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Biotech / Medical : Inhibitex, Inc. (INHX) -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (4)	11/29/2005 10:13:04 AM
From: tuck	Read Replies (1) \| Respond to of 7

>>ATLANTA, Nov. 29 /PRNewswire-FirstCall/ -- Inhibitex, Inc. (Nasdaq: INHX - News) today announced several regulatory developments related to its lead drug candidate, Veronate, which it is developing for the prevention of hospital- associated infections in very low birth weight infants. Inhibitex reported that the United States Food and Drug Administration (FDA) has indicated that in addition to the pre-determined primary endpoint of the 2,000 patient pivotal Phase III trial, the FDA will consider the licensure of Veronate based upon a sub-group analysis of data from that trial. Specifically, the FDA has now proposed that if the primary endpoint of preventing Staphylococcus aureus (S. aureus) bloodstream infections (late onset sepsis) in premature, very low birth weight infants weighing between 500 and 1,250 grams at birth is not achieved in the overall study population, but is achieved in a lower birth weight group, licensure could be granted for that lower birth weight population. The Company also announced that the European Medicines Agency (EMEA) has issued a favorable opinion to grant Orphan Medicinal Product (OMP) designation for Veronate in Europe for the prevention of late onset sepsis in premature infants of less than 32 weeks gestational age. "We are very pleased with these regulatory developments," stated David Wonnacott Ph.D., Vice President of Regulatory Affairs and Quality at Inhibitex. "We believe that the FDA's flexibility in considering the licensure of Veronate on a sub-group basis reflects the severity of the unmet medical need in the most vulnerable neonates. It is well documented that premature, very low birth infants have a much higher probability of infection as their birth weight decreases, and we believe that Veronate may have the greatest potential impact in these smaller neonates." In a Phase II trial of Veronate in premature infants weighing between 500 and 1,250 grams at birth, a higher infection rate was observed in the lower birth weight infants. Specifically, a 12% S. aureus infection rate was observed in infants that received placebo and weighed between 500 and 900 grams at birth, compared to a 7% S. aureus infection rate in the overall placebo cohort. Further, in infants weighing between 500 and 900 grams at birth, a 75% relative reduction in S. aureus infections was seen in those neonates that received 750 mg/kg of Veronate as compared to those that received placebo. Dr. Wonnacott continued, "Receiving OMP designation is the first tangible step in our development strategy for Veronate outside of North America. Pending the outcome of our Phase III study, we intend to seek scientific advice from the EMEA regarding a marketing application for Veronate in Europe." Inhibitex expects to receive formal approval of the OMP designation from the European Commission within the next several months. OMP designation is granted to drugs that are being developed to prevent or treat life-threatening or very serious conditions that impact not more than 5 out of 10,000 individuals in the European Union. OMP designation provides for 10 years of market exclusivity versus similar drugs for the same indication. Other benefits include a reduction in fees associated with marketing applications and access to scientific advice from the EMEA at no cost. The Company recently completed enrollment in its 2,000 patient pivotal Phase III trial of Veronate and anticipates that top line data from this trial will be available in the second quarter of 2006. The FDA has granted Veronate both Fast Track designation and Orphan Drug status. The Company has retained all world-wide rights to Veronate and, if approved, anticipates commercializing it independently in the United States.<< snip Nice that the FDA will approve even on subset analysis, though if INHX has to resort to that, Veronate's market will be that much smaller . . . Cheers, Tuck