Protalix BioTherapeutics and Chiesi Farmaceutici S.p.A to Apply for Accelerated Approval of pegunigalsidase alfa for the Trea...
06 June 2019 - 9:00PM
Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE:
PLX), or Protalix, and Chiesi Farmaceutici S.p.A, an international
research-focused healthcare Group, or Chiesi, today announced that,
following a series of meetings and correspondence with the U.S.
Food and Drug Administration (FDA), they plan to file a biologics
license application, or a BLA, for pegunigalsidase alfa for the
treatment of Fabry disease in the first quarter of 2020 via the
FDA’s Accelerated Approval pathway.
Over the last several months, Protalix and Chiesi have engaged
the FDA in a dialogue regarding the potential eligibility of
pegunigalsidase alfa for accelerated approval based on readily
available data generated by Protalix from its clinical studies of
pegunigalsidase alfa.
As a result of this dialogue and a recent letter received from
the FDA, Protalix and Chiesi have initiated preparations for a BLA
submission based on data from the completed phase I/II clinical
trials of pegunigalsidase alfa and from the ongoing phase III
BRIDGE clinical trial. Protalix and Chiesi are targeting a
BLA submission for the first quarter of 2020.
If approved, Protalix will be eligible to receive a milestone
payment from Chiesi.
“We are very excited to be one step closer to an approved
product to help a patient population that desperately needs a
better option than those currently available on the market.
This regulatory approval path is a significant achievement as it
means that we can start the application process and potentially
attain market approval significantly earlier than the initial plan
of data from our ongoing phase III BALANCE clinical trial. We
plan to continue the BALANCE study to further strengthen the
profile of pegunigalsidase alfa,” commented Moshe Manor, Protalix’s
President and Chief Executive Officer. “Approval will depend
on the formal FDA review, but based on communications with the
agency, Protalix remains optimistic that the FDA will approve
pegunigalsidase alfa on the accelerated basis.”
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 the Chiesi Group
Based in Parma, Italy, Chiesi Farmaceutici is an international
research-oriented group with over 80 years’ experience in the
pharmaceutical sector, and is present in 27 countries. The
group researches, develops and commercializes innovative medicines
in the respiratory disease, special care and rare disease
therapeutic areas. The Group’s Research & Development
center is based in Parma (Italy) and integrated with 6 other
important research and development groups in France, the USA, the
UK and Sweden, to promote its pre-clinical, clinical and
registration programs. The Group employs around 5,700 people.
For more information please 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 and the final results of a clinical trial may
be different than the preliminary findings for the clinical
trial. 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: risks that the FDA will not accept an
application for accelerated approval of PRX-102 with the data
generated to date or will request additional data or other
conditions of our submission of any application for accelerated
approval of PRX-102; lack of sufficient funding to finance clinical
trials; 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; and inability or
unwillingness of medical investigators and institutional review
boards to follow our clinical protocols; 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 amount and sufficiency
of our cash and cash equivalents; risks related to the amount of
our future revenues, operations and expenditures; 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
Alan Lada, Vice President Solebury Trout 617-221-8006
alada@soleburytrout.com
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