Staff Writer

The Medicines Co. has received U.S. approval of its intravenous drug for high blood pressure, Cleviprex, the first new I.V. antihypertensive to come on the market in 10 years.

The Parsippany, N.J.-based company is planning a September launch for Cleviprex (clevidipine butyrate) for use in the critical care setting, such as hospital emergency rooms, intensive care units and the operating room.

Shares in the company rose nearly 6 percent on the approval news.

Cleviprex is expected to improve on current available therapies and provide a new alternative to oral therapy, the company said. The product differs from many current I.V. antihypertensive agents that are metabolized by the kidney and/or liver, according to MDCO. Cleviprex is metabolized in the blood and tissues and does not accumulate in the body.

"A Cleviprex advantage is its ability to be used in patients with liver or kidney problems and with other medications, which are cleared through these two organs," Leerink Swann analyst Joseph Swartz wrote in a research note.

The product has the potential to double the company's sales, Schwartz said. As a comparison, he pointed to PDL BioPharma Inc.'s Cardene I.V., used in the neurological setting, with annual sales of about $175 million. Cleviprex is likely to find use in a broader market, Schwartz said, in neurology, cardiology, the emergency room and intensive care.

John Kelley, MDCO president and chief operating officer, said in a statement that Cleviprex could "treat a broad array of patients who need rapid and precise blood pressure control."

An estimated 3.4 million U.S. patients receive an I.V. antihypertensive agent each year, according to the company's figures. This year's sales are projected to reach $5 million to $10 million and peak sales could reach $225 million in 2019, Schwartz wrote. Assuming the company receives five extra years of marketing exclusivity under the Hatch-Waxman Act, 2019 is the last full year of exclusivity for the product, Schwartz said.

Poorly controlled blood pressure can be a life-threatening condition, and often is found in patients undergoing surgery and in patients presenting in the emergency department.

Recent data showing a clear relationship between blood pressure control and clinical outcomes should give the company significant traction, Schwartz predicted.

That was a first-cycle FDA approval of Cleviprex, based on six Phase III trials of 1,406 patients. All Phase III trials met all of their primary endpoints.

The most common adverse reactions seen with Cleviprex were headache, nausea and vomiting.

Cleviprex may produce systemic hypotension and reflex tachycardia.

The company's other marketed product is the blood thinner Angiomax for patients undergoing coronary angioplasty procedures. It also has a late-stage drug in development, cangrelor, an injectable antiplatelet agent for use during coronary procedures such as angioplasty.

Cangrelor was licensed exclusively in December 2003 from AstraZeneca plc, of London. Under the terms of the agreement, The Medicines Co. has exclusive license rights to develop, market and sell cangrelor worldwide, excluding Japan, China, Korea, Taiwan and Thailand.

Shares in MDCO (NASDAQ:MDCO) rose $1.25 or 5.5 percent, closing at $23.85.