Onxeo Signs Exclusive License Agreement with Pint Pharma for the Commercialization of Beleodaq® in PTCL in South America


•Agreement covering seven South American countries
•Onxeo to receive upfront payment, regulatory and commercial milestones, and
sales royalties for a total deal value greater than USD 20 million
PARIS & COPENHAGEN, Denmark--(BUSINESS WIRE)-- 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 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 medicine 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
•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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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).
Onxeo
Judith Greciet, CEO
Nicolas Fellmann, CFO
investors@onxeo.com
+33 1 45 58 76 00
or
Caroline Carmagnol /Florence Portejoie – Alize RP (France)
onxeo@alizerp.com
+33 6 64 18 99 59 / +33 6 47 38 90 04
or
Kirsten Thomas / Lee Roth – The Ruth Group (U.S.)
kthomas@theruthgroup.com / lroth@theruthgroup.com
+1 508 280 6592 / +1 646 536 7012

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