LifeCycle signs three deals for new drug delivery system
companies for the development of new anti-cholesterol products
using its novel drug delivery technologies.
Firstly, the Danish biotechnology firm has entered into an exclusive deal with German generics company Sandoz for the development of an undisclosed fenofibrate product - fenofibrate is used to reduce the amount of cholesterol and fatty substances in the blood.
The two companies will be jointly responsible for the development and Sandoz will be solely in charge of the commercialisation of the product in the US, while LifeCycle Pharma will receive milestone payments and royalty rate on future sales.
LifeCycle has also teamed up with Merck Generics - a subsidiary of chemical giant Merck KgaA - through a similar deal for the development of another undisclosed fenofibrate product developed by LyfeCycle, but targeting, this time, the European markets.
Up to 34.5m people in the US suffer from high cholesterol in the blood, and in 2005, global sales of all fenofibrate drugs were estimated at $1.5bn (€1.2bn).
Fenofibrate has proven to be effective at lowering triglyceride (TG) concentrations and increasing high density lipoprotein (HDL), also known as good cholesterol.
The main drawback for oral absorption of drugs with low water-solubility is the transfer of drug substance particles into soluble molecules that can penetrate the gastrointestinal tract and enter the bloodstream.
These new fenofibrate products will be created with LifeCycle's Meltdose technology, a drug-delivery system that improves the bioavailability of compounds with low water-solubility, according to the firm.
LifeCycle said its Meltdose technology allows these solubilised individual molecules to be formulated into tablets and therefore eliminates the primary limitation of oral absorption of drugs.
"By decreasing the particle size of the drug substance, it has been possible to increase the bioavailability of a drug substance that would normally be highly water-insoluble," LifeCycle Pharma said.
Meanwhile, LifeCycle has also announced a third agreement, with Lundbeck - the company from which LifeCycle was spun out in June 2002.
Under the terms of the deal, Lundbeck has been granted rights to LifeCycle Pharma's MeltDose technology in connection with Lundbeck's further development of two internal preclinical central nervous system (CNS)-related projects.
LifeCycle Pharma said it will receive milestone payments related to results in the future developments of these projects.
"These new partnerships provide a strong validation of our innovative MeltDose technology which improves the bioavailability of drugs with low water solubility," said Flemming Ornskov, president and CEO of LifeCycle Pharma.
"We are now also a significant step closer to the first commercial launch of a product derived from LifeCycle Pharma's R&D pipeline."
To meet the demand for this market, the Danish firm has also developed a franchise of three fenofibrate products - LCP-Feno, LCP-Fenochol and LCP-AtorFen. The company said it expects to file an application to the Food and Drug Administration (FDA) before the end of the year to market its fist product within its franchise, LCP-FenoChol, in the US.
