Thursday August 13, 5:45 am Eastern Time
Company Press Release
SOURCE: Isis Pharmaceuticals
Isis Grants Exclusive Patent License
to CpG ImmunoPharmaceuticals For
Use of DNA Technology in Novel Immunotherapeutic
Products
CARLSBAD, Calif., and WELLESLEY, Mass., Aug. 13 /PRNewswire/ -- Isis Pharmaceuticals
(Nasdaq: ISIP - news) and CpG ImmunoPharmaceuticals, Inc. today announced that Isis has
exclusively licensed its issued patents covering immune stimulation by phosphorothioate
oligonucleotides (S-oligos) to CpG ImmunoPharmaceuticals. The agreement grants CpG
ImmunoPharmaceuticals exclusive worldwide rights to the methods and applications covered by
issued U.S. Patents No. 5,663,153; No. 5,723,335; and related patent applications, not including
claims for antisense therapeutics. Under terms of the agreement, Isis will receive a licensing fee, a
portion of sublicensing revenues relating to the technology and a meaningful equity position in CpG
ImmunoPharmaceuticals.
The original patent for this method was filed in 1995 after Isis observed that the introduction of an
S-oligo into the skin triggered a localized immunostimulatory response. Because vaccines and
other immunotherapeutic products are designed to elicit a potent immune response to a
disease-specific antigen, the administration of a vaccine with such a modified oligonucleotide may
improve the performance of the product and confer enhanced immunity.
CpG ImmunoPharmaceuticals is developing innovative therapeutic and prophylactic products
based on CpG DNA, a broadly enabling technology for immune modulation that is complementary
to the in-licensed Isis S-oligo technology. Discovered in 1994 by Dr. Arthur Kreig, Co-Founder
and Chief Scientific Officer of CpG ImmunoPharmaceuticals, CpG DNA consists of proprietary
DNA sequences that rapidly activate both cellular and humoral responses and potentially offer the
most potent and selective immune stimulation the body can provide.
''Isis is pleased that the licensing agreement will support CpG ImmunoPharmaceuticals' efforts to
create novel products to improve and direct immune responses in humans,'' said B. Lynne
Parshall, Executive Vice President of Isis. ''This agreement underscores the value of Isis' patent
portfolio and demonstrates our ability to leverage valuable assets for our own use as well as for
corporate partnering. It further demonstrates our technology leadership in oligonucleotide
therapeutics and is structured to allow Isis stockholders to participate in the future value created
by this innovative company.''
''This license from Isis complements CpG ImmunoPharmaceuticals' existing patent position to give
us what we believe is a dominant intellectual property position in using DNA as an immune
modulator,'' said Robert Bratzler, Ph.D., President and Chief Executive Officer of CpG
ImmunoPharmaceuticals. ''Our core technology platform now encompasses human-specific
sequences of CpG DNA, methods for using CpG DNA for pharmaceutical applications, and
conventional and S-oligos for immune stimulation. This broad technology base will allow CpG
ImmunoPharmaceuticals to advance novel products in multiple disease indications, including
treatment of or protection against infectious diseases, cancer, asthma, allergy and genetic
disorders.'' Dr. Bratzler added that the Company expects to initiate its first human clinical trials for
protection against hepatitis B in late 1998 and for treatment of hepatitis B and of lymphoma in
1999.
''CpG ImmunoPharmaceuticals is pleased to enter into this licensing agreement with Isis, a
recognized leader in the antisense field,'' said Arthur Krieg, Chief Scientific Officer of CpG
ImmunoPharmaceuticals. ''The safety and potential utility of oligonucleotide-based drugs is
supported by the recent advisory committee recommendation for FDA approval of Isis'
Vitravene(TM), the first antisense drug to receive such recommendation. We are optimistic that
Isis' experience and expertise with S-oligo technology will enhance our efforts to develop
important CpG DNA-based therapeutic products.''
CpG ImmunoPharmaceuticals, Inc. is a privately held biotechnology company focused on the
development and commercialization of innovative therapeutic and prophylactic products based on
CpG DNA technology. Current investors include TechnoVenture Management and Alafi Capital.
CpG ImmunoPharmaceuticals, Inc. was founded in 1997 and is based in Wellesley,
Massachusetts. A backgrounder with additional information on CpG ImmunoPharmaceuticals is
available upon request.
Isis Pharmaceuticals, based in northern San Diego County, is engaged in the discovery and
development on novel human therapeutic compounds. Isis has six compounds in human clinical
trials: Vitravene(TM), to treat CMV-induced retinitis in AIDS patients, has completed Phase III
clinical trials and an NDA has been filed and has been recommended for approval by an FDA
advisory committee; Isis 2302, an inhibitor of ICAM-1, is in a pivotal quality trial for Crohn's
disease; Phase III clinical trials for renal transplant rejection, rheumatoid arthritis and ulcerative
colitis, and is being explored as a topical treatment for psoriasis and an aerosol administration for
asthma; 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 retinitis
in AIDS patients. The company also has several additional compounds in preclinical development.
Isis has filed over 300 U.S. patents of which 122 are issued and 39 are allowed; these cover
multiple aspects of oligonucleotide chemistry, biology and manufacturing. Isis' broad medicinal
chemistry and biology research programs support efforts in both antisense and small molecule drug
discovery.
This release contains forward-looking statements concerning the licensing agreement between Isis
and CpG. Such statements are subject to certain risk factors 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 the endeavor of building a business around such
potential products. 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. These and other
risks are described in additional detail in Isis' Annual Report on Form 10-K for the year end
December 31, 1997 and in the Company's most recent quarterly report on Form 10-Q, which are
available from the company.
SOURCE: Isis Pharmaceuticals |
