10.07.2007 21:00:00
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Valeant Pharmaceuticals Selects Next-Generation Potassium-Channel Openers for Pre-Clinical Development
Valeant Pharmaceuticals International (NYSE:VRX) today announced that it
has selected several pre-Investigational New Drug (IND) candidates for
its next-generation potassium-channel opener program. These new
compounds add to Valeant’s growing expertise
with a novel and promising new class of anti-epileptic drugs. Valeant is
currently conducting two pivotal Phase 3 studies for retigabine, a
neuronal potassium-channel opener as an adjunctive treatment for
partial-onset seizures in patients with refractory epilepsy.
Potassium-channel openers are a clinically validated target for epilepsy
and show potential in treating other neurological conditions such as
neuropathic pain.
The newly selected candidates, similar in molecular structure to
retigabine, have demonstrated much greater potency and potential
efficacy in pre-clinical models, including a model of pharmacoresistant
epilepsy. The compounds have demonstrated potency at levels that are 10
to 50 times higher than retigabine in opening the potassium-channel and
at inhibiting seizure activity in animal models. In addition, the
compounds demonstrated favorable pharmacokinetic and metabolic profiles.
The candidates could represent a significant enhancement to the
retigabine profile and therefore provide the potential for a sustainable
potassium-channel franchise.
"We are enthusiastic about the progress we are
making to advance these promising next-generation potassium-channel
openers,” said Wesley P. Wheeler, president,
North America and Research and Development. "Our
expanded understanding of neuronal potassium-channel openers, coupled
with our development experience with retigabine and other neurology
products, will allow us to develop this exciting new class of drugs for
the market.”
Following the completion of enabling studies, Valeant plans to submit an
IND application to the United States Food and Drug Administration (FDA)
in early 2008.
About Retigabine
Retigabine, an investigational compound, is currently being investigated
in the Retigabine Efficacy and Safety Trials for Partial Onset Epilepsy
(RESTORE), two large, pivotal Phase 3 trials that will evaluate the
safety and efficacy of retigabine in refractory patients who are
receiving one, two or three antiepileptic drugs (AEDs). Enrollment into
RESTORE 1 is nearly complete and enrollment into RESTORE 2 is expected
to complete in the third quarter. At the completion of these trials and
the open-label extension studies offered to all patients following
completion of their participation in the RESTORE studies, retigabine
will have been studied in more than 1,300 patients with epilepsy, more
than 300 of whom will have taken the investigational product for a
minimum of 12 months.
Retigabine has not been found by the FDA or any other regulatory agency
to be safe or effective in the diagnosis, mitigation, treatment or cure
of any disease or illness. It may not be sold or promoted in the United
States unless and until the FDA has approved a New Drug Application.
Similar restrictions apply in other countries.
The most common side effects associated with retigabine to date include
somnolence, dizziness, confusion, speech disorder, vertigo, tremor,
amnesia, abnormal thinking, abnormal gait, paresthesia, diplopia,
incoordination, nervousness, abnormal vision, asthenia, headache, nausea
and diarrhea.
About Valeant
Valeant Pharmaceuticals International (NYSE:VRX) is a global specialty
pharmaceutical company that develops, manufactures and markets a broad
range of pharmaceutical products primarily in the areas of neurology,
infectious disease and dermatology. More information about Valeant can
be found at www.valeant.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements, including, but
not limited to, statements regarding the company’s
plans to submit an IND application for the new potassium-channel opener
compounds to the FDA in early 2008 and the potential of such compounds
to address epilepsy and other neurological disorders, and the completion
of RESTORE 1 and RESTORE 2 clinical trials. 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 related to the completion of the company’s
clinical trials on retigabine and its ability to successfully advance
new potassium-channel opener compounds through clinical development,
including the validity of pre-clinical models and pharmacokinetic
studies in predicting efficacy in treatment of diseases in humans, and
market launch and other risks and uncertainties discussed in the company’s
filings with the SEC. Valeant wishes to caution the reader that these
factors are among the factors that could cause actual results to differ
materially from the expectations described in the forward-looking
statements. Valeant also cautions the reader that undue reliance should
not be placed on any of the forward-looking statements, which speak only
as of the date of this release. The company undertakes no obligation to
update any of these forward-looking statements to reflect events or
circumstances after the date of this release or to reflect actual
outcomes.
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