Impax Pharmaceuticals Announces Presentation of RYTARYTM (IPX066) (Carbidopa and Levodopa) Extended-Release Capsules Phase III

  Impax Pharmaceuticals Announces Presentation of RYTARYTM (IPX066) (Carbidopa
  and Levodopa) Extended-Release Capsules Phase III and Open-Label Extension
  Data at the American Academy of Neurology 2013 Annual Meeting

Business Wire

HAYWARD, Calif. -- March 19, 2013

Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL),
today announced the presentation of results from its RYTARY^TM (IPX066) Phase
III and open-label extension trials at the 65^th 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,
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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
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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 andother 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.

Contact:

Impax Laboratories, Inc.
Mark Donohue
Sr. Director, Investor Relations and Corporate Communications
215-558-4526
 
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