Jazz Pharmaceuticals, Inc. Announces Receipt of FDA Orphan Drug Designation
for Recurrent Acute Repetitive Seizures Product Candidate
PALO ALTO, Calif., Jan. 7 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals,
Inc. (Nasdaq: JAZZ) announced today 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.
SOURCE Jazz Pharmaceuticals, Inc.
Karen L. Bergman, +1-650-575-1509, or Michelle Corral, +1-415-794-8662, both
of BCC Partners, for Jazz Pharmaceuticals, Inc.; or Jim Karrels, Executive
Director, Finance of Jazz Pharmaceuticals, Inc., +1-650-496-2800,
investorinfo@jazzpharmaceuticals.com
