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Isis Pharmaceuticals (ISIS) Identifies SARS Antisense Drug Candidates Through Collaboration With Industrial Technology Research Institute (ITRI); Achieved Two Milestones

10/19/2005 5:09:40 PM

CARLSBAD, Calif. and HSINCHU, Taiwan, Jan. 14 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc., announced today that it has achieved two milestones in its antisense drug discovery partnership with the Industrial Technology Research Institute (ITRI) of Taiwan focused on the coronavirus associated with Severe Acute Respiratory Syndrome (SARS). The milestones relate to the identification of potent, second-generation antisense drugs that inhibit SARS virus replication and the successful completion of preclinical studies evaluating aerosol and parenteral delivery of antisense drugs as specified under the agreement. The achievement of these milestones has resulted in payments totaling $1.0 million to Isis.

"We are very pleased with the progress made in our collaboration with Isis, and the efficiency of antisense drug discovery," said Johnsee Lee, Ph.D., President of ITRI. "This partnership is very important to protecting the health of the people worldwide and to establishing the platform technology of antisense drugs in Taiwan. We are committed to developing new SARS treatments, and therefore, are supportive of the continued development of the inhaled and intravenously delivered antisense drug candidates discovered by Isis."

"This initial phase of antisense drug discovery has prepared us to initiate a full-scale SARS drug development program should the virus reappear. In advance of a potential outbreak, we will continue to further optimize the inhibitors we have identified and conduct additional preclinical research to expand and strengthen the data package," said C. Frank Bennett, Ph.D., Isis' Vice President, Antisense Research. "Further, these studies are important for antisense technology as they demonstrate that second-generation antisense drugs can be administered by aerosol. At Isis, the progress we have made in aerosol delivery can be used for future drugs for pulmonary and respiratory diseases."

In preclinical studies, Isis scientists and a team of virologists led by Professor Michael J. Buchmeier of The Scripps Research Institute in La Jolla, California, observed dose-dependent inhibitory activity of several antisense inhibitors in well-established in vitro models of the growth and spread of the coronavirus associated with SARS. Isis will work with ITRI and The Scripps Research Institute team to plan additional studies to support the further development of the lead drug candidates.

Isis and ITRI established a SARS antisense drug discovery collaboration in June 2003. The primary goals of the initial phase of the collaboration were to identify one or more SARS antisense drugs and develop aerosol and intravenous formulations in preparation for preclinical toxicology studies. To date, Isis scientists have evaluated more than 240 different antisense oligonucleotides (inhibitors), including siRNA oligonucleotides, in the SARS virus assay. Isis is also working with the Economic Development Board in Singapore to determine the safety profile of SARS antisense drugs discovered by Isis through this collaboration.

Antisense technology is well-suited to address a SARS outbreak. Antisense drugs work at the molecular level by binding to messenger RNA to interrupt the process by which disease-related proteins are produced. These drugs are highly selective and able to target areas in RNA that seem less likely to mutate. Antisense drugs can also be formulated for aerosol and parenteral delivery. Studies show that antisense drugs delivered through these routes readily reach the lung and intestine, which are primary locations for SARS virus replication. Further, the safety and pharmacokinetics of Isis' proprietary second-generation antisense drugs are well understood, enabling rapid drug discovery and development.

About SARS

Severe Acute Respiratory Syndrome (SARS) is a respiratory illness that has been reported in Asia, North America and Europe. According to the World Health Organization, approximately 8,100 probable cases and 774 deaths from SARS have been reported worldwide as of September 23, 2003. Scientists from multiple laboratories throughout the world have detected a previously unrecognized coronavirus (called SARS CoV) in patients with SARS. This novel coronavirus is believed to be the cause of SARS. SARS symptoms include fever, headache, an overall feeling of discomfort, body aches, and respiratory symptoms, which may be mild or may become severe and life threatening. The primary way that SARS appears to spread is by close person-to-person contact.

About ITRI

The Industrial Technology Research Institute -- ITRI -- of Taiwan is a non-profit R&D organization engaging in applied research and technical services. It was founded in 1973 by the Ministry of Economic Affairs (MOEA) of the government of Taiwan to attend to the technological needs of Taiwan's industrial development. ITRI's contribution to the IT technology in the past is a key factor in the recent economic growth in Taiwan and ITRI is currently engaging in a wide range of industrial research projects under governmental and private contracts. ITRI has highly-regarded teams working together in electronics/optoelectronic, computer and communications, chemical/material sciences, biomedical engineering, machinery/automation, and industrial safety/health. The Biomedical Engineering Center (BMEC) at ITRI is involved in R&D of genomics technology including gene chips, proteomics, bio- informatics, miniaturized medical device research including biophotonics and nanobiotechnology, tissue engineering research including biomaterials and stem cell research, pharmaceutical research including drug delivery, peptidomemetics and herbal drug development. Additional information about ITRI or BMEC can be obtained at .

About Isis Pharmaceuticals, Inc.

Isis Pharmaceuticals, Inc., is exploiting its expertise in RNA to discover and develop novel human therapeutic drugs. The company has successfully commercialized the world's first antisense product, and has 11 antisense products in development. In the company's GeneTrove(TM) program, Isis uses antisense technology as a tool to determine the function of genes and uses that information to direct the company's internal drug discovery research and that of its corporate partners. Through its Ibis Therapeutics(TM) program, Isis is developing a novel diagnostic tool to detect infectious organisms and is focused on the discovery of small molecule drugs that bind to RNA. As an innovator in RNA-based drug discovery and development, Isis is the owner or exclusive licensee of more than 1,300 issued patents worldwide. Additional information about Isis is available at .

About Scripps Research Institute

The Scripps Research Institute in La Jolla, California, is one of the world's largest, private, non-profit biomedical research organizations. It stands at the forefront of basic biomedical science that seeks to comprehend the most fundamental processes of life. The Scripps Research Institute is internationally recognized for its research into immunology, molecular and cellular biology, chemistry, neurosciences, autoimmune diseases, cardiovascular diseases and synthetic vaccine development.

This press release contains forward-looking statements concerning Isis' drug discovery and development plans for the treatment of SARS. Any statement describing a goal, expectation, intention or belief of Isis is a forward- looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and financing such activities. Actual results could differ materially from those projected in this release. As a result, you are cautioned not to rely on these forward- looking statements. These and other risks concerning Isis' research and development programs are described in additional detail on Form 10-Q for the period ended September 30, 2003, which is on file with the U.S. Securities and Exchange Commission, copies of which are available from the company.

GeneTrove(TM) and Ibis Therapeutics(TM) are trademarks of Isis Pharmaceuticals, Inc.

Isis Pharmaceuticals, Inc.

CONTACT: Kristina Peterson of Isis, +1-760-603-2521; or Chungcheng Liuof ITRI, +886-3-591-2131

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