New MA Program initiated for ixazomib

30 November 2015

Clinigen Group Initiates Managed Access Programfor Ixazomib for Patients with Multiple Myeloma

Clinigen Group plc's (AIM: CLIN, 'Clinigen' or the 'Group') Managed Access division has initiated a Managed Access Program for ixazomib for patients with multiple myeloma. Ixazomib is developed and manufactured by Takeda Pharmaceutical Company Limited.

Ixazomib was approved by the US Food and Drug Administration (FDA) on 20 November 2015 under the trade name NINLARO (ixazomib) capsules after receiving Priority Review status in September. The European Medicines Agency has accepted a Marketing Authorization Application for the drug and in July 2015 the Committee for Medicinal Products for Human Use also granted ixazomib accelerated assessment. Ixazomib is the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients of multiple myeloma who have received at least one prior therapy.

The access program will enable individual patients with multiple myeloma that live outside of the US, to receive ixazomib in specific countries where the drug is not yet available.

Multiple myeloma is the second most common blood cancer. There are approximately 26,000 new cases of multiple myeloma in the US and 114,000 new cases globally per year. Although considered incurable, recent advancements in cancer research have meant that it is a treatable disease.

Simon Estcourt, Managing Director, Managed Access, Clinigen Group said: "Multiple myeloma is a devastating blood cancer with thousands of patients requiring treatment all over the world. As leaders in the specialist management of ethical access to innovative medicines, we will use our regulatory capabilities and global reach to support Takeda to provide early access for ixazomib - helping physicians to treat their patients with a current unmet medical need."

Access to ixazomib will be provided by Clinigen's Managed Access division following a physician request for individual patients who meet the established eligibility criteria. Healthcare professionals can obtain details about the ixazomib Managed Access program by calling +44 1283 494340 or emailing [email protected] 

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About IxazomibIxazomib is an investigational oral proteasome inhibitor which is being studied in multiple myeloma, systemic light-chain (AL) amyloidosis, and other malignancies. Ixazomib was granted orphan drug designation in multiple myeloma in both the U.S. and Europe in 2011 and for AL amyloidosis in both the U.S. and Europe in 2012. Ixazomib received Breakthrough Therapy status by the US FDA for relapsed or refractory AL amyloidosis in 2014. It is also the first oral proteasome inhibitor to enter Phase 3 clinical trials.About Clinigen GroupClinigen Group is a global pharmaceutical and services company with a unique combination of businesses dedicated to delivering the right drug to the right patient at the right time.

The Group consists of four synergistic businesses that provide medicines to patients with unmet medical need; through Clinigen Clinical Trial Services we manage the supply of commercial medicines for clinical trials, through Idis Managed Access we run early access programs for our own and other companies' portfolios, our Idis Global Access team works directly with healthcare providers to enable ethical compliant access to unlicensed medicines, and through Clinigen Specialty Pharmaceuticals, we market our own portfolio of niche commercial products.

Clinigen is the global leader in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet need, and in the supply of comparator and adjuvant therapies for clinical trials. In October 2015, Clinigen acquired Link Healthcare, further strengthening our international distribution network in the AAA region - Asia, Africa and Australasia.

For more information, please visit www.clinigengroup.com

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