FAIR LAWN, NJ--(Marketwire - March 10, 2009) - Vyteris, Inc. (
OTCBB:
VYTR), manufacturer of
the first FDA-approved active transdermal drug delivery system and a leader
in active transdermal drug delivery technology, has announced the
initiation of a Phase II clinical trial sponsored by its development
partner, Ferring Pharmaceuticals Inc. The trial evaluates Vyteris' smart
patch technology for the safety and efficacy of a pulsatile delivery of a
peptide hormone for the treatment of infertility in women.
"The initiation of this Phase II clinical trial is an important milestone
for Vyteris in developing an effective peptide transdermal delivery system.
We look forward to continuing our strong partnership with Ferring to
achieve success with this project for the benefit of infertility patients,"
said Dr. Haro Hartounian, chief executive officer of Vyteris. "Ferring's
confidence in moving forward with this trial further demonstrates the
commercial potential of our smart patch technology to deliver peptides and
other biopharmaceuticals using Vyteris' transdermal delivery system."
"This Phase II clinical trial will provide guidance on the roles that the
smart patch technology may play in treating women with infertility
problems," said Wayne Anderson, chief executive officer of Ferring. "The
non-invasive nature of this product and increased patient comfort will
create a new standard of care for infertility treatment."
The trial will be a multi-center clinical trial conducted at approximately
35 centers throughout the U.S. and will enroll approximately 500 female
patients between the ages of 18 and 38 years with anovulatory /
oligoovulatory infertility. In this clinical trial, the safety and
tolerability of Vyteris' transdermal delivery system will be evaluated over
the trial period. The trial is currently enrolling subjects and is expected
to be fully enrolled by July 2009.
With the initiation of the Phase II clinical trial, Vyteris earned a $2.5
million milestone payment from Ferring, which had been previously advanced
in July 2008 in the form of an interest bearing loan, the principal amount
of which has now been satisfied through application of this milestone
payment.
About Vyteris
Vyteris, Inc. is a specialty pharmaceutical company developing and
commercializing innovative technology for controlled delivery of peptide
and small molecule therapeutics. Vyteris' first product, LidoSite®, which
provides dermal analgesia prior to venipuncture (IV catheter insertions,
blood draws, etc.) and superficial dermatological procedures, was the first
FDA-approved active patch. Vyteris' proprietary transdermal drug delivery
technology delivers drugs comfortably through the skin using low-level
electrical energy. This active patch technology allows precise dosing,
giving physicians and patients control in the rate, dosage and pattern of
drug delivery that can result in considerable therapeutic, economical, and
lifestyle advantages over existing methods of drug administration. For more
information, please visit us at
www.vyteris.com.
About Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a
privately owned, international pharmaceutical company. Ferring
Pharmaceuticals offers a line of urology, orthopaedic and infertility
products in the U.S. markets. They include: EUFLEXXA®, (1% sodium
hyaluronic acid), BRAVELLE® ( urofollitropin for injection, purified),
MENOPUR® and REPRONEX® (menotropins for injection, USP), NOVAREL®
(chorionic gonadotropin for injection, USP), ENDOMETRIN® (progesterone)
Vaginal Insert, ACHTREL® (corticorelin ovine triflutate for injection),
PROSED® DS (methenamine, phenyl salicylate, methylene blue, benzoic acid,
hyoscyamine sulfate), and DESMOPRESSIN.
Ferring Pharmaceuticals specializes in the research, development and
commercialization of compounds in general and pediatric endocrinology,
urology, orthopaedics, gastroenterology, obstetrics/gynecology and
infertility. For more information, please visit
www.FerringUSA.com.
Vyteris Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning
of the safe harbor provisions of the United States Private Securities
Litigation Reform Act of 1995. Words such as "expect," "estimate,"
"project," "anticipate," "intend," "plan," "may," "will," "could," "would,"
"should," "believes," and similar expressions are intended to identify such
forward-looking statements. Forward-looking statements in this press
release include, without limitation, statements concerning the potential
impact of the new marketing agreement and other matters that involve known
and unknown risks, uncertainties and other factors that may cause actual
results, performance or achievements to differ materially from results
expressed or implied by this press release. Such risk factors include,
among others, the competitive environment and competitive responses to the
new marketing arrangement. The Company has described other important risks
and uncertainties under the caption "Risk Factors" in its most recent
Annual Report on Form 10-KSB and in various filings made with the SEC.
Actual results may differ materially from those contained in the
forward-looking statements in this press release.
Contact Information: Contacts:
Joseph Himy
Chief Financial Officer
Tel: (201) 300-1160
James Lee
The Lee Strategy Group, Inc.
Tel: (310) 229-5771
Email: