US group Abbott Laboratories and Anglo-Swedish drug major AstraZeneca have linked arms to develop a new power pill targeting the three blood lipids that play a major role in heart disease - LDL-C, or 'bad' cholesterol, HDL-C, or 'good' cholesterol, and triglycerides - in a move which could ultimately give birth to a new standard of treatment for patients with complex lipid disease.
The drugmakers are planning to carry out two parallel development programmes, one assessing a fixed combination of AstraZeneca’s Crestor (rosuvastatin) and Abbott’s TriCor (fenofibrate) and the other a combo of Crestor and ABT-335, Abbott’s next-generation fenofibrate currently in Phase III evaluation. Only one of the two programmes will be selected for final development on the back of these initial studies, the groups said in a statement.
The importance of tackling these three lipids in the prevention of heart disease, in particular raising levels of HDL-C, is really just starting to hit home. TriCor and Crestor are both lipid-regulating agents, the former boosting HDL-C while reducing triglycerides and the latter cutting down LDL-C, so this combination would offer all these actions in a single pill, potentially inducing better patient compliance and treatment outcomes.
If it makes it to market, such a drug could have huge potential, given that more than 38 million Americans have complex lipid disease and the cholesterol market is currently valued at $17 billion, of which 15% is made up of the fast-growing segment of overall cholesterol management, the firms noted.
Under the terms of the deal, all development costs and profits over the course of the partnership will be broadly shared. Abbott will carry out the clinical trial programme and is responsible for regulatory registration of the new therapy, while AstraZeneca will hold the New Drug Application. If the trials are successful, the companies are targeting a regulatory submission in 2009.
Shortly after the news emerged, Irish drugmaker Elan said it has granted Abbott US rights to use its proprietary NanoCrystal Technology in the development of the TriCor/Crestor combo. In return, Elan will receive payments based on development, clinical and regulatory milestones for the new product, as well as royalties on future sales in the US.