NeoPharm going it alone
US biotech company NeoPharm has has terminated an agreement with Pfizer relating to the development of LEP (liposome encapsulated paclitaxel) and LED (liposome encapsulated doxorubicin). As a result, all development rights and IND (investigational new drug) applications will revert to and be the responsibility of NeoPharm.
US biotech company NeoPharm has has terminated an agreement with Pfizer relating to the development of LEP (liposome encapsulated paclitaxel) and LED (liposome encapsulated doxorubicin). As a result, all development rights and IND (investigational new drug) applications will revert to and be the responsibility of NeoPharm.
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 commercialisation.
'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 chief executive officer 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.'
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.
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.
About NeoLipid drug delivery technology
NeoLipid technology uses an innovative liposome-based system to deliver anticancer drugs to tumours. Liposomes are microscopic membrane-like structures created from lipids (fats). NeoLipid technology combines drugs or other compounds with the company's proprietary lipids and allows for the creation of a stable liposome. Because tumour cells need to consume large amounts of fats to sustain their extremely rapid growth, they perceive the liposomal drug as a potential source of nutrition.
About LEP-ETU
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. It is sold by Bristol-Myers Squibb as Taxol. Common side effects of this approved anticancer agent include nausea, vomiting, hair loss, and nerve and muscle pain. In addition, Taxol cannot be introduced into the body unless it is first formulated in a mixture of castor oil (Cremophor) and ethanol, which often leads to another set of debilitating side effects including hypersensitivity reactions. NeoLipid technology eliminates the need for Cremophor. As a result, LEP-ETU may overcome many of the current limitations of Taxol treatment for cancer patients as well as its subsequent side effects.