Sebvio Approved in China as New Treatment Option for Patients with Chronic HBV

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Sebvio Approved in China as New Treatment Option for Patients with Chronic

Hepatitis B

PR Newswire Europe (inc. UK Disclose) - Mar. 02, 2007

CAMBRIDGE, Mass., March 2 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals,

Inc. announced today that SEBIVO® (telbivudine) has received approval from

the Chinese State Food and Drug Administration (SFDA) as a once-a-day

treatment, taken orally with or without food, for the treatment of chronic

hepatitis B (CHB). CHB remains a significant global health care concern,

particularly in China where it affects more than 100 million people(1-3) -

representing about one-third of those infected worldwide.(2) SEBIVO is

expected to be available in China in April.

" The Chinese approval of telbivudine is positive news for the many CHB

patients in China, " said Dr. Calvin Q. Pan, MD, Director, Clinical

Research/Hepatology, Mount Sinai Services at Elmhurst Hospital in New York

City. " As a physician who treats many CHB patients in the U.S., it is good

to know that the patients in China will also have access to this new

treatment option. Now, Chinese patients may also benefit from telbivudine's

ability to provide early viral suppression, a primary goal of treatment. "

Telbivudine received regulatory approval in the United States from the Food

and Drug Administration (FDA) in October 2006 for the treatment of CHB in

adult patients with evidence of viral replication and active liver disease.

Telbivudine is called TYZEKA in the United States and is called SEBIVO in

all other countries. The approval of SEBIVO in China follows earlier

approvals in Canada, Australia, Switzerland and several countries in Asia

and Latin America. SEBIVO also recently received a positive opinion from the

European Medicines Agency's (EMEA) Committee for Medicinal Products for

Human Use (CHMP) recommending approval by the European Commission.

Worldwide regulatory submissions have been based primarily on one-year data

from the GLOBE study, the largest worldwide registration trial including

hepatitis B e-antigen (HBeAg)-positive and HBeAg-negative patients with CHB,

and the first to include patients from China. The study results demonstrated

that telbivudine provided potent viral suppression and high rates of PCR-

negativity after one year. An additional Chinese phase III trial, involving

332 adult Chinese patients with CHB, corroborated these findings and

supplemented the filing in China.

About the GLOBE Study

Data from the worldwide phase III clinical trial, known as the GLOBE study,

compared telbivudine to lamivudine, a commonly used antiviral therapy for

the treatment of CHB, in 1,367 patients. In the GLOBE study, 60 and 40

percent of HBeAg-positive patients and 88 and 71 percent of HBeAg-negative

patients achieved undetectable levels of HBV DNA (PCR-negativity) with

telbivudine and lamivudine, respectively, at 52 weeks. Additionally,

patients who achieved undetectable HBV DNA levels at 24 weeks were more

likely to undergo e-antigen seroconversion, PCR-negativity, normalize ALT,

and minimize resistance at one year.

The primary efficacy endpoint of the GLOBE study was therapeutic response at

one year, a composite endpoint coupling viral suppression (serum HBV DNA

suppression below 100,000 copies/mL) with either improved liver disease

markers (ALT normalization) or loss of detectable HBeAg. In HBeAg-positive

patients, therapeutic response was 75% (n=345/458) among patients treated

with telbivudine and 67% (n=310/463) for those patients treated with

lamivudine, while the response for HBeAg-negative patients was 75%

(n=167/222) vs. 77% (n=173/224), respectively.

In the GLOBE study, telbivudine was generally well tolerated with most

adverse experiences classified as mild or moderate in severity. Frequently

occurring adverse events (> 5%) for telbivudine v. lamivudine, respectively,

were upper respiratory tract infection (14% v. 13%), fatigue and malaise

(12% v. 11%), abdominal pain (12% v. 13%), nasopharyngitis (11% v. 10%),

headache (11% v. 14%), blood CPK increased (9% v. 7%), cough (7% v. 6%),

nausea and vomiting (7% v. 6%), influenza and influenza-like symptoms (7% v.

8%), post- procedural pain (7% v. 6%), diarrhea and loose stools (7% v. 5%)

and pharyngolaryngeal pain (5% v. 4%). Please see Important Safety

Information.

Idenix/Novartis collaboration

Idenix and Novartis Pharma AG are co-promoting TYZEKA/SEBIVO, for the

treatment of chronic hepatitis B, and co-developing valtorcitabine, a second

hepatitis B compound, and valopicitabine, a hepatitis C compound, under a

development and commercialization arrangement established in May 2003. Under

this agreement, Novartis and Idenix will co-promote TYZEKA/SEBIVO and, if

approved, valtorcitabine and valopicitabine in the United States, France,

Germany, Italy, Spain and the UK. Novartis has the exclusive right to

commercialize TYZEKA/SEBIVO, valtorcitabine and valopicitabine in the rest

of the world.

Important Information about Telbivudine

The following information about telbivudine is adapted from the U.S. Food

and Drug Administration's approved product label. It is anticipated that

similar language related to the product's indication and important safety

information will pertain to the product in global labeling.

Telbivudine is indicated for the treatment of chronic hepatitis B in adult

patients with evidence of viral replication and either evidence of

persistent elevations in serum aminotransferases (ALT or AST) or

histologically active disease. This indication is based on virologic,

serologic, biochemical and histologic responses after one year of treatment

in nucleoside-treatment-naïve adult patients with HBeAg-positive and

HBeAg-negative chronic hepatitis B with compensated liver disease. Full

prescribing information is available at http://www.tyzeka.com/.

Important Safety Information about Telbivudine -- Lactic acidosis and severe

hepatomegaly with steatosis, including fatal

cases, have been reported with the use of nucleoside analogues alone or

in combination with antiretrovirals. -- Severe acute exacerbations of

hepatitis B have been reported in

patients who have discontinued anti-hepatitis B therapy, including

telbivudine. Hepatic function should be monitored closely with both

clinical and laboratory follow-up for at least several months in

patients who discontinue anti-hepatitis B therapy. If appropriate,

resumption of anti-hepatitis B therapy may be warranted. -- Cases of

myopathy have been reported with telbivudine use several weeks

to months after starting therapy. Myopathy has also been reported with

some other drugs in this class. Physicians considering concomitant

treatment with these or other agents associated with myopathy should

weigh carefully the potential benefits and risks and should monitor and

advise patients to report any signs or symptoms of unexplained muscle

pain, tenderness or weakness, particularly during periods of upward

dosage titration. Telbivudine therapy should be interrupted if myopathy

is suspected, and discontinued if myopathy is diagnosed. -- Because

telbivudine is eliminated primarily by renal excretion, co-

administration of telbivudine with drugs that affect renal function may

alter plasma concentrations of telbivudine and/or the co-administered

drug. Dose interval adjustment is recommended in patients with

creatinine clearance < 50mL/min including those with ESRD on

hemodialysis. For patients on hemodialyis, telbivudine should be

administered after hemodialysis. -- The safety and efficacy of telbivudine

in liver transplant recipients

are unknown. If telbivudine treatment is determined to be necessary for

a liver transplant recipient who has received or is receiving an

immunosuppressant that may affect renal function, such as cyclosporine

or tacrolimus, renal function should be monitored both before and

during treatment with telbivudine. -- Patients should be advised that

treatment with telbivudine has not been

shown to reduce the risk of transmission of HBV to others through

sexual contact or blood contamination. -- Safety and effectiveness of

telbivudine in pediatric patients under the

age of 16 years have not been established. -- Creatine kinase (CK)

elevations were more frequent among subjects on

telbivudine treatment. Grade 3/4 CK elevations occurred in 9% of

telbivudine-treated patients and 3% of lamivudine-treated patients. -- The

optimal duration of treatment with telbivudine has not been

established. The relationship of initial treatment response to

outcomes such as hepatocellular carcinoma and decompensated cirrhosis

are unknown.

About Idenix

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, MA, is a

biopharmaceutical company engaged in the discovery and development of drugs

for the treatment of human viral and other infectious diseases. Idenix's

current focus is on the treatment of infections caused by hepatitis B virus,

hepatitis C virus and human immunodeficiency virus (HIV). For further

information about Idenix, please refer to http://www.idenix.com/.

Forward-looking statements

This press release contains " forward-looking statements " within the meaning

of The Private Securities Litigation Reform Act of 1995. Such

forward-looking statements can be identified by the use of forward-looking

terminology such as " commitment, " " may, " " promising, " " will, " or similar

expressions, or by express or implied discussions regarding potential

approvals of telbivudine in additional markets or potential future revenues

from telbivudine. Such forward-looking statements involve known and unknown

risks, uncertainties and other factors that may cause actual results to be

materially different from any future results, performance or achievements

expressed or implied by such statements. There can be no guarantees that

telbivudine will be approved for sale in any additional markets or that

revenues from the sale of telbivudine will reach any particular level. In

particular, management's expectations could be affected by unexpected

regulatory actions or delays, or government regulation generally; unexpected

clinical trial results, including additional analysis of existing clinical

data and new clinical data; the company's ability to obtain additional

funding required to conduct its research, development and commercialization

activities; the ability of the company to attract and retain qualified

personnel; government, industry, and general public pricing pressures;

competition in general; and the company's ability to obtain, maintain and

enforce patent and other intellectual property protection for telbivudine,

valopicitabine, its other product candidates and its discoveries. These and

other risks which may impact management's expectations regarding telbivudine

are described in greater detail under the caption " Risk Factors " in the

company's most recent quarterly report on Form 10-Q filed with the

Securities and Exchange Commission and other filings that the company makes

with the Securities and Exchange Commission.

All forward-looking statements reflect the company's expectations only as of

the date of this release and should not be relied upon as reflecting the

company's views, expectations or beliefs at any date subsequent to the date

of this release. Idenix anticipates that subsequent events and developments

may cause these views, expectations and beliefs to change. However, while

Idenix may elect to update these forward-looking statements at some point in

the future, it specifically disclaims any obligation to do so.

References

(1) Z Sun et. al. Prevention and control of hepatitis B in China. J Med

Virol 2002, 67:447-450.

(2) Lesmana LA, Leung NW, Mahachai V, et al. Hepatitis B: overview of the

burden of disease in the Asia-Pacific region. Liver Int 2006 Dec; 26 Suppl

2: 3-10.

(3) Guan Z, Dong Z, Wang Q, et al. Cost of chronic hepatitis B infection in

China. J Clin Gastroenterol 2004 Nov; 38(10 Suppl): S175-S178.

Idenix Pharmaceuticals' Contacts:

Media: Teri Dahlman (617) 995-9905

Investors: Amy Sullivan (617) 995-9838

Idenix Pharmaceuticals, Inc.

Contact: For media, Teri Dahlman, +1-617-995-9905, or investors, Amy

Sullivan, +1-617-995-9838, both for Idenix Pharmaceuticals, Inc.

Web site: http://www.idenix.com/

http://www.tyzeka.com/

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