Immune shareholders to receive additional pro rata shares in Cytovia
NEW YORK–(BUSINESS WIRE)– Immune Pharmaceuticals (NASDAQ: IMNP) (“Immune”) today confirmed it is
continuing to structure and pursue a spin-off of Cytovia, Inc.
(“Cytovia”), its subsidiary dedicated to the development and
commercialization of Oncology drugs and drug candidates, into a
separate, stand-alone publicly-traded company. It is contemplated that a
pro rata distribution of shares in Cytovia would be issued to Immune
shareholders as a dividend. The spin-off is expected to create two
independent publicly-traded companies with distinct strategic plans,
leadership, growth strategies, and operational and development
priorities.
The new Cytovia, will focus on the development and commercialization of
novel immuno-oncology and hematology therapeutics to meaningfully
improve cancer patients’ lives. Cytovia aims to grow into a global
specialty biopharmaceuticals company through potential acquisitions and
rejuvenation of late-stage development or commercial-stage products. The
initial core asset of Cytovia will be CEPLENE (histamine
dihydrochloride) an immunotherapy treatment approved in Europe in
combination with low-dose IL2 for remission maintenance in patients with
Acute Myeloid Leukemia (“AML”).
Cytovia Update
As previously disclosed in a press release and our current report on
Form 8-K filed with Securities and Exchange Commission (“SEC”) on June
15, 2017, Immune signed, on behalf of its subsidiary Cytovia, a
definitive asset purchase agreement with Mylan to acquire the rights to
Ceplene in the territories that Immune did not previously own; namely
Asia, Europe, Middle East and Africa. The European Marketing
Authorization allows us to commercialize in 30 EU countries and serves
as the basis for approval in Latin America, Russia and other Eastern
European countries and countries in the Middle East, Africa and Asia.
The addressable market for remission maintenance of Acute Myeloid
Leukemia patients that could be treated with Celine exceeds 10,000
patients in Europe, Russia and other Eastern European countries. The
current reimbursement in Europe is $25,000 for a full course of
treatment.
On July 11, 2017, Cytovia entered into a definitive licensing and
commercialization agreement with Pint Pharma Int’l Ltd. for all the
markets in Latin America. Pint will implement Early Market Access
programs until full registration in those countries. The addressable
Latin American market for Ceplene is estimated at 4,000 patients. Under
the Pint agreement, Cytovia is eligible to receive 35% of net sales in
Latin America subject to the terms contained therein. Additionally, Pint
has committed to make a $4 million equity investment in Cytovia.
Cytovia is committed to further development of Ceplene in additional
indications such as Myelo-Displasic Syndrome (MDS), also known as CMML (
chronic mono-myelocytic leukemia) for which a pilot clinical study has
been initiated in Sweden.
Cytovia Strategic Plan
Cytovia expects that it will be well-positioned to establish itself as a
“pure play” commercial stage specialty pharmaceutical company in the
highly attractive immuno-oncology field, with an integrated pipeline
portfolio.
Cytovia’s strategic plan includes the following initiatives:
-
Commercialize Ceplene in select territories directly and through
partnerships with leading regional companies in other territories
following the business model being implemented with Pint Pharma in
Latin America -
Focus development resources toward an approval of Ceplene in the
United States for remission maintenance in patients with AML as well
as the extension of the use of Ceplene to new indications; -
Consider potential acquisitions and rejuvenation of synergistic
late-stage development or commercial-stage immuno-oncology drugs; -
Realize the strategic potential of its pipeline, including through
potential collaborative partnerships of its phase 2 drug candidates,
Azixa and crolibulin, its bi-specific antibody platform technology and
other early-stage drug candidates
Additional Information about the Proposed Cytovia Spin-off and Next
Steps
The spin-off transaction is intended to take the form of a tax-free
distribution to Immune’s shareholders of common stock of a new
publicly-traded Cytovia; however, as the proposed transaction
progresses, or as we may receive SEC or other tax related comments, this
structure may be revised accordingly. The stock distribution ratio and
other matters, including the stock exchange on which the new Cytovia
stock will be listed, will be determined at a later date. Immune will
continue to be listed on the NASDAQ under its existing symbol, “IMNP.”
More details about Cytovia, including pro forma financial information,
will be disclosed in any Form 10 registration statement we file with the
SEC in connection with the transaction. The initial filing of the Form
10 registration statement is expected to occur in the third quarter of
2017. The transaction is expected to be completed in 2017, subject to
certain conditions and regulatory review, including the receipt of a
favorable opinion from outside tax counsel, execution of inter-company
agreements by Immune and Cytovia, the effectiveness of the Form 10
registration statement and final approval of the transaction by Immune’s
board of directors. The transaction will not require the approval of
Immune’s shareholders. The record date will be announced by the board of
directors after the filling of the Form 10 and receipt of initial
feedback from the SEC.
Immune Pharmaceuticals
The transaction will allow Immune to become a pure play
immuno-inflammation, clinical stage. development company with all
resources being allocated to its lead assets, bertilimumab and
nano-cyclosporin, with a special interest in Immuno-Dermatology.
Immune’s core assets are bertilimumab, a first-in-class human monoclonal
antibody targeted at eotaxin-1, currently in phase 2 development in
bullous pemphigoid and ulcerative colitis, with a planned phase 2 in
severe atopic dermatitis, and a proprietary topical nano-cyclosporine
for the treatment of atopic dermatitis and of moderate psoriasis.
Immune expects that the spin-off transaction will enhance the
capitalization of the company and will allow for a focused deployment of
resources to accelerate growth and thereby attract increased attention
from institutional and other investors.
About Immune Pharmaceuticals Inc.
Immune Pharmaceuticals Inc. (NASDAQ: IMNP) is dedicated to alleviating
the burden of patients suffering from autoimmune diseases by developing
novel immunotherapeutic agents. Immune’s lead product candidate,
bertilimumab, is in Phase 2 clinical development for bullous pemphigoid,
an orphan autoimmune dermatological condition, and for ulcerative
colitis. Other potential relevant indications for bertilimumab include
atopic dermatitis, Crohn’s disease, severe asthma and Non-Alcoholic
Steato-Hepatitis (NASH). Also, Immune’s pipeline includes topical
nano-formulated cyclosporine-A for the treatment of psoriasis and atopic
dermatitis and AmiKet™ and AmiKet™ Nano™ for the treatment of
neuropathic pain.
Immune’s oncology subsidiary, Cytovia, plans to develop and
commercialize Ceplene® in combination with IL-2 for maintenance
remission in AML. Additional oncology pipeline products include Azixa®
and crolibulin, which are clinical stage vascular disrupting
agents, and bispecific antibodies and NanomAbs™, which are novel
technology platforms.
For more information, please visit Immune’s website at www.immunepharma.com,
the content of which is not a part of this press release.
Forward-Looking Statements
This news release, and any oral statements made with respect to the
information contained in this news release, may contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. You are urged to consider statements that include
the words « may, » « will, » « would, » « could, » « should, » « believes, »
« estimates, » « projects, » « potential, » « expects, » « plans, » « anticipates, »
« intends, » « continues, » « forecast, » « designed, » « goal » or the negative
of those words or other comparable words to be uncertain and
forward-looking. Such forward-looking statements include statements that
express plans, anticipation, intent, contingency, goals, targets, future
development and are otherwise not statements of historical fact.
Forward-looking statements include, among others, statements regarding
the Company’s ability to reduce expenses, capitalize on strategic
alternatives, develop its assets, and generate value for shareholders.
These statements are based on our current expectations and are subject
to risks and uncertainties that could cause actual results or
developments to be materially different from historical results or from
any future results expressed or implied by such forward-looking
statements.
There can be no assurance that the Company will ever successfully
complete its anticipated corporate restructuring, or that the Company
will be able to reduce expenses, capitalize on strategic alternatives,
develop its assets, and generate value for shareholders. The Company
may, at any time and for any reason until the proposed spin-off is
complete, abandon the spin-off or modify its terms and conditions, or
consider competing, alternate or complimentary transactions or offers by
third parties at the discretion of Immune’s board of directors. Factors
that may cause actual results or developments to differ materially
include, but are not limited to: the risks associated with the adequacy
of our existing cash resources and our ability to continue as a going
concern; the risks associated with our ability to continue to meet our
obligations under our existing debt agreements; the risk that ongoing or
future clinical trials will not be successful; the risk that our
compounds under development will not receive regulatory approval or
achieve significant commercial success; the risk that we will not be
able to find a partner to help conduct future trials or commercialize
our product candidates on attractive terms, on a timely basis or at all;
the risk that our product candidates that appear promising in early
research and clinical trials do not demonstrate safety and/or efficacy
in larger-scale or later-stage clinical trials; the risk that we will
not obtain approval to market any of our product candidates; the risks
associated with dependence upon key personnel; the risks associated with
reliance on collaborative partners and others for further clinical
trials, development, manufacturing and commercialization of our product
candidates; the cost, delays and uncertainties associated with our
scientific research, product development, clinical trials and regulatory
approval process; our history of operating losses since our inception;
the highly competitive nature of our business; risks associated with
litigation; and risks associated with our ability to protect our
intellectual property. These factors and other material risks are more
fully discussed in our periodic reports, including our reports on Forms
8-K, 10-Q and 10-K and our other filings with the U.S. Securities and
Exchange Commission.
You are urged to carefully review and consider the disclosures found in
our filings, which are available at www.sec.gov or
at www.immunepharma.com.
You are cautioned not to place undue reliance on any forward-looking
statements, any of which could turn out to be wrong due to inaccurate
assumptions, unknown risks or uncertainties or other risk factors. We
expressly disclaim any obligation to publicly update any forward-looking
statements contained herein (including those relating to the corporate
reorganization and exploration of strategic alternatives), whether as a
result of new information, future events or otherwise, except as
required by law.
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Source: Immune Pharmaceuticals Inc.
Cet article Immune Pharmaceuticals Provides Update on Plan to Implement a
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