Monday, January 12, 2015
Shire plans to relocate over 500 positions to Massachusetts from its Chesterbrook, Pa., site and establish Lexington, Mass., as the company’s U.S. operational headquarters. The transition is a continuation of the company’s “One Shire” efficiency program and will streamline business globally through two principal locations—Massachusetts and Switzerland—with support from a limited number of regional and country-based offices around the world.
Spark Therapeutics, a late-stage gene therapy company developing treatments for debilitating genetic diseases, has announced that its lead product candidate, SPK-RPE65, has received Breakthrough Therapy designation from the FDA. Breakthrough Therapy designation is intended to expedite the development and review of investigational therapies for serious or life-threatening conditions where initial clinical evidence demonstrates a significant improvement over existing therapies. SPK-RPE65 targets a group of blinding conditions known as inherited retinal dystrophies (IRDs) caused by autosomal recessive mutations in the RPE65 gene, and for which there currently is no pharmacologic treatment available.
The widely-discussed $54.6 billion acquisition of Dublin-based Shire by AbbVie is officially canceled, having crumbled after a notice by the U.S. Treasury Department to tighten tax rules that deter U.S. companies from moving their legal headquarters to countries with lower business taxes.
In what could have been a major pharmaceutical acquisition and one of the biggest tax inversion deals, Chicago-based AbbVie has recommended its shareholders vote against its proposed $54 billion takeover of Shire, a Dublin-headquartered pharmaceutical company specializing in medications to treat attention deficit disorder and rare diseases
Shire has reached a final agreement with the U.S. Attorney’s Office to resolve a civil investigation of its sales and marketing practices for a period ending in 2010 relating to Adderall XR, Vyvanse, Daytrana, Lialda and Pentasa. Shire will pay $56.5 million, plus interest, fees and costs.
Shire, a global specialty biopharmaceutical company, and ArmaGen, a U.S. privately held biotechnology company, have announced a worldwide licensing and collaboration agreement for AGT-182, an investigational enzyme replacement therapy (ERT) for the potential treatment of both the central nervous system (CNS) and somatic manifestations in patients with Hunter syndrome (MPS II).