ANA598 Receives Fast Track Designation From the FDA for the Treatment of Chronic Hepatitis C Infection

[Guest guest]

PRESS RELEASE

ANA598 Receives Fast Track Designation From the FDA for the Treatment of Chronic

Hepatitis C Infection

Last update: 6:38 p.m. EST Dec. 1, 2008

SAN DIEGO, Dec 01, 2008 /PRNewswire-FirstCall via COMTEX/ -- Anadys

Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration

(FDA) has granted fast track designation to ANA598 for the treatment of chronic

hepatitis C virus (HCV) infection. ANA598 is Anadys' investigational hepatitis C

non-nucleoside polymerase inhibitor. Anadys is currently enrolling patients in a

Phase Ib study evaluating ANA598 for the treatment of patients chronically

infected with HCV.

Under the FDA Modernization Act of 1997, fast track designation is designed to

facilitate the development and expedite the review of new drugs that are

intended to treat serious or life-threatening conditions. Compounds selected

must demonstrate the potential to address an unmet medical need for such a

condition. Mechanisms intended to facilitate development include opportunities

for frequent dialogue with FDA reviewers and for timely review of submitted

protocols. However, the designation does not guarantee approval or expedited

approval of any application for the product. The granting of fast track status

for the ANA598 development program is consistent with the need for HCV

treatments with novel mechanisms of action, oral administration, non-overlapping

resistance profiles and improved safety and efficacy over the existing standard

of care for both treatment-naive and treatment-experienced patients.

" The FDA's fast track designation for ANA598 acknowledges the need for new HCV

therapies to improve treatment outcomes, " commented Freddo, M.D., Anadys'

Senior Vice President, Drug Development and Chief Medical Officer. " We

anticipate continuing to work closely with the FDA on the development and

regulatory review of ANA598, one of the few non-nucleoside polymerase inhibitors

in clinical development for the treatment of HCV. We continue to believe this

class of antivirals holds great promise as a component of future HCV treatment

regimens. "

About ANA598

Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV

patients. In the Phase Ib study, naive genotype 1a and 1b patients are to

receive ANA598 over three days at doses of 200 mg bid (twice-a-day), 400 mg bid

or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving

active drug and two receiving placebo.

In a Phase I study in healthy volunteers, ANA598 was administered as capsules at

single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000

mg. In addition, a separate cohort received two 800 mg doses 12 hours apart.

ANA598 was well tolerated at all doses and there were no serious adverse events

or withdrawals from the study, although definitive conclusions regarding product

safety and tolerability cannot be made until the results of future clinical

trials of longer duration in more patients are known. All reported adverse

events were classified as mild or moderate, with no apparent dose relationship.

The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with

a half-life of 24 to 30 hours in the fasted state and 22 hours in the fed state,

consistent with the potential for once-daily or twice-daily oral dosing.

Preclinical evaluation of ANA598 was completed in the first quarter of 2008,

leading to submission of an Investigational New Drug Application (IND) to the

FDA, subsequent allowance of the IND by the FDA and initiation of clinical

investigation in the second quarter of 2008. In the preclinical program, ANA598

was well tolerated at all doses tested in 28-day GLP toxicology studies. In

September, Anadys initiated long-term, chronic toxicology studies of ANA598. If

ANA598 is successful in early stage clinical trials, it is anticipated that the

acceleration of these and other non-clinical activities into 2008 will enable a

more rapid and continuous development path into Phase II studies during 2009.

Clinical Need and Market Opportunity in HCV Infection

Chronic HCV infection is a serious public health concern affecting approximately

3.2 million people in the United States and approximately 170 million people

worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and

cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not

successfully treated. Cirrhosis of the liver resulting from chronic HCV

infection is the leading indication for liver transplantation in the U.S. Due to

the asymptomatic nature of HCV infection, it often goes undetected for up to 20

years following initial infection. Each year, 8,000 to 10,000 people in the U.S.

die from complications of HCV.

The current standard of care is a combination of pegylated interferon and

ribavirin. Inadequate response rates, in particular for patients infected with

genotype 1 HCV, along with significant side effects of approved therapy, support

the medical need for improved treatment options. It is estimated that fewer than

5% of people with chronic HCV infection living in the U.S. are under treatment

today. Most infected individuals are unaware of their infection status and the

large majority of individuals who know their condition do not currently receive

drug therapy. There is also a growing number of individuals who have failed

interferon-based regimens who may be successfully treated with combinations of

two or more direct antivirals. It is expected that the next generation of

therapies for treatment of HCV will include small molecules, such as ANA598,

that directly act upon specific viral enzymes to inhibit viral replication.

These new therapies are expected to improve overall therapy by increasing cure

rates and potentially improving tolerability and convenience of treatment if

doses of currently used agents can be reduced or eliminated.

About Anadys

Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company

dedicated to improving patient care by developing novel medicines in the areas

of hepatitis C and oncology. For the treatment of chronic hepatitis C, the

Company is developing two potentially complementary agents, ANA598, a

non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug.

The Company is also developing ANA773 for the treatment of cancer.

Safe Harbor Statement

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 (i) the potential for fast track designation to

expedite the development of ANA598; (ii) the belief that ANA598 is one of the

few non-nucleoside polymerase inhibitors in clinical development for the

treatment of HCV; (iii) the potential for once-daily or twice-daily oral dosing

of ANA598; (iv) the ability of Anadys to transition into Phase II studies of

ANA598 during 2009; and (v) expectations regarding the evolution of the market

for HCV therapies. 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. For example, the results of

preclinical and early clinical studies may not be predictive of future results,

and Anadys cannot provide any assurances that ANA598 will not have unforeseen

safety issues, will have favorable results in future clinical trials, will

maintain fast track designation or will receive regulatory approval. In

addition, Anadys' results may be affected by risks related to competition from

other biotechnology and pharmaceutical companies, its effectiveness at managing

its financial resources, its ability to enter into collaborations around its

product candidates, its ability to successfully develop and market products,

difficulties or delays in its preclinical studies or clinical trials,

difficulties or delays in manufacturing its clinical trials materials, the scope

and validity of patent protection for its products, regulatory developments

involving its product candidates and its ability to obtain additional funding to

support its operations. Risk factors that may cause actual results to differ are

more fully discussed in Anadys' SEC filings, including Anadys' Form 10-K for the

year ended December 31, 2007 and Anadys' Form 10-Q for the quarter ended

September 30, 2008. 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.

http://www.anadyspharma.com

[Guest guest]

PRESS RELEASE

ANA598 Receives Fast Track Designation From the FDA for the Treatment of Chronic

Hepatitis C Infection

Last update: 6:38 p.m. EST Dec. 1, 2008

SAN DIEGO, Dec 01, 2008 /PRNewswire-FirstCall via COMTEX/ -- Anadys

Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration

(FDA) has granted fast track designation to ANA598 for the treatment of chronic

hepatitis C virus (HCV) infection. ANA598 is Anadys' investigational hepatitis C

non-nucleoside polymerase inhibitor. Anadys is currently enrolling patients in a

Phase Ib study evaluating ANA598 for the treatment of patients chronically

infected with HCV.

Under the FDA Modernization Act of 1997, fast track designation is designed to

facilitate the development and expedite the review of new drugs that are

intended to treat serious or life-threatening conditions. Compounds selected

must demonstrate the potential to address an unmet medical need for such a

condition. Mechanisms intended to facilitate development include opportunities

for frequent dialogue with FDA reviewers and for timely review of submitted

protocols. However, the designation does not guarantee approval or expedited

approval of any application for the product. The granting of fast track status

for the ANA598 development program is consistent with the need for HCV

treatments with novel mechanisms of action, oral administration, non-overlapping

resistance profiles and improved safety and efficacy over the existing standard

of care for both treatment-naive and treatment-experienced patients.

" The FDA's fast track designation for ANA598 acknowledges the need for new HCV

therapies to improve treatment outcomes, " commented Freddo, M.D., Anadys'

Senior Vice President, Drug Development and Chief Medical Officer. " We

anticipate continuing to work closely with the FDA on the development and

regulatory review of ANA598, one of the few non-nucleoside polymerase inhibitors

in clinical development for the treatment of HCV. We continue to believe this

class of antivirals holds great promise as a component of future HCV treatment

regimens. "

About ANA598

Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV

patients. In the Phase Ib study, naive genotype 1a and 1b patients are to

receive ANA598 over three days at doses of 200 mg bid (twice-a-day), 400 mg bid

or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving

active drug and two receiving placebo.

In a Phase I study in healthy volunteers, ANA598 was administered as capsules at

single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000

mg. In addition, a separate cohort received two 800 mg doses 12 hours apart.

ANA598 was well tolerated at all doses and there were no serious adverse events

or withdrawals from the study, although definitive conclusions regarding product

safety and tolerability cannot be made until the results of future clinical

trials of longer duration in more patients are known. All reported adverse

events were classified as mild or moderate, with no apparent dose relationship.

The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with

a half-life of 24 to 30 hours in the fasted state and 22 hours in the fed state,

consistent with the potential for once-daily or twice-daily oral dosing.

Preclinical evaluation of ANA598 was completed in the first quarter of 2008,

leading to submission of an Investigational New Drug Application (IND) to the

FDA, subsequent allowance of the IND by the FDA and initiation of clinical

investigation in the second quarter of 2008. In the preclinical program, ANA598

was well tolerated at all doses tested in 28-day GLP toxicology studies. In

September, Anadys initiated long-term, chronic toxicology studies of ANA598. If

ANA598 is successful in early stage clinical trials, it is anticipated that the

acceleration of these and other non-clinical activities into 2008 will enable a

more rapid and continuous development path into Phase II studies during 2009.

Clinical Need and Market Opportunity in HCV Infection

Chronic HCV infection is a serious public health concern affecting approximately

3.2 million people in the United States and approximately 170 million people

worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and

cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not

successfully treated. Cirrhosis of the liver resulting from chronic HCV

infection is the leading indication for liver transplantation in the U.S. Due to

the asymptomatic nature of HCV infection, it often goes undetected for up to 20

years following initial infection. Each year, 8,000 to 10,000 people in the U.S.

die from complications of HCV.

The current standard of care is a combination of pegylated interferon and

ribavirin. Inadequate response rates, in particular for patients infected with

genotype 1 HCV, along with significant side effects of approved therapy, support

the medical need for improved treatment options. It is estimated that fewer than

5% of people with chronic HCV infection living in the U.S. are under treatment

today. Most infected individuals are unaware of their infection status and the

large majority of individuals who know their condition do not currently receive

drug therapy. There is also a growing number of individuals who have failed

interferon-based regimens who may be successfully treated with combinations of

two or more direct antivirals. It is expected that the next generation of

therapies for treatment of HCV will include small molecules, such as ANA598,

that directly act upon specific viral enzymes to inhibit viral replication.

These new therapies are expected to improve overall therapy by increasing cure

rates and potentially improving tolerability and convenience of treatment if

doses of currently used agents can be reduced or eliminated.

About Anadys

Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company

dedicated to improving patient care by developing novel medicines in the areas

of hepatitis C and oncology. For the treatment of chronic hepatitis C, the

Company is developing two potentially complementary agents, ANA598, a

non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug.

The Company is also developing ANA773 for the treatment of cancer.

Safe Harbor Statement

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 (i) the potential for fast track designation to

expedite the development of ANA598; (ii) the belief that ANA598 is one of the

few non-nucleoside polymerase inhibitors in clinical development for the

treatment of HCV; (iii) the potential for once-daily or twice-daily oral dosing

of ANA598; (iv) the ability of Anadys to transition into Phase II studies of

ANA598 during 2009; and (v) expectations regarding the evolution of the market

for HCV therapies. 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. For example, the results of

preclinical and early clinical studies may not be predictive of future results,

and Anadys cannot provide any assurances that ANA598 will not have unforeseen

safety issues, will have favorable results in future clinical trials, will

maintain fast track designation or will receive regulatory approval. In

addition, Anadys' results may be affected by risks related to competition from

other biotechnology and pharmaceutical companies, its effectiveness at managing

its financial resources, its ability to enter into collaborations around its

product candidates, its ability to successfully develop and market products,

difficulties or delays in its preclinical studies or clinical trials,

difficulties or delays in manufacturing its clinical trials materials, the scope

and validity of patent protection for its products, regulatory developments

involving its product candidates and its ability to obtain additional funding to

support its operations. Risk factors that may cause actual results to differ are

more fully discussed in Anadys' SEC filings, including Anadys' Form 10-K for the

year ended December 31, 2007 and Anadys' Form 10-Q for the quarter ended

September 30, 2008. 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.

http://www.anadyspharma.com

[Guest guest]

PRESS RELEASE

ANA598 Receives Fast Track Designation From the FDA for the Treatment of Chronic

Hepatitis C Infection

Last update: 6:38 p.m. EST Dec. 1, 2008

SAN DIEGO, Dec 01, 2008 /PRNewswire-FirstCall via COMTEX/ -- Anadys

Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration

(FDA) has granted fast track designation to ANA598 for the treatment of chronic

hepatitis C virus (HCV) infection. ANA598 is Anadys' investigational hepatitis C

non-nucleoside polymerase inhibitor. Anadys is currently enrolling patients in a

Phase Ib study evaluating ANA598 for the treatment of patients chronically

infected with HCV.

Under the FDA Modernization Act of 1997, fast track designation is designed to

facilitate the development and expedite the review of new drugs that are

intended to treat serious or life-threatening conditions. Compounds selected

must demonstrate the potential to address an unmet medical need for such a

condition. Mechanisms intended to facilitate development include opportunities

for frequent dialogue with FDA reviewers and for timely review of submitted

protocols. However, the designation does not guarantee approval or expedited

approval of any application for the product. The granting of fast track status

for the ANA598 development program is consistent with the need for HCV

treatments with novel mechanisms of action, oral administration, non-overlapping

resistance profiles and improved safety and efficacy over the existing standard

of care for both treatment-naive and treatment-experienced patients.

" The FDA's fast track designation for ANA598 acknowledges the need for new HCV

therapies to improve treatment outcomes, " commented Freddo, M.D., Anadys'

Senior Vice President, Drug Development and Chief Medical Officer. " We

anticipate continuing to work closely with the FDA on the development and

regulatory review of ANA598, one of the few non-nucleoside polymerase inhibitors

in clinical development for the treatment of HCV. We continue to believe this

class of antivirals holds great promise as a component of future HCV treatment

regimens. "

About ANA598

Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV

patients. In the Phase Ib study, naive genotype 1a and 1b patients are to

receive ANA598 over three days at doses of 200 mg bid (twice-a-day), 400 mg bid

or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving

active drug and two receiving placebo.

In a Phase I study in healthy volunteers, ANA598 was administered as capsules at

single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000

mg. In addition, a separate cohort received two 800 mg doses 12 hours apart.

ANA598 was well tolerated at all doses and there were no serious adverse events

or withdrawals from the study, although definitive conclusions regarding product

safety and tolerability cannot be made until the results of future clinical

trials of longer duration in more patients are known. All reported adverse

events were classified as mild or moderate, with no apparent dose relationship.

The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with

a half-life of 24 to 30 hours in the fasted state and 22 hours in the fed state,

consistent with the potential for once-daily or twice-daily oral dosing.

Preclinical evaluation of ANA598 was completed in the first quarter of 2008,

leading to submission of an Investigational New Drug Application (IND) to the

FDA, subsequent allowance of the IND by the FDA and initiation of clinical

investigation in the second quarter of 2008. In the preclinical program, ANA598

was well tolerated at all doses tested in 28-day GLP toxicology studies. In

September, Anadys initiated long-term, chronic toxicology studies of ANA598. If

ANA598 is successful in early stage clinical trials, it is anticipated that the

acceleration of these and other non-clinical activities into 2008 will enable a

more rapid and continuous development path into Phase II studies during 2009.

Clinical Need and Market Opportunity in HCV Infection

Chronic HCV infection is a serious public health concern affecting approximately

3.2 million people in the United States and approximately 170 million people

worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and

cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not

successfully treated. Cirrhosis of the liver resulting from chronic HCV

infection is the leading indication for liver transplantation in the U.S. Due to

the asymptomatic nature of HCV infection, it often goes undetected for up to 20

years following initial infection. Each year, 8,000 to 10,000 people in the U.S.

die from complications of HCV.

The current standard of care is a combination of pegylated interferon and

ribavirin. Inadequate response rates, in particular for patients infected with

genotype 1 HCV, along with significant side effects of approved therapy, support

the medical need for improved treatment options. It is estimated that fewer than

5% of people with chronic HCV infection living in the U.S. are under treatment

today. Most infected individuals are unaware of their infection status and the

large majority of individuals who know their condition do not currently receive

drug therapy. There is also a growing number of individuals who have failed

interferon-based regimens who may be successfully treated with combinations of

two or more direct antivirals. It is expected that the next generation of

therapies for treatment of HCV will include small molecules, such as ANA598,

that directly act upon specific viral enzymes to inhibit viral replication.

These new therapies are expected to improve overall therapy by increasing cure

rates and potentially improving tolerability and convenience of treatment if

doses of currently used agents can be reduced or eliminated.

About Anadys

Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company

dedicated to improving patient care by developing novel medicines in the areas

of hepatitis C and oncology. For the treatment of chronic hepatitis C, the

Company is developing two potentially complementary agents, ANA598, a

non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug.

The Company is also developing ANA773 for the treatment of cancer.

Safe Harbor Statement

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 (i) the potential for fast track designation to

expedite the development of ANA598; (ii) the belief that ANA598 is one of the

few non-nucleoside polymerase inhibitors in clinical development for the

treatment of HCV; (iii) the potential for once-daily or twice-daily oral dosing

of ANA598; (iv) the ability of Anadys to transition into Phase II studies of

ANA598 during 2009; and (v) expectations regarding the evolution of the market

for HCV therapies. 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. For example, the results of

preclinical and early clinical studies may not be predictive of future results,

and Anadys cannot provide any assurances that ANA598 will not have unforeseen

safety issues, will have favorable results in future clinical trials, will

maintain fast track designation or will receive regulatory approval. In

addition, Anadys' results may be affected by risks related to competition from

other biotechnology and pharmaceutical companies, its effectiveness at managing

its financial resources, its ability to enter into collaborations around its

product candidates, its ability to successfully develop and market products,

difficulties or delays in its preclinical studies or clinical trials,

difficulties or delays in manufacturing its clinical trials materials, the scope

and validity of patent protection for its products, regulatory developments

involving its product candidates and its ability to obtain additional funding to

support its operations. Risk factors that may cause actual results to differ are

more fully discussed in Anadys' SEC filings, including Anadys' Form 10-K for the

year ended December 31, 2007 and Anadys' Form 10-Q for the quarter ended

September 30, 2008. 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.

http://www.anadyspharma.com

[Guest guest]

PRESS RELEASE

ANA598 Receives Fast Track Designation From the FDA for the Treatment of Chronic

Hepatitis C Infection

Last update: 6:38 p.m. EST Dec. 1, 2008

SAN DIEGO, Dec 01, 2008 /PRNewswire-FirstCall via COMTEX/ -- Anadys

Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration

(FDA) has granted fast track designation to ANA598 for the treatment of chronic

hepatitis C virus (HCV) infection. ANA598 is Anadys' investigational hepatitis C

non-nucleoside polymerase inhibitor. Anadys is currently enrolling patients in a

Phase Ib study evaluating ANA598 for the treatment of patients chronically

infected with HCV.

Under the FDA Modernization Act of 1997, fast track designation is designed to

facilitate the development and expedite the review of new drugs that are

intended to treat serious or life-threatening conditions. Compounds selected

must demonstrate the potential to address an unmet medical need for such a

condition. Mechanisms intended to facilitate development include opportunities

for frequent dialogue with FDA reviewers and for timely review of submitted

protocols. However, the designation does not guarantee approval or expedited

approval of any application for the product. The granting of fast track status

for the ANA598 development program is consistent with the need for HCV

treatments with novel mechanisms of action, oral administration, non-overlapping

resistance profiles and improved safety and efficacy over the existing standard

of care for both treatment-naive and treatment-experienced patients.

" The FDA's fast track designation for ANA598 acknowledges the need for new HCV

therapies to improve treatment outcomes, " commented Freddo, M.D., Anadys'

Senior Vice President, Drug Development and Chief Medical Officer. " We

anticipate continuing to work closely with the FDA on the development and

regulatory review of ANA598, one of the few non-nucleoside polymerase inhibitors

in clinical development for the treatment of HCV. We continue to believe this

class of antivirals holds great promise as a component of future HCV treatment

regimens. "

About ANA598

Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV

patients. In the Phase Ib study, naive genotype 1a and 1b patients are to

receive ANA598 over three days at doses of 200 mg bid (twice-a-day), 400 mg bid

or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving

active drug and two receiving placebo.

In a Phase I study in healthy volunteers, ANA598 was administered as capsules at

single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000

mg. In addition, a separate cohort received two 800 mg doses 12 hours apart.

ANA598 was well tolerated at all doses and there were no serious adverse events

or withdrawals from the study, although definitive conclusions regarding product

safety and tolerability cannot be made until the results of future clinical

trials of longer duration in more patients are known. All reported adverse

events were classified as mild or moderate, with no apparent dose relationship.

The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with

a half-life of 24 to 30 hours in the fasted state and 22 hours in the fed state,

consistent with the potential for once-daily or twice-daily oral dosing.

Preclinical evaluation of ANA598 was completed in the first quarter of 2008,

leading to submission of an Investigational New Drug Application (IND) to the

FDA, subsequent allowance of the IND by the FDA and initiation of clinical

investigation in the second quarter of 2008. In the preclinical program, ANA598

was well tolerated at all doses tested in 28-day GLP toxicology studies. In

September, Anadys initiated long-term, chronic toxicology studies of ANA598. If

ANA598 is successful in early stage clinical trials, it is anticipated that the

acceleration of these and other non-clinical activities into 2008 will enable a

more rapid and continuous development path into Phase II studies during 2009.

Clinical Need and Market Opportunity in HCV Infection

Chronic HCV infection is a serious public health concern affecting approximately

3.2 million people in the United States and approximately 170 million people

worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and

cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not

successfully treated. Cirrhosis of the liver resulting from chronic HCV

infection is the leading indication for liver transplantation in the U.S. Due to

the asymptomatic nature of HCV infection, it often goes undetected for up to 20

years following initial infection. Each year, 8,000 to 10,000 people in the U.S.

die from complications of HCV.

The current standard of care is a combination of pegylated interferon and

ribavirin. Inadequate response rates, in particular for patients infected with

genotype 1 HCV, along with significant side effects of approved therapy, support

the medical need for improved treatment options. It is estimated that fewer than

5% of people with chronic HCV infection living in the U.S. are under treatment

today. Most infected individuals are unaware of their infection status and the

large majority of individuals who know their condition do not currently receive

drug therapy. There is also a growing number of individuals who have failed

interferon-based regimens who may be successfully treated with combinations of

two or more direct antivirals. It is expected that the next generation of

therapies for treatment of HCV will include small molecules, such as ANA598,

that directly act upon specific viral enzymes to inhibit viral replication.

These new therapies are expected to improve overall therapy by increasing cure

rates and potentially improving tolerability and convenience of treatment if

doses of currently used agents can be reduced or eliminated.

About Anadys

Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company

dedicated to improving patient care by developing novel medicines in the areas

of hepatitis C and oncology. For the treatment of chronic hepatitis C, the

Company is developing two potentially complementary agents, ANA598, a

non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug.

The Company is also developing ANA773 for the treatment of cancer.

Safe Harbor Statement

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 (i) the potential for fast track designation to

expedite the development of ANA598; (ii) the belief that ANA598 is one of the

few non-nucleoside polymerase inhibitors in clinical development for the

treatment of HCV; (iii) the potential for once-daily or twice-daily oral dosing

of ANA598; (iv) the ability of Anadys to transition into Phase II studies of

ANA598 during 2009; and (v) expectations regarding the evolution of the market

for HCV therapies. 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. For example, the results of

preclinical and early clinical studies may not be predictive of future results,

and Anadys cannot provide any assurances that ANA598 will not have unforeseen

safety issues, will have favorable results in future clinical trials, will

maintain fast track designation or will receive regulatory approval. In

addition, Anadys' results may be affected by risks related to competition from

other biotechnology and pharmaceutical companies, its effectiveness at managing

its financial resources, its ability to enter into collaborations around its

product candidates, its ability to successfully develop and market products,

difficulties or delays in its preclinical studies or clinical trials,

difficulties or delays in manufacturing its clinical trials materials, the scope

and validity of patent protection for its products, regulatory developments

involving its product candidates and its ability to obtain additional funding to

support its operations. Risk factors that may cause actual results to differ are

more fully discussed in Anadys' SEC filings, including Anadys' Form 10-K for the

year ended December 31, 2007 and Anadys' Form 10-Q for the quarter ended

September 30, 2008. 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.

http://www.anadyspharma.com