Protalix BioTherapeutics and Brazil's Ministry of Health Enter Into Supply and Technology Transfer Agreement for UPLYSO(TM) (al
19 Juin 2013 - 8:00AM
Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX) (TASE:PLX), announced
today that it has entered into a supply and technology transfer
agreement with Fundação Oswaldo Cruz (commonly referred to as
Fiocruz), an arm of the Brazilian Ministry of Health for UPLYSO™
(alfataliglicerase), the Company's proprietary enzyme replacement
therapy for the treatment of Gaucher disease. Gaucher disease is a
rare lysosomal storage disorder that affects approximately 10,000
people worldwide.
The technology transfer is expected to take place during a
seven-year term and is intended to transfer to Fiocruz the capacity
and skills required for the Brazilian government to construct its
own manufacturing facility, at its sole expense, and to produce a
sustainable, high quality, and cost effective supply of
UPLYSO. Under the agreement, Fiocruz has committed to purchase
at least approximately US$40 million worth of UPLYSO during the
first two years of the agreement. In subsequent years, Fiocruz is
required to purchase at least approximately US$40 million worth of
UPLYSO per year. Additionally, Protalix is not required to
complete the final stage of the technology transfer until Fiocruz
purchases at least approximately US$280 million worth of
UPLYSO. The agreement may be extended for an additional
five-year term, as needed, to complete the technology
transfer. All of the terms of the arrangement, including the
minimum annual purchases, will apply during the additional
term.
"We are excited to be working with the Brazilian government in
its efforts to provide UPLYSO to Gaucher patients in Brazil and to
collaborate with Fiocruz regarding our plant cell technology," said
Dr. David Aviezer, Protalix BioTherapeutics' President and Chief
Executive Officer. "We are encouraged by the recognition of our
drug and our technology by both Fiocruz and Brazil's Ministry of
Health, and believe that this agreement will further establish a
reliable supply of treatment for patients living with Gaucher
disease."
The technology transfer agreement becomes effective after the
parties receive approval of the agreement by the Brazilian National
Institute of Industrial Property, which is expected to occur in
approximately one month. During the technology transfer period,
Fiocruz will apply for its own registration of UPLYSO with the
Brazilian National Health Surveillance Agency (ANVISA, Agencia
Nacional de Vigilancia Sanitaria) and continue to make the product
available. Once the technology transfer is complete, the
government will be the sole source of this important treatment
option for Gaucher patients in Brazil.
"It is an honor to announce this agreement with Protalix for the
supply and production of UPLYSO in Brazil," commented Dr. Alexandre
Padilha, Brazil's Minister of Health. "Through this collaboration,
we are able to strengthen our technological and industrial
capabilities in the area of biologics manufacturing and improve the
health of Brazilian citizens who are impacted by this rare
disorder."
In March 2013, the Brazilian National Health Surveillance Agency
(ANVISA, Agencia Nacional de Vigilancia Sanitaria) granted
regulatory approval to Pfizer for UPLYSO which is indicated for the
long-term enzyme replacement therapy for adults with a confirmed
diagnosis of Type I Gaucher disease.
To facilitate the arrangement with Fiocruz, the Company's
commercialization partner for UPLYSO, Pfizer Inc., amended its
exclusive license and supply agreement and returned
commercialization rights in Brazil to the Company. In
consideration for the return of these rights, the Company will pay
Pfizer a maximum amount of approximately US$12.5 million from the
Company's net profits generated in Brazil per year of the
agreement. During the transition of commercial rights back to
the Company, Pfizer will continue to support Gaucher disease
patients in Brazil who are being treated with UPLYSO.
The Company will pay a fee equal to 5% of the net proceeds
generated in Brazil to its agent for services provided in assisting
the Company to complete the agreement.
UPLYSO is marketed as ELELYSOTM in the United States and
Israel.
The Company's management will discuss certain terms and
conditions of the agreement during its previously scheduled analyst
event on Thursday, June 20, 2013 at 8:00 AM EDT. The event
audio and slide presentation will be webcast live and archived on
the Company's website for a 30-day period. The webcast will be
available at www.protalix.com on the Events Calendar page. The
slides will be available under the presentation tab on the
Company's website after the presentation.
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,
taliglucerase alfa, was approved for marketing by the U.S. Food and
Drug Administration (FDA) in May 2012, by Israel's Ministry of
Health in September 2012, by the Brazilian National Health
Surveillance Agency (ANVISA) in March 2013, by the Mexican Federal
Commission for the Protection against Sanitary Risk (COFEPRIS) in
April 2013, and by the regulatory authorities of other
countries. Marketing applications for taliglucerase alfa have
been filed in additional territories as well. Protalix has
partnered with Pfizer Inc. for the worldwide development and
commercialization of taliglucerase alfa, excluding Israel, where
Protalix retains full rights. 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 produced and
encapsulated within 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 related to the acceptance and use of
UPLYSO by physicians, patients and the Brazilian Ministry of
Health; risks related to our and Fiocruz's ability to market UPLYSO
to the Brazilian Ministry of Health; our dependence on performance
by third party providers of services and supplies relating to the
commercialization of taliglucerase alfa in Brazil; the inherent
risks and uncertainties in developing drug platforms and products
of the type we are developing; the impact of development of
competing therapies and/or technologies by other companies and
institutions; potential product liability risks, and risks of
securing adequate levels of product liability and other necessary
insurance coverage; and 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
Marcy Beth Nanus
The Trout Group, LLC
646-378-2953
MNanus@troutgroup.com
Media Contact
Kari Watson
MacDougall Biomedical Communications
781-235-3060
kwatson@macbiocom.com