Prospects for Oral Factor Xa Inhibitors Rivaroxaban, Apixaban - Part 1 of 3: Trifecta for Sanofi?

During the past couble of months, many of you have found Pharmayst's little blog by typing in phrases like "rivaroxaban peak sales" and "apixaban sales projections" in your Google search boxes. Therefore Pharmalyst decided to start studying these compounds and found a rather interesting market. Based on what Pharmalyst has read, these drugs could easily generate $2bn-$3bn of revenues by 2011 if (a big IF given that the anticoagulation market is the a very challenging one to crack) all goes well with the current clinical trials underway.

Both Rivaroxaban and Apixaban are Factor Xa inhibitors. Rivaroxaban will probably be the first drug on the market in this class and is being developed by Bayer and J&J (which owns the US rights). They expect to file for approval in 2008. Apixaban was discovered by BMS and is being jointly developed by BMS and Pfizer.

Both Rivaroxaban and Apixaban are expected to be indicated for Venous Thromboembolism VTE (Both prevention and treatment) and for stroke prevention in atrial fibrillation. There could be additional indications like acure coronary syndrome. So how big is this market? In a word - HUGE. According to the CDC, every year, thromboembolic disease is a leading cause of mortality in the US with Actute MI leading to 171,000 deaths, Ischemic Stroke leading to 139,000 and Pulmonary Embolism leading to 29,000 deaths in 2006. Perhaps one can expect similar numbers for Western Europe.

Courtesy: JNJ Investor Relations Site

The current US anticoagulant market is estimated to be $3.1 billion annually. Looks like J&J and Decision Resources expect this market to grow to $8.4 billion by 2014....a compounded growth rate of 13%. Some of the current therapies like Warfarin and Heparins have been used for over 50 years.

Courtesy: JNJ Investor Relations Site

If Rivaroxaban and Apixaban are successful, one company that will be hurting is Sanofi, given that their low molecular weight heparin Enoxaparin, generated 3 billion euros in sales last year (it maybe a trifecta for Sanofi with Ambien going generic and Zimulti/Acomplia being rejected by the FDA).












Stay tuned for parts 2 & 3

Part 2 - Unmet needs in the anticoagulation market
Part 3 - Factor Xa inhibitors value proposition