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IDENIX PHARMACEUTICALS, INC. From S-1 1/27/04 OUR BUSINESS Idenix is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Since our inception in May 1998, our focus has been on the treatment of infections caused by hepatitis B virus, or HBV, hepatitis C virus, or HCV, and human immunodeficiency virus, or HIV. We believe that our drug candidates will have significant advantages over, and will address substantial therapeutic limitations that exist with, currently approved therapies. Such limitations include inadequate antiviral potency, the emergence of viral strains resistant to drug therapies and patient non-compliance resulting from drug-related adverse side effects and inconvenient dosing regimens. We believe that large market opportunities exist for improved treatments that address these limitations. Our lead drug candidate, telbivudine, is being evaluated for the treatment of chronic hepatitis B, an inflammatory liver disease associated with chronic HBV infection. We believe that the annual worldwide market for chronic hepatitis B antivirals will exceed $1 billion by 2009. In May 2003, we initiated an international phase III clinical trial of telbivudine. If the data from this phase III clinical trial are positive, we expect to file a new drug application, or NDA, with the U.S. Food and Drug Administration, or FDA, in late 2005 for marketing approval of telbivudine as an oral, once-a-day treatment of chronic hepatitis B. Additionally, in February 2004 we expect to begin enrollment of patients with decompensated liver disease in a second phase III clinical trial. This clinical trial, which is expected to enroll 280 patients, is being undertaken to provide additional data in support of the application for approval to market telbivudine that we expect to file beginning in 2005. While we anticipate that telbivudine will successfully treat a majority of patients with chronic hepatitis B, treatment with more than one therapeutic agent may be required to successfully treat a subset of the HBV patient population. For patients who do not experience optimal early antiviral effects with single-agent therapy, we are developing a second HBV drug candidate, valtorcitabine, which we believe may be effective in combination therapy with telbivudine. In mid 2004, we expect to initiate a phase IIb clinical trial of the combination of valtorcitabine with telbivudine. Our lead hepatitis C drug candidate, NM 283, a nucleoside analog, is currently being evaluated in a phase I/II clinical trial. We believe that the annual worldwide market for chronic hepatitis C therapeutics currently exceeds $3 billion. This market is large despite significant limitations associated with the current standard of care, ribavirin in combination with pegylated interferon, which we refer to as interferon in this prospectus. We are developing NM 283 as single-agent therapy for use by patients, including liver transplant patients, for whom interferon-based treatment is not appropriate. We are also developing NM 283 as a more effective alternative to ribavirin in an interferon-based treatment combination. In mid 2004, we expect to initiate a phase IIb clinical trial that will allow us to evaluate the long term safety and efficacy of NM 283 alone, and in combination with interferon, in patients infected with the genotype 1 strain of HCV. In the U.S., Western Europe and Japan, the genotype 1 strain of HCV accounts for more than 70% of the reported cases of hepatitis C. We believe that treatment with NM 283 alone, or in combination with interferon, will address the limitations of current therapy in treating patients infected with the genotype 1 strain of HCV. In addition to NM 283, we are developing a second HCV drug candidate which is also a nucleoside analog. We anticipate that this drug candidate, which is currently in late stage preclinical studies, may be used in combination with NM 283 or other drugs and, if successfully developed, could replace interferon in the combination therapy standard of care. We believe that successful development of two or more nucleoside analogs that may be used in combination with other orally administered drugs will enable us to establish a franchise in this therapeutic area by offering treatments to the broadest possible hepatitis C patient population, including those patients that cannot be treated with interferon or those for whom drug-related adverse side effects and inconvenient dosing regimens reduce compliance. In addition to our HBV and HCV drug candidates, we are also developing a drug candidate from the class of compounds known as non-nucleoside reverse transcriptase inhibitors, or NNRTIs, for treatment of HIV. We estimate that the annual worldwide market for existing HIV therapeutics currently exceeds $6 billion. We believe that large opportunities continue to exist for HIV drugs that address the limitations of currently approved therapies. We expect to file an investigational new drug application, or IND, and initiate phase I/II clinical trials in early 2005. OUR RELATIONSHIP WITH NOVARTIS In May 2003, we entered into a collaboration with Novartis Pharma AG, or Novartis, relating to the worldwide development and commercialization of our drug candidates. Novartis paid us a license fee of $75 million for our lead HBV drug candidates, telbivudine and valtorcitabine, has agreed to provide full development funding for these HBV drug candidates and will make milestone payments which could total up to $35 million upon the achievement of regulatory approval milestones, as well as additional milestone payments based upon achievement of predetermined sales levels. Novartis also acquired an option to license our HCV and other drug candidates. If Novartis exercises its option to collaborate with us on NM 283, it would be required to provide full development funding and pay us up to $550 million in license fees and regulatory milestone payments, as well as additional milestone payments based upon achievement of predetermined sales levels. With Novartis, we will co-promote or co-market in the U.S., the U.K., France, Germany, Italy and Spain all products Novartis licenses from us. Novartis has the exclusive right to promote and market such products in the rest of the world. Simultaneously with the collaboration described above, Novartis purchased approximately 54% of our outstanding capital stock from our stockholders for $255 million in cash, with an additional aggregate amount of up to $357 million contingently payable to these stockholders if we achieve predetermined development milestones relating to an HCV drug candidate. Currently, Novartis and its affiliate, Novartis BioVentures Ltd., or Novartis BioVentures, which was an existing stockholder at the time of the Novartis stock purchase, collectively own approximately 57% of our outstanding common stock and, assuming the consummation of the anticipated concurrent private offering, will continue to own approximately 57% of our outstanding common stock. OUR DRUG CANDIDATES Each of our current clinical drug candidates is a nucleoside or nucleoside analog which is intended to have significant competitive advantages in one or more therapeutic areas, such as safety, efficacy, resistance profile or convenience of dosing, compared to currently approved treatments. Nucleosides are small, natural chemical compounds that function as the building blocks of human and viral genetic material, commonly referred to as deoxyribonucleic acid, or DNA, or ribonucleic acid, or RNA. Nucleoside analogs are synthetic compounds that are structurally similar to natural nucleosides. Each of these are small molecules that effectively target viral polymerases. These classes of small molecule compounds have a proven record of success as antiviral agents and can also be used to target other infectious diseases. We have discovered and are developing selective and specific oral once-a-day nucleosides and nucleoside analogs which we believe may be used in combination with other therapeutic agents to improve clinical benefits. Telbivudine We are developing telbivudine, a nucleoside, as a once-a-day, orally administered treatment for chronic hepatitis B. We are conducting a two-year international phase III clinical trial which will compare telbivudine to lamivudine, currently the leading therapy for hepatitis B. We anticipate that the one-year results from this clinical trial will be the cornerstone of our NDA and foreign marketing applications that we currently expect to file with the FDA and foreign regulatory agencies beginning in late 2005. In May 2003, we completed a 52-week phase IIb clinical trial of telbivudine that showed significantly better results for telbivudine, as compared to lamivudine. The primary endpoint of this clinical trial was reduction in the levels of HBV circulating in a patient's blood, or serum viral levels. We assessed the overall magnitude of the reduction of serum viral levels and determined the percentage of patients achieving undetectable serum viral levels. After one year, the serum viral levels of patients receiving telbivudine were reduced by a mean 6.01 log(10) copies of HBV in each milliliter of blood, or one million-fold. This is substantially greater than the mean 4.57 log(10), or 50,000-fold, reduction of HBV copies in each milliliter of blood in patients treated with lamivudine. In addition, HBV serum viral levels became undetectable in nearly twice the percentage, or 61%, of patients treated with telbivudine as compared to the patients treated with lamivudine. Serum alanine aminotransferase levels, or ALT levels, a measure of liver disease, became normal in 86% of patients receiving telbivudine, significantly more than the 63% of patients who achieved this response receiving lamivudine. We have also analyzed the results of our phase IIb clinical trial using a composite measure, which we refer to as therapeutic response, the primary endpoint of our phase III clinical trial. This analysis has demonstrated that 82% of the patients treated with telbivudine in our phase IIb clinical trial achieved the therapeutic response, an observation which supports the design of our phase III clinical trial. This rate of response is significantly higher than the 58% rate of therapeutic response that the patients treated with lamivudine would have realized in the same clinical trial. Valtorcitabine We are developing valtorcitabine for use as a fixed dose combination therapy with telbivudine for treatment of hepatitis B patients who are in need of more intensive antiviral treatment than that achieved by single-agent therapy. We are currently conducting a phase I/II clinical trial of valtorcitabine in Asia under FDA and local regulatory authorizations. Preliminary data from the phase I/II clinical trial indicate that valtorcitabine produces a rapid reduction of HBV serum viral levels at all dose levels that have been evaluated. To date, valtorcitabine has been well-tolerated and there have been no significant adverse side effects reported. We expect to commence a phase IIb clinical trial of valtorcitabine in combination with telbivudine in hepatitis B patients in mid 2004. NM 283 We are currently conducting a phase I/II clinical trial of NM 283 in adult patients with chronic hepatitis C. To date, based on experience with more than 50 HCV patients receiving NM 283, the overall safety profile of NM 283 has been satisfactory, with no serious adverse side effects and no dose-limiting toxicities. Preliminary results have also demonstrated that the antiviral activity of NM 283 increased as doses increased and that the levels of NM 283 in the patient's blood increased directly in proportion to the dose administered. Additionally, after cessation of treatment, the patient's HCV serum viral levels rebounded to levels nearly commensurate with the levels existing prior to the initiation of treatment. This rebound confirms that NM 283 suppressed HCV viral replication during the treatment period. In mid 2004, we expect to initiate a phase IIb clinical trial of NM 283 to evaluate the long term safety and antiviral efficacy of NM 283 alone and in combination with interferon, in patients infected with the genotype 1 strain of HCV. OUR STRATEGY Our goal is to become a leader in the discovery, development and commercialization of drugs for the treatment of viral and other infectious diseases. To achieve this goal we are: - targeting diseases in large and growing markets with unmet medical needs; - creating a leading franchise in markets such as hepatitis B and hepatitis C by developing multiple first or best in class products which become the standard of care; - maximizing value through our collaboration with Novartis; and - building upon our drug discovery capabilities to sustain a pipeline of drug candidates. OUR MANAGEMENT AND SCIENTIFIC TEAM We have assembled and continue to enhance a management and scientific team, which we believe has the expertise and experience necessary to discover, develop and commercialize our drug candidates. Our team includes leading experts in antiviral research and development with significant experience successfully discovering, developing and commercializing antiviral drug candidates. We also have two scientific advisory boards that include recognized experts in the fields of hepatitis and HIV therapeutics. From these boards and their members, we seek and receive advice regarding our drug discovery, development and commercialization efforts. PRIVATE OFFERING OF COMMON STOCK TO NOVARTIS In connection with this offering, Novartis has the right to purchase from us that number of shares of our common stock as is required to enable Novartis and its affiliates, other than Novartis BioVentures, to maintain its percentage ownership in our company, after giving effect to the number of shares of common stock we sell in this offering. Novartis has given us notice that it currently intends to exercise this right and we therefore anticipate that concurrently with the completion of this offering we will offer up to shares of our common stock to Novartis in a private offering at a per share purchase price equal to the initial public offering price appearing on the front cover of this prospectus. As a result, we expect that Novartis and its affiliates would continue to own approximately 57% of our outstanding common stock. | ||||||||||||||
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