Date: 2015-06-26
Type of information: Nomination
Compound:
Company: Flamel Technologies (France)
Therapeutic area:
Type agreement: nomination
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Details: * On June 26, 2015, Flamel Technologies announced the Company has appointed Sandy Hatten as Senior Vice President of Quality and Regulatory Affairs and Gregory J. Davis as its Vice President of Business and Corporate Development. Ms. Hatten will be responsible for all quality and regulatory functions surrounding contract manufacturing organization (CMO) activity, API procurement and R&D efforts. Mr. Davis will lead activities to establish external partnerships for a select group of the Company\'s proprietary products and build Flamel\'s internal strategic pipeline through acquisitions of products and technologies. Ms. Hatten joins the Company from Mallinckrodt Pharmaceuticals where she served as Senior Vice President of Quality. Throughout her tenured career of over 30 years she has held a number of senior leadership roles in Quality spanning manufacturing, drug development and drug applications of branded and generic pharmaceuticals, quality assurance and quality control, and regulatory functions, at companies such as Mallinckrodt, KV Pharmaceuticals, Catalent Pharma Solutions and Perrigo. Ms. Hatten holds a M.A. and B.A. from Marshall University. Flamel currently has approvals for and markets two previously Unapproved Marketed Drugs (\"UMDs\") in the USA, Bloxiverz® (neostigmine methylsulfate injection) and Vazculep™ (phenylephrine hydrochloride injection). The Company intends to add to this branded business by creating additional products, focusing on the development of products utilizing Flamel\'s proprietary drug delivery platforms. Flamel currently has several products in development utilizing Micropump® (oral sustained release microparticles platform) along with its related technologies, LiquiTime® and Trigger Lock™. The lead project for Micropump is Sodium Oxybate. LiquiTime allows for the extended-release of liquid medicines (such as Ibuprofen and Guaifenesin) and Trigger Lock is an abuse-resistant iteration of Micropump, designed specifically for long-acting opioids. Additionally, the Company has developed a long acting injectable platform, Medusa™, a hydrogel depot technology currently being studied with Exenatide. Flamel\'s products are targeting high-value molecules and will utilize either the 505(b)(2) approval process for NDAs or biosimilar pathways ultimately approved by FDA and other regulatory authorities. The Company is headquartered in Lyon, France and has operations in St. Louis, Missouri, USA, and Dublin, Ireland.
Mr. Davis spent eight years as the Director of Worldwide Business Development at GlaxoSmithKline and more recently has held positions as Vice President of Corporate Development for Patheon and Chief Business Officer of Flag Therapeutics, a company which he also co-founded. Throughout his career, Mr. Davis has led and negotiated a substantial number of large transactions, including acquisitions of products and businesses as well as licensing agreements. Mr. Davis holds a B.A. in Economics from the University of North Carolina, Chapel Hill and an M.B.A. from Keenan Flagler Business School.
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