Research and Markets: Is There No Longer A Gold Standard Therapy For Hypertension?

DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com) has announced the addition of Pipeline Insight: Antihypertensives - Together We Stand, Divided We Fail to their offering

Hypertension is a relatively well served therapeutic field, with a range of well-tolerated drug classes.

Despite this, the majority of patients are not controlled.

Results of large-scale outcome studies in the last decade suggest there is no longer a gold standard therapy for hypertension. Will ARBs become the next gold standard and are there any new classes in development that may be superior?

Scope of Report:

--Evaluation of patient potential for developmental antihypertensives over the period 2004-2012

--Scrutiny of key impacts on the R&D approach and cost, evaluation of optimal clinical trial end points and identification of suitable comparators

--Evaluation of key players in the hypertensive market and opposing company approaches to development and commercialization

--Analysis of key antihypertensive drugs in development, their commercial prospects, and their ability to satisfy unmet market and therapeutic needs

Report Highlights:

It is no longer possible to select a gold standard drug class in the treatment of hypertension. Ongoing large-scale clinical trials with ARBs are resulting in a shift in physician preference from ACE inhibitors to ARBs and many believe we have reached a significant turning point in the future of ACE inhibitors.

Aliskiren will be the first oral renin inhibitor to be launched. Its intervention at an earlier stage in the Renin Angiotensin System means it may offer significant advantages in efficacy and tolerability over both ARBs and ACE inhibitors and is likely to become a blockbuster.

We believe that fixed dose combination therapy will grow substantially over the forecast period, exceeding the growth of single pills. Successful strategies for controlling hypertension will need to merge fixed dose combination options with patient-led therapeutic regimes.

Reasons to Purchase Report:

View independent sales forecasts for products in late stage development for treatment of hypertension in both existing and novel classes

Understand physicians views on ARBs as the potential future gold standard class and the threats faced by existing and developmental products

Identify early stage antihypertensive compounds with high potential being developed by companies seeking a marketing partner

CHAPTER 1 EXECUTIVE SUMMARY 3

Scope of the analysis 3

Insight into the hypertension market 5

It is no longer possible to identify one particular class of drugs as the current gold-standard treatment in hypertension. 6

While many physicians remain frustrated by the limited capability of individual antihypertensive agents to lower blood pressure to target levels, there is no superclass on the horizon with the ability to treat hypertension effectively using monotherapy. Instead, the solution will lie in physicians' acceptance of the need to use effective drug combinations earlier in treatment and the wider issue of patient education and involvement in therapy decisions. 7

The need to address risk factors beyond hypertension, in particular raised lipids, has led to a demand for combination therapies that can treat more than one risk factor at a time. Antihypertensive combinations, both with and without a statin, are likely to be common in the future. 9

BMS's vasopeptidase inhibitor Vanlev (omapatrilat) had demonstrated the greatest antihypertensive efficacy among novel compounds in recent years, giving rise to the development of several other potential members in this class. However, it appears that fear of litigation surrounding the potential for angioedema has restricted further progress of this class. 10

Despite continued research into logical hypertension targets such as endothelin and vasopressin, the potential for any of these agents to be successful in the treatment of essential hypertension appears limited. 11

The only agent likely to significantly challenge the unbridled growth of the ARBs during the forecast period will be Novartis's oral renin inhibitor, aliskiren. While renin inhibition has long been a logical therapeutic objective, formulation difficulties had kept it an elusive goal until now. Its intervention in the familiar renin angiotensin aldosterone system (RAAS) at a point earlier than both ACE inhibitors and ARBs may mean it will offer superior blockade of the RAAS than either class without the bradycardia-related side effects of ACE inhibitors. 12

CHAPTER 2 PATIENT POTENTIAL 25

CHAPTER 3 R&D APPROACH 56

CHAPTER 4 HYPERTENSION PIPELINE ANALYSIS 82

CHAPTER 5 DRUGS ACTING ON RENIN ANGIOTENSIN SYSTEM 87

CHAPTER 6 DRUGS NOT ACTING ON RENIN ANGIOTENSIN SYSTEM 149

CHAPTER 7 KEY PHASE I COMPOUNDS 195

For more information visit http://www.researchandmarkets.com/reports/c5529