The diabetes medicine Galvus produced by Novartis received a positive opinion from European health authorities after the drug maker made changes to prescribing recommendations amid liver-safety concerns.
The drug, which was expected to generate more than $1 billion in sales before the liver and other safety issues became apparent, will be available in the first European markets in the first half of 2008, Novartis said.
Skin-toxicity worries also have delayed Galvus's approval in the U.S., where the company aims to resubmit the drug in 2009.
"A path for U.S. approval of Galvus is still not clear," said Lanksbanki Kepler analyst Denise Anderson. "Thus, our forecasts for the drug are modest, at $270 million by 2010, as we expect cheaper generics to be preferred in most markets and due to lingering safety concerns," she said.
Vontobel analysts estimate Galvus's peak sales, excluding the U.S., could reach $400 million a year.
In November, Novartis said it had found liver-safety problems with a higher dose of Galvus. The discovery disappointed analysts who had been expecting the drug to generate significant annual sales.
The medicine's launch was pushed back, giving Merck's rival treatment, Januvia, an even greater lead in the market for next-generation diabetes treatments.
Both Galvus and Januvia are DPP-4 inhibitors, designed to boost the body's ability to lower elevated blood sugar. They are expected to become a key way of treating type 2, or maturity onset, diabetes. The drugs are expected to do well as they aren't associated with weight gain, a major side effect of some diabetes drugs.
Formal approval would come from the European Commission, which generally follows the committee's recommendations. A decision is expected within three months.
The drug, which was expected to generate more than $1 billion in sales before the liver and other safety issues became apparent, will be available in the first European markets in the first half of 2008, Novartis said.
Skin-toxicity worries also have delayed Galvus's approval in the U.S., where the company aims to resubmit the drug in 2009.
"A path for U.S. approval of Galvus is still not clear," said Lanksbanki Kepler analyst Denise Anderson. "Thus, our forecasts for the drug are modest, at $270 million by 2010, as we expect cheaper generics to be preferred in most markets and due to lingering safety concerns," she said.
Vontobel analysts estimate Galvus's peak sales, excluding the U.S., could reach $400 million a year.
In November, Novartis said it had found liver-safety problems with a higher dose of Galvus. The discovery disappointed analysts who had been expecting the drug to generate significant annual sales.
The medicine's launch was pushed back, giving Merck's rival treatment, Januvia, an even greater lead in the market for next-generation diabetes treatments.
Both Galvus and Januvia are DPP-4 inhibitors, designed to boost the body's ability to lower elevated blood sugar. They are expected to become a key way of treating type 2, or maturity onset, diabetes. The drugs are expected to do well as they aren't associated with weight gain, a major side effect of some diabetes drugs.
Formal approval would come from the European Commission, which generally follows the committee's recommendations. A decision is expected within three months.
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