Clinigen Group plc’s (AIM: CLIN, ‘Clinigen’ or the ‘Group’) Managed Access (MA) division has partnered with Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) to manage its compassionate use program for vosaroxin. The program has been initiated today and will be made available to eligible patients in the U.S. and selected European countries diagnosed with relapsed or refractory acute myeloid leukemia (AML).
Vosaroxin is an investigational treatment and is currently not approved for use by any regulatory agency. Compassionate use programs are put in place to provide access to medicines for patients who have serious, or immediately life-threatening illnesses, and for whom no alternative treatment options are available. Access is provided in response to an unsolicited request from a physician for his/her patient with an unmet medical need.
Simon Estcourt, Managing Director of Idis Managed Access, Clinigen Group said: “AML is the most common acute leukemia affecting adults, with a very low survival rate, so there is a real need for new treatment options in these patients. By using our global logistical and regulatory expertise we will work with Sunesis and the AML community to provide ethical access to vosaroxin to help eligible patients who have no alternative treatment options.”
“Sunesis is committed to providing patients and healthcare providers around the globe with more options for treating relapsed and refractory AML, a disease for which the standard of care has changed little in the last four decades,” said Par S Hyare, VP Global Oncology Operations, Sunesis. "We are pleased to be working with Idis MA, a recognized leader in providing ethical access to medicines that address unmet needs and will be working towards gaining approval for vosaroxin in the U.S. and Europe for the treatment of relapsed and refractory AML."
For more information about Idis’ services and its Managed Access Programs, healthcare professionals may contact Idis via telephone on +44 (0)1932 824 135, fax on +44 (0)1932 824 335. To contact Idis by e-mail, U.S. physicians only use vosaroxinUS@idispharma.com. Physicians from all other countries please use firstname.lastname@example.org.
Vosaroxin is an anti-cancer quinolone derivative (ADQ) under investigation for the treatment of AML. Vosaroxin intercalates DNA and inhibits topoisomerase II, causing replication-dependant, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation for potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational medicine and has not been approved for use by any regulatory agency.
About Clinigen Group
Clinigen 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
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the potential treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer.
For additional information on Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals, Inc.
Clinigen Group plc
Peter George, Group Chief Executive Officer
Shaun Chilton, Group Deputy Chief Executive Officer
Tel: +44 (0) 1283 495 010
Instinctif Partners (Clinigen media relations)
Melanie Toyne-Sewell / Jen Lewis / Emma Barlow
Tel: +44 (0) 20 7457 2020
Sunesis Pharmaceuticals, Inc.
Tel: +1 650-266-3717
This press release contains forward-looking statements, including statements related to Sunesis' estimated timelines for regulatory interactions and regulatory progress, including the anticipated submission of the MAA for vosaroxin with the EMA and plans to gain marketing approval of vosaroxin in the U.S., Sunesis' overall strategy, the design, conduct and results of clinical trials, including the expected progress in its kinase inhibitor pipeline, estimated new cases of AML, its prevalence across major global markets, prognosis for patients with AML, the need for and the role of vosaroxin as a potential new treatment option, and Sunesis' clinical development of vosaroxin, including the analysis of the results from the VALOR clinical trial. Words such as "anticipates," "estimates," "expect," "intends," "plan," "potential," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk that Sunesis may not be able to submit timely the MAA to the EMA, the risk that Sunesis' clinical studies for vosaroxin may not lead to regulatory approval in the U.S. or Europe, that Sunesis' development activities for vosaroxin could be otherwise halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for vosaroxin or other product candidates may not demonstrate safety or efficacy or lead to regulatory approval, the risk that data to date and trends may not be predictive of future data or results, risks related to the conduct of Sunesis' clinical trials, risks related to Sunesis' need for substantial additional funding to complete the development and commercialization of vosaroxin, and risks related to Sunesis' ability to raise the capital that it believes to be accessible and is required to fully finance the development and commercialization of vosaroxin. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2015. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Sunesis' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.