Exclusive Rights to Leading Technology and Intellectual Property to Develop
RNAi Therapeutics for Influenza and Respiratory Diseases
BOTHELL, Wash., Feb. 23 /PRNewswire-FirstCall/ -- Nastech Pharmaceutical
Company Inc. (Nasdaq: NSTK), a leader in developing therapeutics using
advanced molecular biology based drug delivery technologies, announced today
the expansion of its RNAi therapeutics pipeline by initiating an RNAi
therapeutics program targeting influenza and respiratory diseases. In
connection with this new program, Nastech also announced the acquisition of
the RNAi intellectual property estate and other RNAi technologies of Galenea
Corp., Cambridge, MA, which includes certain intellectual property licensed
from the Massachusetts Institute of Technology (MIT) for the development of
RNAi therapeutics against respiratory viral infections, including influenza,
rhinovirus, and other respiratory diseases. Financial terms of the
transaction were not disclosed.
"This unique combination of Nastech's proprietary RNAi therapeutics
delivery technologies with the intellectual property and technology developed
by Galenea and MIT advances Nastech's position in developing innovative RNAi
therapeutics. This acquisition strengthens Nastech's existing RNAi
therapeutics pipeline through the addition of Galenea's ongoing programs that
target influenza and other respiratory diseases," stated Steven C. Quay, M.D.,
Ph.D., Chairman, President and CEO of Nastech. "The RNAi therapeutics program
targeting the influenza virus is a high priority for Nastech as we believe it
may offer an effective treatment for a future influenza pandemic, which is an
urgent global concern. This program complements Nastech's current TNF-alpha
RNAi program targeting inflammation, since a consequence of influenza
infection can be life-threatening respiratory and systemic inflammation. The
strategic acquisition of Galenea's intellectual property rights and technology
in the respiratory antiviral field is critical to developing and partnering
products in this area."
The intellectual property acquired from Galenea includes patent
applications licensed from MIT that have early priority dates in the antiviral
RNAi field. Nastech also acquired Galenea's research and intellectual
property relating to pulmonary drug delivery technologies. Additionally,
Nastech assumes Galenea's pending grant applications from the National
Institute of Allergy and Infectious Diseases, a division of the National
Institutes of Health, and the Department of Defense to support the development
of RNAi-based antiviral drugs.
Galenea's lead RNAi product, G00101, has demonstrated efficacy against
multiple influenza strains, including avian flu strains (H5N1) in animals.
Nastech expects to work closely with the NIH, CDC and FDA to accelerate G00101
development given the urgent need for influenza therapeutics. G00101
represents a first-in-class approach to fight influenza and is one of the most
advanced anti-influenza compounds based on the recently discovered cellular
mechanism known as small-interfering ribonucleic acid (siRNA). It is
currently administered by inhalation to maximize delivery to the lung
epithelium. The product is designed for ease of use by patients and for
long-term stability -- essential for stockpiling the product for rapid
mobilization during a flu epidemic. G00101 works by preventing viral
replication and transcription in the airway epithelium. In vitro and in vivo
studies have shown that these RNAi sequences provide broad-spectrum influenza
protection and have reduced potential of drug resistance.
"It is anticipated that Nastech's RNAi delivery technology combined with
the MIT intellectual property and the Galenea RNAi technology will provide a
superior strategy to significantly speed the development of these promising
new approaches for treating respiratory diseases, including influenza," said
Jianzhu Chen, Ph.D., Professor of Immunology at MIT and developer of the
acquired RNAi antiviral technology, who will become a consultant to Nastech.
"The development of RNAi therapeutics targeting sequences that are highly
conserved across all flu genomes, including avian and others having pandemic
potential, represents a novel approach to the development of new therapies
against influenza viruses."
According to the World Health Organization (WHO), in a typical year,
influenza infects 5-15% of the world's population, resulting in 250,000 to
500,000 deaths. The WHO and the Centers for Disease Control and Prevention
are concerned about the potential for a major global pandemic such as the 1918
"Spanish flu" in which up to 50 million people may have died worldwide.
Pandemic flu emerges from a sudden change in the influenza virus that results
in a new flu strain, against which there is no immunity. Vaccines currently
represent the mainstay of flu prevention, but vaccines have two key
limitations. First, they are developed against individual, known strains of
flu and therefore may not be effective against new flu strains. Second,
vaccines are produced using a lengthy process requiring incubation in chicken
eggs, thus vaccine against a new flu strain will take months or years to
stockpile. Antiviral medications approved to treat influenza have the
potential drawback that influenza virus strains can become resistant to one or
more of these medications. The potential advantage of RNAi antiviral
therapeutics is that RNAi can be targeted against the so-called "conserved
region" of the influenza virus. This means that an RNAi therapeutic would be
expected to be effective against all strains of flu, whether new or old.
Therefore stockpiling of an effective RNAi treatment is possible in advance of
a global influenza pandemic. In addition to a potential role in a pandemic
flu outbreak, RNAi therapeutics could serve as a treatment for the more common
seasonal flu that as noted above can result in hospitalization and death.
About RNA Interference (RNAi)
RNA interference, or RNAi, is a cellular mechanism that can be used to
turn off the production of a protein. In the case of an RNAi directed against
influenza, the target is one or more proteins critical for the virus'
replication. By turning off the production of such proteins, the spread of
infection is prevented or slowed. Nastech's RNAi research and development
programs seek to develop safe and effective therapeutics by identifying key
protein targets, designing the RNAi that will turn those proteins off, and
developing a formulation for the systemic delivery of this potential new class
Dr. Chen and his co-authors have published a series of papers about their
RNAi antiviral work, including recent papers in the Proceedings of the
National Academy of Sciences in March 2003 and June 2004.
Conference Call and Webcast Information
Nastech management will host a conference call to discuss its RNAi
therapeutic programs and the acquisition of RNAi related assets from Galenea.
The call is scheduled for today, February 23, 2006, at 10:00 a.m. Eastern Time
(7:00 a.m. Pacific Time). To participate in the live conference call, U.S.
residents should dial (800) 299-0148 and international callers should dial
(617) 801-9711. The access code for the live conference call is 26749217. To
access the 24-hour telephone replay, U.S. residents should dial (888) 286-8010
and international callers should dial (617) 801-6888. The access code for the
replay is 45140729.
Alternatively, log on to http://www.nastech.com to access a live webcast
or the subsequent 30-day archive. Please connect to the Investor section of
Nastech's website several minutes prior to the start of the live conference
call to ensure adequate time for any software download that may be necessary.
We are a pharmaceutical company developing innovative products based on
proprietary molecular biology-based drug delivery technologies. We and our
collaboration partners are developing products for multiple therapeutic areas
including respiratory disease, inflammatory conditions, obesity and
osteoporosis. Additional information about Nastech is available at
Nastech Forward Looking Statements
Statements made in this press release may be forward-looking statements
within the meaning of Federal Securities laws that are subject to certain
risks and uncertainties and involve factors that may cause actual results to
differ materially from those projected or suggested. Factors that could cause
actual results to differ materially from those in forward-looking statements
include, but are not limited to: (i) the ability of Nastech to obtain
additional funding; (ii) the ability of Nastech to attract and/or maintain
manufacturing, research, development and commercialization partners; (iii)
Nastech's and/or a partner's ability to successfully complete product research
and development, including preclinical and clinical studies and
commercialization; (iv) Nastech's and/or a partner's ability to obtain
required governmental approvals; and (v) Nastech's and/or a partner's ability
to develop and commercialize products that can compete favorably with those of
competitors. Additional factors that could cause actual results to differ
materially from those projected or suggested in any forward-looking statements
are contained in Nastech's most recent periodic reports on Form 10-K and Form
10-Q that are filed with the Securities and Exchange Commission. Nastech
assumes no obligation to update and supplement forward-looking statements
because of subsequent events.
About Galenea Corp.
Galenea Corp. is an emerging biotechnology company dedicated to enhancing
and saving lives through the discovery of novel therapies for central nervous
system and respiratory diseases. Founded in 2004 based upon technology
developed by Drs. Jianzhu Chen, Susumu Tonegawa and David Gerber of the
Massachusetts Institute of Technology and Dr. Maria Karayiorgou of the
Rockefeller University, Galenea is focusing initially on utilizing proprietary
technologies to generate calcineurin-related treatments for schizophrenia.
Galenea is based in Cambridge, Massachusetts.
Nastech Pharmaceutical Company Inc.
Senior Investor Relations Manager
Matthew Haines (Investors/Media)
SOURCE: Nastech Pharmaceutical Company Inc.
CONTACT: Ed Bell, Senior Investor Relations Manager of Nastech
Pharmaceutical Company Inc., +1-425-908-3639, firstname.lastname@example.org; or Matthew
Haines, Investors/Media of Noonan Russo, +1-212-845-4235, for Nastech
Pharmaceutical Company Inc.