Tekmira Provides Update on Licensed Product Candidate, Marqibo(R)
Spectrum Pharmaceuticals Acquires Talon Therapeutics and Guides for Launch of
Marqibo Later This Year
VANCOUVER, British Columbia, July 18, 2013 (GLOBE NEWSWIRE) -- Tekmira
Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of
RNA interference (RNAi) therapeutics, disclosed that its licensee, Talon
Therapeutics, Inc. (OTCBB:TLON), announced that it will be acquired by
Spectrum Pharmaceuticals, Inc. (Nasdaq:SPPI).
Marqibo®, which is a liposomal formulation of the chemotherapy drug
vincristine, was licensed from Tekmira to Talon in 2006. In August 2012,
Marqibo (vinCRIStine sulfate LIPOSOME injection) received accelerated approval
from the FDA for the treatment of adult patients with Philadelphia chromosome
negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse
or whose disease has progressed following two or more anti-leukemia therapies.
Tekmira is entitled to royalty payments based on Marqibo's commercial sales.
Spectrum has guided that it expects Marqibo to be launched later this year
through Spectrum's existing hematology sales force.
"The future sales of Marqibo represent a recurring revenue stream for Tekmira.
We are pleased that the commercialization plans for Marqibo continue to
advance and that an innovative new treatment based on Tekmira technology will
soon be available to cancer patients in need," said Dr. Mark J. Murray,
Tekmira's President and CEO.
In 2006, three products that were originally developed by Tekmira – Marqibo
(Optisomal Vincristine), Alocrest (Optisomal Vinorelbine) and Brakiva
(Optisomal Topotecan) – were exclusively licensed to Talon and have now been
acquired by Spectrum. Talon agreed to pay milestones and royalties and was
responsible for all future development activities and expenses. Tekmira is
eligible to receive milestone payments of up to US$18.0 million upon
achievement of further development and regulatory milestones and, will also
receive royalties based on product sales. In 2012, Tekmira received a US$1.0
million milestone payment based on the FDA approval of Marqibo and will
receive royalty payments based on Marqibo's commercial sales.
For more detailed information about Spectrum's acquisition of Talon, please
refer to the news releases issued by Talon and Spectrum, which can be found at
http://www.talontx.com/ and http://www.sppirx.com.
About RNAi and Tekmira's LNP
RNAi therapeutics have the potential to treat a broad number of human diseases
by "silencing" disease causing genes. The discoverers of RNAi, a gene
silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for
Physiology or Medicine. RNAi therapeutics, such as "siRNAs," require delivery
technology to be effective systemically. Tekmira believes its LNP technology
represents the most widely adopted delivery technology for the systemic
delivery of RNAi therapeutics. Tekmira's LNP platform is being utilized in
multiple clinical trials by both Tekmira and its partners. Tekmira's LNP
technology (formerly referred to as stable nucleic acid-lipid particles or
SNALP) encapsulates siRNAs with high efficiency in uniform lipid nanoparticles
that are effective in delivering RNAi therapeutics to disease sites in
numerous preclinical models. Tekmira's LNP formulations are manufactured by a
proprietary method which is robust, scalable and highly reproducible, and
LNP-based products have been reviewed by multiple FDA divisions for use in
clinical trials. LNP formulations comprise several lipid components that can
be adjusted to suit the specific application.
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on
advancing novel RNAi therapeutics and providing its leading lipid nanoparticle
delivery technology to pharmaceutical partners. Tekmira has been working in
the field of nucleic acid delivery for over a decade and has broad
intellectual property covering LNPs. Further information about Tekmira can be
found at www.tekmirapharm.com. Tekmira is based in Vancouver, B.C.
Forward-Looking Statements and Information
Forward-looking statements in this news release include statements about
Tekmira's strategy, future operations, clinical trials, prospects and the
plans of management; RNAi (ribonucleic acid interference) product development
programs; the acquisition of Talon Therapeutics by Spectrum Pharmaceuticals;
Tekmira's entitlement to receive milestone and royalty payments based on the
development and commercialization of Marqibo, Alocrest and Brakiva; and, the
anticipated timing of the launch of Marqibo later this year.
With respect to the forward-looking statements contained in this news release,
Tekmira has made numerous assumptions regarding, among other things: LNP's
status as a leading RNAi delivery technology; Tekmira's research and
development capabilities and resources; Tekmira's entitlement to receive
milestone and royalty payments based on the development and commercialization
of Marqibo, Alocrest and Brakiva; the anticipated timing of the launch of
Marqibo later this ; and, the time required for development partners and
licensees to complete research and product development activities. While
Tekmira considers these assumptions to be reasonable, these assumptions are
inherently subject to significant business, economic, competitive, market and
social uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause
Tekmira's actual results, performance or achievements to be materially
different from any future results, performance or achievements expressed or
implied by the forward-looking statements contained herein. Known risk factors
include, among others: the timing and terms of the acquisition of Talon
Therapeutics by Spectrum Pharmaceuticals may not occur as currently
anticipated; the anticipated milestone or royalty payments from Marqibo,
Alocrest or Brakiva may not be received in the quantum and/or within the
timing currently anticipated, or at all; Marqibo may not be launched within
the time frame currently anticipated, or at all; Tekmira's development
partners and licensees conducting clinical trial, development programs and
joint venture strategic alliances will not result in expected results on a
timely basis, or at all; anticipated payments under contracts with Tekmira's
collaborative partners may not be received by Tekmira on a timely basis, or at
all, or in the quantum expected by Tekmira; Tekmira's cash runway may not
extend as far as anticipated, and may be substantially less than required to
continue current operations; and the possibility that Tekmira has not
sufficiently budgeted for expenditures necessary to carry out planned
A more complete discussion of the risks and uncertainties facing Tekmira
appears in Tekmira's annual report on Form 20-F for the year ended December
31, 2012 (Annual Report), which is available at www.sedar.com or at
www.sec.gov/edgar.shtml. All forward-looking statements herein are qualified
in their entirety by this cautionary statement, and Tekmira disclaims any
obligation to revise or update any such forward-looking statements or to
publicly announce the result of any revisions to any of the forward-looking
statements contained herein to reflect future results, events or developments,
except as required by law.
Director, Investor Relations
Longview Communications Inc.
Tekmira Pharmaceuticals Logo
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