Scientists have harnessed genetic technology to develop a potentially potent treatment for the B strain of the viral liver disease hepatitis.

They have found a way to inject tiny molecules into the blood that switch off genes that play a vital role in the reproduction of the virus.

The jabs have cut viral levels in infected animals by around 90%.

The Nature Biotechnology study, by Sirna Therapeutics, raises hopes of new drugs to tackle the disease.

It is interesting, but we are long, long way from clinical application – Dr Mark Thursz

Hepatitis B is the most common serious liver infection in the world. It is thought to be the leading cause of liver cancer.

The World Health Organization estimates that hepatitis B infections lead to more than one million deaths every year.

There are vaccines to protect against infection, but drug treatments are expensive and relatively ineffective.

Protective fat

The researchers incorporated the key molecules - called small interfering RNAs (siRNAs) into fat-like particles that protect them from attack by digestive enzymes in the blood.

These enzymes normally degrade RNA molecules in cells or the circulation.

Not only did this increase the stability when injected into mice, it also reduced the dose needed for therapeutic effect.

Previous studies suggested that the amounts of siRNA needed to achieve a therapeutic effect in people far exceed safe levels of exposure.

The researchers say their work paves the way for the development of human jab that is both safe and effective.

In their experiments, mice carrying replicating hepatitis B virus were given daily doses of encapsulated siRNAs.

The new formulation was much more effective than previous attempts to use unprotected siRNAs - and worked at much lower doses.

It also showed signs of blocking the virus when administered just once a week.

The researchers plan to begin the first human trials next year.

Lead researcher Dr David Morrissey said: "Our research shows low doses of siRNA introduced into an animal's circulatory system can reach its intended target, in this case hepatitis B virus in the liver, and result in a very significant reduction of virus levels.

"Based on this, we are confident we will be able apply these approaches to developing efficacious therapies for people."

Dr Mark Thursz, secretary of the British Association for Study of the Liver, told the BBC News website it was a major achievement to translate siRNA technology from a cell culture into a living animal.

However, he warned that there was still a long way to go before it could be applied to humans.

"The problem is that you might get lots of problems with toxicity when you scale up to a human-sized animal from a mouse-sized animal," he said.

Dr Thursz said other technologies - such as therapeutic vaccination - had failed to work in humans despite producing promising effects in mice.

Professor Roger Williams, consultant hepatologist at University College London, agreed that a human application was a long way off.

But he said potentially the therapy might benefit patients who did not respond to current anti-viral drugs, or those who carried the virus without showing any symptoms.

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July 26th, 2005


Hepatitis-C New Threat to Nagaland
Source: http://www.telegraphindia.com

AIDS is not the only threat for intravenous drug users in Nagaland.

A survey conducted by the Indian Council of Medical Research in the state capital revealed that Hepatitis-C might soon take over as the bigger killer.

Eleven cases of Hepatitis-C have been reported by the council following the survey.

Of the 28 blood samples collected by the medical council, 11 tested Hepatitis-C positive while only one had the HIV virus.

All the respondents of the survey had contracted the disease through infected needles.

The highly-contagious disease can be transmitted to a baby from an infected mother, through contaminated food and water and even by sharing daily articles like razors or toothbrushes of an infected patient. Vaccine for Hepatitis-C is still beyond the reach of the common man. Even the pathological tests required for detecting the disease are expensive.

“It is alarming,” said Kumuni Kathipri, project director of the Nagaland State AIDS Control Society. The threat has spilled over into Manipur and Mizoram, forcing the National AIDS Control Organisation to take notice.

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IAS: Hepatitis C Treatment Should Last for 48 Weeks in HIV Co-infected Patients, Study Shows
http://www.aidsmap.com
Chris Gadd

HIV-positive patients co-infected with the hepatitis C virus (HCV) should be treated with anti-HCV therapy for 48, and not 28 weeks, according to the results of an Italian randomised controlled trial presented at the Third International AIDS Society Conference on HIV Pathogenesis and Treatment in Rio de Janeiro on July 25th.

Treatment of HCV in co-infected patients with a combination of peginterferon alfa and ribavirin is known to be effective in clearing HCV infection in most patients. However, some uncertainty surrounds the optimal duration of therapy.

For patients with the varieties of HCV called genotypes 2 or 3, a course of anti-HCV therapy of 48 weeks is recommended. However, some experts have called this into question by advocating the use of HCV drugs for only 24 weeks, as is recommended for HIV-negative patients. In contrast, others have found that this shorter treatment results in an elevated risk of relapse after HCV therapy is stopped.

To examine the effect of treatment duration in HIV co-infected patients, researchers from Italy recruited 128 patients with CD4 cell counts above 200 cells/mm3 and HIV viral loads below 10,000 copies/ml, or who had been on highly active antiretroviral therapy for at least six months.

All of the patients had HCV infection confirmed by a blood test and a liver biopsy at least three years prior to the start of the study. Although it was restricted to those with genotypes 2 or 3, Massimo Puoti, presenting, claimed that almost all of the patients had genotype 3, as genotype 2 is very rare among HIV co-infected patients in Italy.

For the first 24 weeks, all of the patients received a combination of 180 µg peginterferon alfa 2a (Pegasys) once a week and ribavirin at a dose of 800 to 1200mg once a day, depending on body weight. At the end of this period, 74 of the 82 patients who had not dropped out of the study had become HCV-negative. These patients were then randomised either to receive a further 24 weeks of anti-HCV therapy or to remain off treatment.

Twenty-four weeks later, 15 (40%) of the 38 patients who stopped treatment after 28 weeks had relapsed, following detection of HCV in their blood.

In contrast, only two (10%) of the 20 patients who were still HCV-negative after completing 48 weeks of treatment had relapsed after 24 weeks. This was significantly lower than in the patients who were treated for 28 weeks (p = 0.02).

Using a multivariate analysis, the investigators calculated that the patients treated for 48 weeks were 5.46 times more likely to achieve a ‘sustained virological response’ (SVR), defined as persistent HCV negativity 24 weeks after the end of treatment.

Other factors that were significantly associated with SVR were and having a higher number of platelets in the blood (OR = 1.01; p = 0.019) and being HCV-negative after four weeks of treatment (odds ratio [OR] = 5.57; p < 0.001). However, the researchers found that a successful response at four weeks in an individual patient did not mean that a shorter duration of treatment would necessarily be possible.

Dr Puoti acknowledged that his study included a high number of patients who discontinued therapy early. These drop-outs were mostly due to side-effects and intolerance of HCV therapy, with more than half of these patients relapsing to being HCV-positive after leaving the study.

However, he said that the incidence of side-effects was lower after the first 28 weeks of HCV treatment.

“These results suggest that the optimal duration of treatment in HIV-positive [patients] with HCV genotypes 2 or 3 is at least of 48 weeks,” he concluded.

Reference

Zanini B et al. The optimal duration of treatment for HIV-infected patients with chronic hepatitis C (CHC) and genotype 2 or 3 is 48 weeks: results of a randomised controlled trial. Third International AIDS Society Conference on HIV Pathogenesis and Treatment, Rio de Janeiro, abstract MoPpLB0103, 2005.

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GlobeImmune Initiates Phase 1b Study of GI-5005 for Chronic Hepatitis C Infection
http://biz.yahoo.com

DENVER, July 26 /PRNewswire/ -- GlobeImmune, Inc., a biopharmaceutical company that discovers, develops and manufactures immunotherapeutic products known as Tarmogens(TM) to treat cancer and infectious disease, today announced that it has initiated a Phase 1b study of GI-5005, a Tarmogen for the treatment of chronic hepatitis C infection (HCV). This study is being conducted under an Investigational New Drug application (IND) that was filed with the U.S. Food and Drug Administration in March 2005.

The Phase 1b study is a double-blind, placebo controlled, dose-escalation, multi-center trial evaluating the safety, immunogenicity, and efficacy of GI- 5005, a Tarmogen expressing a NS3-Core fusion protein. NS3 and Core are HCV protein antigens that are expressed in infected cells and are essential for virus replication. GI-5005 has demonstrated robust activity in preclinical models of HCV. Because Tarmogens elicit a balanced immune response that is similar to the response occurring in the minority of individuals who successfully clear primary hepatitis C infection, the Company believes that the GI-5005 Tarmogen may represent a successful approach to treating this difficult disease.

"Hepatitis C is an area of major unmet medical need," said Timothy C. Rodell, M.D., CEO of GlobeImmune. "We are hopeful that GI-5005 will ultimately be able to treat the significant proportion of patients for whom there is currently no effective therapy. This is a significant event for GlobeImmune, as this milestone represents the second Tarmogen product to enter human clinical trials in 18 months and the first clinical trial of a Tarmogen for the treatment of an infectious disease."

Chronic hepatitis C infection, a viral liver disease, is a global health epidemic. Currently, there are approximately 170 million people worldwide who are infected with the hepatitis C virus. Of these, 4-5 million live in the United States with an additional 5 million living in Western Europe. Approximately 20-30% of all hepatitis C patients will face life threatening complications as a result of their disease. Hepatitis C accounts for 20% of cases of acute hepatitis, 70% of cases of chronic hepatitis, 40% of cases of end-stage cirrhosis, 60% of cases of hepatocellular carcinoma (liver cancer) and 30% of liver transplants in the United States.

The incidence of new symptomatic infections with hepatitis C has been estimated to be 13 cases/100,000 persons annually. For every one person that is infected with the AIDS virus, there are more than four infected with hepatitis C. The Centers for Disease Control Prevention (CDC) estimate that there are up to 230,000 new hepatitis C infections in the United States every year. Currently, 8,000 to 10,000 deaths each year are attributed to the disease.

ABOUT GLOBEIMMUNE

GlobeImmune, Inc., is an emerging biopharmaceutical company pioneering the discovery, development and manufacturing of potent, targeted molecular immunotherapies called Tarmogens for the treatment of cancer and infectious diseases. The Company's lead products are in Phase 1 testing for the treatment of hepatitis C infection and for the treatment of cancers of the lung and gastrointestinal tract. Tarmogens are whole, heat-killed recombinant Saccharomyces cerevisiae yeast genetically modified to express one or more protein antigens that stimulate the immune system against diseased cells.

For additional information, please visit the Company's website at www.globeimmune.com.

Source: GlobeImmune, Inc.

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July 28th, 2005


Telbivudine Achieves Primary Endpoint in Phase III GLOBE Trial, Largest Ever Registration Trial in Hepatitis B
SourceURL:http://biz.yahoo.com

* Idenix and Novartis anticipate first regulatory filing by the end of 2005

* Complete GLOBE results to be submitted for presentation at American Association for the Study of Liver Diseases meeting in November 2005

CAMBRIDGE, Mass., July 28 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News) and Novartis Pharma AG announced today that the phase III GLOBE registration trial for telbivudine successfully reached its primary, composite efficacy endpoint of therapeutic response at one year in chronic hepatitis B patients. This endpoint, which was designed to assess if telbivudine was at least as effective as lamivudine, evaluated the combination of viral suppression (serum HBV DNA suppression below 100,000 copies/mL) coupled with either improved liver function (ALT normalization) or loss of detectable hepatitis B e-antigen (HBeAg).

The largest hepatitis B registration trial to date, GLOBE enrolled more than 1,350 patients in over 130 medical centers worldwide. The ongoing trial is evaluating the safety and efficacy of telbivudine compared to lamivudine in patients with HBeAg-positive and HBeAg-negative compensated chronic hepatitis B for two years of treatment in two daily treatment regimens: telbivudine 600 mg or lamivudine 100 mg.

The one-year analysis of this trial will be the primary data used for preparing the marketing registration applications. Idenix and Novartis plan to file with the U.S. Food and Drug Administration (FDA) by the end of 2005 for marketing approval of telbivudine for the treatment of chronic hepatitis B. Worldwide marketing filings, including the filing that will be submitted to the European Medicines Agency (EMEA), are expected in the first quarter of 2006. Idenix and Novartis are co-developing telbivudine.

The World Health Organization (WHO) has estimated that approximately 350 million people, or 5% of the world's population, are chronically infected with hepatitis B virus (HBV). Current treatment options are often associated with limited efficacy, poor tolerability or resistance concerns, and new therapeutic options are needed to respond to the significant unmet need in treating chronic hepatitis B.

"We are very pleased that telbivudine met the primary endpoint in the phase III GLOBE study and may provide an important new therapeutic option for patients with chronic hepatitis B," commented Nathaniel Brown, M.D., executive vice president of clinical development and chief medical officer of Idenix. "Bringing our first clinical candidate through this stage of development is a major milestone for Idenix, particularly given the large international scope of the GLOBE study."

The companies anticipate that complete data from the GLOBE study will be submitted for presentation to the American Association for the Study of Liver Diseases (AASLD) meeting in San Francisco, California, November 11-15, 2005.

More About Telbivudine

Telbivudine is a specific and selective, oral, once-daily nucleoside that is unique in its preferential inhibition of 2nd strand HBV DNA synthesis. This distinct mechanism of action may be responsible for the rapid and profound viral suppression associated with telbivudine treatment.

The GLOBE study results continue to support a favorable overall safety profile for telbivudine with no substantial safety issues being identified to date through the combined two years of treatment in the phase IIb clinical trial and in the phase III clinical program to date. The most frequently reported adverse events, regardless of attributability to study treatment, were upper respiratory infection and fatigue, which were equally common for telbivudine (14% and 12 %, respectively) and lamivudine (13% and 10% respectively).

An additional phase III trial is evaluating the safety and efficacy of telbivudine compared to lamivudine in HBeAg-positive and HBeAg-negative patients with decompensated chronic hepatitis B. This ongoing trial has enrolled 87 patients to date.

About Hepatitis B

Chronic Hepatitis B is caused by a virus that attacks the liver. The virus, which is called hepatitis B virus (HBV), can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death. The WHO estimates that annually over 50 million people become infected with HBV and that more than one million individuals die from HBV-related chronic liver disease.

Idenix/Novartis Collaboration

Idenix is developing its hepatitis B clinical product candidates, telbivudine and valtorcitabine, in collaboration with Novartis Pharma AG under a development and commercialization arrangement established in May 2003. The collaboration arrangement further provides that Novartis and Idenix will co- promote in the United States, France, Germany, Italy, Spain and the UK those product candidates Novartis has licensed, including telbivudine and valtorcitabine, that are approved for marketing. Novartis holds the exclusive license to telbivudine and valtorcitabine in the rest of the world.

The collaboration also provides Novartis with an exclusive option to license and collaborate with Idenix in the development and commercialization of other product candidates in Idenix's portfolio, including valopicitabine (NM283), a direct antiviral hepatitis C product candidate.

About Idenix

Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization 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). Idenix's headquarters are located in Cambridge, Massachusetts. The company also has drug discovery and development operations in Montpellier, France and drug discovery operations in Cagliari, Italy. 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 "will be," "plan to," "expected," "anticipates," or similar expressions, or by express or implied discussions regarding the potential therapeutic benefits, the potential development or the potential future sales of telbivudine. Such forward-looking statements are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. There can be no guarantee that telbivudine will be approved for sale in any market, or that telbivudine will achieve any particular level of sales. Any such commercialization can be affected by, among other things, uncertainties relating to clinical trials; new clinical data with respect to telbivudine, or additional analysis of existing clinical data; uncertainties regarding the timing and success of submission, acceptance and approval of regulatory filings; the company's dependence on its collaboration with Novartis Pharma AG; 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; competition in general; government, industry, and general public pricing pressures; the company's ability to obtain, maintain and enforce patent and other intellectual property protection for telbivudine and its related discoveries; as well as other factors discussed under the caption "Factors That May Affect Future Results" in the company's quarterly report on Form 10-Q for the quarter ended March 31, 2005 and 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.

Contact:

Idenix Pharmaceuticals, Inc.
Media: Teri Dahlman (617) 995-9905
Investors: Amy Sullivan (617) 995-9838

Source: Idenix Pharmaceuticals, Inc.

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InterMune, Array BioPharma expand Hepatitis C Drug Discovery Collaboration
SourceURL:http://www.pharmabiz.com/

InterMune, Inc. and Array BioPharma Inc. have expanded their current collaboration to discover and develop novel small molecule inhibitors of the Hepatitis C Virus (HCV) NS3/4 protease.

The program, which began in 2002, has produced several promising candidates that InterMune is advancing toward IND-enabling studies. In addition to extending the current agreement, the program has been expanded to allow Array and InterMune to enhance their combined discovery efforts. Array will continue to conduct process research and cGMP scale-up of drug candidates to support clinical development.

Under the terms of the agreement, InterMune will fund drug discovery, preclinical and process development at Array. InterMune maintains responsibility for clinical development and commercialization of the resulting products. Array will be entitled to receive milestone payments based on the selection and progress of clinical drug candidates, as well as royalties on net sales of products derived from the collaboration. In June 2004, Array received a milestone payment from InterMune for creating the first lead compound for this program. Other terms were not disclosed, a release from InterMune said.

Dan Welch, CEO and president of InterMune said, "To date, this program has resulted in drug candidates which we believe have the potential to provide superior treatment for HCV patients. We have expanded the collaboration to accelerate the development of this important class of novel HCV inhibitors. In addition to our protease inhibitor program, we are advancing our late stage HCV pipeline in PEG-nonresponders and growing our marketed brand, Infergen (interferon alfacon-1) for the re-treatment of chronic HCV."

According to the Centres for Disease Control, an estimated 3.9 million Americans have been infected with HCV, of whom 2.7 million are chronically infected, and the prevalence of chronic HCV is increasing.

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Fight Looming over Safe-Injection Sites
SourceURL:http://ottawa.cbc.ca
CBC News

A fight is shaping up over a plan to study the need for a safe-injection site for intravenous drug users in Ottawa.

The study, to be headed up by a professor from the University of Ottawa's epidemeology department, will look at whether providing such sites would help stop the spread of HIV and hepatitis-C infections.

A recent report revealed that one-fifth of the city's addicts are HIV-positive, and three-quarters have hepatitis C.

FROM JULY 26, 2005: City considers safe-injection site

Nonetheless, the call for a study is facing opposition, both from city councillors and from people who treat drug addicts.

Lynn Atterbury, the program director at Rideauwood Addiction and Family Services, is worried that any new initiatives would divert much-needed money from existing treatment programs.

Atterbury says her agency established a waiting group for those trying to get assessed for treatment. They meet once a week, and a counsellor encourages them to hang in until a spot opens up.

Now, she says, demand is so great that there's a waiting list to join the waiting group.

"I would say, typically, we have anywhere from 20 to 30 people waiting just to get into the initial wait-list group," Atterbury said.

"They have a wait of probably eight weeks or longer to get in, and some of them, of course, will just drop out."

While Atterbury understands the need for harm-reduction initiatives like safe-injection sites, she doesn't want to see money earmarked for treatment diverted to set up new programs.

She says Rideauwood had 3,000 people seek its help last year, which was almost twice as many as it was able to serve.

Coun. Rick Chiarelli agrees. He says, even if the study finds that Ottawa needs a safe-injection site, he won't vote in favour of it.

"Our priority has to be a comprehensive strategy that reduces drug use," he said. "Any money spent on these other things is diverting money away from solutions."

But Coun. Alex Cullen says Ottawa has a responsibility to HIV-positive drug users, despite perceptions that a safe-injection sites condone drug use.

"What you do when you have a drug [population] with a high risk of AIDS and hep C? You want to engage in methods that control spread of diseases," Cullen said.

Safe-injection sites have been an issue right across the country. Health Canada offered to fund three pilot projects, but only Vancouver asked for one.

In Toronto, the issue has been mulled over for 10 years without any decision being made.

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Idenix Pharmaceuticals Reports Second Quarter and Six Month Financial Results
SourceURL:http://biz.yahoo.com

-- Initial results indicate that telbivudine has met the primary endpoint in the phase III GLOBE study --

CAMBRIDGE, Mass., July 28 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News), a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases, today reported unaudited financial results for the second quarter and six months ended June 30, 2005.

For the second quarter ended June 30, 2005, Idenix reported total revenues of $16.1 million, compared with total revenues of $42.8 million in the second quarter of 2004. Total revenues include reimbursement by Novartis of expenses incurred by Idenix in connection with the development of telbivudine and valtorcitabine, Idenix's drug candidates for the treatment of hepatitis B, and amortization of the up-front fees paid to Idenix in May 2003 when Novartis licensed Idenix's hepatitis B drug candidates. In the 2004 quarter, total revenues also included a $25 million milestone payment received from Novartis related to the successful completion by Idenix of a phase I clinical trial of valopicitabine, or NM283, Idenix's lead drug candidate for the treatment of hepatitis C. Idenix reported a net loss of $13.4 million or a loss of $0.28 per diluted share for the second quarter ended June 30, 2005, compared to net income of $21.0 million, or $0.53 per diluted share for the second quarter ended June 30, 2004.

For the six months ended June 30, 2005, Idenix reported total revenues of $31.0 million, compared with total revenues of $59.5 million for the six months ended June 30, 2004. The company reported a net loss of $22.7 million, or a loss of $0.47 per diluted share for the six months ended June 30, 2005, compared with net income of $15.1 million, or $0.39 per diluted share for the six months ended June 30, 2004.

The profitability experienced by the company for the quarter ended and six months ended June 30, 2004 was due to the recognition of the $25 million milestone payment received from Novartis during the second quarter of 2004. At June 30, 2005, Idenix's cash, cash equivalents and marketable securities totaled $129.1 million.

Business Highlights

"We have achieved significant milestones in our hepatitis B and hepatitis C development programs over the last three months," said Jean-Pierre Sommadossi, chairman and chief executive officer of Idenix. "Most significantly, as we reported in a separate press release today, the initial data indicate that telbivudine has met the primary efficacy endpoint in the 1,370 patient phase III GLOBE study. We anticipate finalizing the GLOBE data set shortly and plan to submit the complete data as a late-breaker abstract to the American Association for the Study of Liver Diseases for presentation at its annual meeting in November."

Additionally, the following accomplishments were realized by Idenix over the last three months:

* The company presented 2-year phase IIb telbivudine data at the 2005 Digestive Disease Week annual meeting that further demonstrated the correlation between early and profound viral suppression and markers of improved clinical outcomes.

* The company completed enrollment (with 190 patients) of the phase IIb clinical trial of valopicitabine in treatment refractory patients. This clinical trial, which has been extended to 48 weeks, is a head-to-head trial comparing the combination of valopicitabine plus Pegasys® to ribavirin plus Pegasys® in hepatitis C genotype 1 patients who have previously failed at least 3 months of treatment with pegylated interferon plus ribavirin, the current standard therapy. Idenix expects to report preliminary clinical data from this phase IIb trial in the fall of 2005 and currently anticipates initiating a phase III clinical trial in this patient population in the first half of 2006.

* The company initiated the phase IIb trial of valopicitabine in treatment-naive hepatitis C genotype 1 patients at clinical sites in late July. This trial is designed to quantitatively assess the antiviral dose-response relationship for valopicitabine in treatment regimens comprising combinations of Pegasys® with various valopicitabine dosing regimens. The goal of this study is to identify the optimal combination regimen (valopicitabine plus pegylated interferon) for further study in phase III trials in treatment naïve patients.

2005 Expectations

Based on the expected timing and cost of current and anticipated clinical trials and the planned growth of Idenix's commercial operations, the company currently expects its net use of cash to be between $70 million and $80 million in 2005, which would result in 2005 year-end cash, cash equivalents and marketable securities of between $77 million and $87 million.

Conference Call Information

Idenix will hold a conference call today at 4:30 p.m. Eastern time. Company management will review financial results, provide an update on ongoing clinical trials, review 2005 corporate milestones and discuss updated financial guidance. A live webcast of the call will be available on the company's website http://www.idenix.com. Please log in approximately 10 minutes before the call to ensure a timely connection.

About Idenix

Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News) is a biopharmaceutical company engaged in the discovery, development and commercialization 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). Idenix's headquarters are located in Cambridge, Massachusetts. The company also has drug discovery and development operations in Montpellier, France and drug discovery operations in Cagliari, Italy. 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 "anticipate," "plan to," "expects," or similar expressions or by express or implied discussions regarding potential therapeutic benefits and successful development of telbivudine, valopicitabine and the company's other product candidates. Such forward-looking statements are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. These risks and uncertainties relate to the results of clinical trials and other studies with respect to telbivudine, valopicitabine and the other product candidates that the company has under development; the timing and success of submission, acceptance and approval of regulatory filings; the company's dependence on its collaboration with Novartis Pharma AG; 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; 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 are described in greater detail under the caption "Factors That May Affect Future Results" in the company's quarterly report on Form 10-Q for the quarter ended March 31, 2005 and 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.

Pegasys® is a registered trademark of Hoffmann-La Roche.

Contact:

Idenix Pharmaceuticals, Inc.
Media: Teri Dahlman (617) 995-9905
Investors: Amy Sullivan (617) 995-9838

Source: Idenix Pharmaceuticals, Inc.

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July 29th, 2005


West Nile Virus Detected in Blood Donated in Ottawa: Canadian Blood Services
Canadian Press

OTTAWA (CP) - A unit of blood donated earlier this week by a resident of eastern Ontario has tested positive for West Nile virus, Canadian Blood Services said Thursday.

It's the first positive test for the mosquito-borne disease this year, the agency said. "The donor and officials from the Ottawa and Eastern Ontario Public Health Units have been notified of the test results," Blood Services said in a statement.

"The unit of donated blood has been withdrawn from inventory and was not shipped to a hospital for transfusion. The blood donor will not be eligible to donate again for 56 days."

The blood donation was made in Ottawa. Because of the positive test result, added precautions are taking place in the Ottawa and Eastern Ontario Public Health Units.

As of Wednesday, blood donations in the area will be subject to single unit testing - in other words, each individual unit of blood is tested for the virus. Ordinarily, mini-pool testing takes place, with six units pooled for testing at one time.

"Single unit testing is believed to be able to identify extremely low levels of virus in blood donations from people who have just become infected," the agency said. After a two-week period, the region will go back to mini-pool testing if there are no new positive donors reported.

Every blood donation has been tested for West Nile virus since the summer of 2003. More than 1.9 million blood donations have been checked between July 1, 2003 and July 24 of this year.

Fourteen positives were detected in 2003, but there were no positives at all in 2004.

"We want donors and recipients to continue to feel confident in their blood system," Dr. Graham Sher, CEO of Canadian Blood Services, said in a release.

"A greater risk than West Nile virus is that Canadians will not continue to donate and there will be a blood shortage."

Earlier this week, Saskatchewan officials said they were investigating the province's first possible human case of West Nile virus this year. Preliminary tests on a Regina woman in her 40s who was showing mild symptoms of the disease came back positive. But further testing is needed to confirm the result.

Saskatchewan had five human cases of the virus last year, but that was down sharply from 2003, when more than 900 people tested positive and six people died.

KENILWORTH, N.J., July 29 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News) today reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of revised dosing instructions which allow a shorter, 24-week course of weight-based PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800 - 1,200 mg) daily combination therapy among a subgroup of patients with hepatitis C virus (HCV) genotype 1 infection and low viral load (< 600,000 IU/ml). A shorter 24-week course of therapy can be considered for these patients who have achieved rapid virologic response, defined as undetectable virus (HCV-RNA negative) at week 4 of treatment that is maintained through week 24. A 92 percent sustained virologic response was achieved with 24 weeks of treatment among the 41 percent of patients who met the criteria for early response.

PEGINTRON and REBETOL combination therapy was previously approved in the EU for a 48-week course of therapy for all patients with genotype 1 who exhibit virological response at week 12. Approval of this shorter PEGINTRON and REBETOL combination treatment regimen cuts by half the duration of therapy for a subset of hepatitis C patients with genotype 1 and low viral load. This is the only treatment regimen approved in the European Union (EU) for a 24-week course of therapy in certain genotype 1 patients.

The CHMP recommendation serves as the basis for a European Commission approval of this labeling change. A Commission Decision will result in Marketing Authorization with unified labeling that will be valid in the current EU 25 member states as well as in Iceland and Norway.

"The important results of this clinical study with PEGINTRON and REBETOL reflect the ongoing efforts of Schering-Plough to define optimal dose and treatment schedules for specific HCV patient groups," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute.

Study Results

The recommended labeling change for PEGINTRON and REBETOL is based on results of a clinical study involving 235 patients with HCV genotype 1 and low viral load who received 24 weeks of combination therapy with weight-based PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800 - 1,400 mg daily); only two patients weighing >105 kg received the 1,400 mg dose). In the study, 41 percent of patients (97/235) had undetectable plasma HCV-RNA levels at week 4 and week 24 of therapy. Patients in this subgroup achieved a 92 percent (89/97) rate of sustained virological response (SVR). The high sustained response rate in this group of patients was identified in an interim analysis and prospectively confirmed.

Genotype 1 virus is the most common worldwide, the most difficult to treat successfully and accounts for about 70 percent of HCV infections among European patients overall, varying by geography. For patients with HCV genotypes 2 or 3, the EU labeling for PEGINTRON recommends that all patients be treated for 24 weeks. Patients infected with HCV genotype 4 are considered harder to treat and generally 48 weeks of therapy is recommended.

About PEGINTRON and REBETOL Combination Therapy

PEGINTRON and REBETOL combination therapy for chronic hepatitis C was approved in the European Union (EU) in March 2001. The recommended dose in the EU for combination therapy is PEGINTRON 1.5 mcg/kg/once weekly plus REBETOL 800-1,200 mg daily, adjusted to body weight. PEGINTRON had previously received centralized marketing authorization in the EU and is marketed as a monotherapy in cases of intolerance or contraindication to ribavirin for the treatment of adult patients with chronic hepatitis C.

PEGINTRON, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy dosed according to patient body weight that is designed to achieve an effective balance between antiviral activity and elimination half-life. REBETOL is an oral formulation of ribavirin, a synthetic nucleoside analog with broad-spectrum antiviral activity.

Chronic hepatitis C is estimated to affect more than 10 million people in major world markets, including 5 million in Europe. It is a leading cause of chronic liver disease and one of the most common reasons for liver transplant in Europe.

Important Information Regarding U.S. Labeling for PEG-INTRON and REBETOL

WARNING

Alpha interferons, including PEG-INTRON, cause or aggravate fatal or life- threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping PEG-INTRON therapy.

Ribavirin causes hemolytic anemia. Anemia associated with REBETOL therapy may exacerbate cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated.

REBETOL and combination REBETOL/PEG-INTRON therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy. REBETOL and combination REBETOL/PEG-INTRON therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (at least two reliable forms) during treatment and during the 6- month post-treatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064.

PEG-INTRON

There are no new adverse events specific to PEG-INTRON as compared to INTRON® A (interferon alfa-2b, recombinant) for Injection, however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEG-INTRON were "flu-like" symptoms, occurring in approximately 50% of patients, which may decrease in severity as treatment continues. Application site disorders were common (47%), but all were mild (44%) or moderate (4%) and no patient discontinued, and included injection site inflammation and reaction (i.e., bruise, itchiness, irritation). Injection site pain was reported in 2% of patients receiving PEG-INTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEG-INTRON.

Psychiatric adverse events, which include insomnia, were common (57%) with PEG-INTRON, but similar to INTRON A (58%). Depression was most common at 29%. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1% of patients during or shortly after completing treatment with PEG-INTRON.

PEG-INTRON/REBETOL is contraindicated in patients with autoimmune hepatitis, decompensated liver disease, and in patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).

The following serious or clinically significant adverse events have been reported at a frequency less than 1% with PEG-INTRON or interferon alpha: severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.

In the PEG-INTRON/REBETOL combination trial the incidence of serious adverse events was 17% in the PEG-INTRON/REBETOL groups compared to 14% in the INTRON A/REBETOL group. The incidence of severe adverse events in the PEG-INTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEG-INTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEG-INTRON (1.5 mcg/kg)/ REBETOL and in 34% of those receiving INTRON A/REBETOL.

REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.

Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company's Web site is www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: This press release contains "forward- looking statements" within the meaning of the Securities Litigation Reform Act of 1995, related to the market for PEG-INTRON and REBETOL combination therapy and the market for drugs to treat hepatitis C. Forward-looking statements relate to expectations or forecasts of future events and not to historical information. Schering-Plough does not assume the obligation to update any forward-looking statement. There are no guarantees about the market performance of PEG-INTRON and REBETOL combination therapy, Schering-Plough stock or Schering-Plough's business. Actual results may vary materially from Schering-Plough's forward-looking statements due to many factors and uncertainties, which include the market acceptance of PEG-INTRON and REBETOL combination therapy, trade buying patterns, the introduction and performance of competitive products in the market, legislation that may impact the pricing/availability of PEG-INTRON and REBETOL combination therapy and other items. For further details about these factors and other risks and uncertainties that may impact Schering-Plough's forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the company's second quarter 2005 10-Q.

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