Impax Pharmaceuticals Announces Presentation of IPX066 Phase II Data at 13th International Congress of Parkinson's Disease & ...
June 08 2009 - 7:52AM
Business Wire
Impax Pharmaceuticals, the brand products division of Impax
Laboratories, Inc. (NASDAQ: IPXL) today announced the positive
interim results from a recent Phase II trial of its late-stage drug
candidate IPX066 were presented at the 13th International Congress
of Parkinson�s Disease (PD) and Movement Disorders in Paris,
France. The IPX066 data was presented as part of a plenary session
on Parkinson�s disease entitled �Promising New Therapies in
Development�.
The interim results demonstrate superior clinical benefit in the
duration of PD motor symptom control as compared to conventional
carbidopa-levodopa. IPX066 provided more than two additional hours
of reduction in motor �off� time during waking hours as well as two
to three hours of increasing duration of finger tapping speeds
compared to Sinemet� (carbidopa-levodopa). In addition to the data
presented, IPX066 treated-patients also experienced prolonged
improvements in walking speeds as compared to Sinemet�. The
decrease in motor �off� time, and improvements in walking and
finger tapping represent clinically significant improvement in PD
motor symptom control as compared to Sinemet�. No unexpected
treatment-emergent adverse events were reported in either treatment
group. The Phase II study is an active-controlled, multi-center,
crossover study in advanced PD patients. The results reported are
based on data from the first 13 patients with total enrollment of
27 patients.
Impax plans to present the completed Phase II data at a clinical
meeting later this year. �The findings to date are very
encouraging,� stated Michael Nestor, President of Impax
Pharmaceuticals. �The potential to significantly reduce �off� time
compared to carbidopa-levodopa, increasing time when the motor
symptoms of PD are controlled, and increasing duration of finger
tapping, would be indicative of significant benefits to
patients.�
Impax is currently enrolling patients in the Phase III APEX-PD
study of IPX066 in levodopa naive Parkinson�s disease patients in
North America and Europe and plans to commence a second Phase III
trial of IPX066 in patients with advanced PD patients by early
2010.
About IPX066 and Parkinson�s Disease
IPX066 is an investigational extended release carbidopa-levodopa
product intended to produce a fast and sustained concentration of
levodopa, potentially improving PD clinical symptom management.
IPX066 has the potential to offer improved and more reliable
control of PD symptoms, leading to clinically meaningful reductions
in �off� time, a key objective in the management of PD. �Off� time
is the time during which antiparkinson medications are not working
and PD symptoms are more prominent. In addition IPX066 extended
release formulation is designed to reduce dosing frequency,
enhancing patient convenience.
Parkinson�s disease is a chronic neurodegenerative movement
disorder affecting an estimated one million people in the U.S.
About $1 billion per year is spent on medications to treat PD in
the U.S.
"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 Impax�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; ability to timely file periodic reports required by the
Exchange Act; ability to maintain an effective system of internal
control over financial reporting; ability to sustain profitability
and positive cash flows; ability to maintain sufficient capital to
fund operations; any delays or unanticipated expenses in connection
with the construction of our Taiwan facility; ability to
successfully develop and commercialize pharmaceutical products; the
uncertainty of patent litigation; consumer acceptance and demand
for new pharmaceutical products; the impact of competitive products
and pricing; the difficulty of predicting Food and Drug
Administration (�FDA�) filings and approvals; inexperience in
conducting clinical trials and submitting new drug applications;
reliance on key alliance agreements; the availability of raw
materials; the regulatory environment; exposure to product
liability claims; fluctuations in operating results and other risks
detailed from time to time in our filings with the Securities and
Exchange Commission. Forward-looking statements speak only as to
the date on which they are made, and Impax 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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