Phase II
Pure Anti-Estrogen
In light of changing research and development priorities, a decision was made to seek outside partners for the future development of a pure anti-estrogen. Post-menopausal studies in Phase II had been on hold pending the outcome of FDA guidance on hormone replacement therapy products. This agent will no longer appear on the company’sProduct Pipeline.
CCR5 Receptor Antagonistfor HIV infection has advanced to Phase II on theProduct Pipeline.
Phase III
ASMANEX (MDI)
Development of the ASMANEX MDI formulation in Phase III has been discontinued. This formulation will no longer appear on the company’sProduct Pipeline.
Garenoxacin
In June, Schering-Plough signed a definitive license agreement with Toyama Chemical Co. Ltd. for garenoxacin, Toyama’s proprietary quinolone antibacterial agent in late-stage development. As previously disclosed, the company is proceeding with its review of the product dossier and implementation of technology transfer steps, and expects to be in a position to file a U.S. NDA by late 2005.
The following compounds or indications have advanced to Phase III on theProduct Pipeline:INTEGRILINfor early acute coronary syndrome,Posaconazolefor prophylactic treatment of serious fungal infections andTEMODARfor first-line glioblastoma multiforme.
NDA/HRD Filed
U.S. regulatory submissions have been accepted as filed for the following compounds:CLARINEX-D 24 Hourfor seasonal allergic rhinitis,NASONEXfor polyposis andPosaconazolefor serious fungal infections.
International regulatory submissions have been accepted as filed for the following compounds:REMICADEfor psoriatic arthritis,ASMANEX DPIfor COPD andPosaconazolefor serious fungal infections.
Note:
As part of the current Phase II program for theAdenosine 2a Receptor Antagonistin Parkinson’s disease, the company is reviewing several back up compounds to determine whether they offer a better profile than the original compound.
CLARINEX-D 12 Houris listed in Phase III on theProduct Pipeline. As previously reported, based on an analysis of an October 2001 “approvable” letter, SGP has determined that it intends to reformulate the product and seek approval for a new version with improved stability.
Recent Approvals
VYTORIN2 (ezetimibe/simvastatin)
Cholesterol lowering [U.S. 7/04, Germany, Mexico 4/04]
REMICADE1
Early rheumatoid arthritis [EU 6/04]
REMICADE1
Maintenance of fistulizing Crohn’s disease [EU 10/03]
PEG-INTRON REDIPEN
Hepatitis C [U.S. 10/03]
REBETOLoral solution
Pediatric use [U.S. 7/03]
REMICADE1
Ankylosing spondylitis [EU 5/03]
CAELYX1
Metastatic breast cancer [EU 1/03]
1 International rights only 2 J.V. with Merck
The SGPProduct Pipelineis solely intended to provide to investors general information regarding Schering-Plough products in development and, for this reason, the information is not represented to be complete. Due to market factors and the nature of the development and approval process, the information – including the status of these products – is subject to change.
“International Status” does not necessarily imply that the company will be marketing the compound in all major countries.
The trademarks indicated by CAPITAL LETTERS are the property of, licensed to, promoted or distributed by Schering-Plough, its subsidiaries or related companies.