30.03.2008 22:10:00
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Alnylam Forms New Agreement with Tekmira Related to the Planned Tekmira-Protiva Business Combination
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi
therapeutics company, announced today that it has formed a new agreement
with Tekmira Pharmaceuticals Corporation (TSX: TKM) related to Tekmira’s
planned business combination with Protiva Biotherapeutics, Inc. Upon the
effective date for the Tekmira-Protiva transaction, the new agreement
will expand Alnylam’s access to key technology
and intellectual property (IP) for the delivery of RNAi therapeutics
with liposomal delivery technologies. In addition, Alnylam has agreed to
make a $5 million equity investment in Tekmira upon completion of the
planned Tekmira-Protiva transaction.
"We have long valued the technologies and
know-how of both Tekmira and Protiva and are pleased that this key
technology and IP can now reside in one entity. For quite some time,
this has been the right answer for the scientific and clinical
advancement of RNAi therapeutics,” said Barry
Greene, President and Chief Operating Officer of Alnylam. "Our
expanded relationship with the new Tekmira significantly broadens our
access to key technologies and IP related to systemic delivery of RNAi
therapeutics.” "The business combination between Tekmira and
Protiva provides Alnylam with a stronger partner in the delivery of RNAi
therapeutics and we will continue to build on the successful
relationship we have developed with Alnylam since 2006,”
said Timothy M. Ruane, President and Chief Executive Officer of Tekmira.
"The Alnylam investment is a strong
endorsement of the new company’s undivided
and focused commitment to the delivery of RNAi therapeutics and we look
forward to working together with Alnylam to advance products into
clinical development,” added Dr. Mark J.
Murray, Chairman, President and Chief Executive Officer of Protiva, and
President and Chief Executive Officer of Tekmira following completion of
the business combination.
As part of the agreement, Alnylam will make an equity investment of $5.0
million in Tekmira at a price of $2.40 per share upon the closing. This
investment is representative of Alnylam’s
continued commitment to pursuing novel delivery strategies for RNAi
therapeutics. As a result of the new agreement, Alnylam is no longer
providing a $5.0 million capital equipment loan to Tekmira. Alnylam
maintains its exclusive rights to the Semple (U.S. Patent No. 6,858,225)
and Wheeler (U.S. Patent Nos. 5,976,567 and 6,815,432) patents which the
company believes are critical for cationic liposomal delivery. Alnylam
will also have rights to IP controlled by Protiva prior to the
combination and to new IP generated by the combined entity.
In addition, Alnylam is granting to the new company InterfeRx™
licenses to discover, develop, and commercialize RNAi therapeutics
towards seven gene targets, a number that includes three previously
announced InterfeRx licenses granted to Tekmira as part of its January
2007 agreement. The targets covered by these InterfeRx license grants
are subject to Alnylam’s consent and any
required consent from third parties. In return for these licenses,
Alnylam may be eligible to receive milestone fees and royalties. Alnylam
created the InterfeRx licensing program to grant licenses under its
intellectual property to biotechnology and pharmaceutical companies
wishing to pursue RNAi therapeutics against specific targets outside
Alnylam’s core strategic interests.
Alnylam has retained the option to co-develop and co-commercialize the
new company’s PLK1 SNALP program for the
treatment of certain cancers, which is one of the seven gene targets for
which the new company has received an InterfeRx license. PLK1 SNALP
targets the polo-like kinase 1 gene which has been shown to be involved
in the growth of certain types of solid tumors and has been shown in
pre-clinical studies to selectively kill cancer cells, while sparing
normal healthy cells in the same tissue. Alnylam has the right to
exercise its option for this program up until the commencement of Phase
II clinical trials.
Alnylam is developing a systemically delivered RNAi therapeutic,
ALN-VSP, for the treatment of liver cancers and potentially other solid
tumors. ALN-VSP comprises two siRNAs in a liposomal formulation. These
two siRNAs target two separate genes involved in the growth and
development of tumors: kinesin spindle protein, or KSP, and vascular
endothelial growth factor, or VEGF. Alnylam recently presented data from
its ALN-VSP program which were generated using Protiva’s
stable nucleic acid-lipid particles, or SNALP, technology. These data
were presented at Alnylam’s R&D Day held
March 6, 2008 and at the "RNAi, MicroRNA, and
Non-Coding RNA” Keystone Symposium held March
25-30, 2008 in Whistler, British Columbia. Alnylam also has rights to
use Protiva SNALP formulation technology in the advancement of its other
systemically delivered RNAi therapeutic programs, including ALN-PCS for
the treatment of hypercholesterolemia.
About RNA Interference (RNAi)
RNAi (RNA interference) is a revolution in biology, representing a
breakthrough in understanding how genes are turned on and off in cells,
and a completely new approach to drug discovery and development. Its
discovery has been heralded as "a major
scientific breakthrough that happens once every decade or so,”
and represents one of the most promising and rapidly advancing frontiers
in biology and drug discovery today which was awarded the 2006 Nobel
Prize for Physiology or Medicine. RNAi is a natural process of gene
silencing that occurs in organisms ranging from plants to mammals. By
harnessing the natural biological process of RNAi occurring in our
cells, the creation of a major new class of medicines, known as RNAi
therapeutics, is on the horizon. RNAi therapeutics target the cause of
diseases by potently silencing specific messenger RNAs (mRNAs), thereby
preventing disease-causing proteins from being made. RNAi therapeutics
have the potential to treat disease and help patients in a fundamentally
new way.
About Alnylam Pharmaceuticals
Alnylam is a biopharmaceutical company developing novel therapeutics
based on RNA interference, or RNAi. The company is applying its
therapeutic expertise in RNAi to address significant medical needs, many
of which cannot effectively be addressed with small molecules or
antibodies, the current major classes of drugs. Alnylam is leading the
translation of RNAi as a new class of innovative medicines with
peer-reviewed research efforts published in the world’s
top scientific journals including Nature, Nature Medicine,
and Cell. The company is leveraging these capabilities to build a
broad pipeline of RNAi therapeutics; its most advanced program is in
Phase II human clinical trials for the treatment of respiratory
syncytial virus (RSV) infection. In addition, the company is developing
RNAi therapeutics for the treatment of a wide range of disease areas,
including hypercholesterolemia, liver cancers, and Huntington’s
disease. The company’s leadership position in
fundamental patents, technology, and know-how relating to RNAi has
enabled it to form major alliances with leading companies including
Medtronic, Novartis, Biogen Idec, and Roche. To reflect its outlook for
key scientific, clinical, and business initiatives, Alnylam has
established "RNAi 2010”
which includes the company’s plan to
significantly expand the scope of delivery solutions for RNAi
therapeutics, have four or more programs in clinical development, and to
form four or more new major business collaborations, all by the end of
2010. Alnylam is a joint owner of Regulus Therapeutics LLC, a joint
venture focused on the discovery, development, and commercialization of
microRNA therapeutics. Founded in 2002, Alnylam maintains headquarters
in Cambridge, Massachusetts. For more information, visit www.alnylam.com.
Alnylam Forward-Looking Statements
Various statements in this release concerning Alnylam’s
future expectations, plans and prospects, including statements regarding
Alnylam’s expectations regarding the success
of Protiva and Tekmira technology and the importance of Tekmira and
Protiva intellectual property, constitute forward-looking statements for
the purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995. Actual results may differ materially from
those indicated by these forward-looking statements as a result of
various important factors, including risks related to: Alnylam’s
approach to discover and develop novel drugs, which is unproven and may
never lead to marketable products; obtaining, maintaining and protecting
intellectual property; Alnylam’s ability to
enforce its patents against infringers and to defend its patent
portfolio against challenges from third parties; Alnylam’s
ability to obtain additional funding to support its business activities;
Alnylam’s dependence on third parties for
development, manufacture, marketing, sales and distribution of products;
obtaining regulatory approval for products; competition from others
using technology similar to Alnylam’s and
others developing products for similar uses; Alnylam’s
dependence on collaborators; and Alnylam’s
short operating history; as well as those risks more fully discussed in
the "Risk Factors”
section of its most recent annual report on Form 10-K on file with the
Securities and Exchange Commission. In addition, any forward-looking
statements represent Alnylam’s views only as
of today and should not be relied upon as representing its views as of
any subsequent date. Alnylam does not assume any obligation to update
any forward-looking statements.
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