Pressured by patent expirations, new hypertension solutions found

High blood pressure, also known as hypertension, afflicts 1-in-3 Americans, and costs associated with the malady were estimated at $63.5 billion in 2006, according to the Centers for Disease Control.

Half of the population over 60 has high blood pressure, and it also is statistically more prevalent among blacks than any other ethnic group. So widespread, it is the leading reason for doctor office visits in the country.

Hypertension often is referred to as the “silent killer.” While it has no outward symptoms, it can lead to heart disease, stroke and kidney failure. The severity can be modified through proper diet, weight management, minimal alcohol consumption and avoidance of tobacco. But once developed, the condition rarely disappears. High blood pressure is defined as 140/90 mmHg or higher.

In 2006, just the top three performing hypertension drugs—Norvasc, Diovan and Cozaar/Hyzaar—reaped sales of more than $12 billion, according to data from research firm Wood MacKenzie. All three posted sales increases for the year.

But brand market share is likely to start shifting. For one, market leader Norvasc loses its patent rights in September, opening the door for generics. In June, Novartis received Food and Drug Administration approval for Exforge, a new treatment option that combines active ingredients from its Diovan (valsartan) product and Pfizer’s Norvasc (amlodipine).

Earlier in the year, Novartis won approval for Tekturna (also called Rasilez). It created a new class of drugs called direct renin inhibitors, which target renin, an enzyme responsible for triggering a process that can lead to high blood pressure. The company declared it is “the first new type of blood pressure medicine in more than a decade.”

Furthermore, in July, Novartis issued results from a new study showing that when combined, Tekturna and Diovan improved results in some patients. “There is a strong need for new therapies like Tekturna since nearly 70 percent of patients with high blood pressure still are not achieving treatment goals,” Novartis said in a statement.

In other news, the FDA in June approved Letairis, an orphan drug designed to treat pulmonary arterial hypertension. It is manufactured by Gilead Sciences of Foster City, Calif.