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 withholding taxes.
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stock validly tendered and not withdrawn prior to the scheduled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 therapeutic regimen.
Please see full Prescribing Information, including BOXED
WARNINGS, for ZEVALIN and rituximab. Full prescribing information
for ZEVALIN can be found at www.ZEVALIN.com.
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. 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.
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.
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.
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