Matters of the heart

February 13, 2009 – 1:38 pm by Michael Christel

Who says there’s no love these days in pharma land? It’s Valentine’s Day tomorrow (whoops! I need to call the florist – just joking, honey!), and for four drug giants, in particular, when it comes to matters of the heart therapy variety, Cupid struck a little early this year.

Sanofi-Aventis, Novartis, Eli Lilly, and Daiichi Sankyo have all made significant news on the R&D cardiovascular front in recent days. Remember, this is a market that has clearly become a high-risk proposition for new treatment endeavors.

• Wednesday, The New England Journal of Medicine reported favorable clinical trial results for Sanofi’s atrial fibrillation hopeful, dronedarone, or Multaq. The drug, according to the study, reduced by 24% the risk of a first hospitalization from cardiovascular disease or death by any cause among patients who added dronedarone to other treatment. The compound, which was rejected by FDA for congestive heart failure in 2006, has priority review for atrial fibrillation because of the scarcity of available medicines for the disorder. These new findings should help Sanofi’s cause when an FDA panel meets next month to assess dronedarone.

• Also this week, Novartis officially obtained worldwide licensing rights to elinogrel, a Phase II anti-clotting compound that could one day compete with Plavix in helping prevent heart attacks and strokes. Novartis will fork over $75 million in upfront money to Portola Pharmaceuticals, a private California biotech, and will be responsible for the Phase III development, manufacturing, and commercialization of elinogrel. Novartis executives say their new drug has an instant onset of action and its effect is reversible, two advantages they claim give elinogrel an edge over Plavix and other approved antiplatelets. Nevertheless, the drug is only in the middle of Phase II testing, and even if all goes smooth from here, elinogrel won’t likely hit the market until at least 2013, as the The Times story notes.

• The more immediate threat to Plavix’s antiplatelet reign is prasugrel. The Lilly and Daiichi Sankyo blood thinner has endured a seemingly endless new drug application review, but the recent unanimous FDA panel recommendation could accelerate prasugrel’s approval for patients with acute coronary syndromes. The panel was not put off by the drug’s risk for increased bleeding, contending that clinical data has suggested a “worthwhile risk-benefit profileâ€� for the targeted patient population. The panel’s review centered mainly on data from a Phase III head-to-head trial in which prasugrel reduced the relative risk of cardiovascular death, non-fatal heart attack, or non-fatal stroke by almost 20% when compared with Plavix. Prasugrel’s potential in heart disease was one factor that convinced R&D Directions editors to pick Daiichi Sankyo, which discovered the drug, as having the industry’s Best Cardiovascular Pipeline for the magazine’s annual January top pipelines issue.

• Staying with the Valentine’s Day theme, maybe Robert Palmer was right, we really are addicted to love. And if you believe some researchers, clinically addicted. Romance, according to these findings, originates in the brain, not the heart, and is likened chemically with a drug addiction. Try putting that on a greeting card.