLOTYN® may differ from
those expected. Spectrum Pharmaceuticals and Allos Therapeutics do not
plan to update any such forward-looking statements and expressly
disclaim any duty to update the information contained in this press
release except as required by law.
This press release is neither an offer to purchase nor a solicitation
of an offer to sell securities. The tender offer is being made pursuant
to a tender offer statement (including an offer to purchase, letter of
transmittal, and related tender offer documents), which has been filed
by Spectrum Pharmaceuticals and Sapphire Acquisition Sub, Inc. with the
U.S. Securities and Exchange Commission (the "SEC") on April 13, 2012,
and has been subsequently amended. In addition, on April 13, 2012, Allos
filed a solicitation/recommendation statement on Schedule 14D-9 with the
SEC related to the tender offer, which has been subsequently amended.
Stockholders of Allos are strongly advised to read the tender offer
statement and the related solicitation/recommendation statement because
they contain important information that stockholders should consider
before making any decision regarding tendering their shares. The tender
offer statement and certain other offer documents, as well as the
solicitation/recommendation statement, will be made available to all
Allos stockholders at no expense to them. These documents will be
available at no charge on the SEC's website at www.sec.gov.
In addition, a copy of the tender offer statement will be made available
free of charge to all stockholders of Allos who direct a request to
MacKenzie Partners, Inc., the Information Agent for the offer, toll-free
at (800) 322-2885.
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50390499&lang=en
Shiv Kapoor, 702-835-6300
President, Strategic Planning & Investor Relations
Monique Greer, 720-540-5268
Corporate Communications & Investor Relations
Source: Spectrum Pharmaceuticals and Allos Therapeutics
News Provided by Acquire Media
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