Small biotech issues can be highly volatile. Impax Laboratories Inc (NASDAQ:IPXL) shares are down around 15% on news today that the FDA sent the company a Form 483 with ten inspectional observations after a general GMP inspection and a Pre-Approval Inspection (PAI) for RYTARY at the Impax’s Taiwan manufacturing facility from July 21 to July 26, 2014.
Impax’s Taiwan plant was approved for pharmaceutical product manufacturing by the FDA back in September 2009 and by the Taiwanese FDA in July 2010. The plant manufactures a dozen products for distribution in the U.S.
RYTARY is Impax’s extended-release capsule formulation of known agents carbidopa and levodopa for the treatment of idiopathic Parkinson’s disease.
Impax Laboratories Inc (NASDAQ:IPXL) Investors worried
Investors are worried that the problems found with the manufacturing facility could potentially delay the upcoming FDA approval or commercial availability of RYTARY. The FDA did not provide any status or classification about its observations, and per policy the agency will wait until they have reviewed the Company’s response to publicly release any further details on the matter. Impax Laboratories Inc (NASDAQ:IPXL) has not been given any information by the FDA regarding the impact of the Form 483 on RYTARY’s October 9, 2014 PDUFA approval date.
Impax Laboratories Inc (NASDAQ:IPXL) Statement from Impax CEO
“We are already working diligently to address the observations raised by the FDA and will respond to these observations within the required 15 business day period from the receipt of the Form 483,” said Fred Wilkinson, president and CEO of Impax Laboratories Inc (NASDAQ:IPXL). “We remain committed to our overarching goal of implementing a world class continuous quality improvement program and maintaining the highest quality standards across our facilities.”
Impax Laboratories Inc (NASDAQ:IPXL) More on RYTARY
According to the Impax website, “RYTARY is an investigational extended-release capsule formulation of carbidopa and levodopa for the treatment of idiopathic Parkinson’s disease. It is not approved or licensed anywhere in the world. Results from the phase III studies of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced.”