Inhibitex Inc. joined the ranks of private biotech companies looking to take advantage of a more receptive market with an initial public offering filing aimed at raising $86.25 million.
U.S. Bancorp Piper Jaffray, of Minneapolis, and New York-based Lazard Freres & Co. are co-lead managers of the offering, while Thomas Weisel Partners LLC, of San Francisco, is acting as co-manager. Inhibitex has not determined the number of shares to be offered or the price range.
Inhibitex plans to list its stock on the Nasdaq National Market under the symbol "INHX."
William Johnston, president and CEO of Inhibitex, declined comment due to SEC-imposed quiet-period rules.
According to the company's prospectus, Inhibitex would use 80 percent of the proceeds to advance the discovery, development and manufacturing of its products, and the rest would be used for working capital or general corporate purposes.
The company focuses on the discovery, development and commercialization of antibody-based products for the prevention and treatment of bacterial and fungal infections in hospitals. Inhibitex has two product candidates in late-stage clinical development and three in preclinical development. The candidates are based on MSCRAMM proteins, which are located on the surface of pathogenic organisms. The proteins enable organisms to initiate and maintain an infection by adhering to specific sites on human tissue or implanted medical devices. Inhibitex's products are designed to bind to specific MSCRAMM proteins in order to prevent infections or reduce their severity.
The company's lead product, Veronate, likely will enter a confirmatory Phase III trial in the second half of this year to prevent hospital-associated infections in premature, very low-birth-weight (VLBW) infants. In 2001, there were about 60,000 VLBW infants born in the U.S., the U.S. Census Bureau said. Studies have indicated that 30 percent to 50 percent of all VLBW infants weighing 1,250 grams or less at birth will develop at least one hospital-associated infection, sometimes resulting in death.
Inhibitex completed a 512-patient Phase II trial in December that demonstrated Veronate was safe and well tolerated. Compared to placebo, a 750-mg/kg dose of Veronate showed a 63 percent reduction in the frequency of infection due to Staphylococcus aureus, a 67 percent reduction in the frequency of infection due to Candida and a 36 percent reduction in mortality. The product has fast-track and orphan drug status.
Inhibitex's second candidate, Aurexis, is being evaluated in a Phase II trial as a first-line therapy, in combination with standard-of-care antibiotics, to treat S. aureus bloodstream infections in hospitalized patients.
Aurexis, a humanized monoclonal antibody, targets the same MSCRAMM protein on S. aureus as Veronate. S. aureus is a leading cause of hospital-associated infections, and accounted for about 1 million of the infections worldwide in 2002. S. aureus is becoming resistant to antibiotics, with the number of methicillin-resistant S. aureus infections doubling in the U.S. between 1994 and 2002.
Inhibitex expects Aurexis to be used adjunctively with an antibiotic. The Phase II trial should complete enrollment of 60 patients by the end of 2004, and initial data are expected during the first half of 2005. The company also is studying Aurexis in cystic fibrosis and end-stage renal disease, and might initiate additional Phase II trials in those indications.
Inhibitex has worldwide commercialization rights to both clinical products, as well as two preclinical candidates, which are humanized monoclonal antibodies that target hospital-associated enterococcal and Candida infections. The company expects to establish a specialized hospital-based sales force to market its products.
Wyeth, of Madison, N.J., as part of a worldwide license and collaboration agreement with Inhibitex, is developing the third preclinical candidate, a human staphylococcal vaccine. (See BioWorld Today, Sept. 18, 2001.)
Inhibitex believes its MSCRAMM proteins provide advantages over existing anti-infective therapies by preventing infection in patients when the use of antibiotics is not appropriate or recommended, and by reducing side infections, relapse rates, mortality and length of hospital stay. The proteins also offer fewer side effects and a lower likelihood of inducing patterns of drug resistance due to their mechanisms of action, the company said.
Inhibitex was founded in May 1994 in Alpharetta, Ga. It raised $20 million in January in a Series E round, bringing the total raised since inception to about $85 million. The company's burn rate is about $2 million a month. (See BioWorld Today, Jan. 13, 2004.)