NeoPharm Inc has entered into a License Termination Agreement with Pfizer relating to the development of LEP (liposome encapsulated paclitaxel) and LED (liposome encapsulated doxorubicin). As a result of the Termination Agreement, all development rights and IND (investigational new drug) Applications will revert to and be the responsibility of NeoPharm.

According to a release, the Termination Agreement returns worldwide development and marketing rights for both LEP and LED, including the rights to develop liposomal formulations for other taxane and anthracycline drugs, to NeoPharm. NeoPharm currently plans to pursue a 505(b)(2) filing strategy with the FDA for the approval of LEP-ETU (liposome-entrapped paclitaxel Easy-To-Use), which could potentially allow for a quicker path to commercialization.

"We are pleased to have the rights to these compounds restored. The return of these drugs allows us to actively pursue licensing deals for our patented liposome based drug delivery system," said Greg Young, president and CEO of NeoPharm. "Results from phase I clinical studies lead us to believe that our LEP-ETU formulation could allow us to pursue a 505(b)(2) strategy. LEP-ETU is the first of several drug candidates that we anticipate could benefit from this strategy," he added.

Pre-clinical and clinical study data conducted to date indicate that the pharmacokinetic profiles of LEP-ETU and Taxol are similar, though LEP-ETU appears to be better tolerated given the absence of Cremophor from the formulation. Data from the LEP-ETU phase I study will be presented on October 30th at the upcoming 29th Annual European Society for Medical Oncology (ESMO) congress being held from October 29th to November 2nd, 2004 in Vienna, Austria, a company release said.

NeoPharm is evaluating a head-to-head clinical bioequivalence study comparing pharmacokinetics of LEP-ETU versus Taxol, which could commence in the fourth quarter, and, if initiated at that time, would be expected to be completed within the first half of 2005. After such a bioequivalence study, LEP-ETU would be ready to enter a 100-patient comparative efficacy and safety study. Under such a scenario, and assuming the trials meet their primary endpoints, the Company would be in a position to file a New Drug Application (NDA) under a 505(b)(2) filing strategy during 2006, the release added.

NeoLipid technology uses an innovative liposome-based system to deliver anticancer drugs to tumours. Liposomes are microscopic membrane-like structures created from lipids (fats). LEP-ETU is the Company's NeoLipid liposomal non-sonicated formulation of the widely used cancer drug, paclitaxel. Paclitaxel has been approved in the US for the treatment of ovarian, breast, and lung cancers.