The UK-based drug delivery developer has signed a deal with Kos Pharmaceuticals, who will market and distribute Flutiform in the US, with right of first negotiation in Canada.
The product is currently in late-stage Phase III clinical trials and is expected to reach the market in 2009, SkyePharma spokesperson Peter Laing told In-PharmaTechnologist.com.
The deal may provide the first sign of reprieve for the troubled firm that has experienced months of unrest, culminating in the ousting of top-tier management by shareholders - including chairman and founder Ian Gowrie-Smith - over the failure to strike a deal for the drug, as well as a very unpopular discounted rights issue. The turbulence led the cash-strapped company to put itself up for sale late last year, although no suitable buyers came forward and the firm has since withdrawn the sale.
Flutiform (fluticasone and formoterol) is a fixed dose combination of a corticosteroid and beta agonist that is made using SkyePharma's patented SkyeDry formulation technology, designed to stabilise the active components and thereby ensure a reproducible dose even after prolonged storage, said the company.
"Formoterol is a very hard compound to control and stabilise," said Laing.
The drug is delivered as an aerosol spray via its proprietary HydroFluoroAlkane (HFA) metered dose inhaler, which also has a dose counter.
"HFA inhalers are the accepted replacement for hydro fluorocarbon (HFC) inhalers and we are only one of a handful of companies making these," said Laing.
The two drug compounds will be produced for SkyePharma by two undisclosed generics manufacturers, where they will then be shipped to SkyePharma's facility in Lyon, France to be formulated.
The new drug formulation will then shipped to another undisclosed contract manufacturer, where the delivery devices will be made and the final product filled.
The US market for asthma drugs exceeded $10bn (€7.8bn) in 2005 and the fastest-growing segment of this market is fixed combination treatments, such as Flutiform, which combine a long-acting bronchodilator with an inhaled steroid in a single delivery device.
Combinations are not only more convenient for patients than carrying two separate inhalers but also have been shown to optimise the efficacy of the individual agents, said SkyePharma.
Once it hits the market, Flutiform will have to compete with an already established blockbuster, GlaxoSmithKline's Advair/Seretide (salmeterol and fluticasone) as well as AstraZeneca's Symbicort (formoterol and budesonide), which is also expected to be on the market by this time.
According to SkyePharma, however, Formoterol provides 12 hours of bronchodilation and has a rapid onset of action of 1-3 minutes.
Salmeterol, the bronchodilator used in GSK's Advair/Seretide also provides 12 hours of bronchodilation, but needs up to 30 minutes after inhalation to take effect.
In addition, the inhaled steroid fluticasone (which is also a component of Advair/Seretide) has low systemic absorption and is perceived to have a better safety and efficacy profile than budesonide, the steroid used in AstraZeneca's Symbicort - the current physician-preferred inhaled steroid in the US, said the company.
SkyePharma therefore believes Flutiform also has the potential to be a $1bn-a-year blockbuster, and said it could receive up to $165m in milestone payments under the new deal, including an upfront payment of $25m, as well as mid-teens sales royalties.
However many analysts believe that mid-size pharma company Kos may not have enough muscle to take on the marketing prowess of the pharma giants GSK and AstraZeneca.
Laing refuted this suggestion, stating: "We don't see the need to have a vast sales force as our drug is an aerosol and not a dry powder formulation like GSK and AstraZeneca's products."
"Although by the time the drug comes to market, Kos will have over 1,000 sales reps dedicated to the product and when GSK first launched Symbicort in the US a few years ago they did so with a sales team of 2,000 and the market is much more established now," he said.
SkyePharma is now in negotiations with other potential licensing partners for Flutiform in Europe, Japan and Latin America.
"These deals will be finalised this year, although we have given up trying to predict exactly when as past predictions have proved incorrect," said Laing.
"It will most likely be a number of partners as its difficult to get pan-European distribution and we will make announcements on these deals in due course."
Meanwhile the company is still forging ahead with plans to sell its injectables business and is hoping to close a deal within the next few months.
The sale will allow SkyePharma to focus soley on its oral and inhalable drug pipeline, of which Flutiform is the flagship product.
"We don't have the resources to focus on our injectables pipeline anymore. The lead candidate in this pipeline, DepoBupivacaine, (for post-operative pain) has completed Phase II clinical trials but would now require a substantial investment to put it through Phase III trials, as well as a significant expansion of the injectables manufacturing plant in San Diego," said Laing.
"The sale is being handled by UBS and they are in talks with several companies."