Protalix BioTherapeutics Signs Clinical Development Agreement With Pfizer for ELELYSO(TM) (taliglucerase alfa)
06 Dezember 2012 - 1:44PM
Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX) (TASE:PLX), announced
today that it has entered into a Clinical Development Agreement
with Pfizer Inc. under which Protalix will continue to manage,
administer and sponsor current, ongoing clinical trials relating to
ELELYSOTM (taliglucerase alfa). Protalix is currently sponsoring
adult and pediatric extension studies of ELELYSO. New
clinical trials for ELELYSO will be conducted and sponsored by
Pfizer.
Under the terms of the agreement, Protalix is eligible to
receive a milestone payment of $8.3 million upon the achievement of
certain near-term clinical development milestones.
This agreement helps to maintain the continuity of the ongoing
clinical trials for Gaucher patients and physicians and reinforces
the companies' mutual commitment to the Gaucher community.
On November 30, 2009, Pfizer and Protalix entered into an
agreement to develop and commercialize taliglucerase alfa, an
enzyme replacement therapy for the treatment of Gaucher disease.
Under the terms of the agreement, Pfizer received exclusive
worldwide licensing rights for the commercialization of
taliglucerase alfa, while Protalix retained the exclusive
commercialization rights in Israel.
Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the
development and commercialization of recombinant therapeutic
proteins expressed through its proprietary plant cell based
expression system, ProCellEx®. Protalix's unique expression
system presents a proprietary method for developing recombinant
proteins in a cost-effective, industrial-scale
manner. Protalix's first product manufactured by ProCellEx,
Elelyso™ (taliglucerase alfa), was approved for marketing by the
U.S. Food and Drug Administration in May 2012, and by the Israeli
Ministry of Health in September 2012. Protalix is partnered
with Pfizer Inc. for worldwide development and commercialization,
excluding Israel, where Protalix retains full
rights. Marketing applications for taliglucerase alfa have
been filed in additional territories as well. Protalix's
development pipeline also includes the following product
candidates: PRX-102, a modified version of the recombinant human
alpha-GAL-A protein for the treatment of Fabry disease; PRX-105, a
pegylated recombinant human acetylcholinesterase in development for
several therapeutic and prophylactic indications, a biodefense
program and an organophosphate-based pesticide treatment program;
an orally-delivered glucocerebrosidase enzyme that is naturally
encased in carrot cells, also for the treatment of Gaucher disease;
pr-antiTNF, a similar plant cell version of etanercept (Enbrel®)
for the treatment of certain immune diseases such as rheumatoid
arthritis, juvenile idiopathic arthritis, ankylosing spondylitis,
psoriatic arthritis and plaque psoriasis; and others.
Forward-Looking Statements
To the extent that statements in this press release are not
strictly historical, all such statements are forward-looking, and
are made pursuant to the safe-harbor provisions of the Private
Securities Litigation Reform Act of 1995. The terms
"anticipate," "believe," "estimate," "expect," "plan" and "intend"
and other words or phrases of similar import are intended to
identify forward-looking statements. These forward-looking
statements are subject to known and unknown risks and uncertainties
that may cause actual future experience and results to differ
materially from the statements made. These statements are
based on our current beliefs and expectations as to such future
outcomes. Drug discovery and development involve a high degree
of risk. Factors that might cause material differences
include, among others: risks and uncertainties related to our
ability to perform under the clinical development agreement and,
accordingly, to earn the milestone payment set forth therein; risks
related to Pfizer's performance of its obligations under the
clinical development agreement; the inherent risks and
uncertainties in developing drug platforms and products of the type
we are developing; other factors described in our filings with the
U.S. Securities and Exchange Commission. The statements in
this release are valid only as of the date hereof and we disclaim
any obligation to update this information.
CONTACT: Investor Contact
Tricia Swanson
The Trout Group, LLC
646-378-2953
tswanson@troutgroup.com
Media Contact
Kari Watson
MacDougall Biomedical Communications
781-235-3060
kwatson@macbiocom.com