Biotechnology Events

Home

Impax Laboratories Inc.

.

PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

.

Impax Submits Marketing Authorization Application to EMA for IPX066 (Carbidopa-Levodopa) Extended-Release Capsules

11/06/2014

AMSTERDAM, Nov. 6, 2014 /PRNewswire/ -- Impax Laboratories (Netherlands) B.V., a wholly owned subsidiary of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it has submitted a Marketing Authorization Application for IPX066 to the European Medicines Agency (EMA). IPX066 is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson's disease.

"The submission of the EMA Marketing Authorization Application for IPX066 brings us one step closer to providing this new treatment option to patients who are suffering from Parkinson's disease," said Fred Wilkinson, president and chief executive officer of Impax. "We look forward to working with the EMA as it conducts its review of IPX066."

The EMA filings follow the New Drug Application resubmission of IPX066 (brand name RYTARY™ in the United States) to the U.S. Food and Drug Administration (FDA) which was announced on April 11, 2014. The Prescription Drug User Fee Act (PDUFA) date for a decision by the FDA is January 9, 2015. The company has initiated a process to find a partner to commercialize IPX066 for territories outside the United States.
More
Source: press release, 11/06/14. http://investors.impaxlabs.com/Media-Center/Press-Releases/Press-Release...

.

Compound/DeviceSpecialtyIndicationCompound ClassTarget
RYTARY (IPX066)NeurologyParkinsons diseaseCarbidopa-levodopaDopamine receptors

Mechanism of action: RYTARY (IPX066) is an investigational extended-release capsule formulation of carbidopa-levodopa being developed for the symptomatic treatment of adult patients with idiopathic Parkinson’s disease.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2016-02-26

Results:

.

Impax Receives European Commission Marketing Authorization for NUMIENT™ (Levodopa and Carbidopa) Modified-Release Capsules for the Symptomatic Treatment of Adult Patients with Parkinson's Disease
11/25/2015

AMSTERDAM, Nov. 25, 2015 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the European Commission (EC) has granted marketing authorization for NUMIENT (Levodopa and Carbidopa), a modified-release oral capsule formulation for the symptomatic treatment of adult patients with Parkinson's disease. The review of this application was conducted under the centralized licensing procedure as a therapeutic innovation, and is applicable in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

Logo - http://photos.prnewswire.com/prnh/20150310/180590LOGO

"We are pleased that NUMIENT was approved by the European Commission as this not only showcases our R&D capabilities outside the US but is an additional positive review of our quality systems by another regulatory authority," said Fred Wilkinson, President and Chief Executive Officer of Impax. "NUMIENT addresses one of the most significant unmet needs for patients living with this disease, which is to reduce the amount of time during the day when their symptoms are not adequately controlled."

"This is our first branded drug approved for commercialization outside the United States and we are in active discussions with potential partners to support the commercialization of NUMIENT in Europe and the rest of the world. We are analyzing the options that will help facilitate the introduction of this product into the global market," concluded Mr. Wilkinson.

The EC decision is based on results from three Phase 3 controlled clinical studies which assessed the safety and efficacy of NUMIENT in patients with early (levodopa-naive) and advanced Parkinson's disease in the U.S. and in Europe. Refer to the "Summary of the Three Phase 3 Controlled Clinical Studies" for additional information.
More
Source: press release, 11/25/15. http://investors.impaxlabs.com/Media-Center/Press-Releases/Press-Release...

.

Impax Receives Positive CHMP Opinion for NUMIENT™ (Levodopa and Carbidopa) Modified-Release Capsules for the Symptomatic Treatment of Adult Patients with Parkinson's disease
09/25/2015
Download this Press Release (PDF 74 KB)
AMSTERDAM, Sept. 25, 2015 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) 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 commercialize NUMIENT in Europe. If approved, we will work quickly to bring NUMIENT to patients," concluded Mr. Wilkinson.

The CHMP's positive opinion is based on results from three Phase 3 controlled clinical studies which assessed the safety and efficacy of NUMIENT in patients with early (levodopa-naive) and advanced Parkinson's disease in the U.S. and in Europe. Refer to the "Summary of the Three Phase 3 Controlled Clinical Studies" for additional information.
More
Source: press release, 9/25/15. http://investors.impaxlabs.com/Media-Center/Press-Releases/Press-Release...

.