TESARO Partners With Clinigen to Initiate European Managed Access Program for Niraparib in Patients With Recurrent Ovarian Ca...
11 May 2017 - 4:01PM
TESARO Inc. (NASDAQ:TSRO) and Clinigen Group plc’s (AIM:CLIN)
('Clinigen') Idis Managed Access division 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 authorization application is
under review by the European Medicines Agency.
Niraparib was recently approved by the United
States (U.S.) Food and Drug Administration under the brand name
ZEJULA™ 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 for 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, M.D., Senior Vice President, Chief
Medical Officer for 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.”
About NiraparibIn 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.
Managed Access Program
Contact: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.
About TESAROTESARO 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.
About Clinigen GroupClinigen
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, revitalizes and markets its own portfolio of niche
hospital products.
For more information, please visit
www.clinigengroup.com.
U.S. Media/Global Investor Contact:
Jennifer Davis
Vice President, Corporate Affairs & Investor Relations
+1 781 325 1116 or jdavis@tesarobio.com
Ex-U.S. Media Contact:
Shannon Altimari
Head of Corporate Affairs, International
+41 (0) 41 588 08 68 or saltimari@tesarobio.com
Clinigen Group plc Contacts:
Shaun Chilton, Group Chief Executive Officer
Steve Glass, Chief Commercial Officer, North America and Europe
+44 (0) 12 8349 5010
Instinctif Partners (media relations - Clinigen)
Melanie Toyne-Sewell / Alex Shaw / Deborah Bell
+44 (0) 20 7457 2020 or clinigen@instinctif.com
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