Needham & Company Maintains a 'Hold' on Warner Chilcott (WCRX); Warning Letter Could Complicate “Sweetest” Doryx 150mg Settlement Outcomes
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Price: $22.93 --0%
Rating Summary:
4 Buy, 8 Hold, 1 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 15 | Down: 9 | New: 6
Rating Summary:
4 Buy, 8 Hold, 1 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 15 | Down: 9 | New: 6
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Needham & Company maintains a 'Hold' on Warner Chilcott (NASDAQ: WCRX).
Needham analyst says, "Impax (Nasdaq: IPXL)(Hold), the odds on first generic ANDA filer on WCRX key dermatology Doryx 150mg, has received an FDA warning letter tied to its primary manufacturing facility in Hayward, CA. Why should WCRX shareholders care? The 30-month tentative approval date by which IPXL has to at least obtain tentative FDA approval by or risk forfeiting its 180-day exclusivity on Doryx 150mg is rapidly approaching; June 19, 2011 to be exact. Note that this date is different than the 30-month stay of approval triggered by outstanding litigation which prevents final FDA approval until Sep. 2011. IF IPXL can not obtain tentative approval by this date and today’s announcement of a warning letter virtually guarantees this, IPXL could be forced to relinquish its 180-day exclusivity thus removing a key blocking factor to other potential subsequent generic paragraph IV challengers, notably Mylan (NYSE: MYL)(Strong Buy), Sandoz and Heritage Pharma. It has also been recently suggested, based on ANDA sequencing, that MYL could actually be in a shared exclusivity position on Doryx 150mg though IPXL management continues to maintain its belief that it is in a sole exclusivity position."
For more ratings news on Warner Chilcott click here and for the rating history of Warner Chilcott click here.
Shares of Warner Chilcott closed at $22.24 yesterday.
Needham analyst says, "Impax (Nasdaq: IPXL)(Hold), the odds on first generic ANDA filer on WCRX key dermatology Doryx 150mg, has received an FDA warning letter tied to its primary manufacturing facility in Hayward, CA. Why should WCRX shareholders care? The 30-month tentative approval date by which IPXL has to at least obtain tentative FDA approval by or risk forfeiting its 180-day exclusivity on Doryx 150mg is rapidly approaching; June 19, 2011 to be exact. Note that this date is different than the 30-month stay of approval triggered by outstanding litigation which prevents final FDA approval until Sep. 2011. IF IPXL can not obtain tentative approval by this date and today’s announcement of a warning letter virtually guarantees this, IPXL could be forced to relinquish its 180-day exclusivity thus removing a key blocking factor to other potential subsequent generic paragraph IV challengers, notably Mylan (NYSE: MYL)(Strong Buy), Sandoz and Heritage Pharma. It has also been recently suggested, based on ANDA sequencing, that MYL could actually be in a shared exclusivity position on Doryx 150mg though IPXL management continues to maintain its belief that it is in a sole exclusivity position."
For more ratings news on Warner Chilcott click here and for the rating history of Warner Chilcott click here.
Shares of Warner Chilcott closed at $22.24 yesterday.
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