Intrabiotics' Iseganan VAP programme selected for Pilot 2 study

IntraBiotics Pharmaceuticals' ongoing late-stage pivotal development program for its lead product, an oral solution of iseganan hydrochloride (iseganan), for the prevention of ventilator-associated pneumonia (VAP), has been accepted for inclusion in the FDA's Continuous Marketing Application (CMA) Pilot 2 Program.

Participation in this initiative is limited to no more than one Fast Track product for each review division within the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) over the course of the program. Iseganan is the only Fast Track product selected by CDER's division of anti-infective drug products.

'We are honoured to have been selected for inclusion into this exclusive and pioneering program. Our selection builds on iseganan's fast track status and special protocol assessment (SPA) agreement to potentially further speed and clarify the pathway to approval for this agent for VAP, an important unmet medical need,' said Dr Hank Fuchs, president and ceo of IntraBiotics. 'Iseganan's selection underscores the collective commitment to addressing VAP, the most common infection occurring in patients in hospital intensive care units. We look forward to broadening discussions with the FDA regarding this development program, which we believe will be greatly enhanced by the frequency of scientific interactions enabled by this new pilot program.'

The objective of the Pilot 2 program is to evaluate the costs and benefits of enhanced sponsor access to guidance and feedback from the FDA during the Investigational New Drug (IND) phase of new drug development of fast track products and determine whether such activity can improve the efficiency of the drug development and review process. Once selected, participants and FDA define specific agreements on the nature and timing of feedback and interactions between the participant and FDA. Eligibility is limited to drug and biological products that have been designated fast track and have been subject to an end of phase 1 or equivalent meeting. Criteria for selection included the FDA's assessment of the potential value of enhanced interaction with emphasis on the health benefits likely to result from successful drug development.

Iseganan and Ventilator-Associated Pneumonia

The first of two planned pivotal trials is now well underway to evaluate iseganan oral solution for the prevention of VAP in 900 patients in the US and Europe, and data is expected by the end of 2004. A completed Phase I/II trial in mechanically-ventilated patients demonstrated that iseganan oral solution was well tolerated, safe, and effective in decreasing the amount of bacteria and yeast in the mouths of these patients. Both fast track designation status of iseganan oral solution for preventing VAP and a SPA agreement on the design of two pivotal efficacy trials for this indication have been granted by the FDA.

About Ventilator-Associated Pneumonia (VAP)

Pneumonia is the most common infection among patients in the intensive care unit. The longer a patient is ventilated, the higher the risk of developing VAP. VAP occurs in approximately 15-30% of patients receiving mechanical ventilation for more than 48 hours. Despite the use of potent, broad-spectrum antibiotics, patients who develop VAP generally remain dependent on artificial ventilation and remain in the intensive care unit for longer periods of time than patients who do not develop VAP. As a consequence, studies have demonstrated that patients who develop VAP can incur more than $40,000 in additional hospital charges. The Company estimates that over one million patients annually are mechanically ventilated for more than 48 hours in North America, Western Europe and Japan combined, making VAP a significant unmet medical need.

About IntraBiotics

IntraBiotics Pharmaceuticals is focused on the development of novel biopharmaceutical products for the prevention and treatment of serious infections for which current therapeutic options are inadequate. The Company is developing protegrins, a novel class of naturally occurring, host-defence peptides that have microbe-killing activity against a broad spectrum of bacteria and fungi and have a low propensity to engender resistance. IntraBiotics' lead product, iseganan, has received fast track status in development for the prevention of VAP, the most common infection occurring in patients in hospital intensive care units. The ongoing pivotal clinical trial has been designed under the SPA process with FDA.