By ANITA GREIL
July 10, 2007
ZURICH -- Swiss drug maker Novartis AG Monday said it received approval from the U.S. Food and Drug Administration for its Exelon skin patch for the treatment of Alzheimer's disease.
Novartis, based in Basel, said this was the first approval world-wide for the patch, which delivers the medicine for mild to moderate Alzheimer's disease patients through a skin patch instead of an oral capsule.
"The unique delivery system helps both the patient and the caregiver by providing a much easier way to manage their therapy," said physician George Gros*****erg at St. Louis University in Missouri in a statement.
"The patch provides a visual reassurance for the caregiver that the patient is receiving their medication and helps the patient stay engaged in the activities of daily living."
The patch was designed with compliance in mind, Novartis said. It was preferred to capsules by more than 70% of doctors and nurses as a method of drug delivery according to clinical study data, because it helped them follow the treatment schedule. It also interfered less with daily life and was easier to use overall than the oral medication, Novartis said, citing the company-sponsored study.
"Innovation isn't just about developing new compounds, but also about meeting therapeutic needs by taking existing knowledge and applying it in new ways," said James Shannon, head of development at Novartis, in a statement. "Exelon Patch addresses an important medical need by delivering a proven drug in an entirely new form that meets the needs of patients and their caregivers."
Alzheimer's disease is a progressive, degenerative disease that alters the brain, causing impaired memory, thinking and behavior. Around 18 million people world-wide have Alzheimer's disease. In the U.S. alone, more than five million people suffer from the disease and almost 10 million people provide care for someone living with dementia, most of which is related to Alzheimer's disease.
Approval had been expected, and therefore didn't have an impact on Novartis's shares. At 1340 GMT, Novartis was down 0.35 Swiss franc, or 0.5%, at 67.15 Swiss francs, in a slightly higher Swiss market.
"Although widely expected, the U.S. approval of Exelon patch is positive news for Novartis as it should reaccelerate sales growth of the drug that has significantly declined due to intense competition," said Odile Rundquist, pharmaceutical analyst in Geneva with Swiss private bank Vontobel, which has a sector outperform rating on Novartis.
Exelon generated sales of $525 million last year. Vontobel expects sales to rise to around $924 million, but warns that competition from Pfizer Inc.'s Aricept, which can be prescribed to more types of patients, and from the market entry of Forest Laboratories' Nameda is fierce.
Write to Anita Greil at anita.greil@dowjones.com2
July 10, 2007
ZURICH -- Swiss drug maker Novartis AG Monday said it received approval from the U.S. Food and Drug Administration for its Exelon skin patch for the treatment of Alzheimer's disease.
Novartis, based in Basel, said this was the first approval world-wide for the patch, which delivers the medicine for mild to moderate Alzheimer's disease patients through a skin patch instead of an oral capsule.
"The unique delivery system helps both the patient and the caregiver by providing a much easier way to manage their therapy," said physician George Gros*****erg at St. Louis University in Missouri in a statement.
"The patch provides a visual reassurance for the caregiver that the patient is receiving their medication and helps the patient stay engaged in the activities of daily living."
The patch was designed with compliance in mind, Novartis said. It was preferred to capsules by more than 70% of doctors and nurses as a method of drug delivery according to clinical study data, because it helped them follow the treatment schedule. It also interfered less with daily life and was easier to use overall than the oral medication, Novartis said, citing the company-sponsored study.
"Innovation isn't just about developing new compounds, but also about meeting therapeutic needs by taking existing knowledge and applying it in new ways," said James Shannon, head of development at Novartis, in a statement. "Exelon Patch addresses an important medical need by delivering a proven drug in an entirely new form that meets the needs of patients and their caregivers."
Alzheimer's disease is a progressive, degenerative disease that alters the brain, causing impaired memory, thinking and behavior. Around 18 million people world-wide have Alzheimer's disease. In the U.S. alone, more than five million people suffer from the disease and almost 10 million people provide care for someone living with dementia, most of which is related to Alzheimer's disease.
Approval had been expected, and therefore didn't have an impact on Novartis's shares. At 1340 GMT, Novartis was down 0.35 Swiss franc, or 0.5%, at 67.15 Swiss francs, in a slightly higher Swiss market.
"Although widely expected, the U.S. approval of Exelon patch is positive news for Novartis as it should reaccelerate sales growth of the drug that has significantly declined due to intense competition," said Odile Rundquist, pharmaceutical analyst in Geneva with Swiss private bank Vontobel, which has a sector outperform rating on Novartis.
Exelon generated sales of $525 million last year. Vontobel expects sales to rise to around $924 million, but warns that competition from Pfizer Inc.'s Aricept, which can be prescribed to more types of patients, and from the market entry of Forest Laboratories' Nameda is fierce.
Write to Anita Greil at anita.greil@dowjones.com2
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