Tekmira Provides Update on Licensed Product Candidate, Marqibo(R)
Spectrum Pharmaceuticals Launches Marqibo and Ships First Commercial Orders
VANCOUVER, British Columbia, Sept. 3, 2013 (GLOBE NEWSWIRE) -- Tekmira
Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of
RNA interference (RNAi) therapeutics, disclosed that its licensee, Spectrum
Pharmaceuticals, Inc. (Nasdaq:SPPI), announced that it has launched Marqibo
through its existing hematology sales force in the United States and has
shipped the first commercial orders. Tekmira is entitled to royalty payments
based on Marqibo's commercial sales.
"We are pleased that Marqibo – an innovative cancer treatment based on Tekmira
technology – has been successfully launched in the United States with orders
already being shipped. The sales of Marqibo represent a recurring revenue
stream for Tekmira. Furthermore, with two ongoing Phase III trials, we
anticipate data evaluating Marqibo in expanded oncology indications," said Dr.
Mark J. Murray, Tekmira's President and CEO.
Marqibo, which is a novel, sphingomyelin/cholesterol liposome-encapsulated
formulation of the FDA-approved anticancer drug vincristine originally
developed by Tekmira, was licensed from Tekmira to Talon Therapeutics in 2006.
In July 2013, Talon was acquired by Spectrum Pharmaceuticals, Inc. Marqibo's
approved indication is for the treatment of adult patients with Philadelphia
chromosome-negative acute lymphoblastic leukemia (Ph- ALL) in second or
greater relapse or whose disease has progressed following two or more lines of
For more detailed information about the commercial launch of Marqibo, please
refer to Spectrum's news release dated September 3, 2013, which can be found
at http://www.sppirx.com. The full prescribing information for Marqibo can be
found at www.marqibo.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; Tekmira's entitlement to receive milestone and royalty payments
based on the development and commercialization of Marqibo; the launch of
Marqibo; Tekmira's anticipated royalty payments based on the commercial sales
of Marqibo; and the ongoing Phase III trials evaluating Marqibo in expanded
oncology indications and additional data on Marqibo as a result thereof.
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; Marqibo's effectiveness as a treatment
of adult patients with Philadelphia chromosome-negative acute lymphoblastic
leukemia (Ph- ALL) in second or greater relapse or whose disease has
progressed following two or more lines of anti-leukemia therapy; Tekmira's
entitlement to receive milestone and royalty payments based on the commercial
launch of Marqibo in the United States; 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 anticipated milestone or royalty payments from
Marqibo may not be received in the quantum and/or within the timing currently
anticipated, or at all; ongoing Phase III trials for Marquibo may not continue
as anticipated or produce any data evaluating Marqibo in expanded oncology
indications; 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 activities.
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.
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