HAYWARD, Calif.--()--Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced the presentation of results from its RYTARYTM (IPX066) Phase III and open-label extension trials at the 65th Annual Meeting of the American Academy of Neurology in San Diego, CA on March 18, 2013. 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. The IPX066 data was presented as part of a poster session, entitled “Movement Disorders: Parkinson’s Disease Therapy.”
The presentation of IPX066 posters was as follows:
Date and Time (all posters):
March 18, 2013 from 2:00-6:30, with authors in attendance from 5:30-6:30 PM (local time)
Presentation Title and Number:
Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules in Patients with Motor Fluctuations in Advanced Parkinson’s Disease
Abstract / Poster Number: 3706/ P01.065
Presentation Title and Number:
Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules in Patients with Early Parkinson’s Disease
Abstract / Poster Number: 3662/ P01.064
Presentation Title and Number:
Analysis of IPX066 Dosing Data in Advanced Parkinson's Disease (PD) Patients
Abstract / Poster Number: 49/ P01.063
On January 21, 2013, Impax received a complete response letter which indicated that the FDA could not approve the NDA for IPX066 at that time. The complete response letter stated that satisfactory resolution and verification of the deficiencies identified during the inspection of the manufacturing facility in Hayward, California would be required before the NDA for IPX066 may be approved. On March 4, 2013, the Company announced the receipt of a Form 483 following an inspection by the FDA of the Hayward facility. The Form 483 contained several observations specific to IPX066 which the Company believes must be satisfactorily resolved before the NDA for IPX066 may be approved.
Open-Label Extension Study in Advanced Parkinson’s
Disease (PD) Patients
Advanced PD patients with motor fluctuations who completed either study B08-11, a Phase 2, randomized, open-label, 2-period (1 week per period), crossover pharmacokinetic and pharmacodynamic study of IPX066 vs. immediate-release carbidopa-levodopa (IR CD-LD ) or Study B09-02, a randomized, double-blind, active-controlled, parallel group, 13-week comparison of IPX066 vs. IR CD-LD, were eligible for study B09-03, an open-label extension study lasting 9 months.
Three hundred forty nine (349) of 395 eligible advanced PD patients (88.4%) entered the open-label extension study and 313 completed. The most commonly reported adverse events (AEs) during the open-label extension trial were dyskinesia, fall, pain in extremity, hallucinations and arthralgia. The most common AEs reported in the previous trials were headache, nausea, dyskinesia, insomnia and dizziness.
Open-Label Extension Study in Early PD Patients
Early PD patients who completed Study B08-05, a randomized, double-blind, fixed dose study of IPX066 vs. placebo over 30 weeks, were eligible for study B09-03, an open-label extension study lasting nine months. Two hundred sixty eight (268) of 300 eligible early PD patients (89.3%) entered into the extension study and 254 completed. During the open-label extension, the most frequently reported AEs were nausea, insomnia, hypertension and headache. There were 16 serious AEs each reported by one (0.4%) patient. No new patterns of AEs were observed.
Analysis of IPX066 Dosing in Study B09-02
IPX066 dosing in advanced PD patients was evaluated using data from Study B09-02.
IPX066 doses were individually titrated by study investigators according to their clinical evaluation. During this clinical trial, the total daily IPX066 levodopa dose was approximately double that of the levodopa IR dose received. The extended levodopa plasma concentration provided PD patients with higher levodopa exposures without higher overall levodopa maximum concentration. During this clinical study, the median dosing frequency was three times/day for IPX066 while the median dosing frequency was five times/day for CD-LD IR.
About RYTARY (IPX066)
RYTARY is an investigational extended-release capsule formulation of carbidopa-levodopa being developed for the symptomatic treatment of adult patients with idiopathic Parkinson’s disease. It is not approved or licensed anywhere in the world. Results from the phase III studies of RYTARY, APEX-PD (early PD patients), ADVANCE-PD (advanced PD patients) and ASCEND-PD (advanced PD patients) have previously been announced.
About the Impax GSK Collaboration
Impax Pharmaceuticals and GSK announced an agreement for the development and commercialization of IPX066 in December 2010. Under the terms of the agreement, GSK received an exclusive license to register and commercialize IPX066 throughout the world except in the U.S. and Taiwan.
About Impax Pharmaceuticals
Impax Pharmaceuticals is the branded products division of Impax Laboratories, Inc. Impax Pharmaceuticals is focused on targeting significant unmet needs, with a primary focus on developing treatments for central nervous system disorders. For more information, please visit its Web site at: www.impaxpharma.com.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. Impax Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia, Pennsylvania and Taiwan facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.
“Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the effect of current economic conditions on the Company’s industry, business, financial position and results of operations, fluctuations in revenues and operating income, the Company’s ability to promptly correct the issues raised in the warning letter and Form 483 observations received from the FDA, the Company’s ability to successfully develop and commercialize pharmaceutical products in a timely manner, reductions or loss of business with any significant customer, the impact of consolidation of the Company’s customer base, the impact of competition, the Company’s ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Company’s Taiwan facility, the effect of foreign economic, political, legal and other risks on the Company’s operations abroad, the uncertainty of patent litigation, the increased government scrutiny on the Company’s agreements with brand pharmaceutical companies, consumer acceptance and demand for new pharmaceutical products, the impact of market perceptions of the Company and the safety and quality of the Company’s products, the difficulty of predicting FDA filings and approvals, the Company’s ability to achieve returns on its investments in research and development activities, the Company’s inexperience in conducting clinical trials and submitting new drug applications, the Company’s ability to successfully conduct clinical trials, the Company’s reliance on third parties to conduct clinical trials and testing, impact of illegal distribution and sale by third parties of counterfeits or stolen products, the availability of raw materials and impact of interruptions in the Company’s supply chain, the use of controlled substances in the Company’s products, disruptions or failures in the Company’s information technology systems and network infrastructure, the Company’s reliance on alliance and collaboration agreements, the Company’s dependence on certain employees, the Company’s ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, the Company’s ability to protect its intellectual property, exposure to product liability claims, changes in tax regulations, the Company’s ability to manage growth, including through potential acquisitions, the restrictions imposed by the Company’s credit facility, uncertainties involved in the preparation of the Company’s financial statements, the Company’s ability to maintain an effective system of internal control over financial reporting, the effect of terrorist attacks on the Company’s business, the location of the Company’s manufacturing and research and development facilities near earthquake fault lines and other risks described in the Company’s periodic reports filed with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.