Anadys Pharmaceuticals Reports Hepatitis C Viral Load Reduction in Completed Phase IB Clinical Trial of Isatoribine

[Guest guest]

Anadys Pharmaceuticals Reports Hepatitis C Viral Load Reduction in Completed

Phase IB Clinical Trial of Isatoribine

New Data Presented at AASLD Annual Meeting in Boston Demonstrate Biological

Activity in HCV Patients through Activation of Toll-Like Receptor 7

SAN DIEGO, Nov. 3 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc.

(Nasdaq: ANDS), a biopharmaceutical company committed to the discovery,

development and commercialization of novel medicines to treat chronic viral

hepatitis and bacterial infections, reported new data from a recently

completed multi-component Phase IB clinical trial of isatoribine (ANA245) at

the American Association for the Study of Liver Diseases (AASLD) Annual

Meeting yesterday in Boston. The isatoribine family of compounds, which

includes ANA975, Anadys' development candidate for frontline treatment of

chronic hepatitis C virus (HCV) infection, is a new class of drugs being

developed by Anadys to regulate innate immunity by interacting with

Toll-Like Receptor 7.

In a presentation entitled " Isatoribine, a Toll-Like Receptor 7 Agonist,

Significantly Reduced Plasma Viral Load in a Clinical Proof-of-Concept Study

in Patients with Chronic Hepatitis C Virus (HCV) Infection, " Yves Horsmans,

M.D., Professor at Cliniques Universitaires St. Luc in Brussels and

Principal Investigator of the study, reported that isatoribine was safe,

well tolerated and biologically active in the study. Although long-term

therapeutic utility was not a stated objective of the Phase IB clinical

trial and the number of patients was relatively small, results demonstrated

a statistically significant viral load reduction in the plasma of patients

chronically infected with HCV.

" The data from this trial provide the first evidence that a selective

agonist of Toll-Like Receptor 7 can reduce circulating levels of HCV by

activating innate immunity while avoiding the intense adverse effects often

observed with current standard-of-care therapies, " said Prof. Horsmans.

The Phase IB clinical trial was designed to test the safety and tolerability

of isatoribine in patients chronically infected with HCV. The study was a

dose-escalating, open-label evaluation of isatoribine administered

intravenously over a period of seven days to 32 adult patients at 200 mg,

400 mg, 600 mg and 800 mg daily doses. The trial was conducted at two

clinical centers in Western Europe. Patients participating in the study were

either HCV-treatment naive or relapsed from interferon-alpha, a component of

the current standard of treatment. Of the 32 patients in the study, 23 were

infected with HCV genotype 1, which accounts for more than two-thirds of the

infections in the United States yet is the most difficult to treat with

current therapies.

Study results showed that isatoribine was biologically active, as evidenced

by statistically significant changes in 2'-, 5'-oligoadenylate synthetase

(OAS), a biological marker for the activity of interferon-alpha that is

believed to mediate antiviral effects, in patients who received either 600

mg or 800 mg daily for seven days. The amount of HCV in the bloodstream, or

plasma viral load, was most significantly reduced in patients receiving 800

mg daily doses. After seven days, the average decrease in plasma viral load

was 0.76 log10 units, or 82 percent, in these patients. Of the 12 patients

in this 800 mg dose group, 10 were infected with HCV genotype 1. After

completing the dosing phase, OAS expression and plasma viral load returned

to pre-treatment levels in all patients within seven days.

Isatoribine treatment was safe and well tolerated in the study, with no

serious adverse events and a low frequency of mild to moderate side effects,

although definitive conclusions regarding product safety cannot be made

until the results of future clinical trials of longer duration in more

patients are known. No patient altered treatment or withdrew from the study

due to adverse events or clinical laboratory abnormalities. The results from

this completed clinical trial corroborate and extend previously disclosed

safety, tolerability, and pharmacokinetic data derived from single doses of

isatoribine in healthy volunteers and from other components of the Phase IB

clinical trial.

" We are very encouraged by the results of this study, which provide the

foundation for an upcoming clinical trial of our oral prodrug ANA975 for

potential frontline treatment of chronic HCV, " said Steve Worland, Ph.D.,

Anadys' Executive Vice President, Research and Development.

About Hepatitis C

Hepatitis C virus, the most common chronic blood-borne infection in the

United States, causes inflammation of the liver and may progress to more

serious complications such as cirrhosis of the liver, liver cancer and

death. Approximately 2.7 million people in the United States are chronically

infected with HCV, and the Centers for Disease Control (CDC) estimates that

by the year 2010, the number of deaths attributed annually to HCV could

surpass that due to HIV/AIDS. Worldwide sales for HCV products were an

estimated $2.7 billion in 2003, yet current treatments for HCV may be

ineffective in up to 50 percent of patients due to the development of

drug-resistant viral strains, and many treatments are associated with

serious side effects.

About Anadys

Anadys Pharmaceuticals, Inc. (www.anadyspharma.com) is a biopharmaceutical

company committed to advancing patient care by discovering, developing and

commercializing novel small molecule, anti-infective medicines for the

treatment of hepatitis C virus (HCV), hepatitis B virus (HBV) and bacterial

infections. Anadys is advancing its anti-infective portfolio through the

development of its two clinical programs, the isatoribine family of

compounds including the oral prodrug ANA975 for the treatment of HCV, and

ANA380 for the treatment of HBV. In addition, Anadys' anti-infective

therapeutic platform is designed to advance a strong and continual pipeline

of drug candidates into the clinic.

Statements in this press release that are not strictly historical in nature

constitute " forward-looking statements. " Such statements include, but are

not limited to, references to the biological activity of isatoribine in HCV

infected patients, viral load reduction resulting from administration of

isatoribine to HCV infected patients, the effect on a patient's immune

system and the potential for ANA975 to become an orally administered

front-line treatment for chronic HCV. Such forward-looking statements

involve known and unknown risks, uncertainties and other factors which may

cause the actual results of Anadys Pharmaceuticals to be materially

different from historical results or from any results expressed or implied

by such forward-looking statements. In particular, the results of initial

clinical trials are not necessarily predictive of future results, and Anadys

cannot provide any assurances that any of its product candidates will have

favorable results in later clinical trials, or receive regulatory approval.

Such forward-looking statements involve known and unknown risks,

uncertainties and other factors which may cause Anadys' actual results to be

materially different from historical results or from any results expressed

or implied by such forward-looking statements. In particular, the results of

initial clinical trials may not be predictive of future results, and Anadys

cannot provide any assurances that any of its product candidates will have

favorable results in future clinical trials or receive regulatory approval.

In addition, Anadys' results may be affected by competition from other

biotechnology and pharmaceutical companies, its effectiveness at managing

its financial resources, its ability to successfully develop and market

products, difficulties or delays in its clinical trials, difficulties or

delays in manufacturing its clinical trials materials, the scope and

validity of patent protection for its products, regulatory developments

involving future products and its ability to obtain additional funding to

support its operations. These and other factors that may cause actual

results to differ are more fully discussed in the " Risk Factors " section of

Anadys' Form 10-Q for the quarter ended June 30, 2004. All forward-looking

statements are qualified in their entirety by this cautionary statement.

Anadys is providing this information as of this date and does not undertake

any obligation to update any forward-looking statements contained in this

document as a result of new information, future events or otherwise.

SOURCE Anadys Pharmaceuticals, Inc.

11/03/2004

[Guest guest]

Anadys Pharmaceuticals Reports Hepatitis C Viral Load Reduction in Completed

Phase IB Clinical Trial of Isatoribine

New Data Presented at AASLD Annual Meeting in Boston Demonstrate Biological

Activity in HCV Patients through Activation of Toll-Like Receptor 7

SAN DIEGO, Nov. 3 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc.

(Nasdaq: ANDS), a biopharmaceutical company committed to the discovery,

development and commercialization of novel medicines to treat chronic viral

hepatitis and bacterial infections, reported new data from a recently

completed multi-component Phase IB clinical trial of isatoribine (ANA245) at

the American Association for the Study of Liver Diseases (AASLD) Annual

Meeting yesterday in Boston. The isatoribine family of compounds, which

includes ANA975, Anadys' development candidate for frontline treatment of

chronic hepatitis C virus (HCV) infection, is a new class of drugs being

developed by Anadys to regulate innate immunity by interacting with

Toll-Like Receptor 7.

In a presentation entitled " Isatoribine, a Toll-Like Receptor 7 Agonist,

Significantly Reduced Plasma Viral Load in a Clinical Proof-of-Concept Study

in Patients with Chronic Hepatitis C Virus (HCV) Infection, " Yves Horsmans,

M.D., Professor at Cliniques Universitaires St. Luc in Brussels and

Principal Investigator of the study, reported that isatoribine was safe,

well tolerated and biologically active in the study. Although long-term

therapeutic utility was not a stated objective of the Phase IB clinical

trial and the number of patients was relatively small, results demonstrated

a statistically significant viral load reduction in the plasma of patients

chronically infected with HCV.

" The data from this trial provide the first evidence that a selective

agonist of Toll-Like Receptor 7 can reduce circulating levels of HCV by

activating innate immunity while avoiding the intense adverse effects often

observed with current standard-of-care therapies, " said Prof. Horsmans.

The Phase IB clinical trial was designed to test the safety and tolerability

of isatoribine in patients chronically infected with HCV. The study was a

dose-escalating, open-label evaluation of isatoribine administered

intravenously over a period of seven days to 32 adult patients at 200 mg,

400 mg, 600 mg and 800 mg daily doses. The trial was conducted at two

clinical centers in Western Europe. Patients participating in the study were

either HCV-treatment naive or relapsed from interferon-alpha, a component of

the current standard of treatment. Of the 32 patients in the study, 23 were

infected with HCV genotype 1, which accounts for more than two-thirds of the

infections in the United States yet is the most difficult to treat with

current therapies.

Study results showed that isatoribine was biologically active, as evidenced

by statistically significant changes in 2'-, 5'-oligoadenylate synthetase

(OAS), a biological marker for the activity of interferon-alpha that is

believed to mediate antiviral effects, in patients who received either 600

mg or 800 mg daily for seven days. The amount of HCV in the bloodstream, or

plasma viral load, was most significantly reduced in patients receiving 800

mg daily doses. After seven days, the average decrease in plasma viral load

was 0.76 log10 units, or 82 percent, in these patients. Of the 12 patients

in this 800 mg dose group, 10 were infected with HCV genotype 1. After

completing the dosing phase, OAS expression and plasma viral load returned

to pre-treatment levels in all patients within seven days.

Isatoribine treatment was safe and well tolerated in the study, with no

serious adverse events and a low frequency of mild to moderate side effects,

although definitive conclusions regarding product safety cannot be made

until the results of future clinical trials of longer duration in more

patients are known. No patient altered treatment or withdrew from the study

due to adverse events or clinical laboratory abnormalities. The results from

this completed clinical trial corroborate and extend previously disclosed

safety, tolerability, and pharmacokinetic data derived from single doses of

isatoribine in healthy volunteers and from other components of the Phase IB

clinical trial.

" We are very encouraged by the results of this study, which provide the

foundation for an upcoming clinical trial of our oral prodrug ANA975 for

potential frontline treatment of chronic HCV, " said Steve Worland, Ph.D.,

Anadys' Executive Vice President, Research and Development.

About Hepatitis C

Hepatitis C virus, the most common chronic blood-borne infection in the

United States, causes inflammation of the liver and may progress to more

serious complications such as cirrhosis of the liver, liver cancer and

death. Approximately 2.7 million people in the United States are chronically

infected with HCV, and the Centers for Disease Control (CDC) estimates that

by the year 2010, the number of deaths attributed annually to HCV could

surpass that due to HIV/AIDS. Worldwide sales for HCV products were an

estimated $2.7 billion in 2003, yet current treatments for HCV may be

ineffective in up to 50 percent of patients due to the development of

drug-resistant viral strains, and many treatments are associated with

serious side effects.

About Anadys

Anadys Pharmaceuticals, Inc. (www.anadyspharma.com) is a biopharmaceutical

company committed to advancing patient care by discovering, developing and

commercializing novel small molecule, anti-infective medicines for the

treatment of hepatitis C virus (HCV), hepatitis B virus (HBV) and bacterial

infections. Anadys is advancing its anti-infective portfolio through the

development of its two clinical programs, the isatoribine family of

compounds including the oral prodrug ANA975 for the treatment of HCV, and

ANA380 for the treatment of HBV. In addition, Anadys' anti-infective

therapeutic platform is designed to advance a strong and continual pipeline

of drug candidates into the clinic.

Statements in this press release that are not strictly historical in nature

constitute " forward-looking statements. " Such statements include, but are

not limited to, references to the biological activity of isatoribine in HCV

infected patients, viral load reduction resulting from administration of

isatoribine to HCV infected patients, the effect on a patient's immune

system and the potential for ANA975 to become an orally administered

front-line treatment for chronic HCV. Such forward-looking statements

involve known and unknown risks, uncertainties and other factors which may

cause the actual results of Anadys Pharmaceuticals to be materially

different from historical results or from any results expressed or implied

by such forward-looking statements. In particular, the results of initial

clinical trials are not necessarily predictive of future results, and Anadys

cannot provide any assurances that any of its product candidates will have

favorable results in later clinical trials, or receive regulatory approval.

Such forward-looking statements involve known and unknown risks,

uncertainties and other factors which may cause Anadys' actual results to be

materially different from historical results or from any results expressed

or implied by such forward-looking statements. In particular, the results of

initial clinical trials may not be predictive of future results, and Anadys

cannot provide any assurances that any of its product candidates will have

favorable results in future clinical trials or receive regulatory approval.

In addition, Anadys' results may be affected by competition from other

biotechnology and pharmaceutical companies, its effectiveness at managing

its financial resources, its ability to successfully develop and market

products, difficulties or delays in its clinical trials, difficulties or

delays in manufacturing its clinical trials materials, the scope and

validity of patent protection for its products, regulatory developments

involving future products and its ability to obtain additional funding to

support its operations. These and other factors that may cause actual

results to differ are more fully discussed in the " Risk Factors " section of

Anadys' Form 10-Q for the quarter ended June 30, 2004. All forward-looking

statements are qualified in their entirety by this cautionary statement.

Anadys is providing this information as of this date and does not undertake

any obligation to update any forward-looking statements contained in this

document as a result of new information, future events or otherwise.

SOURCE Anadys Pharmaceuticals, Inc.

11/03/2004

[Guest guest]

Anadys Pharmaceuticals Reports Hepatitis C Viral Load Reduction in Completed

Phase IB Clinical Trial of Isatoribine

New Data Presented at AASLD Annual Meeting in Boston Demonstrate Biological

Activity in HCV Patients through Activation of Toll-Like Receptor 7

SAN DIEGO, Nov. 3 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc.

(Nasdaq: ANDS), a biopharmaceutical company committed to the discovery,

development and commercialization of novel medicines to treat chronic viral

hepatitis and bacterial infections, reported new data from a recently

completed multi-component Phase IB clinical trial of isatoribine (ANA245) at

the American Association for the Study of Liver Diseases (AASLD) Annual

Meeting yesterday in Boston. The isatoribine family of compounds, which

includes ANA975, Anadys' development candidate for frontline treatment of

chronic hepatitis C virus (HCV) infection, is a new class of drugs being

developed by Anadys to regulate innate immunity by interacting with

Toll-Like Receptor 7.

In a presentation entitled " Isatoribine, a Toll-Like Receptor 7 Agonist,

Significantly Reduced Plasma Viral Load in a Clinical Proof-of-Concept Study

in Patients with Chronic Hepatitis C Virus (HCV) Infection, " Yves Horsmans,

M.D., Professor at Cliniques Universitaires St. Luc in Brussels and

Principal Investigator of the study, reported that isatoribine was safe,

well tolerated and biologically active in the study. Although long-term

therapeutic utility was not a stated objective of the Phase IB clinical

trial and the number of patients was relatively small, results demonstrated

a statistically significant viral load reduction in the plasma of patients

chronically infected with HCV.

" The data from this trial provide the first evidence that a selective

agonist of Toll-Like Receptor 7 can reduce circulating levels of HCV by

activating innate immunity while avoiding the intense adverse effects often

observed with current standard-of-care therapies, " said Prof. Horsmans.

The Phase IB clinical trial was designed to test the safety and tolerability

of isatoribine in patients chronically infected with HCV. The study was a

dose-escalating, open-label evaluation of isatoribine administered

intravenously over a period of seven days to 32 adult patients at 200 mg,

400 mg, 600 mg and 800 mg daily doses. The trial was conducted at two

clinical centers in Western Europe. Patients participating in the study were

either HCV-treatment naive or relapsed from interferon-alpha, a component of

the current standard of treatment. Of the 32 patients in the study, 23 were

infected with HCV genotype 1, which accounts for more than two-thirds of the

infections in the United States yet is the most difficult to treat with

current therapies.

Study results showed that isatoribine was biologically active, as evidenced

by statistically significant changes in 2'-, 5'-oligoadenylate synthetase

(OAS), a biological marker for the activity of interferon-alpha that is

believed to mediate antiviral effects, in patients who received either 600

mg or 800 mg daily for seven days. The amount of HCV in the bloodstream, or

plasma viral load, was most significantly reduced in patients receiving 800

mg daily doses. After seven days, the average decrease in plasma viral load

was 0.76 log10 units, or 82 percent, in these patients. Of the 12 patients

in this 800 mg dose group, 10 were infected with HCV genotype 1. After

completing the dosing phase, OAS expression and plasma viral load returned

to pre-treatment levels in all patients within seven days.

Isatoribine treatment was safe and well tolerated in the study, with no

serious adverse events and a low frequency of mild to moderate side effects,

although definitive conclusions regarding product safety cannot be made

until the results of future clinical trials of longer duration in more

patients are known. No patient altered treatment or withdrew from the study

due to adverse events or clinical laboratory abnormalities. The results from

this completed clinical trial corroborate and extend previously disclosed

safety, tolerability, and pharmacokinetic data derived from single doses of

isatoribine in healthy volunteers and from other components of the Phase IB

clinical trial.

" We are very encouraged by the results of this study, which provide the

foundation for an upcoming clinical trial of our oral prodrug ANA975 for

potential frontline treatment of chronic HCV, " said Steve Worland, Ph.D.,

Anadys' Executive Vice President, Research and Development.

About Hepatitis C

Hepatitis C virus, the most common chronic blood-borne infection in the

United States, causes inflammation of the liver and may progress to more

serious complications such as cirrhosis of the liver, liver cancer and

death. Approximately 2.7 million people in the United States are chronically

infected with HCV, and the Centers for Disease Control (CDC) estimates that

by the year 2010, the number of deaths attributed annually to HCV could

surpass that due to HIV/AIDS. Worldwide sales for HCV products were an

estimated $2.7 billion in 2003, yet current treatments for HCV may be

ineffective in up to 50 percent of patients due to the development of

drug-resistant viral strains, and many treatments are associated with

serious side effects.

About Anadys

Anadys Pharmaceuticals, Inc. (www.anadyspharma.com) is a biopharmaceutical

company committed to advancing patient care by discovering, developing and

commercializing novel small molecule, anti-infective medicines for the

treatment of hepatitis C virus (HCV), hepatitis B virus (HBV) and bacterial

infections. Anadys is advancing its anti-infective portfolio through the

development of its two clinical programs, the isatoribine family of

compounds including the oral prodrug ANA975 for the treatment of HCV, and

ANA380 for the treatment of HBV. In addition, Anadys' anti-infective

therapeutic platform is designed to advance a strong and continual pipeline

of drug candidates into the clinic.

Statements in this press release that are not strictly historical in nature

constitute " forward-looking statements. " Such statements include, but are

not limited to, references to the biological activity of isatoribine in HCV

infected patients, viral load reduction resulting from administration of

isatoribine to HCV infected patients, the effect on a patient's immune

system and the potential for ANA975 to become an orally administered

front-line treatment for chronic HCV. Such forward-looking statements

involve known and unknown risks, uncertainties and other factors which may

cause the actual results of Anadys Pharmaceuticals to be materially

different from historical results or from any results expressed or implied

by such forward-looking statements. In particular, the results of initial

clinical trials are not necessarily predictive of future results, and Anadys

cannot provide any assurances that any of its product candidates will have

favorable results in later clinical trials, or receive regulatory approval.

Such forward-looking statements involve known and unknown risks,

uncertainties and other factors which may cause Anadys' actual results to be

materially different from historical results or from any results expressed

or implied by such forward-looking statements. In particular, the results of

initial clinical trials may not be predictive of future results, and Anadys

cannot provide any assurances that any of its product candidates will have

favorable results in future clinical trials or receive regulatory approval.

In addition, Anadys' results may be affected by competition from other

biotechnology and pharmaceutical companies, its effectiveness at managing

its financial resources, its ability to successfully develop and market

products, difficulties or delays in its clinical trials, difficulties or

delays in manufacturing its clinical trials materials, the scope and

validity of patent protection for its products, regulatory developments

involving future products and its ability to obtain additional funding to

support its operations. These and other factors that may cause actual

results to differ are more fully discussed in the " Risk Factors " section of

Anadys' Form 10-Q for the quarter ended June 30, 2004. All forward-looking

statements are qualified in their entirety by this cautionary statement.

Anadys is providing this information as of this date and does not undertake

any obligation to update any forward-looking statements contained in this

document as a result of new information, future events or otherwise.

SOURCE Anadys Pharmaceuticals, Inc.

11/03/2004

[Guest guest]

Anadys Pharmaceuticals Reports Hepatitis C Viral Load Reduction in Completed

Phase IB Clinical Trial of Isatoribine

New Data Presented at AASLD Annual Meeting in Boston Demonstrate Biological

Activity in HCV Patients through Activation of Toll-Like Receptor 7

SAN DIEGO, Nov. 3 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc.

(Nasdaq: ANDS), a biopharmaceutical company committed to the discovery,

development and commercialization of novel medicines to treat chronic viral

hepatitis and bacterial infections, reported new data from a recently

completed multi-component Phase IB clinical trial of isatoribine (ANA245) at

the American Association for the Study of Liver Diseases (AASLD) Annual

Meeting yesterday in Boston. The isatoribine family of compounds, which

includes ANA975, Anadys' development candidate for frontline treatment of

chronic hepatitis C virus (HCV) infection, is a new class of drugs being

developed by Anadys to regulate innate immunity by interacting with

Toll-Like Receptor 7.

In a presentation entitled " Isatoribine, a Toll-Like Receptor 7 Agonist,

Significantly Reduced Plasma Viral Load in a Clinical Proof-of-Concept Study

in Patients with Chronic Hepatitis C Virus (HCV) Infection, " Yves Horsmans,

M.D., Professor at Cliniques Universitaires St. Luc in Brussels and

Principal Investigator of the study, reported that isatoribine was safe,

well tolerated and biologically active in the study. Although long-term

therapeutic utility was not a stated objective of the Phase IB clinical

trial and the number of patients was relatively small, results demonstrated

a statistically significant viral load reduction in the plasma of patients

chronically infected with HCV.

" The data from this trial provide the first evidence that a selective

agonist of Toll-Like Receptor 7 can reduce circulating levels of HCV by

activating innate immunity while avoiding the intense adverse effects often

observed with current standard-of-care therapies, " said Prof. Horsmans.

The Phase IB clinical trial was designed to test the safety and tolerability

of isatoribine in patients chronically infected with HCV. The study was a

dose-escalating, open-label evaluation of isatoribine administered

intravenously over a period of seven days to 32 adult patients at 200 mg,

400 mg, 600 mg and 800 mg daily doses. The trial was conducted at two

clinical centers in Western Europe. Patients participating in the study were

either HCV-treatment naive or relapsed from interferon-alpha, a component of

the current standard of treatment. Of the 32 patients in the study, 23 were

infected with HCV genotype 1, which accounts for more than two-thirds of the

infections in the United States yet is the most difficult to treat with

current therapies.

Study results showed that isatoribine was biologically active, as evidenced

by statistically significant changes in 2'-, 5'-oligoadenylate synthetase

(OAS), a biological marker for the activity of interferon-alpha that is

believed to mediate antiviral effects, in patients who received either 600

mg or 800 mg daily for seven days. The amount of HCV in the bloodstream, or

plasma viral load, was most significantly reduced in patients receiving 800

mg daily doses. After seven days, the average decrease in plasma viral load

was 0.76 log10 units, or 82 percent, in these patients. Of the 12 patients

in this 800 mg dose group, 10 were infected with HCV genotype 1. After

completing the dosing phase, OAS expression and plasma viral load returned

to pre-treatment levels in all patients within seven days.

Isatoribine treatment was safe and well tolerated in the study, with no

serious adverse events and a low frequency of mild to moderate side effects,

although definitive conclusions regarding product safety cannot be made

until the results of future clinical trials of longer duration in more

patients are known. No patient altered treatment or withdrew from the study

due to adverse events or clinical laboratory abnormalities. The results from

this completed clinical trial corroborate and extend previously disclosed

safety, tolerability, and pharmacokinetic data derived from single doses of

isatoribine in healthy volunteers and from other components of the Phase IB

clinical trial.

" We are very encouraged by the results of this study, which provide the

foundation for an upcoming clinical trial of our oral prodrug ANA975 for

potential frontline treatment of chronic HCV, " said Steve Worland, Ph.D.,

Anadys' Executive Vice President, Research and Development.

About Hepatitis C

Hepatitis C virus, the most common chronic blood-borne infection in the

United States, causes inflammation of the liver and may progress to more

serious complications such as cirrhosis of the liver, liver cancer and

death. Approximately 2.7 million people in the United States are chronically

infected with HCV, and the Centers for Disease Control (CDC) estimates that

by the year 2010, the number of deaths attributed annually to HCV could

surpass that due to HIV/AIDS. Worldwide sales for HCV products were an

estimated $2.7 billion in 2003, yet current treatments for HCV may be

ineffective in up to 50 percent of patients due to the development of

drug-resistant viral strains, and many treatments are associated with

serious side effects.

About Anadys

Anadys Pharmaceuticals, Inc. (www.anadyspharma.com) is a biopharmaceutical

company committed to advancing patient care by discovering, developing and

commercializing novel small molecule, anti-infective medicines for the

treatment of hepatitis C virus (HCV), hepatitis B virus (HBV) and bacterial

infections. Anadys is advancing its anti-infective portfolio through the

development of its two clinical programs, the isatoribine family of

compounds including the oral prodrug ANA975 for the treatment of HCV, and

ANA380 for the treatment of HBV. In addition, Anadys' anti-infective

therapeutic platform is designed to advance a strong and continual pipeline

of drug candidates into the clinic.

Statements in this press release that are not strictly historical in nature

constitute " forward-looking statements. " Such statements include, but are

not limited to, references to the biological activity of isatoribine in HCV

infected patients, viral load reduction resulting from administration of

isatoribine to HCV infected patients, the effect on a patient's immune

system and the potential for ANA975 to become an orally administered

front-line treatment for chronic HCV. Such forward-looking statements

involve known and unknown risks, uncertainties and other factors which may

cause the actual results of Anadys Pharmaceuticals to be materially

different from historical results or from any results expressed or implied

by such forward-looking statements. In particular, the results of initial

clinical trials are not necessarily predictive of future results, and Anadys

cannot provide any assurances that any of its product candidates will have

favorable results in later clinical trials, or receive regulatory approval.

Such forward-looking statements involve known and unknown risks,

uncertainties and other factors which may cause Anadys' actual results to be

materially different from historical results or from any results expressed

or implied by such forward-looking statements. In particular, the results of

initial clinical trials may not be predictive of future results, and Anadys

cannot provide any assurances that any of its product candidates will have

favorable results in future clinical trials or receive regulatory approval.

In addition, Anadys' results may be affected by competition from other

biotechnology and pharmaceutical companies, its effectiveness at managing

its financial resources, its ability to successfully develop and market

products, difficulties or delays in its clinical trials, difficulties or

delays in manufacturing its clinical trials materials, the scope and

validity of patent protection for its products, regulatory developments

involving future products and its ability to obtain additional funding to

support its operations. These and other factors that may cause actual

results to differ are more fully discussed in the " Risk Factors " section of

Anadys' Form 10-Q for the quarter ended June 30, 2004. All forward-looking

statements are qualified in their entirety by this cautionary statement.

Anadys is providing this information as of this date and does not undertake

any obligation to update any forward-looking statements contained in this

document as a result of new information, future events or otherwise.

SOURCE Anadys Pharmaceuticals, Inc.

11/03/2004