OSI Pharmaceuticals Inc announced that the New Drug Application (NDA) for Tarceva (erlotinib HCl) has been accepted into the US Food and Drug Administration's Pilot 1 Programme for Continuous Marketing Applications. The Pilot 1 Programme is designed for products that have been designated Fast Track status and have demonstrated significant promise in clinical trials as a therapeutic advance over available therapy for the disease or condition.

"We are pleased that Tarceva has been accepted as one of the first drugs to be reviewed under the new Pilot Programme," stated Colin Goddard, Chief Executive Officer at OSI Pharmaceuticals. He added, "We are committed to working closely with the FDA to help demonstrate that this innovative programme can help companies work together with the FDA to ensure a timely review of agents like Tarceva that represent a meaningful step forward in the treatment of diseases for which there is an unmet medical need."

As one of the Prescription Drug User Fee Act (PDUFA) goals, the Pilot 1 Programme is designed to expedite the Continuous Marketing Application ("Rolling NDAs") Concept. Under the programme, applicants with products meeting the requirements are eligible to submit a limited number of portions (or "Reviewable Units") of their NDA in advance of the complete application. The FDA has agreed to complete reviews of the individual Reviewable Units as they are submitted and to provide early feedback to the applicant.

OSI had previously been granted Fast Track status for the advanced NSCLC indication in September 2002 and submitted the non-clinical and CMC sections of the NDA under the standard "rolling submission" provision on January 20, 2004. With the Pilot 1 Programme designation the FDA is committed to initiating the review of these sections on a six-month review timeline as of the notification of Pilot 1 status. OSI also announced that it has filed the BR.21 study report with the FDA, which follows on from the filing of the first clinical section on May 12, 2004. OSI expects to complete its NDA filing for Tarceva over the summer and, assuming a priority review the action date will be six months from the completion of the NDA submission.

Tarceva is designed to block tumour cell growth by inhibiting the tyrosine kinase activity of the HER1/EGFR receptor thereby blocking the HER1/EGFR signalling pathway inside the cell. Tarceva is currently being evaluated in an extensive clinical development programme together with the Company's alliance partners at Genentech and Roche.