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* Sanofi to file drug for US and EU approval by year-end
* Nine Phase III ODYSSEY trials meet primary endpoint
* Alirocumab "generally well tolerated" in trials
By Natalie Huet
PARIS, July 30 (Reuters) - A new drug being developed byFrench drugmaker Sanofi and U.S. partner Regeneron cut "bad" LDL cholesterol more than placebo andexisting treatments in nine late-stage clinical trials, thecompanies said on Wednesday.
The injectable drug, called alirocumab, is from a promisingnew class of medicines, called PCSK9 inhibitors, also beingdeveloped by Amgen Inc and other drugmakers. Ifapproved, these drugs could reap annual sales of $3 billion ormore, according to some industry analysts.
The Phase III ODYSSEY trials showed that after 24 weeks, themean percentage reduction in LDL cholesterol with alirocumab wasconsistent with results seen in previous trials, the companiessaid in a statement.
The trials involved patients whose high LDL cholesterollevels are not sufficiently controlled by existing treatmentssuch as statins, who cannot tolerate these or who present a highor very high cardiovascular risk.
"The robust data from these studies in more than 5,000patients is the basis of our global regulatory submissions,which we expect in the U.S. and EU by year-end," said Sanofi R&Dchief Elias Zerhouni.
PCSK9 inhibitors block a protein that prevents the body fromeliminating LDL cholesterol from the bloodstream and offer a newway of fighting the build-up of artery-clogging fat that putspatients at risk of heart attacks.
These drugs are mainly aimed at the millions of people whoeither cannot tolerate statins such as Pfizer Inc's Lipitor or AstraZeneca Plc's Crestor or who cannot gettheir cholesterol levels under control with statins alone.
In earlier mid-stage studies, when combined with statins,alirocumab and Amgen's own PCSK9 drug cut levels of LDLcholesterol by close to 70 percent, more than statins alone.
The drug was "generally well tolerated" in the trials, withmost common adverse events being nasopharyngitis, upperrespiratory tract infections and injection site reactions.
Serious adverse events and deaths were "generally balanced"between treatment groups as were musculoskeletal, neurocognitiveand liver-related events, the companies added.
An interim safety analysis showed that after 18 months oftreatment, patients on alirocumab were less prone tocardiovascular events (cardiac death, myocardial infarction,stroke, and unstable angina requiring hospitalization) comparedwith those on placebo.
Alirocumab's potential to cut cardiovascular risk is beingassessed in an ongoing 18,000-patient long-term outcomes trial. (Editing by Mark Potter)
