Daiichi Sankyo strengthens US presence with Azor approval

The FDA has approved Japan's third largest pharmaceutical company Daiichi Sankyo's Azor (amlodipine/ olmesartan) for the treatment of hypertension.

Azor is a daily, single 10/ 40 mg tablet combination of the commonly prescribed calcium channel blocker (CCB) amlodipine and olmesartan, the active ingredient in Benicar (olmesartan), an angiotensin receptor blocker (ARB).

Benicar is the fastest-growing product in the class of hypertension therapies called angiotensin receptor blockers, according to Daiichi. Global sales of the product rose 74 per cent to JPY 160.3bn (USD 1.4bn) in FY06.

Azor reduced systolic blood pressure by an average of 30.1 mm of mercury and the diastolic reading by an average of 19.0 mm in its registrational trial.
The combination product helps patients to reduce their blood pressure levels or treats those whose blood pressure is uncontrolled on other medications.

Pfizer's Norvasc (amlodipine) racked up sales of USD 4.9bn for Pfizer in FY06, before generic copies of the drug entered the market in March 2007.
The drug is the most widely used calcium channel blocker, a different type of treatment used to relax blood vessels, according to Daiichi.

Azor will now compete with Novartis' Exforge, a combination of amlodipine and Diovan, which was approved by the FDA in June 2007. Analysts have said that Exforge could bring in sales of USD 1bn a year.

Analysts have said that Exforge's first-to-market status has given it an advantage over Azor, but that the potential market for combination medicines is large. Daiwa Institute of Research analysts have said that in order for Daiichi to compete, it should drop Benecar, which has a greater number of competitor products in the sartans market, to focus on Azor.

US-based Forest Laboratories paid Daiichi Sankyo USD 20m to be a three-year sales partner for Azor in the US. Both firms already have a co-promotional arrangement for Benicar signed back in 2001.

Daiichi Sankyo announced in early August 2007 its plans to bolster the sales force ahead of the launch of Azor. US CEO Joseph Pieroni outlined plans for the expansion, including the addition of 400 sales reps to reach a total of 1,300 before October 2007. Azor is expected to be one of Daiichi Sankyo's major growth drivers in the short-term.

Pieroni said of the approval: "This represents an important milestone for our growing US organisation and underscores our continued commitment to helping more patients reach their recommended blood pressure treatment goals,"