Protalix BioTherapeutics Expands Partnership with Chiesi Farmaceutici to Include Exclusive U.S. Rights for the Development an...
July 24 2018 - 7:00AM
Protalix to receive $25 million upfront, an
additional up to $20 million in development costs and an additional
up to $760 million in potential regulatory and commercial milestone
payments for the U.S. rights
Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a
biopharmaceutical company focused on the development and
commercialization of recombinant therapeutic proteins expressed
through its proprietary plant cell-based expression system,
ProCellEx®, today announced the expansion of its partnership with
Chiesi Farmaceutici S.p.A., or Chiesi. Protalix and Chiesi entered
into an exclusive U.S. license and supply agreement which grants to
Chiesi the United States rights for the development and
commercialization of PRX-102 (pegunigalsidase alfa), the Company’s
chemically modified version of the recombinant protein
alpha-Galactosidase-A protein, for the treatment of Fabry disease.
In October 2017, Protalix announced an exclusive partnership with
Chiesi for the development and commercialization of PRX-102 for the
treatment of Fabry disease outside the United States.
Under the terms of the U.S. license and supply
agreement, Protalix is entitled to an upfront payment of $25
million from Chiesi and additional payments of up to a maximum of
$20 million in development costs, capped at $7.5 million per year.
Protalix is also eligible to receive an additional up to a maximum
of $760 million, in the aggregate, in regulatory and commercial
milestone payments, and tiered royalties ranging from 15% to 40% on
net sales as consideration for product supply. Protalix will
continue to be the manufacturer of PRX-102 for clinical development
and commercial purposes.
“We are very pleased to expand our collaboration
with Chiesi, a growing global company with well-established global
commercial infrastructure with a fast growing commercial presence
in the U.S. Chiesi’s global investment of $95 million in upfront
payments and development costs reimbursement, and additional up to
a maximum of $1 billion in potential milestone payments, combined
in the two agreements reflects Chiesi’s true commitment to the
Fabry space,” commented Moshe Manor, Protalix’s President and Chief
Executive Officer. “Taking into consideration a $25 million upfront
payment and shared development expenses, we expect our cash runaway
to take us through the read outs of all of the Fabry clinical
trials.”
In pre-clinical trials, PRX-102 demonstrated a
significantly enhanced circulatory half-life and higher enzyme
activity in the target organs affected by Fabry disease when
compared to currently available versions of the molecule. In
clinical development, PRX-102 demonstrated strong positive safety
and efficacy data in a phase I/II clinical trial. Fabry patients
are currently being enrolled in a global, pivotal phase III
clinical trial, and Protalix anticipates starting to report data
from these studies in the first half of 2019.
“We believe PRX-102 has the potential to
transform the treatment of Fabry disease and are excited to now
have exclusive commercial rights to PRX-102 worldwide,” said Ugo Di
Francesco, Chiesi’s Chief Executive Officer. “The more we work with
Protalix and see the progress made in the development and the
product’s characteristics, it becomes abundantly clear the
significant role PRX-102 could have in the underserved Fabry market
and to potentially change the treatment paradigm to the benefit of
all stake holders. We believe this U.S. license agreement will
bring many synergies in our fast growing U.S. presence in rare
diseases.”
Additional details regarding the collaboration
can be found in Protalix's Form 8-K to be filed with
the Securities and Exchange Commission.
About 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 and, subsequently, by the regulatory authorities of
other countries. Protalix has licensed to Pfizer Inc. the worldwide
development and commercialization rights for taliglucerase alfa,
excluding Brazil, where Protalix retains full rights. Protalix’s
development pipeline includes the following product candidates:
pegunigalsidase alfa, a modified version of the recombinant human
alpha-GAL-A protein for the treatment of Fabry disease; OPRX-106,
an orally-delivered anti-inflammatory treatment; alidornase alfa
for the treatment of Cystic Fibrosis; and others. Protalix has
partnered with Chiesi Farmaceutici S.p.A., both in the United
States and outside the United States, for the development and
commercialization of pegunigalsidase alfa.
About Chiesi Farmaceutici
S.p.A.
Based in Parma, Italy, Chiesi Farmaceutici is an
international research-focused Healthcare Group, with over 80 years
of experience in the pharmaceutical industry. Chiesi researches,
develops and markets innovative drugs in the respiratory
therapeutics, specialist medicine and rare disease areas. Its
R&D organization is headquartered in Parma (Italy), and
integrated with 6 other key R&D groups in France, the USA, the
UK, Sweden and Denmark to advance Chiesi's pre-clinical, clinical
and registration programmes. Chiesi employs nearly 5,300 people.
For more information, visit www.chiesi.com.
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 “expect,” “anticipate,” “believe,” “estimate,” “project,”
“plan,” “should” 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: failure or delay in the commencement or
completion of our preclinical and clinical trials which may be
caused by several factors, including: slower than expected rates of
patient recruitment; unforeseen safety issues; determination of
dosing issues; lack of effectiveness during clinical trials;
inability to monitor patients adequately during or after treatment;
inability or unwillingness of medical investigators and
institutional review boards to follow our clinical protocols; and
lack of sufficient funding to finance clinical trials; the risk
that the results of the clinical trials of our product candidates
will not support our claims of superiority, safety or efficacy,
that our product candidates will not have the desired effects or
will be associated with undesirable side effects or other
unexpected characteristics; risks related to our ability to
maintain and manage our relationship with Chiesi Farmaceutici and
any other collaborator, distributor or partner; risks related to
the ultimate purchase by Fundação Oswaldo Cruz of
alfataliglicerase pursuant to the stated purchase intentions of
the Brazilian Ministry of Health of the stated amounts,
if at all; risks related to the successful conclusion of our
negotiations with the Brazilian Ministry of
Health regarding the purchase of alfataliglicerase generally;
risks related to our commercialization efforts for
alfataliglicerase in Brazil; risks relating to the compliance
by Fundação Oswaldo Cruz with its purchase obligations
and related milestones under our supply and technology transfer
agreement; risks related to the amount and sufficiency of our cash
and cash equivalents; risks related to the amount of our future
revenues, operations and expenditures; risks related to the amount
and sufficiency of our cash and cash equivalents; the risk that
despite the FDA’s grant of fast track designation for
pegunigalsidase alfa for the treatment of Fabry disease, we may not
experience a faster development process, review or approval
compared to applications considered for approval under conventional
FDA procedures; risks related to the FDA’s ability to withdraw the
fast track designation at any time; risks relating to our ability
to make scheduled payments of the principal of, to pay interest on
or to refinance our outstanding notes or any other indebtedness;
our dependence on performance by third party providers of services
and supplies, including without limitation, clinical trial
services; delays in our preparation and filing of applications for
regulatory approval; delays in the approval or potential rejection
of any applications we file with the FDA or other health
regulatory authorities, and other risks relating to the review
process; our ability to identify suitable product candidates and to
complete preclinical studies of such product candidates; 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 press release are valid only as of the date hereof and we
disclaim any obligation to update this information, except as may
be required by law.
Investor Contact
Marcy NanusSolebury
Trout646-378-2927mnanus@soleburytrout.com
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