Spectrum Pharmaceuticals (NASDAQ: SPPI) and Allos Therapeutics,
Inc. (NASDAQ: ALTH) today announced that they have signed a
definitive agreement under which Spectrum will acquire all of the
outstanding shares of Allos for $1.82 per share in cash plus one
Contingent Value Right (CVR). This CVR entitles Allos stockholders
to an additional payment of $0.11 per share in cash if certain
European regulatory approval and commercialization milestones for
FOLOTYN® are achieved. The upfront portion of the transaction is
valued at up to $206 million on a fully-diluted basis, and $108
million net of Allos’ cash balance at the end of 2011. The
acquisition is expected to be accretive to Spectrum on a cash basis
in the fourth quarter of 2012.
Allos markets FOLOTYN (pralatrexate injection) which is a folate
analogue metabolic inhibitor. 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 peripheral T-cell lymphoma (PTCL). FOLOTYN
generated more than $35 million in U.S. net sales in 2010 and $50
million in 2011.
"For Spectrum, this acquisition adds another diversified source
of revenue, accelerates the development of our hematology
franchise, and affirms our commitment to becoming a leader in the
treatment of lymphoma," said Rajesh C. Shrotriya, MD, Chairman,
Chief Executive Officer and President of Spectrum Pharmaceuticals.
"ZEVALIN® and FOLOTYN are targeted to the same
hematologists/oncologists for the treatment of different forms of
lymphoma. Thus, we are well positioned to immediately leverage the
combined strengths of the two companies, while expanding the number
of cancer patients that can benefit from our products. Because of
our strong operating performance, cash reserves, fiscal discipline,
and a revolving credit line, we do not need to issue any equity to
close this transaction."
Under the agreement, Spectrum will commence a tender offer to
purchase all of the outstanding shares of Allos for $1.82 in cash
plus one CVR. The CVR will entitle each Allos stockholder to an
additional payment of $0.11 per share in cash if FOLOTYN obtains
conditional approval for the treatment of patients with
relapsed/refractory PTCL in Europe in 2012 and achieves its first
reimbursable commercial sale in at least three major EU markets by
December 31, 2013. The CVR will not be publicly traded.
The transaction has been unanimously approved by the Boards of
Directors of both companies. Additionally, Warburg Pincus, Allos’
largest shareholder and the owner of approximately 24% of Allos’
outstanding shares, along with the directors and certain officers
of Allos, have entered into tender and voting agreements pursuant
to which such stockholders have agreed to tender all of their Allos
shares into the tender offer and vote their shares in favor of the
transaction. The transaction is expected to close in the second
quarter of 2012. Spectrum currently intends to finance the
acquisition with a combination of cash on hand and a revolving
credit line from Bank of America, N.A.
“This transaction represents an excellent strategic and cultural
fit that leverages two strong brands in the hematology/oncology
market today with potential for future growth,” commented Paul L.
Berns, President and Chief Executive Officer of Allos Therapeutics.
“Spectrum shares our commitment to patients and their healthcare
providers, and we believe FOLOTYN will be a welcomed addition to
its commercial product offering and diversified portfolio of
development-stage drugs.”
RBC Capital Markets, LLC is acting as Spectrum’s exclusive
financial advisor, and Kirkland & Ellis LLP and Stradling Yocca
Carlson & Rauth, P.C. are acting as legal counsel to Spectrum
Pharmaceuticals. J.P. Morgan Securities LLC is acting as Allos'
financial advisor, and Latham & Watkins LLP is acting as legal
counsel to Allos Therapeutics.
Conference Call
Thursday, April 5,
2012 @ 8:30 a.m. Eastern/5:30 a.m. Pacific
Domestic: (877) 837-3910,
Conference ID# 68595555 International: (973) 796-5077, Conference
ID# 68595555
For interested individuals unable to join the call, a replay
will be available from April 5, 2012 @ 11:30 a.m. ET/8:30 a.m. PT
through April 19, 2012 until 11:59 p.m. ET/8:59 p.m. PT.
Domestic Replay Dial-In #:
(855) 859-2056,
Conference ID# 68595555 International Replay Dial-In #: (404)
537-3406, Conference ID# 68595555
This conference call will also be webcast. Listeners may access
the webcast, which is available on the investor relations page of
Spectrum Pharmaceuticals’ website: www.sppirx.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, a biotechnology company with a primary
focus in oncology and hematology, currently markets two oncology
drugs, FUSILEV® and ZEVALIN®. In addition, Spectrum has two drugs,
apaziquone and belinostat, in late stage development. Spectrum also
has a diversified pipeline of novel drug candidates. Spectrum’s
strategy is comprised of acquiring, developing and commercializing
a broad and diverse pipeline of late-stage clinical and commercial
drug products. Spectrum has aggressive business development and
commercial operation teams that support a robust drug development
program encompassing clinical development, medical research,
regulatory affairs, biostatistics and data management. Spectrum
also leverages the expertise of its worldwide partners to assist in
the execution of its strategy. For more information, please visit
Spectrum’s website 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
analogue 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,
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 and the future performance 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 the 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 the parties’ 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
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; 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. The success and strategic
fit of the combined entities will depend on Spectrum
Pharmaceuticals’ and Allos Therapeutics’ ability to identify,
acquire, develop and commercialize a broad and diverse pipeline of
late-stage clinical and commercial products, and to leverage the
expertise of partners and employees around the world to assist us
in the execution of our combined strategy.
Additional risks that could cause actual results to differ
include, with respect to Spectrum Pharmaceuticals, the possibility
that existing and new drug candidates may not prove safe or
effective, the possibility that our existing and new applications
to the FDA or other regulatory agencies may not receive approval in
a timely manner or at all, the possibility that existing and new
drug candidates, if approved, may not be more effective, safer or
more cost efficient than competing drugs, the possibility that
efforts to acquire or in-license and develop additional drug
candidates may fail, Spectrum Pharmaceuticals’ lack of sustained
revenue history, Spectrum Pharmaceuticals’ limited marketing
experience, Spectrum Pharmaceuticals’ dependence on third parties
for clinical trials, manufacturing, distribution and quality
control and other risks that are described in further detail in the
Spectrum Pharmaceuticals’ reports filed with the Securities and
Exchange Commission, and with respect to Allos Therapeutics,
uncertainties pertaining to the business of Allos Therapeutics,
including those set forth in Allos Therapeutics’ reports filed with
the Securities and Exchange Commission. Neither Spectrum
Pharmaceuticals nor Allos Therapeutics 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.
The tender offer described herein has not yet commenced, and
this press release is neither an offer to purchase nor a
solicitation of an offer to sell securities. At the time the tender
offer is commenced, Spectrum Pharmaceuticals will cause its
subsidiary, Sapphire Acquisition Sub, Inc., to file a tender offer
statement on Schedule TO with the Securities and Exchange
Commission. Investors and Allos stockholders are strongly advised,
prior to making any decisions with respect to whether to tender
their shares of Allos into the tender offer or, if necessary, vote
their shares in favor of the adoption of the Merger Agreement, to
read carefully the tender offer statement (including an offer to
purchase, letter of transmittal and related tender offer documents)
and the related solicitation/recommendation statement on Schedule
14D-9, and if applicable, a proxy statement regarding the merger,
that will be filed by Allos with the Securities and Exchange
Commission, and any amendments to the foregoing, because they will
contain important information about the tender offer and the
merger. These documents will be available at no charge on the
Securities and Exchange Commission’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 Spectrum at www.sppirx.com, and a copy of the tender
offer statement and the solicitation/recommendation statement will
be made available free of charge to all stockholders of Allos at
www.allos.com or by contacting Allos Therapeutics, Inc. at 11080
CirclePoint Road, Suite 200, Westminster, Colorado 80020 or via
phone at (303) 426-6262.
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