Biotech Values

[Preciouslife1]

More on IDENIX for anyone interested in doing more due diligence...IDIX.

http://library.corporate-ir.net/lib..._IDIX_Cowen.pdf

http://www.idenix.com/products/nm283.html
http://www.idenix.com/products/telbivudine.html
http://www.idenix.com/products/valtorcitabine.html

MODE OF ACTION

Valopicitabine is an orally bioavailable pro-drug of a novel ribonucleoside analog, and is an inhibitor of HCV and related viruses. Valopicitabine targets the virus-encoded RNA polymerase that is responsible for synthesizing viral RNA during replication. Valopicitabine appears to act in two ways: it inhibits the viral polymerase directly and it is incorporated into growing strands of viral RNA, which terminates RNA chain extension. In contrast, human RNA dose not appear to be affected by valopicitabine, thus normal cellular functions seem to be protected from potential toxicity. Valopicitabine is the first antiviral agent of this class to enter clinical trials for the treatment of hepatitis C.
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Valtorcitabine
Idenix is also conducting clinical trials of valtorcitabine, or val-LdC, a second drug candidate for the treatment of HBV. Valtorcitabine is being developed as a fixed dose combination with telbivudine for those patients for whom treatment with a single agent may not be adequate. We anticipate evaluating valtorcitabine in combination with telbivudine in a phase IIb clinical program which intiated in late 2004 and is currently underway. In laboratory studies and predictive animal models of HBV disease, telbivudine and valtorcitabine each demonstrate profound and highly specific antiviral activity against HBV. In these preclinical studies, the combination of the two agents have demonstrated even greater antiviral activity than either drug alone. Idenix is developing telbivudine and valtorcitabine in collaboration with Novartis Pharma AG under a development and commercialization agreement established in May 2003.

Telbivudine
Description
Telbivudine is an investigational new drug demonstrating marked antiviral activity against the hepatitis B virus (HBV) and is being evaluated clinically for treatment of patients with chronic hepatitis B. Telbivudine, the generic name for L-deoxythymidine (LdT), has demonstrated high selectivity for HBV. In clinical trials and non-clinical studies, telbivudine has demonstrated virtually no activity against other viruses or infectious pathogens, and has a favorable safety profile. In our phase III clinical trials, telbivudine is dosed orally once daily in a tablet form.

Mode of Action
Telbivudine is an HBV-specific nucleoside analog. Telbivudine specifically targets the viral DNA polymerase enzyme that is responsible for HBV replication. Telbivudine has demonstrated no activity against other viruses that cause human disease. This specificity will permit the treatment of persons co-infected with other viruses without an increased risk of contributing to resistance development for HIV or other viruses. Idenix believes these attributes will contribute to the value of this new agent in managing the different categories of patients with hepatitis B.

The chemical structure of telbivudine is the mirror image of thymidine, a naturally occurring nucleoside building block of DNA. We believe the HBV polymerase mistakenly recognizes telbivudine as if it were natural thymidine, incorporating it into HBV DNA resulting in chain termination and potent inhibition of viral replication. The more selective polymerase enzymes of the human body do not appreciably recognize or interact with telbivudine, thus protecting normal cellular functions from toxic effects. We believe that this high level of selectivity is responsible for the favorable safety of telbivudine in clinical trials.

CLINICAL TRIAL RESULTS

In a recently completed phase IIb clinical trial, one year of telbivudine treatment reduced HBV in the blood to undetectable levels (i.e. less than 200 particles/mL) in 61 percent of patients, significantly more than the 32 percent of patients who achieved this result with lamivudine, the current standard of care (p<0.05). The high degree of viral suppression provided by telbivudine is among the most significant of anti-HBV therapeutic agents in development. Additionally, in this clinical trial, serum ALT, a marker of HBV-related liver inflammation, normalized in 86 percent of telbivudine-treated patients, significantly greater than the 63 percent in the lamivudine group (p<0.05). We believe that this clinical trial demonstrated the importance of maximizing early viral suppression for improving clinical outcome. In all treatment groups, patients with the greatest degree of viral suppression early in the course of therapy (by 24 weeks) had the highest rates of seroconversion (a predictor of durable resolution of disease), ALT normalization (reduction of liver inflammation), and the lowest rate of drug resistance.

Safety & Tolerability
Telbivudine appears to be well tolerated in clinical trials. To date, there has been no pattern of patient discontinuations due to serious adverse events.

Clinical Development
An international phase III clinical trial, known as “the GLOBE study”, is ongoing and fully enrolled, including more than 1,350 patients and approximately 135 clinical centers. It is expected that the initial phase of this clinical trial will be completed in 2005, with submission of worldwide registration applications expected to begin by year-end 2005.


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