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Novartis Gets OK for Blood Pressure Drug

Posted on: Wednesday, 7 March 2007, 18:00 CST

BASEL, Switzerland - Swiss pharmaceutical maker Novartis AG said Tuesday it has received U.S. approval for the hypertension drug Tekturna - a potential blockbuster that has shown the ability to lower blood pressure more effectively than common treatments. Tekturna is the first new type of medicine in more than a decade for treating high blood pressure. Approval from the U.S. Food and Drug Administration makes the United States the first country to allow it to be sold.

"Many patients require two or more medicines to control their blood pressure," said Novartis development chief James Shannon. "As a new treatment approach, Tekturna has the potential to help these patients manage their disease."

The drug is expected to reach U.S. pharmacies later this month, the company said. It is given in oral tablets and acts by targeting renin - an enzyme responsible for high blood pressure.

Douglas C. Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research, said, "Hypertension is rightly called 'the silent killer' because it usually has no symptoms until it causes major damage to the body organs."

"Today's approval adds a new safe and effective treatment option for people who need help to control their blood pressure," Throckmorton said.

The decision was a relief for Novartis after the FDA last month asked for additional data on its other potential blockbuster drug, diabetes treatment Galvus. This means a delay of around 18 months for that drug and some analysts had feared that the U.S. agency's focus on safety when deciding on new drug approvals could also lead to a delay in Tekturna.

Novartis shares closed up 4.9 percent at 70.10 Swiss francs ($57.56; euro43.94) in Zurich.

Analysts said Tekturna should eventually replace Diovan, Novartis' best-selling drug with annual sales of $4.2 billion (euro3.2 billion), but whose patent will probably expire in 2012. Novartis submitted Tekturna to European Union authorities last year but is still waiting for approval.

Clinical studies have indicated that Tekturna lowers high blood pressure when given on its own, or in combination with current treatments. Patients suffering from high blood pressure typically take more than one drug to treat their condition.

Many existing drugs fail to control blood pressure in a sustainable way for longer than a day, causing doctors to often prescribe two doses a day. Studies showed that Tekturna is able to keep blood pressure down for more than 24 hours, reducing the risk of heart attack and stroke.

Later Tuesday some shareholders criticized the high annual compensation for Chief Executive Daniel Vasella, which is estimated to be 44 million francs ($36 million; euro27.48 million).

Thomas Minder, CEO of Swiss cosmetics firm Trybol Ltd., and an activist famed in Switzerland for his push "against rip-off salaries" for corporate leaders, accused Vasella of being autocratic and demanded that he refuse to accept half the salary.

But the 2,500 shareholders voted overwhelmingly to approve the salary, which Vasella said was justified because he also is chairman of the board. He said the board could meet without his presence if they wanted to discuss issues concerning him.

Board Vice Chairman Ulrich Lehner also defended Vasella's salary, saying 90 percent of it was based on performance.

Vasella told the meeting that the company will accept an Indian court ruling on its Gleevec patent whatever the finding.

Novartis wants to clarify to what extent its intellectual property is protected by Indian law, said Thomas Wellauer, head of corporate services and a member of the executive committee.

"Patents are necessary to offer companies an incentive to make long-term investments into the development of new and better medicines," Wellauer said.

Novartis has applied for several patents in India, and Gleevec was the first to be rejected. Novartis sued to challenge India's decision in court in Chennai and filed a separate suit in the court saying that India needed to loosen its laws to make it easier to patent drugs.

India is a big maker of generic medicines supplied to many poor countries.

Critics say the changes in Indian law sought by Novartis would make it harder for poor people to get inexpensive medicines for HIV and other diseases.

"What I don't like in this debate is that we are being criticized for using the legal system in a free government under the law," Vasella said. "We will comply with the law, and will act in accordance with the ruling."

Source: Associated Press/AP Online

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