FDA Approval Obtained, Other Hurdles Remain For Daiichi's Tribenzor
This article was originally published in PharmAsia News
Executive Summary
Daiichi Sankyo obtained U.S. FDA approval for its triple combination fixed-dose hypertension drug Tribenzor on July 23, but the bigger challenges of building a market and winning payer adoption of a product in which two of three components are available as generics remains
|
Daiichi Sankyo obtained U.S. FDA approval for its triple combination fixed-dose hypertension drug Tribenzor on July 23, but the bigger challenges of building a market and winning payer adoption of a product in which two of three components are available as generics remains. Tribenzor consists of three medications with different mechanisms of action for treating high blood pressure - Daiichi's own Benicar (olmesartan medoxomil), an angiotensin II receptor blocker; the calcium channel blocker amlodipine (Pfizer's Norvasc and generics); and the diuretic hydrochlorothiazide. Daiichi already sells double combinations Benicar combined with hydrochlorothiazide ( Benicar HCT ), as well as Benicar combined with amlodipine ( Azor ). Since its launch in 2007, Azor has generated lackluster sales, totaling about $81.4 million in 2008 and $149.5 million in 2009. Benicar HCT sales are so low they generally aren't broken out individually in company revenue reporting. The presence of generic medications in branded products are seen as part of the reason for the slow uptake of such combination products - with heightened awareness of drug costs, payers generally step therapy programs in which a single generic agent is provided initially. The combination product, meanwhile, often is relegated to tier 3 reimbursement (Also see "Payer Cost Strategies Weigh On CV Fixed-Dose Combinations" - Pink Sheet, 2 Mar, 2009.). Tribenzor will be priced competitively with other anti-hypertensive drugs on the market when it launches on Aug. 24, Hilly Paige, executive director of Daiichi's hypertension franchise, said in an e-mail. A tablet consisting of 20 mg Benicar, 5 mg amlodipine, 12.5 mg hydrochlorothiazide will have a wholesale acquisition price of $2.83, while four other dosages (40/5/12.5 mg, 40/5/25 mg, 40/10/12.5 mg, and 40/10/25 mg) will cost $3.58 per tablet. That doesn't include rebates and other discounts Daiichi might offer. Two-thirds of hypertension patients require multiple therapies Daiichi will seek wide formulary approval for Tribenzor, hoping patients will have unrestricted access to the drug, Paige said. While Tribenzor is not approved for first-line hypertension therapy, the company sees a broad market for the three-drug combo considering more than two-thirds of patients with high blood pressure require treatment with two or more anti-hypertensives. Approximately 56 percent of patients on hypertension drugs do not achieve their blood pressure reduction goals, Daiichi says. A particularly promising patient population for Tribenzor might be diabetics, as 70 percent of people with diabetes also have high blood pressure. The basic recommendation for a diabetic with high blood pressure is to reduce to a blood pressure rate of 130/80 mm Hg, where as for hypertension patients without diabetes, the general goal is 140/90 mm Hg. "Fixed-dose high blood pressure combination treatments...have the potential to simplify dosing regimens, reduce pill burden and lower costs associated with co-pay" Paige said. "Research also shows that the use of fixed-dose anti-hypertensive combination treatments may improve patient compliance as compared to taking each medication separately." Paige did not disclose the company's marketing plans, other than to note that Daiichi currently has a sales force of approximately 1,850 reps and managers, some of whom will be detailing Tribenzor. Anti-hypertensives comprise a significant portion of Daiichi's portfolio, however, bringing in an estimated 25 percent of total revenues. With the addition of Tribenzor, Daiichi now offers 15 different dose-strength combinations of four different blood pressure medications. The marketing effort behind Tribenzor should benefit from a strong label. According to TRINITY study subgroup data unveiled last month at the American Diabetes Association conference, the drug produced statistically significant mean reductions in blood pressure in comparison to three other two-drug fixed-dose medications. In hypertension/diabetes patients dosed with the 40/10/25 mg tablet, 41.1 percent achieved the blood pressure goal of <130/80 mm Hg after 12 weeks of therapy compared to rates ranging from 10.1 percent to 16.3 percent for patients receiving double combination therapy. -Joseph Haas ([email protected]) [Editor's note: This story also appeared in "The Pink Sheet" DAILY," July 26, 2010 - click here for a free trial .]
|