SkyePharma used its latest business review meeting to announce the imminent arrival of a new rheumatoid arthritis (RA) drug formulated using its novel controlled release drug delivery technology.
The firm has combined its formulation skills with controlled manufacturing processes to develop a new technology, called GeoClock, that allows the preparation of chronotherapy-focused press coated tablets.
GeoClock tablets have an active drug loaded inside an outer tablet layer consisting of a mixture of hydrophobic wax and brittle material in order to obtain a pH-independent lag time prior to core drug delivery at a predetermined release rate.
This dry coating approach is designed to allow the timed release of both slow release and immediate release active cores by releasing the inner table first after which time the surrounding outer shell gradually disintegrates.
Using this novel technology, the pharma firm has been developing the new RA drug on behalf of another pharma company, Nitec.
According to SkyePharma, the drug, called Lodotra, will deliver the undisclosed active pharmaceutical ingredient (API) at the most appropriate time of day to treat the disease.
For diseases such as asthma, RA and Parkinson's disease, patients often experience increased symptoms in the morning so optimal medication regimen implies dosing at bedtime for nocturnal effect.
Dr Francesco Patalano, managing director of SkyePharma Europe said there was a need in the market for such a product because "despite several available combination therapies, many RA patients still experience considerable pain and stiffness in the morning."
As well as controlled-release, the GeoClock technology also has applications for the improved release of colonic drug delivery, as well as multiple pulse drug delivery to deliver doses of the drug at specific times throughout the day, said Patalano.
The new drug has recently completed Phase III, although data is not yet available, and it is expected to be filed later this year, he said.
Under the deal with SkyePharma, Nitec has the rights for Lodra in Germany and Merck has the rights to the product in Austria.
SkyePharma will receive mid-single digit royalties and will make the drug on behalf of Nitec at its plant in Lyon, France.
Negotiations for other territories are ongoing, said the firm.
Further down the pipeline SkyePharma also has in development a non-benzodiazepine hypnotic, SKP-1041, using this same GeoClock technology.
"This will be the first hypnotic product specifically designed for people who have problems with sleep maintenance," said Patalano.
"Delayed sleep onset affects only a minority of insomniacs and maintaining continuity of sleep is a greater need."
The firm expects to launch the drug in 2011, by which time the US market for insomnia is predicted to be $4.5bn (€3.5bn) and SkyePharma believes its product will be "significantly differentiated from other existing compounds."