Azor

Product
Azor
 
Approval Date
September 26, 2007
 
Release Date
November 1, 2007
 
Company
Daiichi-Sankyo/Forest
 
Class
Antihypertensive (calcium channel blocker + angiotensin IIreceptor blocker)
 
Indication
Hypertension
 
Active ingredient
Amlodipine (as besylate) 5mg, olmesartan medoxomil 20mg;tabs.
 
Agency Roster
AbelsonTaylor (professional)
Greater Than One (interactive)
Hill & Knowlton (PR)
Flashpoint Medica
 
MarketingStrategy/Execution
Daiichi-Sankyo and Forest Labs are co-promoting Azor, a fixed combination of two antihypertensives, Pfizer’s Norvasc (amlodipine) and Forest’s Benicar (olmesartan medoxomil). The marketers are not the first to combine an angiotensin receptor blocker with a calcium channel blocker. Novartis was first to market with Exforge, giving the Swiss juggernaut a competitive edge.
 
The Market

Physician Outlook
Like its competitor Exforge (Diovan + amlodipine), Azor(Benicar + amlodipine) has the capacity to make a very strong impact on the hypertensiontreatment market. While Benicar does not currently match Diovan in ARB marketshare, our research shows that Benicar is the ARB expected to see an increasein use among the largest proportion of physicians. Combined with amlodipine(Norvasc), a leader in the hypertension treatment market, this fixed-dosepairing should position Azor well on achieving aggressive blood pressure goals,currently an unmet need in this market and an attribute on which Benicar isthought to perform well.

—Anna Marie Napolitano, VP, category business leader, cardiovascular,GfK Market Measures, November 2007
 
Also in the Pipeline(according to Adis R&D Insight)
No competitor compounds in late-stage development, US
 
Recent MM&MCoverage
Product News

AbelsonTaylor,Inc.

FlashpointMedica

MM&MAll-Stars Agency of the Year: AbelsonTaylor

Medical/SurgicalJournal Ad Review

Pharmacology
Amlodipine is a calcium channel blocker in thedihydropyridine class. It works by inhibiting the influx of calcium ions intovascular smooth muscle and cardiac muscle, causing a reduction in peripheralvascular resistance and a reduction in blood pressure. Olmesartan medoxomil isa prodrug of olmesartan, an angiotensin II receptor blocking agent. It blocksthe vasoconstrictor effects of angiotensin II by interfering with itsinteraction with the AT1 receptors in vascular smooth muscle. Azor may be usedas add-on therapy for patients inadequately controlled on either amlodipine orolmesartan. This combination product may be taken with other antihypertensivemedications.
 
Clinical trials
Azor was compared to monotherapy with its components in an8-week, double-blind, multicenter, parallel group study involving 1940 patientswith mild to severe hypertension to determine if treatment with the combinationdrug product would result in significant reductions in blood pressure. Patientswere randomized to receive either placebo, amlodipine 5 or 10mg, olmesartanmedoxomil 10mg, 20mg, or 40mg, or combination therapy withamlodipine/olmesartan medoxomil 5/10mg, 5/20mg, 5/40mg, 10/10mg, 10/20mg, or10/40mg. Patients given the combination therapy experienced significantreductions in diastolic and systolic blood pressure compared to those given therespective monotherapies. These reductions were dose-related for bothamlodipine and olmesartan medoxomil. For combination treatment with Azor, theblood pressure lowering effect was maintained throughout the 24-hour dosinginterval.
 
Adverse reactions
Edema, dizziness; headache, hypotension, rash, pruritus,palpitation, urinary frequency, nocturia, hepatic or renal dysfunction,decreased hematocrit, decreased hemoglobin, hyperkalemia (rare).
 
Adults
Not for initial therapy. May be substituted for titratedcomponents. Individualize; titrate at 2-week intervals; may increase dose ofone or both components if BP not controlled on prior therapy. Max one 10/40 tabdaily.
 
Children
Not recommended.
 
Precautions
Correct hypovolemia before starting (may need to reducediuretic) or monitor closely for hypotension. Severe heart failure (if renal functiondepends on renin-angiotensin-aldosterone system). Severe obstructive coronarydisease. Severe aortic stenosis. Severe hepatic or renal impairment. Renalartery stenosis. Elderly (may need lower initial dose of amlodipine). Pregnancy(Cat. C in 1st trimester, Cat. D in 2nd and 3rd trimesters). Nursing mothers:not recommended.