Effective integration of both entities, BioAlliance Pharma and Topotarget, into
newly named Onxeo
Major advancements of company programs
· Validive®: Positive preliminary top-results of the Phase II trial
· Beleodaq®: Grant of U.S. marketing authorization and first sales
· Livatag®: Active recruitment in the ReLive trial with nearly 35% of planned
patients already randomized
Significantly improved cash position
PARIS & COPENHAGEN, Denmark--(BUSINESS WIRE (http://www.businesswire.com/))--
Regulatory News:
Onxeo SA (Paris:ONXEO) (NASDAQ OMX:ONXEO) (Euronext Paris, NASDAQ OMX Copenhagen
- ONXEO), an innovative biopharmaceutical company specializing in the
development of orphan oncology drugs, today publishes the major key milestones
achieved during the third quarter of 2014 and the last few weeks.
Since August 1st, 2014, the newly named company Onxeo resulting from the merger
of Topotarget and BioAlliance Pharma is fully operating with teams in France and
Denmark.
Onxeo has achieved major milestones in the development of its key programs in
orphan oncology:
Validive® (clonidine Lauriad®)
· Positive preliminary top-line results of the international large Phase II
trial comparing the efficacy and safety of Validive® versus placebo in the
prevention of oral severe mucositis in Head and Neck cancer patients. Experts
have confirmed that these data were supportive to further pursue Validive®
development plan. Validive® peak sales potential is estimated between €200 and
€400 million.
Beleodaq® (belinostat)
· Grant of US conditional marketing authorization of Beleodaq® for the
treatment of patients with relapsed or refractory peripheral T-cell lymphoma
(PTCL). This approval has triggered a $25 million milestone payment from
American partner Spectrum Pharmaceuticals, to be received by year-end by the
company. The commercialization of Beleodaq® by the Spectrum Pharmaceuticals’
oncology sales team started in late July 2014 and the first promising sales have
been registered over Q3.
Livatag® (doxorubicin Transdrug™)
· Active recruitment in the phase III trial ReLive in primary liver cancer,
with nearly 35% of planned patients already randomized, in line with the study
planning.
Other programs
· Launch of Sitavig® , approved in the US for the treatment of labial herpes
by the US based licensee Innocutis towards to dermatologists and top tier
general practitioners,first promising sales reported after a few weeks of
promotion.
· Decision to stop Amep® biotherapy development to reinforce focus onOnxeo’s
advanced strategic programs.
Financials
The consolidated turnover for the third quarter 2014 has increased significantly
compared to same period in 2013:
Consolidated revenues – Q3 2014 Q3 2013
IFRS – in thousands Euros
Non-recurring revenues 19,911 133
from out-licensing
agreements
Recurring revenues from 622 113
out-licensing agreements
Other revenues 55 0
TOTAL 20,588 246
· Non-recurring revenues have surged as a result of the $25 million milestone
from Spectrum Pharmaceuticals linked to Beleodaq® market authorization and the
$1.9 million upfront payment from Innocutis due at delivery of the first
commercial batch of Sitavig®.
· Recurring revenues reflect royalties received, including royalties on
Beleodaq® and Sitavig® sales on the US market.
· As a result of the merger and with the €10 million loan from our major
shareholder Financière de la Montagne, put in place in July, the cash position
has been significantly improved and reaches €20.7 million as of September 30th,
2014.
During Q4, this position will be further strengthened with the $25 million
milestone payment from Spectrum Pharmaceuticals and the €1.25 million second
milestone of BPIfrance grant dedicated to the Livatag® development as a part of
the NICE (Nano Innovation for Cancer) consortium.
Governance
Now that the merger process is fully completed, Mr. Per Samuelsson and Dr. Bo
Jesper Hansen are leaving the Board as of November 7th. Dr Hansen has brought to
the Board's attention a newly emerged potential conflict of interest, which
requires his stepping down in line with good governance practices; Mr. Per
Samuelsson has asked to be relieved from the Board to allow more time to other
assignments.
In parallel, the company board of Directors will evolve to add new expertise,
especially to reinforce its scientific skills in line with its ambition to
become a global leader in Orphan Oncology.
“Merger and integration have been successfully achieved, and we at HealthCap
have full confidence that Onxeo has the assets and the teams to achieve its
ambition and create strong value for its shareholders”, declares Per Samuelsson.
“I would like to thank Bo Jesper and Per for their support in the merger process
as well as during the effective implementation”, declares Mr. Patrick Langlois,
chairman of the Board.
Perspectives and clinical challenges
Validive®: Based on the positive phase II results, the company will initiate the
preparation of a phase III trial to evaluate Validive® efficacy. Thanks to its
fast track status in the US, discussions with FDA will be eased and the company
plans to submit this new study in the course of 2015.
Beleodaq®: Following the conditional marketing authorization in 2nd line PTCL, a
phase III trial will be initiated together with Spectrum Pharmaceuticals to
confirm Beleodaq® efficacy and safety in PTCL 1st line, both in the US and
Europe. Other indications are also reviewed by the company and Spectrum
Pharmaceuticals to further develop Beleodaq®’s potential.
Livatag®: As planned, the fifth DSMB will be held Q4 2014, to evaluate the
tolerance of Livatag® in nearly 35% of planned patients randomized. As of now,
DMSB has each time unanimously recommended continuing the study without
modification, based on positive assessment of Livatag® safety data.
“The first months of Onxeo are marked by very successful and crucial
achievements on key products. Beleodaq® has been registered and launched on the
U.S. market, Validive® phase II has shown positive results allowing its passage
into phase III. Next critical steps in the coming months will be to design the
most effective development plans for these two products”. declares Judith
Greciet, CEO of Onxeo
“With a reinforced cash position, a strengthen team thanks to the merger with
Topotarget and enlarged promising pipeline, Onxeo has reinforced during the
course of the past months its postion to become a major player in Orphan
oncology ”, she continues.
About Onxeo
Onxeo has the vision to become a global leader and pioneer in oncology, with a
focus on orphan or rare cancers, through developing innovative therapeutic
alternatives to “make the difference”. The Onxeo teams are determined to develop
innovative medicines to provide patients with hope and significantly improve
their lives.
Key products at advanced development stage are:
Livatag® (Doxorubicin Transdrug™): Phase III in hepatocellular carcinoma
Validive® (Clonidine Lauriad®): Phase II in severe oral mucositis: Positive
preliminary top-line results
Beleodaq® (belinostat): registered in the US in peripheral T-cell lymphoma
For more information, visit the
website www.onxeo.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3
A
%2F%2Fwww.onxeo.com&esheet=50978759&newsitemid=0&lan=en
-US&anchor=www.onxeo.com&index=1&md5=4139f0caf1956202684b05be6ef577dd)
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 2013 Reference
Document filed with the AMF on April 7, 2014, which is available on the AMF
website (http://www.amf
-france.org (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww
.
amf-france.org&esheet=50978759&newsitemid=0&lan=en
-US&anchor=http%3A%2F%2Fwww.amf
-france.org&index=2&md5=fb8474b8d939bfdc1f3a104c3c296fc2)) or on the company’s
website
(www.onxeo.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2F
w
ww.onxeo.com&esheet=50978759&newsitemid=0&lan=en
-US&anchor=www.onxeo.com&index=3&md5=f034103311afce83644ca0a601675ed2)).
Judith Greciet, CEO
j.greciet@onxeo.com
+33 1 45 58 76 00
or
Nicolas Fellmann, CFO
n.fellmann@onxeo.com
+33 1 45 58 76 00
or
Caroline Carmagnol / Sophie Colin – Alize RP
caroline@alizerp.com / scolin@alizerp.com
+33 6 64 18 99 59 / +33 1 44 54 36 62
Onxeo: Quarterly Information as of September 30, 2014
| Source: Onxeo SA