[July 27, 2016] |
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Onxeo Signs Exclusive License Agreement with Pint Pharma for the Commercialization of Beleodaq® in PTCL in South America
Regulatory News:
Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO), an innovative company
specialized in the development of orphan oncology therapeutics, today
announced it has entered into an exclusive license agreement with Pint
Pharma for the commercialization of Beleodaq® (belinostat), Onxeo's
pan-HDAC inhibitor for PTCL (peripheral T-cell lymphoma), in key South
American countries. Beleodaq® is approved in the US, and has been
marketed by Spectrum (News - Alert) Pharmaceuticals since July 2014 as a 2nd-line
treatment for PTCL.
Pint Pharma is a private specialty pharma company well experienced in
commercializing orphan drugs and highly specialized products in South
American healthcare markets.
Under the terms of the agreement, Pint Pharma will register,
commercialize, and promote Beleodaq® in seven countries: Argentina,
Brazil, Chile, Colombia, Ecuador, Peru, and Venezuela.
Onxeo will receive an upfront payment from Pint Pharma, regulatory and
commercial milestone as well as double-digit royalties on the net sales
of Beleodaq® in these territories, representing a deal value of over USD
20 million.
"We are extremely pleased to announce this exclusive licensing
agreement for Beleodaq®, and to have Pint Pharma as a strategic partner
in South America. This is the second Beleodaq® licensing agreement,
demonstrating our product's commercial potential as well as its clinical
value. We look forward to a close collaboration with Pint Pharma as we
leverage their team's strong expertise in this region to provide access
to our treatment to a greater number of PTCL patients," commented
Judith Greciet, CEO of Onxeo.
While initiating the regulatory procedures to obtain market approval,
Pint Pharma also plans to make Beleodaq® available to PTCL patients
through Early Access Programs (EAPs) in eligible countries by the end of
2016.
"This collaboration agreement with Onxeo is a great opportunity for
us to expand our hematology franchise and strengthen our leadership
position in the South American oncology market. We are thrilled to be
working with Onxeo, a company that shares our values and commitment to
making innovative therapeutics available to patients suffering from rare
diseases," commented David Muñoz, CEO of Pint Pharma.
About Early Access Programs Early Access programs, also
known as Named Patient Program (NPP) or compassionate use, is a
mechanism that enables patients with unmet medical need to be provided
with access to a medicine, prior to the medicine being commercially
available in that country. NPPs can take different forms, and are
generally initiated by healthcare professionals contacting the
manufacturer or distributor of a medcine to ask about access for their
patient.
About Pint Pharma Pint Pharma is a private specialty pharma
company which benefits from specialized leaders with extensive
experience in the pharmaceutical sector and whom are based strategically
throughout Latin America and Europe. Pint Pharma has also a long track
record of developing strong relationships with global pharmaceutical and
healthcare companies. Pint Pharma has the ambition to become a leading
Latin American company delivering innovative treatments to patients with
cancers, rare diseases and genetic disorders.
About Onxeo Onxeo is a leading developer of orphan oncology
drugs. The Company is focused on developing innovative therapeutics for
rare cancers, one of the fastest growing markets in the healthcare
industry with high, unmet medical needs. Onxeo's vision is to become a
global leader and pioneer in oncology, with a focus on orphan or rare
cancers, by developing advanced, effective, and safe therapeutics
designed to improve the lives of patients. Onxeo's comprehensive
portfolio features a broad orphan oncology pipeline, with four
independent programs in various stages of clinical development,
including Onxeo's first approved orphan oncology drug, Beleodaq®. The
Company is headquartered in Paris, France and has approximately 50
employees. Onxeo is listed on Euronext in Paris, France (Ticker: ONXEO,
ISIN Code: FR0010095596) and Nasdaq Copenhagen, Denmark (Ticker: ONXEO).
Onxeo's orphan oncology products are:
-
Livatag® (Doxorubicin Transdrug™): Currently being evaluated in
a Phase III trial (ReLive) in patients with hepatocellular carcinoma
(primary liver cancer); and in combination with other cancer agents in
first-line HCC
-
Beleodaq® (belinostat): FDA-approved in the US in 2014 under
the agency's accelerated approval program as a second-line treatment
for patients with peripheral T-cell lymphoma (PTCL) and currently
marketed by Onxeo's partner in the US, Spectrum Pharmaceuticals;
belinostat in combination with other cancer agents is currently in
development in first-line treatment for patients with PTCL (BelCHOP)
and in other solid tumors
-
AsiDNA: The first-in-class siDNA (signal-interfering DNA) which
has successfully undergone a proof-of-concept Phase I trial in
metastatic melanoma
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Validive® (Clonidine Lauriad®): Positive final results from a
Phase II trial in head and neck cancer patients with severe oral
mucositis
In addition, Onxeo has successfully developed and registered two
non-cancer products, which are currently being commercialized in the
U.S. and Europe.
Learn more by visiting www.onxeo.com.
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us on Twitter (News - Alert): @Onxeo_
Disclaimer This communication expressly or implicitly
contains certain forward-looking statements concerning Onxeo and its
business. Such statements involve certain known and unknown risks,
uncertainties and other factors, which could cause the actual results,
financial condition, performance or achievements of Onxeo to be
materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements.
Onxeo is providing this communication as of this date and does not
undertake to update any forward-looking statements contained herein as a
result of new information, future events or otherwise. For a discussion
of risks and uncertainties which could cause actual results, financial
condition, performance or achievements of Onxeo to differ from those
contained in the forward-looking statements, please refer to the Risk
Factors ("Facteurs de Risque") section of the 2015 Reference Document
filed with the AMF on April 29, 2016, which is available on the AMF
website (http://www.amf-france.org)
or on the company's website (www.onxeo.com).
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