Protalix BioTherapeutics Sells Its Share in Collaboration Agreement for ELELYSO and a 6% Equity Stake in Protalix to Pfizer f...
October 13 2015 - 7:30AM
Protalix to Use Funds to Aggressively
Push Its Clinical Pipeline Forward and Execute Its New Strategy of
Developing Clinically Superior Biologics Protalix Receives All
Rights to ELELYSO in Brazil in Exchange for All Rights to ELELYSO
in Israel
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX),
announced today that the Company sold its share in the
collaboration agreement for ELELYSOTM to its commercialization
partner, Pfizer Inc. Under the initial collaboration
agreement, Pfizer and the Company shared revenues and expenses for
the development and commercialization of ELELYSO on a 60%/40% basis
globally, excluding Israel and Brazil. As amended, Pfizer is
responsible for 100% of expenses, and entitled to all of the
revenues, globally for ELELYSO, excluding Brazil, where the Company
will be responsible for all expenses and retain all revenues.
"We are very pleased to have the support of Pfizer as a
shareholder of the Company. The funds we are receiving from
the overall transaction, totaling $46 Million, will yield a strong
pro forma cash balance for the Company of approximately $80 Million
as of September 30, 2015 enabling us to aggressively push our
clinical pipeline forward and concentrate on our new strategy of
developing clinically superior biologics," said Moshe Manor,
Protalix's President and Chief Executive
Officer. "Additionally, we are very happy to restructure and
extend our existing relationship with Pfizer as they have shown
their commitment to Gaucher patients and treating physicians."
Pursuant to the amended collaboration agreement, the Company
will receive $36 Million in cash from Pfizer for the Company's
share in the collaboration agreement and the Israeli territory,
while Pfizer will transfer to the Company full commercialization
rights in Brazil thereby eliminating annual payments of up to $12.5
Million to which Pfizer was entitled.
In addition to the $36 Million cash payment, pursuant to a stock
purchase agreement, Pfizer agreed to make a $10 Million investment
in exchange for 5,649,079 shares of the Company's common stock
subject to certain other terms referenced under the stock purchase
agreement.
"We look forward to expanding the availability of ELELYSO and
our successful patient support programs to the Gaucher patient
community globally," said Michael Goettler, Global Commercial
Officer, Global Innovative Pharma Business, Pfizer Inc. "This
amended agreement underscores Pfizer's long-standing commitment to
serving the needs of patients living with rare diseases."
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,
by Israel's Ministry of Health in September
2012, by the Brazilian National Health Surveillance
Agency (ANVISA) in March 2013, and by the regulatory
authorities of other countries. Protalix's development
pipeline 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-112, an orally-delivered
glucocerebrosidase enzyme that is produced and encapsulated within
carrot cells, for the treatment of Gaucher disease; PRX-106, an
orally-delivered anti-inflammatory treatment; PRX-110 for the
treatment of Cystic Fibrosis; 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 relating to the non-compliance by
Fundação Oswaldo Cruz with its purchase obligations and related
milestones under our supply and technology transfer agreement for
Brazil; risks related to the commercialization efforts for
taliglucerase alfa in Brazil; failure or delay in the commencement
or completion of our preclinical and clinical trials which may be
caused by several factors, including: lack of sufficient funding to
finance clinical trials; unforeseen safety issues; determination of
dosing issues; lack of effectiveness during clinical trials; slower
than expected rates of patient recruitment; inability to monitor
patients adequately during or after treatment; and the 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 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; 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; 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 Nanus
The Trout Group, LLC
646-378-2927
mnanus@troutgroup.com
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