Friday, December 12, 2008 2:11:47 PM
FTY720 has shown impressively better efficacy to Avonex (and presumably to Copaxone as well) but side effect are still troubling even at the lower dose. However, the safety profile of that 0.5mg dose, does look better.
UPDATE 3- Novartis posts Phase III progress for MS drug
http://www.reuters.com/article/marketsNews/idINLC3519320081212?rpc=44
By Martin de Sa'Pinto
ZURICH, Dec 12 (Reuters) - Switzerland's Novartis AG (NOVN.VX: Quote, Profile, Research, Stock Buzz) said first Phase III results for its FTY720 drug showed superior efficacy to a current standard of care for patients with relapsing multiple sclerosis (MS).
Regulatory submissions for the drug in the United States and the European Union remain on track for the end of 2009, the company said on Friday.
Novartis will hold a webcast at 1300 GMT to discuss the trial data, which will be followed by an analysts' question-and-answer session.
Novartis said the first one-year head-to-head Phase III trial of FTY720, which is taken orally, showed better results than standard multiple-sclerosis care interferon beta-1a, an injectable medicine.
"This is the first oral drug aimed at treating MS, and it is an important point from the perspective of patient convenience. However, the jury is still out on FTY side effects," said one analyst who declined to be named.
The analyst said the global market for MS drugs is worth around $7 billion annually.
In a research note the Morgan Stanley pharmaceuticals team said the efficacy of the drug had exceeded expectations.
"We believe FTY720 could be capable of achieving revenues in excess of $2 billion which would add more than 5 percent to our longer term earnings per share forecasts," they said.
However, they also expressed concern over potential side effects of the drug. "Well-documented adverse events remain a concern until better characterized with two-year clinical trial data," they wrote.
If approved, the Novartis compound will compete against MS treatments including Avonex, which in the most recent quarter brought revenue of $573 million to its developer Biogen.
UPDATE 3- Novartis posts Phase III progress for MS drug
http://www.reuters.com/article/marketsNews/idINLC3519320081212?rpc=44
By Martin de Sa'Pinto
ZURICH, Dec 12 (Reuters) - Switzerland's Novartis AG (NOVN.VX: Quote, Profile, Research, Stock Buzz) said first Phase III results for its FTY720 drug showed superior efficacy to a current standard of care for patients with relapsing multiple sclerosis (MS).
Regulatory submissions for the drug in the United States and the European Union remain on track for the end of 2009, the company said on Friday.
Novartis will hold a webcast at 1300 GMT to discuss the trial data, which will be followed by an analysts' question-and-answer session.
Novartis said the first one-year head-to-head Phase III trial of FTY720, which is taken orally, showed better results than standard multiple-sclerosis care interferon beta-1a, an injectable medicine.
"This is the first oral drug aimed at treating MS, and it is an important point from the perspective of patient convenience. However, the jury is still out on FTY side effects," said one analyst who declined to be named.
The analyst said the global market for MS drugs is worth around $7 billion annually.
In a research note the Morgan Stanley pharmaceuticals team said the efficacy of the drug had exceeded expectations.
"We believe FTY720 could be capable of achieving revenues in excess of $2 billion which would add more than 5 percent to our longer term earnings per share forecasts," they said.
However, they also expressed concern over potential side effects of the drug. "Well-documented adverse events remain a concern until better characterized with two-year clinical trial data," they wrote.
If approved, the Novartis compound will compete against MS treatments including Avonex, which in the most recent quarter brought revenue of $573 million to its developer Biogen.
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