TIDMCLIN
Clinigen Group plc
25 April 2017
RNS Reach
25 April 2017
Clinigen and Onxeo initiate Managed Access programme for
belinostat in Europe for patients with peripheral T-cell lymphoma
(PTCL)
Clinigen Group plc's (AIM: CLIN, 'Clinigen' or the 'Group') Idis
Managed Access ('MA') division and Onxeo S.A (Euronext Paris,
Nasdaq Copenhagen: ONXEO, 'Onxeo'), have agreed to launch a Managed
Access programme for belinostat (Beleodaq(R)) in Europe. Belinostat
is for use in patients with relapsed or refractory peripheral
T-cell lymphoma ('PTCL').
PTCL is a form of blood cancer comprising of a group of rare and
aggressive non-Hodgkin lymphomas ('NHLs'), a malignant
lymphoproliferative disorder. PTCL accounts for approximately
10%-15% of all NHL cases.
Belinostat is a histone deacetylase inhibitor used to treat
refractory or relapsed PTCL. The product received accelerated
approval(*) by the US Food and Drug Administration ('FDA') in July
2014 due to the unmet medical need in this rare disease. There are
no approved treatments for PTCL in Europe.
The programme allows physicians to request belinostat for
individual patients for whom alternative treatment options are not
currently available. This enables patients on a named patient basis
in Europe(**) to benefit from belinostat treatment ahead of a
potential European approval.
Steve Glass, Chief Commercial Officer, North America and Europe,
of Clinigen said:
"There is a huge unmet need for patients with aggressive blood
cancers such as PTCL. As the trusted global leader in access to
unlicensed medicines, Clinigen is working in partnership with Onxeo
to help patients gain access to this important medicine.
"As Clinigen and Idis MA, we have delivered over 220 Managed
Access programmes to thousands of patients. We help physicians
access medicines when no other treatment options are available
reducing unmet clinical need. This aligns with our mission of
getting the right medicine to the right patient at the right
time."
Judith Greciet, Chief Executive Officer of Onxeo said:
"Consistent with our efforts to address the unmet needs of
people diagnosed with relapsed or refractory PTCL, we are pleased
to partner with Clinigen to establish this Named Patient programme.
In selected European countries in which local health authorities
permit the programme, the belinostat Managed Access programme will
allow healthcare professionals to prescribe belinostat to specific
patients."
Healthcare Professionals can obtain details about the belinostat
Managed Access programme by calling a Clinigen representative at:
+44 (0) 1283 44 347, or emailing
customer.services@clinigengroup.com.
*Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial.
** Programme will be launched in: United Kingdom, Germany,
France, Spain, Italy, Denmark, Sweden, Norway, Finland, Belgium,
The Netherlands, Luxembourg, and Austria.
- Ends -
Clinigen Group plc Tel: +44 (0) 1283
495 010
Shaun Chilton, Group Chief
Executive Officer
Steve Glass, Group Chief
Commercial Officer, North
America and Europe
Numis Securities Limited Tel: +44 (0) 20 7260
1000
Michael Meade / Freddie Barnfield
(Nominated Adviser)
James Black / Tom Ballard
(Corporate Broking)
RBC Capital Markets - Joint Tel: +44 (0) 20 7653
Broker 4000
Marcus Jackson / Elliot Thomas
/ Jack Wood
Instinctif Partners (media Tel: +44 (0) 20 7457
relations - Clinigen) 2020
Melanie Toyne-Sewell / Alex
Shaw Email: clinigen@instinctif.com
Tel: +33 1 45 58 76
Onxeo 00
Valerie Leroy, Investor Relations Email: investors@onxeo.com
About Peripheral T-Cell Lymphoma (PTCL)
Lymphoma is the most common blood cancer (www.lymphoma.org).
Peripheral T-cell lymphoma. PTCL is a sub-type of non-Hodgkin
lymphoma (NHL). It comprises a group of rare and aggressive NHLs
that develop from mature T-cells. PTCL accounts for approximately
10 to 15% of all NHL cases.
About belinostat
Belinostat has been approved via an accelerated pathway by the
US FDA and is currently commercialised under the name Beleodaq(R)
in the US as 2(nd) -line treatment of PTCL.
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and
services company with a unique combination of businesses focused on
providing access to medicines. Its mission is to deliver the right
medicine to the right patient at the right time.
The Group consists of five synergistic businesses focused in
three areas of global medicine supply; clinical trial, unlicensed
and licensed medicines.
Clinigen Clinical Trial Services is the global market leader in
the management and supply of commercial medicines for clinical
trials.
The Group is also the trusted global leader in ethically
sourcing and supplying unlicensed medicines to hospital pharmacists
and physicians for patients with a high unmet need, through three
of its divisions: Idis Managed Access runs early access programs
for innovative new medicines. Idis Global Access and Link
Healthcare work directly with healthcare professionals to enable
compliant access to unlicensed medicines on a global basis and
niche essential licensed and generic medicines across Australasia,
Africa and Asia (AAA region).
Clinigen Specialty Pharmaceuticals acquires global rights,
revitalises and markets its own portfolio of niche hospital
commercial products.
For more information, please visit www.clinigengroup.com
About Onxeo
Onxeo is a biopharmaceutical company developing innovative drugs
for the treatment of orphan diseases in oncology, driven by high
therapeutic demand in one of the fastest growing segments of the
pharmaceutical industry. Onxeo's objective is to become a major
international player in the field of rare cancers. Its growth
strategy is founded on the development of innovative, effective,
and safe drugs based on breakthrough technologies that can make a
real difference in the treatment of orphan oncology diseases and
considerably improve the quality of life of patients affected by
rare and aggressive cancers.
Onxeo's comprehensive portfolio features a broad orphan oncology
pipeline, with 3 major products in several on-going preclinical and
clinical programs, alone or in combination for various cancer
indications.
The Company is headquartered in Paris, France with offices in
Copenhagen, Denmark (Ticker: ONXEO, ISIN Code: FR0010095596).
Learn more by visiting www.onxeo.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
NRAPGUAUCUPMGMC
(END) Dow Jones Newswires
April 25, 2017 02:01 ET (06:01 GMT)
Clinigen (LSE:CLIN)
Historical Stock Chart
From Apr 2024 to May 2024
Clinigen (LSE:CLIN)
Historical Stock Chart
From May 2023 to May 2024