Neuroscience
From The Wall Street Journal's Health Blog:
AUGUST 17, 2009, 11:12 AM ET
Novartis’s Big Plans for Multiple Sclerosis
By Jeanne Whalen
[snippet]
The FDA gave Novartis the green light today to start selling a copy of Betaseron, the multiple sclerosis drug long sold by Bayer.
Why would Novartis want to sell somebody else’s years-old drug? Largely to gain experience in the MS marketplace as Novartis plots a future launch of the MS drug FTY720.
“It’s a way to build a strong commercial organization and a strong medical organization ahead of FTY,” Novartis pharmaceuticals chief Joe Jimemez told the Health Blog recently.
[snippet]
Read the full blog entry
==========
Note: Here is a reference to FTY720:
Horga A, & Montalban X. (2008). FTY720 (fingolimod) for relapsing multiple sclerosis. Expert Rev Neurother., 8(5) 699-714.
Clinical Neuroinmunology Unit, Multiple Sclerosis Center of Catalonia (CEM-Cat), Vall d'Hebron University Hospital, Barcelona, Spain.
FTY720 (fingolimod) is a structural analogue of sphingosine, an endogenous lysophospholipid, which targets sphingosine-1-phosphate receptors after biotransformation to FTY720-phosphate. The immunomodulatory properties of this agent are mainly related to its ability to entrap lymphocytes in secondary lymphoid organs, reducing their availability for cell-mediated immune responses. Emerging evidence suggests that FTY720 also exerts direct actions on glial and precursor cells of the CNS which may be relevant for the process of tissue repair after injury. The therapeutic effects of the drug observed in animal models of human multiple sclerosis have provided the experimental basis for its clinical application. A recent Phase II study has demonstrated that oral FTY720 is effective in reducing disease activity in relapsing multiple sclerosis with a favorable adverse-effect profile. These results are awaiting confirmation in the three ongoing Phase III clinical trials evaluating FTY720 for relapsing-remitting multiple sclerosis.
PMID: 18457527 [PubMed - indexed for MEDLINE
- Multiple Sclerosis Clinical Trials
Novartis, Merck KGaA Pills Bring ‘New Horizon’ for MS (Update1) By Naomi Kresge Bloomberg 20 January 2010 "Jan. 20 (Bloomberg) -- The first oral medicines for multiple sclerosis from Novartis AG and Merck KGaA may offer patients who are willing to...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab) And Ms
From the FDA: FOR IMMEDIATE RELEASE P06-25 February 16, 2006 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Allows Clinical Studies of Tysabri (natalizumab) for Treatment of MS to Proceed The Food and...
- Business World: Biogen Idec, Elan, Tysabri (natalizumab), And Multiple Sclerosis
From Bloomberg via the New York Times:Move to Reinstate Multiple Sclerosis Drug Published: September 21, 2005 By Bloomberg News Biogen Idec Inc. and the Elan Corporation said yesterday that they would seek federal regulatory approval to resume sales...
- More M.s. Drug Woes: Avonex And 683699
Biogen and F.D.A. Issue Drug Warning By ANDREW POLLACK The New York Times Published: March 17, 2005 Biogen Idec's multiple sclerosis drug Avonex might cause severe liver damage in rare cases, the company and the Food and Drug Administration said...
- Multiple Sclerosis And Tysabri: Fda
From the FDA: FOR IMMEDIATE RELEASE P04-107 November 23, 2004 Full press release Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA First Monoclonal Antibody Treatment For Multiple Sclerosis Approved FDA today licensed a...
Neuroscience
Business World: Novartis, Multiple Sclerosis, FTY720, & Betaseron
From The Wall Street Journal's Health Blog:
AUGUST 17, 2009, 11:12 AM ET
Novartis’s Big Plans for Multiple Sclerosis
By Jeanne Whalen
[snippet]
The FDA gave Novartis the green light today to start selling a copy of Betaseron, the multiple sclerosis drug long sold by Bayer.
Why would Novartis want to sell somebody else’s years-old drug? Largely to gain experience in the MS marketplace as Novartis plots a future launch of the MS drug FTY720.
“It’s a way to build a strong commercial organization and a strong medical organization ahead of FTY,” Novartis pharmaceuticals chief Joe Jimemez told the Health Blog recently.
[snippet]
Read the full blog entry
==========
Note: Here is a reference to FTY720:
Horga A, & Montalban X. (2008). FTY720 (fingolimod) for relapsing multiple sclerosis. Expert Rev Neurother., 8(5) 699-714.
Clinical Neuroinmunology Unit, Multiple Sclerosis Center of Catalonia (CEM-Cat), Vall d'Hebron University Hospital, Barcelona, Spain.
FTY720 (fingolimod) is a structural analogue of sphingosine, an endogenous lysophospholipid, which targets sphingosine-1-phosphate receptors after biotransformation to FTY720-phosphate. The immunomodulatory properties of this agent are mainly related to its ability to entrap lymphocytes in secondary lymphoid organs, reducing their availability for cell-mediated immune responses. Emerging evidence suggests that FTY720 also exerts direct actions on glial and precursor cells of the CNS which may be relevant for the process of tissue repair after injury. The therapeutic effects of the drug observed in animal models of human multiple sclerosis have provided the experimental basis for its clinical application. A recent Phase II study has demonstrated that oral FTY720 is effective in reducing disease activity in relapsing multiple sclerosis with a favorable adverse-effect profile. These results are awaiting confirmation in the three ongoing Phase III clinical trials evaluating FTY720 for relapsing-remitting multiple sclerosis.
PMID: 18457527 [PubMed - indexed for MEDLINE
- Multiple Sclerosis Clinical Trials
Novartis, Merck KGaA Pills Bring ‘New Horizon’ for MS (Update1) By Naomi Kresge Bloomberg 20 January 2010 "Jan. 20 (Bloomberg) -- The first oral medicines for multiple sclerosis from Novartis AG and Merck KGaA may offer patients who are willing to...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab) And Ms
From the FDA: FOR IMMEDIATE RELEASE P06-25 February 16, 2006 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Allows Clinical Studies of Tysabri (natalizumab) for Treatment of MS to Proceed The Food and...
- Business World: Biogen Idec, Elan, Tysabri (natalizumab), And Multiple Sclerosis
From Bloomberg via the New York Times:Move to Reinstate Multiple Sclerosis Drug Published: September 21, 2005 By Bloomberg News Biogen Idec Inc. and the Elan Corporation said yesterday that they would seek federal regulatory approval to resume sales...
- More M.s. Drug Woes: Avonex And 683699
Biogen and F.D.A. Issue Drug Warning By ANDREW POLLACK The New York Times Published: March 17, 2005 Biogen Idec's multiple sclerosis drug Avonex might cause severe liver damage in rare cases, the company and the Food and Drug Administration said...
- Multiple Sclerosis And Tysabri: Fda
From the FDA: FOR IMMEDIATE RELEASE P04-107 November 23, 2004 Full press release Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA First Monoclonal Antibody Treatment For Multiple Sclerosis Approved FDA today licensed a...