Clinigen initiates U.S. Managed Access program for TESARO’s niraparib for patients with ovarian cancer
Clinigen Group plc’s (AIM: CLIN, 'Clinigen') Idis Managed Access (MA) division has partnered with TESARO Inc. (NASDAQ: TSRO), to launch a Managed Access program (also known as an expanded access program (EAP)) for the investigational PARP 1/2 inhibitor, niraparib.
Niraparib is being made available for eligible women in the U.S. with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following a complete or partial response to platinum-based chemotherapy.
Approximately 22,000 women are diagnosed each year with ovarian cancer in the U.S. Despite high response rates to platinum-based chemotherapy, 85% of women with advanced ovarian cancer will recur after first line treatment, at which point, the disease is treatable but incurable.
Most patients who recur after first or second line therapy are treated with a further round of platinum-based chemotherapy, if they responded to the previous one. However most do not receive any type of treatment post-response to the platinum-based treatment regimen and must watch and wait for the inevitable recurrence. Unfortunately, the efficacy of chemotherapy diminishes over time and most women will recur again quickly.
Niraparib is an oral, once-daily PARP 1/2 inhibitor. It is administered following a response to platinum-based chemotherapy which may address the difficult “watchful waiting” periods experienced by patients with recurrent ovarian cancer after the completion of chemotherapy, in between cycles of platinum-based chemotherapy. Niraparib has been accepted for priority review by the U.S. Food and Drug Administration.
The Managed Access program allows physicians to request niraparib for individual, eligible U.S. patients who may not be able to participate in a clinical trial nor have any other treatment option, but who may benefit from access to this investigational therapy prior to approval.
Steve Glass, Chief Commercial Officer, North America and Europe, of Clinigen said:
“As the global leader in providing access to unlicensed medicines, we have delivered over 220 Managed Access programs which have benefited thousands of patients.
“There is a clear area of unmet medical need in the treatment of ovarian cancer, the fifth most common cause of death from cancer among women in the U.S. We are pleased to be partnering with TESARO to deliver this Managed Access program for niraparib, providing women with the opportunity to gain access to this important investigational therapy at the earliest possible moment.”
U.S. based Healthcare Professionals can obtain details about the niraparib Managed Access program by calling a Clinigen representative at: 1-877-786-4303, or emailing niraparibUSEAP@clinigengroup.com.
Clinigen Group plc
Tel: +44 (0) 1283 495010
Shaun Chilton, Group Chief Executive Officer
Martin Abell, Group Chief Financial Officer
Steve Glass, 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 Broker
Tel: +44 (0) 20 7653 4000
Marcus Jackson / Elliot Thomas / Jack Wood
Instinctif Partners (media)
Tel: +44 (0) 20 7457 2020
Melanie Toyne-Sewell / Jen Lewis
Notes to Editors
Niraparib is an oral, once-daily PARP 1/2 inhibitor that is being evaluated in three pivotal trials. TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and across several combinations of niraparib with other therapeutics.
The ongoing niraparib development program includes a Phase 3 trial in patients who achieved a complete or partial response following first-line treatment for ovarian cancer (the PRIMA trial), a Phase 2 registration trial in patients who have progressed following multiple lines of treatment for ovarian cancer (the QUADRA trial), and a Phase 3 trial for the treatment of patients with germline BRCA-mutated, metastatic breast cancer (the BRAVO trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab and niraparib plus bevacizumab.
Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.
Niraparib is an investigational agent and, as such, has not been approved by the U.S. FDA, European Medicines Agency (EMA), or any other regulatory agencies.
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.