25 September 2015 - Impax Laboratories, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending that Numient (IPX066), a modified-release oral capsule formulation of levodopa-carbidopa, be granted approval for the symptomatic treatment of adult patients with Parkinson's disease. The European Commission (EC) will now consider the CHMP positive opinion in its decision of whether to grant marketing authorization for Numient in Europe. The review of this application is being conducted under the centralized licensing procedure as a therapeutic innovation, and the final decision will be applicable in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

"The positive opinion from the CHMP recommending the approval of Numient is a significant step forward to providing a new treatment option to patients in Europe suffering from Parkinson's disease," said Fred Wilkinson, President and Chief Executive Officer of Impax. "We are committed to realizing the full potential of this important franchise and we look forward to the European Commission's decision in the coming months."

"We continue to have discussions with potential partners to help commercialise Numient in Europe. If approved, we will work quickly to bring Numient to patients," concluded Mr. Wilkinson.

For more details, go to: http://investors.impaxlabs.com/Media-Center/Press-Releases/Press-Release-Details/2015/Impax-Receives-Positive-CHMP-Opinion-for-NUMIENT-Levodopa-and-Carbidopa-Modified-Release-Capsules-for-the-Symptomatic-Treatment-of-Adult-Patients-with-Parkinsons-disease/default.aspx