Isis Pharmaceuticals 881866 - 500 Beiträge pro Seite

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Ich würde gerne mal einige Meinungen zu dieser Aktie hören!
thanx

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Gute Info als Ergänzung!
Leider in english, but i hope you can read it.


Isis Pharmaceuticals Provides Update of Phase I/II Clinical Trial of ISIS 3521 In Non-Small Cell Lung Cancer at NCI Symposium

PR Newswire
Friday November 10 7:55am

CARLSBAD, Calif., Nov. 10 /PRNewswire/ -- At the 11th Annual NCI-EORTC-AACR (National Cancer Institute - European Organization for Research in the Treatment of Cancer -- American Association for Cancer Research) Symposium on New Drugs in Cancer Therapy in Amsterdam, Isis Pharmaceuticals (Nasdaq: ISIP) and investigators from Stanford University presented updated data from the Phase I/II trial of ISIS 3521, an antisense anti-cancer drug. The data from the study show that ISIS 3521 in combination with standard chemotherapy agents has promising activity in patients with Stage IIIb or Stage IV non-small cell lung cancer (NSCLC), based on both survival time and response rate. To date the average survival time of patients in the trial is 19 months. Typical survival of patients receiving standard chemotherapy alone is approximately 8 months. In addition, 83% of 48 patients evaluated in the study have improved through complete or partial responses or stable disease. ISIS 3521 has been well tolerated combined with chemotherapy, with minimal side effects attributable to the drug. Based on patient responses observed earlier in this trial, Isis initiated a randomized Phase III clinical trial of ISIS 3521 in NSCLC in October, 2000. The 600 patient Phase III trial will evaluate the ability of ISIS 3521 to safely prolong patients` lives when combined with carboplatin and paclitaxel.

Earlier today, Dr. Alan Yuen, Assistant Professor of Medicine at Stanford University, presented the poster (#529) entitled: "Phase I/II trial of ISIS 3521, an antisense inhibitor of PKC-alpha, with carboplatin and paclitaxel in non-small cell lung cancer." Authors include A. Yuen, J. Halsey, B. Lum, G. Fisher, R. Advani, M. Moore, M. Saleh, P. Rich, G. Harker, F. Ahmed, C. Jones, J. Polikoff, W. Keiser, R. Geary, T. Kwoh, J. Holmlund, A. Dorr, and B. Sikic, of the Oncology Division, Stanford University, Stanford CA, seven additional U.S. trial sites and Isis Pharmaceuticals, Carlsbad, CA.

In the Phase I/II trial to date, two patients have experienced complete responses, which occurs infrequently in advanced NSCLC. Eighteen patients have experienced a partial response, defined as a 50% or greater reduction in tumor size measurements, producing an objective response rate (complete plus partial responses) of 42% (20 of 48 patients). Additionally, 4 of 48 (8%) patients experienced a minor response, defined as a 25-50% reduction in tumor size measurements, and 16 (9%) patients had a stabilization of their disease. The objective response rate may yet increase slightly as several patients are still receiving drug and have the opportunity to improve. Patients in the trial have experienced expected side effects associated with chemotherapy, and minimal side effects associated with ISIS 3521.

"As the Phase I/II data mature, ISIS 3521 with chemotherapy continues to look promising for patients with non-small cell lung cancer," said Dr. Yuen. "A median survival of 19 months represents a meaningful benefit to these patients. We are pleased to have the Phase III trial underway, as patients with this disease are desperately in need of improved therapies."

"These response and survival data remain exciting and we are hopeful that the Phase III trial will confirm that ISIS 3521 provides patients with significant benefit," said Andrew Dorr, M.D., Vice President and Chief Medical Officer. "The report of two complete responses is also encouraging, as such responses are seldom seen in non-small cell lung cancer. Additionally, we have not identified any substantial side effects caused by ISIS 3521. The opportunity to lengthen patients` survival without added toxicity is particularly appealing."

Lung cancer is the leading type of cancer globally, affecting 1.1 million people. Non-small cell lung cancer is the most prevalent form of lung cancer, accounting for approximately 80% of lung cancer in the U.S., as well as the majority of cases worldwide. In 1999, there were an estimated 500,000 patients diagnosed with non-small cell lung cancer in the U.S., Europe and Japan.

ISIS 3521 is a promising new antisense anti-cancer compound that is a potent, selective inhibitor of protein kinase C-alpha (PKC-alpha) expression. PKC is a family of closely-related signal transduction proteins that regulate information flow in and out of cells and modulate cellular responses to environmental stimuli. The PKC family plays a role in normal cell function, and is also involved in abnormal cell growth. ISIS 3521 is an antisense compound that binds to a mRNA sequence specific to PKC-alpha and thus selectively inhibits production of this protein without inhibiting production of other proteins in the PKC family. Using antisense technology it is possible to selectively inhibit a single family member that may play a role in disease while allowing other members of the family to continue to perform normal cellular functions. This high degree of specificity may provide antisense drugs substantial advantage over traditional small molecule drugs in many difficult to treat diseases.

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 patients with AIDS. 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 nearly 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 3521 and its prospects. 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. 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, 1999, 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 Novartis AG. GeneTrove(TM) and Ibis Therapeutics(TM) are trademarks of Isis Pharmaceuticals, Inc.

Source: Isis Pharmaceuticals, Inc.
Contact: Karen Lundstedt of Isis Pharmaceuticals, Inc. Corporate Communications, 760-603-3880

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Und noch ne Info.FDA Grants Isis Pharmaceuticals Fast Track Review Status For Isis 3521 in Non-Small Cell Lung Cancer

PR Newswire
Wednesday November 8 7:55am

CARLSBAD, Calif., Nov. 8 /PRNewswire/ -- Isis Pharmaceuticals (Nasdaq: ISIP) announced today that the U.S. Food and Drug Administration (FDA) has granted fast track review status to ISIS 3521, the company`s antisense drug to treat non-small cell lung cancer (NSCLC). Isis began a 600-patient, randomized Phase III clinical trial of ISIS 3521 in combination with chemotherapy for NSCLC in October 2000.

The FDA`s fast track review process is intended to expedite the review of treatments that have the potential to address unmet medical needs for serious life-threatening diseases. Fast track drug applications are typically reviewed in six months instead of ten months.

"We appreciate the FDA`s interest in new treatments for this deadly cancer, and we are very pleased that the Agency will work to provide a rapid review of ISIS 3521," stated Andrew Dorr, M.D., Vice President and Chief Medical Officer. "Fast track status affords ISIS 3521 the quickest route to approval, during and upon completion of our Phase III clinical trial. We will enroll patients in the Phase III study as rapidly as possible. We hope that the Phase III program will show that ISIS 3521 prolongs the lives patients with NSCLC."

In the Phase II trial, ISIS 3521 added to carboplatin and paclitaxel has produced a median survival of 19 months in patients diagnosed with Stage IIIb or Stage IV non-small cell lung cancer. The typical median survival of patients receiving standard chemotherapy alone is approximately 8 months. Patients treated in the Phase II study have experienced minimal side effects attributable to ISIS 3521.

Lung cancer is the leading type of cancer globally, affecting 1.1 million people. Non-small cell lung cancer is the most prevalent form of lung cancer, accounting for approximately 80% of lung cancer in the U.S., as well as the majority of cases worldwide. In 1999, there were an estimated 500,000 patients diagnosed with non-small cell lung cancer in the U.S., Europe and Japan.

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, five of which are in Phase II human clinical trials and one, ISIS 3521, is in Phase III trials in non-small cell lung cancer. Isis has a broad and proprietary patent estate of nearly 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 3521 and its prospects. 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. 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, 1999, 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 Novartis AG. GeneTrove(TM) and Ibis Therapeutics(TM) are trademarks of Isis Pharmaceuticals, Inc.

Source: Isis Pharmaceuticals
Contact: Karen Lundstedt, Corporate Communications of Isis Pharmaceuticals, 760-603-3880

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Scusi, damit es nicht langweilig wird! :-)))Isis Pharmaceuticals Reports Record Low Quarterly Operating Loss in Third Quarter 2000

PR Newswire
Thursday November 2 8:03am

CARLSBAD, Calif., Nov. 2 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIP), today announced that its loss from operations for the third quarter was $0.4 million on revenues of $18.3 million, compared with $8.0 million on revenues of $10.6 million for the same period last year. The company`s net loss applicable to common stock for the quarter was $5.7 million, or $0.15 per share, compared with a net loss applicable to common stock of $12.6 million, or $0.44 per share, for the same period last year. This reduction in net loss and operating loss represents the continuing impact of the company`s restructuring earlier in the year, together with extraordinary revenue generation from patent licensing in the quarter. Revenues for the quarter included funding from the sale of certain Isis patents to Coley Pharmaceutical Group ("Coley").

Isis reported a loss from operations of $21.2 million for the first nine months of 2000, compared to $30.6 million for the same period in 1999. Isis` net loss applicable to common stock for the year to date was $38.9 million, or $1.08 per share, on revenues of $29.3 million, compared with a loss of $41.8 million, or $1.49 per share, on revenues of $24.4 million for the same period in 1999. The increase in revenues was due primarily to the company`s sale of patents to Coley, the company`s collaborations with Agouron Pharmaceuticals, Inc., a Pfizer Company ("Pfizer") and Aventis, the company`s two joint ventures with Elan, OraSense and HepaSense, and certain government grants and contracts. The increase was partially offset by the conclusion in December 1999 of development funding from Novartis and Boehringer Ingelheim. Isis` net loss for the quarter and nine months ended September 30, 2000 included $3.7 million and $11.7 million, respectively, for Isis` equity in the loss of HepaSense and OraSense.

Operating expenses were flat for the quarter at $18.7 million, compared with the same period in 1999. Expenses for the quarter included one-time start up costs related to the initiation of Phase III clinical trials for ISIS 3521 in non-small cell lung cancer. Additionally, operating expenses for the quarter included $560,000 for the non-cash compensation expense related to an option exchange program offered by Isis to non-officer employees in January 2000 and the grant of stock options to consultants. Options to consultants were granted at fair market value on the date of grant. However, these options are accounted for as variable stock options in accordance with EITF 96-18. Operating expenses for the first nine months of 2000 were $50.5 million compared with $55.0 million for the same period in 1999. The decrease in expenses was primarily due to the company`s restructuring and staff reduction previously announced in January 2000.

Isis continued to strengthen its balance sheet by ending the quarter with $120.7 million in cash and short term investments, compared with $52.8 million at the end of December 1999. The increase came primarily from sales of common stock to institutional investors together with the sale of common stock to Elan International Services, Ltd. ("EIS"), in conjunction with the formation of HepaSense. The increase in cash was also a result of the sale of certain patents to Coley and funding from a collaboration between Ibis Therapeutics(TM) ("Ibis"), a division of Isis, and Pfizer. Working capital for Isis was $114.5 million at the end of the quarter, compared to $44.2 million at December 31, 1999.

"Our ability to leverage our intellectual property position was clearly the financial highlight of the quarter, as we generated approximately $13 million in value by exploiting patents that are non-essential to our business," said B. Lynne Parshall, Isis` Executive Vice President and CFO. "With these revenues, our operating loss for the quarter was less than $400,000, and we remain on track to meet our annual operating loss goal of approximately $30 million. Additionally, we made tremendous progress this quarter in building our pipeline. We added three new development candidates: ISIS 104838 topical for psoriasis, ISIS 13650 for diabetic retinopathy and, perhaps most exciting, ISIS 107772 for Type 2 diabetes. The preclinical data package for ISIS 107772 suggests activity as an insulin sensitizer without causing hypoglycemia and while reducing cholesterol and weight gain. ISIS 107772 inhibits the PTP-1B gene, a gene that major pharmaceutical companies have struggled to inhibit for many years without success."

"Shortly after the close of the quarter, we announced our decision to reinitiate development of ISIS 2302 in Crohn`s disease," added Ms. Parshall. "Based on the final analysis of the pivotal trial that indicated that most patients were underdosed, we are planning additional clinical trials. We expect Phase III studies to begin in the second half of 2001. Two additional important developments subsequent to the quarter close were the initiation of Phase III trials of ISIS 3521 in non-small cell lung cancer and Phase I trials of ISIS 104838 for rheumatoid arthritis and Crohn`s disease. We are very pleased with our clinical progress as we continue to advance our 11 products through development."

Isis` Third Quarter Highlights

Antisense Drug Discovery

Isis presented data demonstrating statistically significant therapeutic benefit of an antisense inhibitor of the PTP-1B gene at a medical meeting focused on phosphatases. The antisense drug reduced elevated glucose levels in blood to normal in several rodent models of Type 2 diabetes. The dramatic decrease in blood glucose levels was observed with only once per week dosing and was not accompanied by an increase in insulin levels, indicating that the antisense inhibitor was acting like an insulin sensitizer. Furthermore, no hypoglycemia was observed in either the diabetic or normal mice at any of the doses studied.
Isis added three compounds to its preclinical development pipeline. ISIS 107772 is an antisense inhibitor of PTP-1B and will be developed to treat Type 2 diabetes. ISIS 13650 is a c-raf kinase inhibitor that will be developed as an intravitreal injection for the treatment of diabetic retinopathy and adult macular degeneration. A topical cream formulation of ISIS 104838, a TNF-alpha inhibitor to treat psoriasis, has been added to the parenteral and oral products already in development. All of these products utilize Isis` proprietary second generation chemistry, which gives them enhanced properties such as improved potency and stability. Patient benefits of second generation chemistry include dosing schedules and formulations that provide greater patient convenience.
GeneTrove(TM) Genomics

Isis initiated an antisense target validation collaboration with R.W. Johnson Pharmaceutical Research Institute (PRI), a member of the Johnson & Johnson family of companies, to assess and prioritize genes as drug discovery targets. GeneTrove will use its proprietary antisense technology to assist PRI to study the function and therapeutic relevance of novel gene targets. This is Isis` fourth GeneTrove target validation collaboration. Financial details surrounding this research collaboration were not disclosed.
Isis joined the prestigious consortium of scientists, the Alliance for Cellular Signaling (AFCS), to further the understanding of all aspects of how cells interact with, or signal, each other in two types of cellular models. Isis` GeneTrove division will provide its expertise in creating and using antisense inhibitors to identify the function of genes and the role they play in cellular interactions, or pathways. Isis is one of only two biotechnology companies participating directly in the consortium, which is led by Nobel laureate Dr. Alfred Gilman, Chairman of Pharmacology at UT Southwestern Medical Center at Dallas.
Ibis Therapeutics(TM)

Isis researchers from its Ibis division received an R&D 100 award for the development of a novel high throughput screening assay for drug discovery. The Multitarget Affinity Specificity/Screening (MASS) technology has been recognized by R&D Magazine as one of the 100 most technologically significant new technologies of the year, as judged by a panel of international experts. The MASS assay is a key invention that enables Ibis Therapeutics to discover small molecule drugs that bind to RNA.
Intellectual Property

Isis sold to Coley Pharmaceutical Group (Coley) patents concerning the use of phosphorothioate oligonucleotides for activating the immune system that are non-essential to Isis` business. In exchange for all rights to this group of immunomodulation patents Coley paid Isis $10.7 million, bringing Coley`s total payment for these patents to Isis to $15.7 million.
Isis licensed its third generation antisense chemistry, Peptide Nucleic Acid (PNA), to Pantheco A/S (Pantheco), a Danish biotechnology company, to treat diabetes and cardiovascular diseases. In exchange for these rights, Isis received a license fee of $1.1 million, paid in Pantheco shares. In addition, Pantheco will pay Isis royalties and milestone payments on products developed. Isis` ownership of Pantheco is approximately 22%.
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 nearly 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 the financial position of Isis Pharmaceuticals, Inc., the therapeutic and commercial potential of compounds developed by the company and the potential value of the company`s functional genomics and drug discovery technology platform. 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, 1999, 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 Novartis AG. GeneTrove(TM) and Ibis Therapeutics(TM) are trademarks of Isis Pharmaceuticals, Inc.

ISIS PHARMACEUTICALS, INC.
SELECTED FINANCIAL INFORMATION
(In Thousands, Except Per Share Data)

Condensed Statements of Operations

Three months ended, Nine months ended,
September 30, September 30,
2000 1999 2000 1999
(Unaudited)
Revenue:
Research and development
revenues under
collaborative agreements $16,521 $9,641 $23,631 $22,032
Research and development
revenues from joint
ventures 1,759 997 5,688 2,390
Total revenue 18,280 10,638 29,319 24,422

Expenses:
Research and development 16,001 16,273 41,986 47,032
General and administrative 2,073 2,406 6,311 7,983
Compensation related to
variable stock options 560 -- 560 --
Restructuring activities 27 -- 1,635 --
Total operating expenses 18,661 18,679 50,492 55,015

(Loss) from operations (381) (8,041) (21,173) (30,593)

Equity in loss of joint
ventures (3,659) (2,018) (11,748) (4,295)
Interest income 1,976 553 4,464 1,760
Interest expense (3,345) (2,924) (9,581) (8,429)

Net loss (5,409) (12,430) (38,038) (41,557)

Accretion of dividends
on preferred stock (311) (150) (898) (267)

Net loss applicable
to common stock ($5,720) ($12,580) ($38,936) ($41,824)

Basic and diluted net
loss per share ($0.15) ($0.44) ($1.08) ($1.49)

Shares used in computing
basic and diluted
net loss per share 38,448 28,838 36,172 28,027


Condensed Balance Sheets

September 30, December 31,
2000 1999
(Unaudited) (Note)
Assets:
Current assets $128,772 $59,197
Property, plant and
equipment, net 23,322 23,945
Other assets 24,481 19,965
$176,575 $103,107

Liabilities and
stockholders` equity:
Current liabilities $14,280 $14,984
Long-term obligations,
net of current portion 96,330 87,254
Stockholders` equity 65,965 869
$176,575 $103,107

Note: The balance sheet at December 31, 1999 has been derived from the audited financial

Source: Isis Pharmaceuticals, Inc.
Contact: Elizabeth Hougen, Vice President, Finance, or Karen Lundstedt, Vice President, Corporate Communications, of Isis Pharmaceuticals, 760-931-9200

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Isis Pharmaceuticals Reports Record Low Quarterly Operating Loss in Third Quarter 2000

PR Newswire
Thursday November 2 8:03am

CARLSBAD, Calif., Nov. 2 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIP), today announced that its loss from operations for the third quarter was $0.4 million on revenues of $18.3 million, compared with $8.0 million on revenues of $10.6 million for the same period last year. The company`s net loss applicable to common stock for the quarter was $5.7 million, or $0.15 per share, compared with a net loss applicable to common stock of $12.6 million, or $0.44 per share, for the same period last year. This reduction in net loss and operating loss represents the continuing impact of the company`s restructuring earlier in the year, together with extraordinary revenue generation from patent licensing in the quarter. Revenues for the quarter included funding from the sale of certain Isis patents to Coley Pharmaceutical Group ("Coley").

Isis reported a loss from operations of $21.2 million for the first nine months of 2000, compared to $30.6 million for the same period in 1999. Isis` net loss applicable to common stock for the year to date was $38.9 million, or $1.08 per share, on revenues of $29.3 million, compared with a loss of $41.8 million, or $1.49 per share, on revenues of $24.4 million for the same period in 1999. The increase in revenues was due primarily to the company`s sale of patents to Coley, the company`s collaborations with Agouron Pharmaceuticals, Inc., a Pfizer Company ("Pfizer") and Aventis, the company`s two joint ventures with Elan, OraSense and HepaSense, and certain government grants and contracts. The increase was partially offset by the conclusion in December 1999 of development funding from Novartis and Boehringer Ingelheim. Isis` net loss for the quarter and nine months ended September 30, 2000 included $3.7 million and $11.7 million, respectively, for Isis` equity in the loss of HepaSense and OraSense.

Operating expenses were flat for the quarter at $18.7 million, compared with the same period in 1999. Expenses for the quarter included one-time start up costs related to the initiation of Phase III clinical trials for ISIS 3521 in non-small cell lung cancer. Additionally, operating expenses for the quarter included $560,000 for the non-cash compensation expense related to an option exchange program offered by Isis to non-officer employees in January 2000 and the grant of stock options to consultants. Options to consultants were granted at fair market value on the date of grant. However, these options are accounted for as variable stock options in accordance with EITF 96-18. Operating expenses for the first nine months of 2000 were $50.5 million compared with $55.0 million for the same period in 1999. The decrease in expenses was primarily due to the company`s restructuring and staff reduction previously announced in January 2000.

Isis continued to strengthen its balance sheet by ending the quarter with $120.7 million in cash and short term investments, compared with $52.8 million at the end of December 1999. The increase came primarily from sales of common stock to institutional investors together with the sale of common stock to Elan International Services, Ltd. ("EIS"), in conjunction with the formation of HepaSense. The increase in cash was also a result of the sale of certain patents to Coley and funding from a collaboration between Ibis Therapeutics(TM) ("Ibis"), a division of Isis, and Pfizer. Working capital for Isis was $114.5 million at the end of the quarter, compared to $44.2 million at December 31, 1999.

"Our ability to leverage our intellectual property position was clearly the financial highlight of the quarter, as we generated approximately $13 million in value by exploiting patents that are non-essential to our business," said B. Lynne Parshall, Isis` Executive Vice President and CFO. "With these revenues, our operating loss for the quarter was less than $400,000, and we remain on track to meet our annual operating loss goal of approximately $30 million. Additionally, we made tremendous progress this quarter in building our pipeline. We added three new development candidates: ISIS 104838 topical for psoriasis, ISIS 13650 for diabetic retinopathy and, perhaps most exciting, ISIS 107772 for Type 2 diabetes. The preclinical data package for ISIS 107772 suggests activity as an insulin sensitizer without causing hypoglycemia and while reducing cholesterol and weight gain. ISIS 107772 inhibits the PTP-1B gene, a gene that major pharmaceutical companies have struggled to inhibit for many years without success."

"Shortly after the close of the quarter, we announced our decision to reinitiate development of ISIS 2302 in Crohn`s disease," added Ms. Parshall. "Based on the final analysis of the pivotal trial that indicated that most patients were underdosed, we are planning additional clinical trials. We expect Phase III studies to begin in the second half of 2001. Two additional important developments subsequent to the quarter close were the initiation of Phase III trials of ISIS 3521 in non-small cell lung cancer and Phase I trials of ISIS 104838 for rheumatoid arthritis and Crohn`s disease. We are very pleased with our clinical progress as we continue to advance our 11 products through development."

Isis` Third Quarter Highlights

Antisense Drug Discovery

Isis presented data demonstrating statistically significant therapeutic benefit of an antisense inhibitor of the PTP-1B gene at a medical meeting focused on phosphatases. The antisense drug reduced elevated glucose levels in blood to normal in several rodent models of Type 2 diabetes. The dramatic decrease in blood glucose levels was observed with only once per week dosing and was not accompanied by an increase in insulin levels, indicating that the antisense inhibitor was acting like an insulin sensitizer. Furthermore, no hypoglycemia was observed in either the diabetic or normal mice at any of the doses studied.
Isis added three compounds to its preclinical development pipeline. ISIS 107772 is an antisense inhibitor of PTP-1B and will be developed to treat Type 2 diabetes. ISIS 13650 is a c-raf kinase inhibitor that will be developed as an intravitreal injection for the treatment of diabetic retinopathy and adult macular degeneration. A topical cream formulation of ISIS 104838, a TNF-alpha inhibitor to treat psoriasis, has been added to the parenteral and oral products already in development. All of these products utilize Isis` proprietary second generation chemistry, which gives them enhanced properties such as improved potency and stability. Patient benefits of second generation chemistry include dosing schedules and formulations that provide greater patient convenience.
GeneTrove(TM) Genomics

Isis initiated an antisense target validation collaboration with R.W. Johnson Pharmaceutical Research Institute (PRI), a member of the Johnson & Johnson family of companies, to assess and prioritize genes as drug discovery targets. GeneTrove will use its proprietary antisense technology to assist PRI to study the function and therapeutic relevance of novel gene targets. This is Isis` fourth GeneTrove target validation collaboration. Financial details surrounding this research collaboration were not disclosed.
Isis joined the prestigious consortium of scientists, the Alliance for Cellular Signaling (AFCS), to further the understanding of all aspects of how cells interact with, or signal, each other in two types of cellular models. Isis` GeneTrove division will provide its expertise in creating and using antisense inhibitors to identify the function of genes and the role they play in cellular interactions, or pathways. Isis is one of only two biotechnology companies participating directly in the consortium, which is led by Nobel laureate Dr. Alfred Gilman, Chairman of Pharmacology at UT Southwestern Medical Center at Dallas.
Ibis Therapeutics(TM)

Isis researchers from its Ibis division received an R&D 100 award for the development of a novel high throughput screening assay for drug discovery. The Multitarget Affinity Specificity/Screening (MASS) technology has been recognized by R&D Magazine as one of the 100 most technologically significant new technologies of the year, as judged by a panel of international experts. The MASS assay is a key invention that enables Ibis Therapeutics to discover small molecule drugs that bind to RNA.
Intellectual Property

Isis sold to Coley Pharmaceutical Group (Coley) patents concerning the use of phosphorothioate oligonucleotides for activating the immune system that are non-essential to Isis` business. In exchange for all rights to this group of immunomodulation patents Coley paid Isis $10.7 million, bringing Coley`s total payment for these patents to Isis to $15.7 million.
Isis licensed its third generation antisense chemistry, Peptide Nucleic Acid (PNA), to Pantheco A/S (Pantheco), a Danish biotechnology company, to treat diabetes and cardiovascular diseases. In exchange for these rights, Isis received a license fee of $1.1 million, paid in Pantheco shares. In addition, Pantheco will pay Isis royalties and milestone payments on products developed. Isis` ownership of Pantheco is approximately 22%.
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 nearly 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 the financial position of Isis Pharmaceuticals, Inc., the therapeutic and commercial potential of compounds developed by the company and the potential value of the company`s functional genomics and drug discovery technology platform. 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, 1999, 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 Novartis AG. GeneTrove(TM) and Ibis Therapeutics(TM) are trademarks of Isis Pharmaceuticals, Inc.

ISIS PHARMACEUTICALS, INC.
SELECTED FINANCIAL INFORMATION
(In Thousands, Except Per Share Data)

Condensed Statements of Operations

Three months ended, Nine months ended,
September 30, September 30,
2000 1999 2000 1999
(Unaudited)
Revenue:
Research and development
revenues under
collaborative agreements $16,521 $9,641 $23,631 $22,032
Research and development
revenues from joint
ventures 1,759 997 5,688 2,390
Total revenue 18,280 10,638 29,319 24,422

Expenses:
Research and development 16,001 16,273 41,986 47,032
General and administrative 2,073 2,406 6,311 7,983
Compensation related to
variable stock options 560 -- 560 --
Restructuring activities 27 -- 1,635 --
Total operating expenses 18,661 18,679 50,492 55,015

(Loss) from operations (381) (8,041) (21,173) (30,593)

Equity in loss of joint
ventures (3,659) (2,018) (11,748) (4,295)
Interest income 1,976 553 4,464 1,760
Interest expense (3,345) (2,924) (9,581) (8,429)

Net loss (5,409) (12,430) (38,038) (41,557)

Accretion of dividends
on preferred stock (311) (150) (898) (267)

Net loss applicable
to common stock ($5,720) ($12,580) ($38,936) ($41,824)

Basic and diluted net
loss per share ($0.15) ($0.44) ($1.08) ($1.49)

Shares used in computing
basic and diluted
net loss per share 38,448 28,838 36,172 28,027


Condensed Balance Sheets

September 30, December 31,
2000 1999
(Unaudited) (Note)
Assets:
Current assets $128,772 $59,197
Property, plant and
equipment, net 23,322 23,945
Other assets 24,481 19,965
$176,575 $103,107

Liabilities and
stockholders` equity:
Current liabilities $14,280 $14,984
Long-term obligations,
net of current portion 96,330 87,254
Stockholders` equity 65,965 869
$176,575 $103,107

Note: The balance sheet at December 31, 1999 has been derived from the audited financial

Source: Isis Pharmaceuticals, Inc.
Contact: Elizabeth Hougen, Vice President, Finance, or Karen Lundstedt, Vice President, Corporate Communications, of Isis Pharmaceuticals, 760-931-9200

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