Burton-on-Trent, UK – 28 May 2015 – Clinigen Group plc (‘Clinigen’, AIM: CLIN) today announce the initiation of a global access program in Europe for rociletinib (CO-1686) which is being developed for the treatment of advanced non-small cell lung cancer (NSCLC).
This program is intended to allow access to rociletinib for individual named patients with advanced or metastatic epidermal growth factor receptor (EGFR)-mutant T790M-positive NSCLC who have previously been treated with an EGFR-targeted therapy and for whom their physician determines that there is no satisfactory alternative therapy or rociletinib clinical trial available.
Lung cancer is the most common cancer worldwide with 1.35 million new cases annually. Of these, approximately 85% of cases are NSCLC. This is a rapidly progressing cancer with a five-year survival rate of less than 5% in advanced patients.
Patients with an EGFR activating mutation often respond well to marketed EGFR inhibitor therapies, including Tarceva® (erlotinib), Iressa® (gefitinib) and Gilotrif® (afatinib). However, most will ultimately see their cancer progress, with approximately 60% developing acquired resistance from a second "gatekeeper" mutation, T790M. Currently, there are no therapies approved for the treatment of this mutation. Clinigen’s Managed Access Programs division will provide rociletinib to individual patients in selected countries in Europe initially, until the approval and launch of the drug.
Rociletinib is an oral, potent, mutant selective inhibitor of EGFR, which is currently in Phase II/III development for the treatment of NSCLC. In 2014, rociletinib was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).
Simon Estcourt, Managing Director, Managed Access Programs, Clinigen Group said: “Non-small cell lung cancer is a devastating disease affecting a huge number of people worldwide. Our experience in managing access programs on a global scale will enable us to provide critically ill patients with rapid access to rociletinib before it is commercially available. We look forward to working with Clovis to address this area of unmet medical need."
“At Clovis, we are preparing our near-term regulatory submissions seeking approval in the U.S. and E.U. for rociletinib for patients with advanced EGFR-mutant lung cancer,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We are very pleased to be working with Clinigen to make rociletinib available for patients until this therapy is commercially available in Europe.”
Rociletinib is an oral, potent, mutant-selective inhibitor of epidermal growth factor receptor (EGFR) under investigation for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). Rociletinib targets the activating mutations of EGFR (L858R and Del19), while also inhibiting the dominant acquired resistance mutation, T790M, which develops in approximately 60 percent of patients treated with first- and second-generation EGFR inhibitors, while sparing wild-type, or “normal” EGFR at anticipated therapeutic doses. Rociletinib was granted Breakthrough Therapy designation by the U.S. FDA in May 2014.
About Global Access Programs
Global Access Programs, also known as Managed Access Programs, provide biopharmaceutical companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests, in a fully compliant manner, where no alternative treatment options are available.
About Clinigen Group
The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group is dedicated to delivering ‘the right drug, to the right patient at the right time’. In April 2015, Clinigen acquired Idis, the market leader in the global supply of unlicensed medicines. The Group now operates as four synergistic businesses; Clinigen Specialty Pharmaceuticals, Clinigen Clinical Trials Supply, Idis Managed Access Programs (this now includes the previously branded Clinigen Global Access Programs business) and Idis General Access.
The Managed Access Programs business develops and implements exclusive access programs for biotechnology and pharmaceutical companies and has provided physicians with an ethical solution to access unlicensed medicines for thousands of patients with an unmet medical need.
For more information, please visit www.clinigengroup.com
Issued for and on behalf of Clinigen Group by Instinctif Partners.
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Melanie Toyne-SewellManaging Partner