WASHINGTON, May 17 (UPI) -- Analysts expressed mixed reactions to new data on Novartis' Exforge and Rasilez that was released Wednesday, with some predicting the blood-pressure medications would be very successful, and others saying longer-term data will be needed to persuade the medical community to embrace them.
Duncan Emerton, an analyst with DataMonitor, told United Press International he estimates Rasilez will do well and ultimately will be a blockbuster, generating $1.4 billion in sales by 2010.
"I think it's going to sell well," Emerton said.
If Rasilez is approved, it would be the first renin inhibitor to reach the market. Novartis filed new drug applications for both Rasilez and Exforge in April.
Emerton said he didn't have any sales projections for Exforge, which is a combination of amlodipine and valsartan, but he added that he thought the Street's projections of $500 million in sales were "a little bit too high."
This is because he thinks Novartis will target the drug to patients with severe hypertension. "The efficacy is so good that to give it to any other patients would lower their blood pressure too low," Emerton said.
The two drugs together with Novartis' other blood-pressure medications, including Diovan and Lotran, will make the company a powerful force in this sector, he said.
"It's not just about how many dollars they make from the drug, it's the overall package they now have," he said. "I can see Novartis doing fantastically well for the next three to five years, up until Diovan goes off patent in 2012," he said.
The data presented Wednesday at the American Society of Hypertension meeting in New York included two studies on Rasilez and one on Exforge.
The first Rasilez study, which was conducted by Alberto Villamil of Fundapres in Buenos Aires, was an eight-week study involving 2,776 high-blood-pressure patients who received Rasilez, hydrochlorothiazide or placebo. The study found that Rasilez provided effective blood-pressure control and was even more effective when combined with hydrochlorothiazide.
In the second study, which was led by Jerry Mitchell of the Texas Center for Drug Development, Rasilez was found to provide sustained blood pressure over a 24-hour dosing period in patients with mild-to-moderate high blood pressure.
In the Exforge study, patients with stage 2 high blood pressure of at least 110 mm Hg who were given the drug achieved an average reduction of 35.8 mm Hg in systolic blood pressure, compared to an average drop of 31.8 mm Hg in patients treated with lisinopril and hydrochlorothiazide.
A subset of patients with a blood pressure of at least 180 mm Hg experienced a drop of 43 mm Hg after receiving Exforge compared to a reduction of 31.2 mm Hg in patients treated with the lisinopril/hydrochlorothiazide combination.
Mary Argent-Katwala, an analyst with Decision Resources, told UPI she didn't think the Exforge or Rasilez data would be sufficient to change the medical community's opinion about the drugs.
"Physicians would want to see long-term data," such as how these medications are going to fare in preventing strokes and heart attacks, Argent-Katwala said. "The drugs look promising, but they need a bit more follow-up from the trials."
Rasilez will probably "find itself used as an adjunct therapy with existing classes of antihypertensive agents," she said. The fact that it would be the first in its class could give it some novel appeal, but she noted that "a lot of clinicians we've spoken to don't think that makes it sufficiently different to be of significant interest."
Argent-Katwala projected Rasilez would generate peak sales of $250 million to $500 million.
She added that one unknown that could provide a boost for Rasilez is how it fares in a head-to-head trial of other agents. She noted Novartis is conducting such a trial, comparing Rasilez to lisinopril, but so far the company has not released any results.
Novartis spokeswoman Maura Bergen told UPI the Food and Drug Administration had accepted both the Rasilez and Exforge NDAs for standard review, so the company was anticipating hearing back from the agency in about 10 to 12 months.
Bergen said the company could not provide projections on anticipated sales or the number of patients who might receive the drugs if they are approved.
