ARLSBAD, CA and MANCHESTER, England, March 23 /PRNewswire/ -- Isis Pharmaceuticals (Nasdaq: ISIP) and
Zeneca LifeScience Molecules (LSM) of Manchester, England, a business division of Zeneca Specialties, announced the
establishment of an antisense oligonucleotide manufacturing collaboration. This agreement brings together Isis, the leader in
antisense technology with Zeneca LSM, a leading supplier of chemical and biological compounds to the pharmaceutical and
biotechnology industries.
This collaboration represents a mutually beneficial and exciting opportunity for both companies. Zeneca LSM is designing a
manufacturing suite with similar capabilites to the one located at Isis' primary manufacturing facility in Carlsbad, CA, to
produce antisense oligonucleotides for use in Isis' clinical trials and for sale to third parties. This collaboration allows Isis to
access Zeneca's extensive manufacturing and scale-up capabilities and for Zeneca to share in Isis' world leadership position
in oligonucleotide manufacturing that, since 1992, has allowed Isis to reduce the cost of oligonucleotide manufacture by
97%. In addition, the combination of Isis' proprietary oligonucletide technology and Zeneca's process development expertise
should continue to enhance manufacturing efficiency and allow Zeneca LSM to build a premiere position in the growing
global market of oligonucleotide manufacturing.
Isis today has an extensive preclinical pipeline of first and second generation antisense drugs, six compounds in clinical
development and is planning to file its first New Drug Application over the coming weeks. The establishment of a second
manufacturing facility at Zeneca LSM's Grangemouth site in the United Kingdom will allow Isis to focus on the production
of both first and second generation compounds and future commercial supplies of product at its Carlsbad facility. It also
allows Isis to continue to develop and enhance its current proprietary manufacturing capabilities while having a strong
external partner supporting production and strengthening Isis' position as the preeminent process chemistry group in
antisense technology today.
Zeneca LSM possesses state-of-the-art technologies, manufacturing facilities and broad integration capabilities which support
the invention, and implementation of cost-effective multi scale chemical manufacturing processes. The business has extensive
experience in process development and a strong analytical and regulatory infrastructure. These strengths have established
LSM as a leading manufacturer of complex chemical intermediates and bulk actives.
"We are extremely pleased to be working with Isis in this manufacturing collaboration." said Peter Doyle, Zeneca Group
Executive Director. "Antisense is an exciting and promising technology. We are delighted to have the opportunity to join our
leading edge oligonucleotide manufacturing capabilities to those of Isis. In doing so we look to strengthen Isis' leading
position as the high quality, cost effective provider of antisense therapeutics."
"This collaboration with Zeneca is a very prudent step for Isis," said Daniel Kisner, M.D., President and Chief Operating
Officer of Isis. "Today, Isis has six drugs in clinical development, an advancing preclinical pipeline, and is progressing
towards commercialization of fomivirsen, the first antisense drug to complete Phase III trials. With Zeneca LSM, we have
found a partner that has the ability to integrate our technology and shares our commitment to quality and continuous
improvements in the cost-effectiveness of manufacturing of antisense drugs."
This press release contains forward-looking statements concerning the manufacturing collaboration between Isis
Pharmaceuticals and Zeneca LifeScience Molecules. 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. Actual results could differ materially from those projected in this release. As a result, the reader is
cautioned not to rely on these forward-looking statements. Risks associated with collaborative partnerships are described in
additional detail in Isis' Annual Report on Form 10-K for the year ended December 31, 1996 and in the Company's most
recent quarterly report on Form 10-Q, which are on file with the U.S. Securities and Exchange Commission, copies of which
are available from the company.
Isis Pharmaceuticals, based in northern San Diego County, is engaged in the discovery and development of novel human
therapeutic compounds. Isis has six compounds in human clinical trials: ISIS 2922, to treat CMV-induced retinitis in patients
with AIDS, has completed Phase III clinical trials; ISIS 2302, an inhibitor of ICAM-1, is in a pivotal quality trial for Crohn's
disease and Phase II clinical trials for renal transplant rejection, rheumatoid arthritis, psoriasis, and ulcerative colitis; ISIS
3521/CGP 64128A is in Phase II trials as a treatment for cancer; ISIS 5132/CGP 69846A is in Phase II clinical trials as a
treatment for cancer; ISIS 2503 is in Phase I trials as a treatment for cancer and ISIS 13312 is in Phase I/II clinical trials for
the treatment of CMV-induced retinitis in AIDS patients. The company also has several additional compounds in preclinical
development. Isis' broad medicinal chemistry and biology research programs support efforts in both antisense and
combinatorial drug discovery.
Zeneca LSM is a leading world supplier of complex chemical and biological actives and intermediates for the pharmaceutical,
agrochemical and biotechnology industry sectors. The business has strong foundations in organic chemistry, process
development and microbial fermentation which are used to design innovative routes for new product manufacture and
successful scale up from laboratory development to full commercial scale manufacture.
Zeneca LSM is a business unit of Zeneca Specialties, part of the Zeneca Group (NYSE:ZEN). The Zeneca Group is an $8.6
billion international bioscience business engaged in the research, development, manufacture and marketing of ethical
(prescription) pharmaceuticals, agricultural and specialty chemical products, and the supply of healthcare services.
SOURCE Isis Pharmaceuticals
-0- 03/23/98 /CONTACT: Christopher Keenan, Corporate Communications, of Isis Pharmaceuticals, 760-603-2641; or
Andrew Smalley, PR/ Communications, of Zeneca Specialties, 011-44-161-721-2441/
(ISIP)
CO: Isis Pharmaceuticals; Zeneca LifeScience Molecules ST: California IN: MTC SU: JVN |
