By Eva von Schaper
March 6 (Bloomberg) -- Novartis AG won U.S. approval of Tekturna, the first new treatment for high blood pressure in more than 10 years. The shares rose 4.9 percent, their biggest jump since 2003.
The drug can be used alone or in combination with other therapies that reduce blood pressure, Basel, Switzerland-based Novartis said today. Analysts say Tekturna may generate sales of at least $1 billion a year.
Tekturna complements the company's two other big-selling blood pressure medicines, Diovan and Lotrel, helping Novartis expand its sales efforts among heart doctors. Diovan and Lotrel brought in $1.4 billion in revenue in the fourth quarter. High blood pressure affects almost 1 billion people worldwide and is uncontrolled in about 70 percent of them, Novartis said.
``This approval is critical in the long term, when Diovan loses patent protection,'' Denise Anderson, an analyst with Kepler Equities in Zurich said in an interview today.
Tekturna is the first so-called oral renin inhibitor to reach the market, Novartis's partner, Speedel Holding AG, said today in a statement. Renin is an enzyme that helps regulate blood pressure, and Tekturna blocks the enzyme, decreasing the activity of the system that causes hypertension. Many older medicines, called ACE inhibitors and angiotensin II receptor antagonists, can increase the effect of the system.
A key advantage of the drug class is 24-hour control, Les Funtleyder, an analyst with Miller Tabak & Co. in New York, said in a note to investors. He estimated peak sales of $1.5 billion. The product probably has a five-year lead over the next generation of rennin inhibitors under development, Speedel said.
Shares Soar
Novartis shares climbed 3.25 Swiss francs to 70.10 francs at in Zurich. Speedel, also based in Basel, soared 40.30 francs, or 26 percent, to 195.20 francs. It was the stock's biggest gain since September 2005.
Hypertension treatments brought in about $35 billion in 2005 in the world's seven biggest pharmaceutical markets, according to analysts at London-based Datamonitor Plc.
Novartis needs new products to replace revenue as older medicines lose patent protection. Diovan, Novartis's best-selling drug with $1.15 billion in revenue in the fourth quarter, may lose patent protection in 2012, Prudential Equity analyst Tim Anderson said. Diovan sales grew 15 percent last year, compared with a 3.4 gain for rival Norvasc, made by Pfizer Inc.
The Swiss drugmaker had a setback with its most important new product last month, when the U.S. Food and Drug Administration asked for more data on the experimental diabetes pill Galvus. The FDA last year extended its review of Tekturna by three months to assess its effect on the stomach lining.
More Medicines
``With Galvus delayed, Novartis should have a greater ability to focus on the launch of this product,'' Prudential's Anderson wrote in a note. ``The hypertension market is crowded and that the uptake of Tekturna will be gradual.''
Tekturna, which will be known as Rasilez outside of the U.S., was developed with Speedel. Heart disease, which is linked to high blood pressure, is the leading cause of death in the U.S. and Europe.
``Many patients require two or more medicines to control their blood pressure,'' James Shannon, Novartis' head of development, said in the release. ``As a new treatment approach, Tekturna has the potential to help these patients manage their disease.'' The drug will be available in U.S. pharmacies this month, the company said.
Novartis has also asked for approval for the cancer drug Tasigna. Novartis hypertension drug Exforge, a new combination of older treatments, was approved in December. Both are expected to generate sales of more than $1 billion a year.
Novartis is the world's fourth-largest drugmaker, ranking behind New York-based Pfizer Inc., the U.K.'s GlaxoSmithKline Plc and France's Sanofi-Aventis SA.
To contact the reporter on this story: Eva von Schaper in Basel at evonschaper@bloomberg.net.
Last Updated: March 6, 2007 13:57 EST
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