Date: 2014-10-30
Type of information: Establishment of a new subsidiary in the EU
Compound:
Company: Impax (USA - CA)
Therapeutic area:
Type agreement: R&D reorganization
Action mechanism:
Disease:
Details: * On October 30, 2014, Impax Laboratories announced a reorganization of its R&D organizations and a prioritization of the project portfolios within the generic and brand businesses. As a result of the reorganization, the generic R&D organization will be responsible for early stage product development and analytical functions for all Impax products, while the brand R&D organization will focus on phase II, III and IV clinical activities, drug safety and pharmacovigilance for all Impax products. This realignment of the R&D organization and reallocation of responsibilities between these teams is intended to better optimize Impax\'s core technologies and scientific expertise, increase efficiencies and process improvements in key areas and allow Impax to maximize its investment in product development. Impax expects to realize approximately $8.0 million of annual cost savings beginning in 2015 and approximately $1.5 million in the fourth quarter of 2014. The cost savings are the result of a net reduction of approximately 49 positions, including 42 in R&D or about 25% of the combined brand and generic R&D organizations. In the fourth quarter 2014, the Company expects to record certain charges of about $2.0 million associated with the reorganization. Generic Portfolio: 23 Abbreviated New Drug Applications pending at the FDA and 23 projects under development. This includes 4 pending and 9 under development that are alternative dosage form products through external collaborations. Branded Portfolio: Rytary™ (IPX066) is a patented extended- release capsule formulation of carbidopa and levodopa, an investigational drug for the symptomatic treatment of Parkinson\'s disease. A New Drug Application is pending at the FDA with a Prescription Drug User Fee Act (PDUFA) review date of January 9, 2015. The Company is also planning to file a Marketing Authorization Application in Europe by the end of 2014. IPX239, an investigational transdermal bupivacaine patch for the treatment of pain associated with post-herpetic neuralgia (PHN) licensed from DURECT Corporation. IPX203, an investigational drug for the symptomatic treatment of Parkinson\'s disease. The Company recently filed an Investigational New Drug Application with the FDA.
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