Valeant Provides Update on Retigabine
21 September 2009 - 10:00PM
PR Newswire (US)
-- U.S. submission expected on or before October 23, 2009 -- EMEA
submission expected on October 30, 2009 -- Modified Release Phase I
clinical study commencing in September ALISO VIEJO, Calif., Sept.
21 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals International
(NYSE:VRX) today provided the following update on the regulatory
applications to the U.S. Food and Drug Administration (FDA) and the
European Medicines Agency (EMEA) for the investigational drug
retigabine, a neuronal potassium channel opener for the adjunctive
treatment for adult epilepsy patients with partial-onset seizures.
Scientists from Valeant and its collaborative partner,
GlaxoSmithKline (GSK), met with the FDA in August to discuss the
technical aspects of the planned New Drug Application (NDA)
submission. The file is now being finalized based on the outcome of
this discussion, as well as a final review of data and documents.
Valeant and GSK expect to submit an NDA to the FDA on or before
October 23, 2009 and to submit a Marketing Authorisation
Application (MAA) to the EMEA on October 30, 2009. Valeant also
announced that three retigabine modified release (MR) technologies
will be assessed in a Phase I clinical study commencing in
September. The purpose of the study is to evaluate these candidate
formulations to identify a lead MR compound that will be advanced
in further research intended to support a product with either a
once- or twice-daily dosing regimen. "We are pleased with the
outcome of the meeting with FDA and the progress we have made,"
stated J. Michael Pearson, chairman and chief executive officer.
"We are confident in our dossier and we are diligently working to
finalize the regulatory submissions which are based on positive
results from two large Phase III trials. In addition, we are
excited to have reached a key milestone in the MR development
program. With three potential MR technologies under evaluation, we
will soon be in a position to determine which MR formulation we
intend to pursue as a once- or twice-a-day option for patients
continuing to suffer from epilepsy seizures." About Retigabine
Retigabine is a neuronal potassium channel opener currently in
late-stage development as an adjunctive treatment for patients with
partial-onset seizures. In Phase III epilepsy trials, retigabine
reduced seizure rates compared to patients taking placebo. The most
common adverse reactions (incidence greater than or equal to 5% and
twice placebo) across all completed trials to date are dizziness,
fatigue, confusional state, vertigo, tremor, coordination abnormal,
diplopia (double vision), disturbance in attention, asthenia
(weakness), and visual blurring. Retigabine Important Note As an
investigational drug, retigabine has not been found by the Food and
Drug Administration (FDA) or any other regulatory agency to be safe
or effective in the treatment of any disease or illness. It may not
be commercialized in the United States unless and until the FDA has
approved a NDA. Similar restrictions apply in other countries.
About Valeant Valeant Pharmaceuticals International (NYSE:VRX) is a
multinational specialty pharmaceutical company that develops,
manufactures and markets a broad range of pharmaceutical products
primarily in the areas of neurology and dermatology. More
information about Valeant can be found at http://www.valeant.com/.
FORWARD-LOOKING STATEMENTS This press release may contain
forward-looking statements, including, but not limited to,
statements regarding the expected submission dates for regulatory
applications, the potential approval of retigabine in the U.S. or
Europe and the plans and prospects for the modified release
candidates. Forward-looking statements may be identified by the use
of the words "anticipates," "expects," "intends," "plans,"
"should," "could," "would," "may," "will," "believes," "estimates,"
"potential," or "continue" and variations or similar expressions.
These statements are based upon the current expectations and
beliefs of management and are subject to certain risks and
uncertainties that could cause actual results to differ materially
from those described in the forward-looking statements. These risks
and uncertainties include, but are not limited to, risks and
uncertainties discussed in the company's most recent annual or
quarterly report filed with the Securities and Exchange Commission,
which factors are incorporated herein by reference. Readers are
cautioned not to place undue reliance on any of these
forward-looking statements. Valeant undertakes no obligation to
update any of these forward-looking statements to reflect events or
circumstances after the date of this press release or to reflect
actual outcomes. (Logo:
http://www.newscom.com/cgi-bin/prnh/20081125/VALEANTLOGO) Contact:
Laurie W. Little Valeant Pharmaceuticals 949-461-6002
http://www.newscom.com/cgi-bin/prnh/20081125/VALEANTLOGO
http://photoarchive.ap.org/ DATASOURCE: Valeant Pharmaceuticals
International CONTACT: Laurie W. Little of Valeant Pharmaceuticals,
+1-949-461-6002, Web Site: http://www.valeant.com/
Copyright