HAYWARD, Calif.--(BUSINESS WIRE)--
Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ:
IPXL), today announced that data from the RYTARYTM Phase III
and open-label extension trials will be presented at the 65th Annual
Meeting of the American Academy of Neurology in San Diego, California,
held from March 16 to March 23. IPX066 is an investigational
extended-release capsule formulation of carbidopa-levodopa for the
treatment of idiopathic Parkinson’s disease.
The presentation of IPX066 posters is as follows:
|
Date: March 18, 2013 (all posters)
Time: 2:00-6:30, with
authors in attendance from 5:30-6:30 PM PT (all posters)
Location:
San Diego Convention Center
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
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About RYTARYTM (IPX066)
RYTARY is an investigational extended-release capsule formulation of
carbidopa-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 RYTARY, APEX-PD (early PD), ADVANCE-PD (advanced
PD) and ASCEND-PD (advanced PD) have previously been announced.
On January 21, 2013, Impax received a complete response letter which
indicated that the FDA could not approve the NDA 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.
RYTARY has been licensed to GlaxoSmithKline (GSK) for countries outside
the U.S. and Taiwan for registration and commercialization.
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 neurological 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 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.
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Source: Impax Laboratories, Inc.