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Doctors Eager to Use First-Line, Singe-Pill Combo

BioWorld Financial Watch Staff Writer

The recent approval of Novartis AG's Diovan/HCT and Exforge as a first-line, single pill combination for high blood pressure represents an approach to treatment that has become standard practice for many physicians — a sign that doctors are likely to embrace this latest product.

"Combination therapy has been a major part of [treatment of hypertension]," said Wallace Johnson, assistant professor of medicine at the University of Maryland School of Medicine.

In his practice where he sees a high percentage of patients with Stage 2 hypertension, in the range of 160 and higher over 100 and higher, Johnson said that such patients are likely to be offered the option to take a single-pill combination therapy.

Johnson's approach is in line with current U.S. guidelines released in a 2004 report sponsored by the National Institutes of Health. The committee that wrote the report recommended starting appropriate patients on combination therapy.

The traditional approach, known as step therapy, called for starting patients on a single medication with gradual increases in dose. Now that approach has given way to what is viewed as a more flexible way of treating patients.

The hope is that such single-pill combinations will help some patients better comply with their treatment regimen by reducing the number of pills they take. In addition, these patients are expected to reach their blood pressure goals quicker by taking combination therapy as opposed to a single agent.

High blood pressure affects about 73 million U.S. adults, and research suggests that up to 80 percent of patients may need multiple medications to help them reach blood pressure goals, according to Novartis.

"Over the past four years, the use of single-pill combinations to treat high blood pressure has grown more than three times as fast as the use of single medications," Marjorie Gatlin, vice president and head of cardiovascular and metabolism medical franchise, U.S. medical and regulatory affairs at Novartis Pharmaceuticals Corp., told BioWorld Financial Watch. She added, "Single-pill combinations offer effective, convenient medications which could help patients reach treatment goals faster than a single agent."

Diovan/HCT and Exforge could face competition from another high blood pressure medication, Avalide (irbesartan-hydrochlorothiazide, Sanofi-Aventis Group, Bristol-Myers Squibb Co.), which was approved late last year for first-line treatment.

Both Avalide and Diovan HCT are single-tablet combinations of an angiotensin II receptor blocker (ARB), irbesartan and valsartan, respectively, plus the diuretic HCTZ. Exforge also combines the Diovan, the world's top selling branded high blood pressure medication with one of the most commonly prescribed calcium channel blockers amlodipine besylate.

Cowen & Co. analyst Steve Scala wrote in a recent research note that sales forecast were increased for Exforge and for some of Novartis's other major products, while sales changes for Diovan were mixed.

Many investors expect that aliskiren — a first-in-class renin inhibitor that Novartis licensed back from partner Speedel Holding AG, of Basel, Switzerland — to eventually replace the blockbuster hypertension drug Diovan (valsartan). In 2007, Diovan topped $5 billion in sales, while aliskiren generated just $40 million (See BioWorld Today, July 11, 2008). Novartis recently acquired a controlling interest in the biotech and announced plans to buy the remaining shares of Speedel, which was founded by a Novartis researcher.

Novartis also is conducting 14 clinical trials to explore the potential of renin inhibition in cardiovascular disease and end-organ protection. Renin is a kidney enzyme associated with the regulation of blood pressure.

The Diovan HCT and Exforge first-line approvals were based on several clinical trials in about 2,000 and 3,500 patients respectively, in which both products demonstrated efficacy and tolerability in patients with mild-to-severe high blood pressure, according to Novartis.

Diovan HCT was approved in the US in 1998 for second-line treatment of high blood pressure and over five million patients have been prescribed the medicine. Exforge was approved in 2007 and since its introduction last year, it has been prescribed to over a quarter of a million patients, the company said.

Published: August 11, 2008