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Jazz Pharmaceuticals, Inc. Announces Receipt Of FDA Orphan Drug Designation For Recurrent Acute Repetitive Seizures Product Candidate
Jazz
Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced that it has received
orphan drug designation from the U.S. Food and Drug Administration (FDA)
for its JZP-8 product candidate for the treatment of recurrent acute
repetitive seizures. In December 2007, Jazz Pharmaceuticals dosed the first
patient in a Phase II clinical trial of JZP-8.
JZP-8 is a novel drug delivery formulation incorporating clonazepam, a
widely prescribed benzodiazepine. The product candidate is designed to be a
fast-acting intranasal spray for the treatment of recurrent acute
repetitive seizures in patients with epilepsy. Jazz Pharmaceuticals
previously completed development activities to select the active
pharmaceutical ingredient for the product, to determine its formulation,
and to assess its safety and tolerability in early stage studies.
"JZP-8 is one of the first development product candidates from our
internal product identification and development program to enter Phase II,"
said Samuel R. Saks, M.D., Chief Executive Officer of Jazz Pharmaceuticals.
"Dosing of the first patient in our Phase II clinical trial and receipt of
orphan drug designation are important milestones for this program."
About Recurrent Acute Repetitive Seizures
Recurrent acute recurrent repetitive seizures (ARS) are bouts of acute
seizure activity occurring within a 24-hour period in adults and a 12-hour
period in children. ARS, also called seizure clusters, occurs in a small
subset of patients with epilepsy who regularly experience breakthrough
seizures in flurries or clusters despite treatment with a regimen of
anti-epileptic drugs. ARS is a rare disorder, with an estimated prevalence
in the United States of approximately 90,000 to 180,000 people.
About Orphan Drug Designation
Orphan drug designation is granted by the FDA to encourage the
development of treatments for diseases or conditions that affect fewer than
200,000 patients in the United States. Drug products that receive orphan
drug designation obtain seven years of marketing exclusivity from the date
of FDA marketing approval, as well as tax credits for clinical trial costs
and waivers of marketing application filing fees.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals, Inc. is a specialty pharmaceutical company
focused on identifying, developing and commercializing innovative products
to meet unmet medical needs in neurology and psychiatry. For further
information, please visit http://www.JazzPharmaceuticals.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform
Act of 1995
This press release contains forward-looking statements, including, but
not limited to, statements related to the development program for the JZP-8
product candidate and the company's internal product concept generation
program. These forward-looking statements inherently involve significant
risks and uncertainties. Jazz Pharmaceuticals' actual results and the
timing of events could differ materially from those anticipated in such
forward- looking statements as a result of these risks and uncertainties,
which include, without limitation, whether or when clinical studies of
JZP-8 will be completed or will be successful, and whether or when the
product candidate will be approved or launched. These and other risk
factors are discussed under "Risk Factors," in the Quarterly Report on Form
10-Q for the quarter ended September 30, 2007 filed by Jazz Pharmaceuticals
with the Securities and Exchange Commission on November 9, 2007. Jazz
Pharmaceuticals undertakes no duty or obligation to update any
forward-looking statements contained in this release as a result of new
information, future events or changes in its expectations.
Jazz Pharmaceuticals, Inc.
http://www.jazzpharmaceuticals.com
View drug information on Clonazepam.
Jazz Pharmaceuticals, Inc Announces primirea FDA Orphan Drug Desemnarea Pentru recurente acute crize repetitive produs candidate - Jazz Pharmaceuticals, Inc. Announces Receipt Of FDA Orphan Drug Designation For Recurrent Acute Repetitive Seizures Product Candidate - articole medicale engleza - startsanatate