Message #78 From:
Stock News Bot Date: January 8, 2007 05:01:00 AM
ALNY News Alnylam Announces Key Product and Business Goals for 2007
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi
therapeutics company, announced today its key product and business goals
for 2007, including financial guidance.
“The year 2006 was transformational for
Alnylam, and for the field of RNAi. We intend to build significantly on
this progress in 2007 with important advances in our pipeline of
proprietary and partnered RNAi therapeutics, including human
proof-of-concept data within the next 12 to 18 months,”
said John Maraganore, Ph.D., President and Chief Executive Officer of
Alnylam Pharmaceuticals. “Further, with the
heightened level of interest in RNAi therapeutics as a source of
innovative medicines, combined with Alnylam’s
unparalleled intellectual property estate, we plan to form at least one
significant new alliance in 2007. Finally, we aim to execute on our
product and business goals while maintaining a solid financial position
with over $180 million in cash at year-end.”
Product Goals
Demonstrate Human Proof-of-Concept Data. Alnylam expects to
publish or present human proof-of-concept data demonstrating the
effectiveness of an RNAi therapeutic to target a specific disease in
human subjects within the next 12 to 18 months.
Advance ALN-RSV01 for the Treatment of Respiratory Syncytial Virus
(RSV) Infection. Alnylam plans to present data from its ongoing
Phase I inhalation trial in adult volunteers in the first half of
2007. The company is also conducting an experimental infection study
in adult volunteers and expects to begin the treatment protocol for
this study in the first half of 2007 and present data in the second
half of 2007. In addition, the company intends to initiate a Phase II
trial in naturally infected patients in the second half of 2007.
Expand Clinical Development Pipeline. Alnylam expects to file
investigational new drug applications (INDs) for two programs in 2007;
candidates include ALN-FLU01 for the treatment of pandemic influenza
and ALN-PCS01 for the treatment of hypercholesterolemia. In addition,
the company expects to announce two new development candidates as it
continues to expand its pipeline of RNAi therapeutics.
Maintain Leadership Position with Systemic Delivery and microRNAs. The
company expects to continue its efforts to optimize systemic delivery
for RNAi therapeutics and plans to present or publish new non-human
primate data in the first half of 2007. Also this year, Alnylam plans
to publish two or more major papers related to in vivo efficacy
for RNAi therapeutics delivered systemically and two or more papers
from its research progress on microRNAs and “antagomirs,”
chemically synthesized molecules that can work to silence
disease-causing microRNAs.
Business Goals
Form Major New Alliance(s). Alnylam intends to form one or more
new alliance(s) with leading companies to continue to develop and fund
its growing pipeline of RNAi therapeutics.
Expand Intellectual Property (IP) Position. The company expects
to further augment its fundamental IP position by obtaining multiple
patent issuances and grants in the U.S. and Europe over the course of
the year.
Monetize IP Position. The company plans to realize additional
near-term value from its IP estate by granting more than five new
InterfeRxTM or research product licenses.
Leverage Alliances. Alnylam expects to receive more than $25
million in alliance-based funding in 2007, which includes expected R&D
funding and achievement of additional objectives under its alliances
with collaborators including Merck, Medtronic, Novartis, and Biogen
Idec.
Maintain Solid Financial Performance. Alnylam is on track to
meet its revised guidance of finishing 2006 with more than $215
million in cash. In 2007, Alnylam aims to maintain a solid financial
position while executing on its product and business goals, and
expects to end the year with greater than $180 million in cash.
AboutRNA Interference (RNAi)
RNA interference, or RNAi, is a naturally occurring mechanism within
cells for selectively silencing and regulating specific genes. The
discovery of RNAi has been widely acknowledged as a major breakthrough
in biology, and the technology was recognized for its potential broad
impact in medicine with the award of the 2006 Nobel Prize for Physiology
or Medicine. Since many diseases are caused by the inappropriate
activity of specific genes, the ability to silence genes selectively
through RNAi could provide a new way to treat a wide range of human
diseases. RNAi is induced by small, double-stranded RNA molecules. One
method to activate RNAi is with chemically synthesized small interfering
RNAs, or siRNAs, which are double-stranded RNAs that are targeted to a
specific disease-associated gene. The siRNA molecules are used by the
natural RNAi machinery in cells to cause targeted gene silencing.
About Alnylam
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 building a
pipeline of RNAi therapeutics; its lead program is in Phase I human
clinical trials for the treatment of respiratory syncytial virus (RSV)
infection, which is the leading cause of hospitalization in infants in
the U.S. 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
Merck, Medtronic, Novartis, and Biogen Idec. The company, founded in
2002, maintains global headquarters in Cambridge, Massachusetts, and has
an additional operating unit in Kulmbach, Germany. For more information,
visit www.alnylam.com.
AlnylamForward-Looking Statements
Various statements in this release concerning our future expectations,
plans and prospects, including without limitation, the need for novel
RNAi therapeutics, our views with respect to the potential for RNAi
therapeutics, including ALN-RSV01, and our expectations with respect to
the timing and success of our clinical and pre-clinical trials, the
timing of regulatory filings, the expansion of our pipeline of product
candidates, the formation of new alliances and the grant of additional
licenses, the receipt of funding, and our cash position at the end of
2006 and 2007, 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: our approach to discover
and develop novel drugs, which is unproven and may never lead to
marketable products; our ability to fund and the results of further
pre-clinical and clinical trials; obtaining, maintaining and protecting
intellectual property utilized by our products; our ability to enforce
our patents against infringers and to defend our patent portfolio
against challenges from third parties; our ability to obtain additional
funding to support our business activities; our dependence on third
parties for development, manufacture, marketing, sales, and distribution
of products; the successful development of our product candidates, all
of which are in early stages of development; obtaining regulatory
approval for products; competition from others using technology similar
to ours and others developing products for similar uses; our dependence
on collaborators; and our short operating history; as well as those
risks more fully discussed in the “Risk Factors”
section of our most recent report on Form 10-Q on file with the
Securities and Exchange Commission. In addition, any forward-looking
statements represent our views only as of today and should not be relied
upon as representing our views as of any subsequent date. Alnylam does
not assume any obligation to update any forward-looking statements.
