The lowest formulated dose of cholesterol-busting fenofibrate has been approved for the US market using a new formulation platform.
Denmark-based LifeCycle Pharma has developed two new strength formulations - 120mg and 40mg - of the active pharmaceutical ingredient (API) fenofibrate using an alternative technology, Meltdose technology, which is designed to provide enhanced absorption and greater bioavailability.
While a brand name for the two dosage strengths has yet to be agreed on, the US launch, marketed by Sciele Pharma, is expected by the end of the year.
The new formulations mark a significant market move away from the traditional NanoCrystal technology used for the formulations of the other marketed fenofibrate drugs such as Oscient Pharmaceuticals' Antara, Abbott's Tricor, Cipher Pharmaceuticals' Lipofen, and Sciele's Triglide.
"This is the first proven alternative technology," LifeCycle Pharma chief executive Dr Flemming Ornskov told in-PharmaTechnologist.com.
"[Fenofibrate] is the first product approved using this technology, therefore the technology has been approved also."
Ornskov said the new competitor to Elan's proprietary NanoCrystal technology, was an improvement.
While NanoCrystal technology takes the API and squeezes it into a nanoparticle size to improve the absorption rate, Meltdose technology keeps the API in a solid formulation state.
The method results in a granulate, using no water or organic solvents, which is manufactured into tablets.
The technique is advantageous for compounds, such as fenofibrate, that are water insoluble.
The Meltdose technology also reduces variability in absorption rates, Ornskov said.
The 40mg dosage strength would become the lowest dosage of fenofibrate available. Antara is currently the lowest available in 43mg tablets.
"The low dose is attractive in the market place. With this technology you can go to lower doses and still have the same efficacy . . . The low dose is good for fenofibrate because patients are also often diabetics who take statins and there are worries of interactions between statins and fenofibrate."
At present, LifeCycle Pharma was not targeting the European market for its fenofibrate, which was more fragmented and generic-based.
"Fenofibrate is bigger and more attractive in the US than Europe," Ornskov said.
According to the American Heart Association, more than 140 million US adults have excessive total blood cholesterol values.
The fenofibrate market was worth $1.7bn (€1.2) last year, which represented a 16 per cent increase on the previous year. In the US alone, fenofibrate sales totalled $1.3bn in 2006.
Ornskov hoped LifeCycle Pharma's new dosage formulations would carve an $80m to $120m market.
Under the terms of the agreement with Sciele, LifeCycle Pharma has already received an up-front payment of $5m, and will receive a further $4m milestone payment now that this fenofibrate product has received US Food and Drug Administration (FDA) approval.
LifeCycle Pharma will also receive milestone payments of up to $8m when certain sales targets are met, and tiered royalty payments on product sales.