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News Breaks
February 8, 2013
08:01 EDTIPXL, SHPGImpax, Shire settle litigation on supply of authorized generic Adderall XR
Impax Laboratories (IPXL) announced that it has settled all pending litigation with Shire LLC (SHPG) and Shire Laboratories, Inc.relating to supply of its authorized generic Adderall XR under the partiesí License and Distribution Agreement that was signed in January 2006. As part of the settlement, the parties will submit a stipulation of dismissal for entry by the Court. Shire has agreed to make a one-time cash payment to Impax of $48M upon the courtís order of dismissal. The parties have entered into an amended License and Distribution Agreement which will govern the future supply of authorized generic Adderall XR from Shire to Impax. Following the end of the supply term on September 30, 2014, Impax will continue to have the right to sell its products on hand or owed to it under the agreement until depleted and will continue to pay a profit share to Shire on sales of such products. Impax will continue to pursue approval of its pending Abbreviated New Drug Application for generic Adderall XR which was filed with the U.S. Food and Drug Administration in September 2003.
News For IPXL;SHPG From The Last 14 Days
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September 17, 2014
09:06 EDTIPXLImpax granted extension of Rytary FDA review date to January 9, 2015
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07:43 EDTSHPGBofA/Merrill to hold a conference
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September 16, 2014
11:51 EDTSHPGOECD looks to close tax loopholes with new proposals
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September 15, 2014
10:55 EDTSHPGRegulators to determine AbbVie, Shire deal by next month, Reuters says
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08:01 EDTSHPGShire announces FDA acceptance for filing of sNDA for Vyvanse
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September 10, 2014
08:37 EDTSHPGMedgenics appoints Scott Applebaum as Chief Legal Officer
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07:06 EDTSHPGSangamo plans to submit IND application for hemophilia B in 2Q15
Sangamo BioSciences (SGMO) plans to submit an Investigational New Drug application for the treatment of hemophilia B in Q2 2015. This program, partnered with Shire (SHPG), is the first therapeutic application of Sangamo's zinc finger nuclease-mediated In Vivo Protein Replacement Platform. Sangamo is developing the IVPRP as a generally applicable strategy to provide a one-time, permanent genetic cure for monogenic diseases that are currently managed by protein replacement therapy, which involves costly repeat infusions over the lifetime of the patient.

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