Belgian chemical and pharmaceutical group Solvay aims to extend the franchise for its cholesterol-lowering fenofibrate product with a new product, Synordia, intended for use by patients with type 2 diabetes.
Solvay submitted Synordia, which combines fenofibrate with the oral antidiabetic agent metformin, to the European Medicines Agency (EMEA) earlier this week. If approved it will be the first product on the market that combines a lipid lowering drug with an oral antidiabetic in one pill.
The idea is to make it easier to control both blood lipids and blood glucose, which are often both elevated in diabetics. Patients often require treatment with both cholesterol-lowering agents and oral antidiabetics to manage their condition, so a single pill should make it easier for them to do so.
Solvay’s Phase III programme for Synordia, carried out in more than 1,000 patients, demonstrated the safety and efficacy of the fixed-dose combination and reinforces data from two previous trials (DAIS and FIELD) which have also indicated that the combination therapy of fenofibrate/metformin has benefits for type 2 diabetics.
Fenofibrate, which Solvay purchased with its acquisition of specialist French pharmaceuticals group Fournier Pharma for 1.2 billion euros last year had revenues of 265 million euros in the last five months of 2005, and pulled in more than a billion dollars for US licensee Abbott last year, although in the latter market it is now facing generic competition from Teva Pharmaceutical Industries.
Solvay and Abbott have been working hard to manage the lifecycle of the drug via a number of formulation developments and combination products. This strategy has maintained fenofibrate as a blockbuster product, despite its advancing years and near 30-year heritage on the pharmaceutical market.
Earlier this month, Solvay and Abbott announced a collaboration with AstraZeneca to develop a product combining fenofibrate with Crestor (rosuvastatin) that is scheduled for submission to the US Food and Drug Administration in 2009.
Analysts at lehman Brothers said earlier this year that Synordia would be one of the key drivers for Solvay's business in the next couple of years, along with: schizophrenia drug bifeprunox and tedisamil, a new bradycardic agent intended for use in the prevention of cardiac arrhythmia. Both are at the registration phase of development.