Orasense Joint Venture Initiates Oral Solid Dosing Trial Of ISIS 104838 in Humans

Apr 10, 2001, 01:00 ET from Isis Pharmaceuticals, Inc.

    CARLSBAD, Calif., April 10 /PRNewswire/ -- Orasense(TM) Ltd., a joint
 venture of Elan Corporation, plc (NYSE:   ELN) ("Elan") and Isis
 Pharmaceuticals, Inc. (Nasdaq:   ISIP) ("Isis"), announced today it has
 initiated the first human clinical trial of oral solid formulations of a
 second-generation antisense drug.  Orasense is using ISIS 104838 to develop
 platform oral delivery technology for antisense drugs.  ISIS 104838, an
 antisense inhibitor of TNF-alpha, is being developed to treat patients with
 inflammatory diseases such as rheumatoid arthritis.
     The oral dosing trial is the first of several studies that will be
 conducted over the next 12 months to evaluate the absorption, distribution,
 metabolism and elimination of ISIS 104838 in oral dosage forms.  In this
 study, the pharmacokinetic profile of intravenous (IV) doses of ISIS 104838
 will be compared to that of orally administered tablets.  Multiple oral
 formulations of the drug will be evaluated.
     "Our research thus far suggests that oral dosing of antisense drugs is
 feasible," said Mary Martin, Ph.D., Managing Director of Elan Biotechnology
 Research.  "These trials are designed to provide the additional information we
 need to refine our oral formulation.  Once the delivery system is optimized,
 we plan to proceed into efficacy trials with an oral dosage form of ISIS
 104838."
     "Initiation of oral tablet studies represents a major milestone for
 antisense technology and for Isis," said Stanley T. Crooke, Isis' Chairman and
 CEO.  "The data suggest that antisense drugs can be delivered in a variety of
 ways: parenterally, topically, orally and by inhalation.  This versatility
 broadens the range of therapeutic applications available to antisense
 significantly beyond our initial expectations.  We now are developing
 antisense drugs to treat cancer, Crohn's disease, rheumatoid arthritis,
 psoriasis and diabetes.  The successful development of oral forms of antisense
 drugs will make our drugs more convenient to patients and more competitive in
 the marketplace."
     In parallel with the development of antisense oral formulation technology,
 Isis is advancing the clinical development of intravenous, subcutaneous and
 topical formulations of ISIS 104838.  Isis expects to initiate Phase II
 clinical trials of the intravenous (IV) and subcutaneous formulation of this
 drug for rheumatoid arthritis before the end of this year.  Phase II clinical
 trials of ISIS 104838 delivered topically to patients with psoriasis are
 scheduled to begin in the first half of 2001.
 
     Isis Pharmaceuticals, Inc. is exploiting its expertise in RNA to discover
 and develop novel human therapeutic drugs.  The company has commercialized its
 first product, Vitravene(TM) (fomivirsen), to treat CMV-induced retinitis in
 AIDS patients.  In addition, Isis has 11 products in its development pipeline,
 with two in late-stage development and four in Phase II human clinical trials.
 ISIS 3521, an inhibitor of PKC-alpha, is in Phase III trials for non-small
 cell lung cancer.  Isis is preparing to initiate a Phase III program for ISIS
 2302, an ICAM-1 inhibitor, in Crohn's disease.  Isis has a broad and
 proprietary patent estate of more than 700 issued and allowed patents
 worldwide.  Isis' GeneTrove(TM) division uses antisense to assist
 pharmaceutical industry partners in validating and prioritizing potential gene
 targets through customized services and access to an extensive gene function
 database.  Ibis Therapeutics(TM) is a division focused on the discovery of
 small molecule drugs that bind to RNA.
 
     This press release contains forward-looking statements concerning ISIS
 104838 and Isis' research and development efforts.  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, the reader is cautioned not to rely on these forward-looking
 statements.  These and other risks concerning Isis' research and development
 programs are described in additional detail in Isis' Annual Report on Form
 10K-A for the year ended December 31, 2000, which is on file with the U.S.
 Securities and Exchange Commission, copies of which are available from the
 company.
 
     Vitravene(TM) is a trademark of Ciba Vision, a Novartis company.
 
     GeneTrove(TM) and Ibis Therapeutics(TM) are trademarks of Isis
 Pharmaceuticals, Inc.
 
     Orasense(TM) is a trademark of Orasense, Ltd.
 
 

SOURCE Isis Pharmaceuticals, Inc.
    CARLSBAD, Calif., April 10 /PRNewswire/ -- Orasense(TM) Ltd., a joint
 venture of Elan Corporation, plc (NYSE:   ELN) ("Elan") and Isis
 Pharmaceuticals, Inc. (Nasdaq:   ISIP) ("Isis"), announced today it has
 initiated the first human clinical trial of oral solid formulations of a
 second-generation antisense drug.  Orasense is using ISIS 104838 to develop
 platform oral delivery technology for antisense drugs.  ISIS 104838, an
 antisense inhibitor of TNF-alpha, is being developed to treat patients with
 inflammatory diseases such as rheumatoid arthritis.
     The oral dosing trial is the first of several studies that will be
 conducted over the next 12 months to evaluate the absorption, distribution,
 metabolism and elimination of ISIS 104838 in oral dosage forms.  In this
 study, the pharmacokinetic profile of intravenous (IV) doses of ISIS 104838
 will be compared to that of orally administered tablets.  Multiple oral
 formulations of the drug will be evaluated.
     "Our research thus far suggests that oral dosing of antisense drugs is
 feasible," said Mary Martin, Ph.D., Managing Director of Elan Biotechnology
 Research.  "These trials are designed to provide the additional information we
 need to refine our oral formulation.  Once the delivery system is optimized,
 we plan to proceed into efficacy trials with an oral dosage form of ISIS
 104838."
     "Initiation of oral tablet studies represents a major milestone for
 antisense technology and for Isis," said Stanley T. Crooke, Isis' Chairman and
 CEO.  "The data suggest that antisense drugs can be delivered in a variety of
 ways: parenterally, topically, orally and by inhalation.  This versatility
 broadens the range of therapeutic applications available to antisense
 significantly beyond our initial expectations.  We now are developing
 antisense drugs to treat cancer, Crohn's disease, rheumatoid arthritis,
 psoriasis and diabetes.  The successful development of oral forms of antisense
 drugs will make our drugs more convenient to patients and more competitive in
 the marketplace."
     In parallel with the development of antisense oral formulation technology,
 Isis is advancing the clinical development of intravenous, subcutaneous and
 topical formulations of ISIS 104838.  Isis expects to initiate Phase II
 clinical trials of the intravenous (IV) and subcutaneous formulation of this
 drug for rheumatoid arthritis before the end of this year.  Phase II clinical
 trials of ISIS 104838 delivered topically to patients with psoriasis are
 scheduled to begin in the first half of 2001.
 
     Isis Pharmaceuticals, Inc. is exploiting its expertise in RNA to discover
 and develop novel human therapeutic drugs.  The company has commercialized its
 first product, Vitravene(TM) (fomivirsen), to treat CMV-induced retinitis in
 AIDS patients.  In addition, Isis has 11 products in its development pipeline,
 with two in late-stage development and four in Phase II human clinical trials.
 ISIS 3521, an inhibitor of PKC-alpha, is in Phase III trials for non-small
 cell lung cancer.  Isis is preparing to initiate a Phase III program for ISIS
 2302, an ICAM-1 inhibitor, in Crohn's disease.  Isis has a broad and
 proprietary patent estate of more than 700 issued and allowed patents
 worldwide.  Isis' GeneTrove(TM) division uses antisense to assist
 pharmaceutical industry partners in validating and prioritizing potential gene
 targets through customized services and access to an extensive gene function
 database.  Ibis Therapeutics(TM) is a division focused on the discovery of
 small molecule drugs that bind to RNA.
 
     This press release contains forward-looking statements concerning ISIS
 104838 and Isis' research and development efforts.  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, the reader is cautioned not to rely on these forward-looking
 statements.  These and other risks concerning Isis' research and development
 programs are described in additional detail in Isis' Annual Report on Form
 10K-A for the year ended December 31, 2000, which is on file with the U.S.
 Securities and Exchange Commission, copies of which are available from the
 company.
 
     Vitravene(TM) is a trademark of Ciba Vision, a Novartis company.
 
     GeneTrove(TM) and Ibis Therapeutics(TM) are trademarks of Isis
 Pharmaceuticals, Inc.
 
     Orasense(TM) is a trademark of Orasense, Ltd.
 
 SOURCE  Isis Pharmaceuticals, Inc.