Elan 公司获得FDA对长效偏头痛药物的批准
WASHINGTON (Reuters Health) - Elan Corporation said on Friday that it has received approval from the US Food and Drug Administration (FDA) to market a longer-acting triptan for adult migraine attacks.
Dublin, Ireland-based Elan said it received FDA approval for Frova (frovatriptan succinate), a tablet for acute treatment of migraine attacks with or without aura.
Frova, formerly referred to by the company as Frovelan, is a selective 5-hydroxytryptamine (5-HT) receptor agonist believed to inhibit the dilation of arteries associated with migraine attacks.
Elan licensed exclusive North American sales and distribution rights to the drug from UK-based Vernalis in 1998. With the FDA approval, Vernalis has earned a $15 million milestone payment. The company "expects to receive further performance-based milestones as well as royalties on Elan's sales of the product," it said on Friday. It has previously projected that its royalties could total as much as $30 million during the first three years of sales.
Frovatriptan has also been approved in France, which is serving as the reference member state for the EU. Menarini, which will market the drug in Europe under the brandname Migard, hopes for a launch in the first half of 2002.
Frova has a 26-hour half-life, Max Gershenoff, a spokesman for Elan, told Reuters Health. In contrast, currently-marketed triptans have half-lives of six hours or less, he said, noting that migraine attacks usually last between four and 72 hours.
"It's obviously not the only advantage, but it is of key importance," Gershenoff said.
He said Elan will not release pricing information until the product launches because it is still in discussions with potential co-promotion partners. Elan plans to complete its launch plans before the end of this year, he noted.
The company intends to use its existing neurological products salesforce to promote Frova, Gershenoff said. Elan has also said that it hopes to put in place a sizable detailing program aimed at general practitioners.
The company estimates that 10% of Americans suffer from migraine attacks and that over half remain either undiagnosed or undertreated.
In afternoon trading on the New York Stock Exchange, shares of Elan were down 0.76 at 43.64., 百拇医药
Dublin, Ireland-based Elan said it received FDA approval for Frova (frovatriptan succinate), a tablet for acute treatment of migraine attacks with or without aura.
Frova, formerly referred to by the company as Frovelan, is a selective 5-hydroxytryptamine (5-HT) receptor agonist believed to inhibit the dilation of arteries associated with migraine attacks.
Elan licensed exclusive North American sales and distribution rights to the drug from UK-based Vernalis in 1998. With the FDA approval, Vernalis has earned a $15 million milestone payment. The company "expects to receive further performance-based milestones as well as royalties on Elan's sales of the product," it said on Friday. It has previously projected that its royalties could total as much as $30 million during the first three years of sales.
Frovatriptan has also been approved in France, which is serving as the reference member state for the EU. Menarini, which will market the drug in Europe under the brandname Migard, hopes for a launch in the first half of 2002.
Frova has a 26-hour half-life, Max Gershenoff, a spokesman for Elan, told Reuters Health. In contrast, currently-marketed triptans have half-lives of six hours or less, he said, noting that migraine attacks usually last between four and 72 hours.
"It's obviously not the only advantage, but it is of key importance," Gershenoff said.
He said Elan will not release pricing information until the product launches because it is still in discussions with potential co-promotion partners. Elan plans to complete its launch plans before the end of this year, he noted.
The company intends to use its existing neurological products salesforce to promote Frova, Gershenoff said. Elan has also said that it hopes to put in place a sizable detailing program aimed at general practitioners.
The company estimates that 10% of Americans suffer from migraine attacks and that over half remain either undiagnosed or undertreated.
In afternoon trading on the New York Stock Exchange, shares of Elan were down 0.76 at 43.64., 百拇医药