| Inhibitex, Inc. (INHX) Prelim S-1
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Our Business
We are a biopharmaceutical company engaged in the discovery, development and commercialization of novel antibody-based products for the prevention and treatment of serious bacterial and fungal infections in the hospital setting. We currently have two product candidates in late-stage clinical development and three product candidates in preclinical development. Our product candidates have been developed based on our expertise in MSCRAMM proteins for which we own or have licensed numerous patents and patent applications. MSCRAMM proteins are located on the surface of pathogenic organisms, such as bacteria and fungi, and play a prominent role in the process of infection. These proteins enable organisms to initiate and maintain an infection by adhering to specific sites on human tissue or implanted medical devices. Our antibody-based product candidates are designed to bind to specific MSCRAMM proteins, thereby preventing infections or reducing their severity.
Our lead product candidate, Veronate, which we expect will enter a Phase III clinical trial in the second half of 2004, is being developed for the prevention of hospital-associated infections in premature, very low birth weight, or VLBW, infants. Veronate has been granted Fast Track and Orphan Drug status by the FDA. Our second product candidate, Aurexis, is currently being evaluated in a Phase II clinical trial as a first-line therapy, in combination with standard of care antibiotics, to treat serious, life-threatening Staphylococcus aureus, or S. aureus, bloodstream infections in hospitalized patients. We have retained worldwide commercialization rights to both Veronate and Aurexis and two of our three preclinical product candidates. We expect to commercialize Veronate, and potentially Aurexis, in the United States by establishing a specialized, hospital-based sales force.
Our Product Candidates
Veronate
We are developing Veronate as a prophylactic product to prevent hospital-associated infections in VLBW infants. Veronate contains concentrated amounts of antibodies that target specific MSCRAMM proteins found on the surface of staphylococci.
According to the United States Census Bureau, there were approximately 60,000 VLBW infants born in the United States in 2001. VLBW infants are typically cared for in neonatal intensive care units for, on average, the first two months of their lives. During this time, VLBW infants are highly susceptible to infection given the intensity of medical care, duration of hospitalization, and the use of intravenous catheters to deliver nutritional fluids and medication. Studies indicate that 30-50% of all VLBW infants weighing 1,250 grams or less at birth will develop at least one hospital-associated infection. Hospital-associated infections result in significant mortality and morbidity among VLBW infants. The mortality rate among VLBW infants who acquire a hospital-associated infection caused by S. aureus or candida, a fungus, is approximately 17% and 34%, respectively. In addition to this associated mortality, VLBW infants who develop a hospital-associated infection spend, on average, 19 additional days in the hospital as compared to those that do not develop such an infection.
In December 2003, we completed a 512-patient, multi-center, randomized, double-blind, placebo-controlled Phase II clinical trial of Veronate for the prevention of hospital-associated infections in VLBW infants weighing 500 to 1,250 grams at birth. The trial was designed to evaluate the safety, dosing and preliminary efficacy of Veronate in this patient population. Results from the trial demonstrated that Veronate was generally safe and well tolerated among treated infants. The preliminary efficacy findings from the Phase II trial comparing Veronate at a dose of 750 mg/kg to placebo were:
• a 63% reduction in the frequency of infection due to S. aureus;
• a 67% reduction in the frequency of infection due to candida; and
• a 36% reduction in mortality.
Based on these results, we expect to initiate a multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial for Veronate in the second half of 2004. This trial will be designed to further evaluate and confirm the efficacy and safety of Veronate at a dose of 750 mg/kg in VLBW infants weighing 500 to 1,250 grams at birth.
Aurexis
Aurexis is a humanized monoclonal antibody being developed as a first-line therapy, in combination with standard of care antibiotics, for serious, life-threatening S. aureus bloodstream infections in hospitalized patients. Aurexis and Veronate target the same MSCRAMM protein on S. aureus. We believe the results from our Phase II Veronate trial and our preclinical efficacy studies provide validation for the S. aureus MSCRAMM protein.
S. aureus is one of the leading causes of hospital-associated infections. There were an estimated one million hospital-associated S. aureus infections worldwide in 2002, of which approximately 225,000 occurred in the United States. Of the estimated 225,000 S. aureus infections in the United States, we estimate that approximately 50,000 were serious bloodstream infections. S. aureus is becoming increasingly resistant to antibiotics. According to the Centers for Disease Control and other sources, the percentage of hospital-associated S. aureus infections caused by methicillin-resistant S. aureus, or MRSA, in intensive care units in the United States doubled between 1994 and 2002, increasing from 30% to nearly 60%. The mortality rate for bloodstream infections associated with MRSA is 30-50%, as compared to the mortality rate associated with methicillin-susceptible S. aureus bloodstream infections of approximately 20%. S. aureus infections are typically treated with intravenous antibiotics, including vancomycin, which is generally administered to patients with MRSA. We believe Aurexis will be used adjunctively as a first-line therapy to treat S. aureus bloodstream infections, regardless of which antibiotic is prescribed for treatment.
We are currently conducting a 60-patient, multi-center, randomized, double-blind, placebo-controlled Phase II clinical trial for Aurexis. Hospitalized patients with documented S. aureus bloodstream infections are randomized to receive standard of care antibiotic therapy combined with either Aurexis or placebo. The Phase II trial is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of Aurexis. We expect to complete enrollment of this trial by the end of 2004 and have final data from this trial during the first half of 2005. We are also exploring the use of Aurexis in patients with cystic fibrosis and end stage renal disease and those who are undergoing cardiac surgery. We may initiate additional Phase II clinical trials in one or more of these indications in the future.
Preclinical Product Candidates
We currently have three product candidates in preclinical development, all of which are based on the use of MSCRAMM proteins. Two of these candidates are humanized monoclonal antibodies, one of which targets hospital-associated enterococcal infections, the other of which targets hospital-associated candida infections. Our third candidate is a human staphylococcal vaccine being developed by Wyeth that is the subject of a worldwide license and collaboration agreement.
Benefits of Our MSCRAMM Protein Approach
We believe that antibody-based product candidates developed utilizing MSCRAMM proteins may provide the following advantages over existing anti-infective therapies:
• the ability to be used prophylactically in patients where the preventive use of antibiotics is not appropriate or recommended;
• improved patient outcomes by reducing the incidence of secondary site infections, relapse rates, mortality and length of hospital stay;
• a lower likelihood of inducing patterns of drug resistance due to their novel mechanisms of action; and
• fewer side effects.
Our Strategy
Our goal is to become a leading biopharmaceutical company that discovers, develops and commercializes novel, antibody-based products to prevent and treat serious bacterial and fungal infections in the hospital setting. In order to achieve this goal, we are focused on the following key strategies:
• complete the Phase III clinical trial and obtain regulatory approval for Veronate;
• advance the development of Aurexis and our preclinical product candidates;
• establish a specialized, hospital-based sales force in the United States to sell our products;
• utilize our expertise in MSCRAMM proteins to discover and develop additional first-in-class products; and
• expand our product portfolio through in-licensing and acquisitions.
Corporate Information
We were incorporated in Delaware in May 1994. Our principal executive offices are located at 1165 Sanctuary Parkway, Suite 400, Alpharetta, Georgia 30004. Our telephone number is (678)746-1100. Our website is www.inhibitex.com. Information contained on our website is not incorporated by reference into and does not constitute part of this prospectus. |
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