Clinigen Group plc Clinigen and TESARO launch European MA Program
11 May 2017 - 4:01PM
RNS Non-Regulatory
TIDMCLIN
Clinigen Group plc
11 May 2017
RNS Reach
11 May 2017
Clinigen and TESARO partner to initiate European Managed Access
Program for niraparib for patients with recurrent ovarian
cancer
Clinigen Group plc's (AIM: CLIN, 'Clinigen') Idis Managed Access
division and TESARO Inc. (NASDAQ: TSRO) have partnered to launch a
Managed Access Program (also known as an Early Access Program) in
Europe for the investigational PARP 1/2 inhibitor, niraparib, for
patients with recurrent ovarian cancer.
Niraparib is currently an investigational agent in Europe and as
such has not been granted approval by the European Commission. The
niraparib marketing authorisation application is under review by
the European Medicines Agency.
Niraparib was recently approved by the United States (US) Food
and Drug Administration under the brand name ZEJULA(TM) for the
maintenance treatment of adult patients with recurrent epithelial
ovarian, fallopian tube, or primary peritoneal cancer who are in a
complete or partial response to platinum-based chemotherapy.
Approximately 65,000 women are diagnosed with ovarian cancer in
Europe every year. Ovarian cancer is the fifth-most frequent cause
of cancer death among women. Despite high initial response rates to
platinum-based chemotherapy, 85% of women with advanced ovarian
cancer will see a recurrence of the disease after first line
treatment. The efficacy of chemotherapy also diminishes over
time.
Steve Glass, Chief Commercial Officer, North America and Europe,
of Clinigen said:
"Following the successful delivery of the niraparib Managed
Access Program in the US, we are pleased to be partnering with
TESARO once again, providing eligible women in Europe the
opportunity to gain access to this important investigational
therapy."
Martin Huber, MD., Senior Vice President, Chief Medical Officer,
of TESARO said:
"We are proud to partner with Clinigen on this important Managed
Access Program for women bravely facing ovarian cancer. The team at
Clinigen has proven to be a partner of choice for TESARO as we look
to address the needs of the ovarian cancer community."
-Ends-
Contact Details
Clinigen Group plc
Shaun Chilton, Group Chief Tel: +44 (0) 1283
Executive Officer 495010
Steve Glass, Chief Commercial
Officer, North America and
Europe
Tel: +44 (0) 20 7260
Numis Securities Limited 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 / Deborah Bell Email: clinigen@instinctif.com
TESARO
Jennifer Davis, Vice President, Tel: +1 781 325 1116
Corporate Affairs & IR Email: jdavis@tesarobio.com
Tel: +41 (0) 41 588
Shannon Altimari, Head of 08 68
Corporate Affairs, International Email: saltimari@tesarobio.com
Contact Details - Managed Access Program
European based Healthcare Professionals can obtain details about
the niraparib Managed Access Program by calling a Clinigen
representative at: +44 1283 494 340, or emailing
customer.services@clinigengroup.com.
Notes to Editors
About niraparib
In Europe, niraparib is an investigational oral, once-daily poly
(ADP-ribose) polymerase (PARP) 1/2 inhibitor for the maintenance
treatment of adult patients with recurrent epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in a complete
or partial response to platinum-based chemotherapy. In preclinical
studies, niraparib concentrates in the tumor relative to plasma,
delivering greater than 90% durable inhibition of PARP 1/2 and a
persistent antitumor effect.
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
products.
For more information, please visit www.clinigengroup.com.
About TESARO
TESARO is an oncology-focused biopharmaceutical company devoted
to providing transformative therapies to people bravely facing
cancer. For more information, visit www.tesarobio.com and follow us
on Twitter and LinkedIn.
This information is provided by RNS
The company news service from the London Stock Exchange
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