Cytovia Inc, Immune Pharmaceuticals' Oncology Subsidiary, Enters into a Definitive Agreement with Pint Pharma for the Licensing and Commercialization of Ceplene® in Latin America
NEW YORK--(BUSINESS WIRE)--
Cytovia Inc. ("Cytovia") the oncology subsidiary of Immune
Pharmaceuticals Inc. (NASDAQ: IMNP)
("Immune") announced today that it has entered into a licensing
agreement with Pint Pharma International S.A. ("Pint") a pharmaceutical
company focused on Latin America and other markets, for the marketing
and distribution of Ceplene throughout Latin America (the "territory").
Pint Gmbh will separately enter into an investment agreement, which will
lead to an investment of $4 million into Cytovia. Dr. Massimo Radaelli,
Executive Chairman of Pint, will also join the board of Cytovia upon
completion of the investment and effective spin off of Cytovia from
"Following the acquisition from Mylan of Ceplene rights in Europe and
Asia, Cytovia is pleased to confirm the partnership with Pint for Latin
America markets. This will provide Cytovia an opportunity to generate
revenues from Latin American sales of Ceplene. This potential is
incremental to revenues expected from European sales where Ceplene is
approved in thirty countries," said Daniel Teper, of Cytovia.
"We intend to immediately initiate regulatory registration of Ceplene in
the LATAM markets based on the European approval. Furthermore, Pint has
extensive experience with Early Access Programs for orphan drugs and is
planning to offer a similar program to AML patients who are candidates
for treatment with Ceplene," added David Munoz, CEO of Pint.
Ceplene is the only drug currently approved in 30 European countries and
Israel for the maintenance of first remission in Acute Myeloid Leukemia
(AML). Ceplene has a reimbursed cost of therapy of approximately
$25,000/year in Europe based on a full course of treatment. The
addressable market for remission maintenance in AML is estimated at 7000
patients in Europe. Additionally the addressable market in Latin America
is estimated at 4000 patients. There are currently no alternative drugs
approved in the remission setting.
Ceplene (histamine dihydrochloride) is administered in conjunction with
low dose interleukin-2 (IL-2), for maintenance of first remission in
patients with Acute Myeloid Leukemia (AML). It has been shown in
clinical studies to prevent leukemic relapses in AML patients in first
remission and prolong leukemia-free survival, while maintaining good
quality of life during treatment. Ceplene acts by enhancing the
immunostimulatory effect of IL-2 and countering reactive oxygen
species-induced dysfunction and apoptosis of T and NK cells, thereby
inducing immune-mediated killing of leukemic cells, providing a strong
rationale for this combination therapy. A recent Phase IV study
presented at the meeting of the American Association for Cancer Research
in 2016 confirmed the safety and efficacy of Ceplene in the
international study that supported European approval.
About Acute Myeloid Leukemia (AML)
AML patients receive intensive induction treatment with chemotherapeutic
drugs at diagnosis and typically become free of detectable leukemia,
achieving "complete remission." However, within 1-2 years, the majority
(75-80%) of adult patients will experience a relapse of leukemia, with a
survival prognosis of 33% in younger patients and 15-20% in patients
over 60 years of age. According to the American Cancer Society, there
will be approximately 21,380 new cases of AML and 10,590 deaths from AML
in the US in 2017. The prognosis following first remission is poor and
there are no other effective remission therapies currently available.
AML represents an orphan condition with high unmet need.
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
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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
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. 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. There is no certainty that Cytovia or its
commercial partners will achieve a certain market share of the
addressable market in AML. There is also uncertainty that the
reimbursement price will be maintained in Europe or that it will
accepted in Latin America. In addition, among other risks, there can be
no guarantee that concomitant investment by Pint will be completed, or
if it is completed, that it will close within the anticipated time
period or that the expected benefits of the licensing and investment
agreements will be realized.
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
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.