• Mundipharma strengthens global portfolio with the addition of Zubsolv, a potential new option for the treatment of opioid dependency.
• Zubsolv was approved in the US in 2013 for the maintenance treatment of opioid dependence, as part of a complete treatment plan, and will be submitted to the European Medicines Agency (EMA) for marketing authorisation pending the completion of a registrational bioequivalence study. Other ex-US regulatory submissions will follow.
• Around 20 million people outside the US are estimated to suffer from opioid dependence.1
Cambridge, (UK), 30 June, 2016 – Mundipharma today announced an agreement with Orexo granting Mundipharma’s network of independent associated companies exclusive global (ex-US) rights to Zubsolv® (buprenorphine and naloxone sublingual tablet), a potential new treatment option for patients outside the US with opioid dependence. Under the terms of the agreement, Orexo receives an upfront payment of 7 million euros and, pending achievement of marketing authorisations and certain commercial milestones, they are also entitled to receive further milestone payments as well as tiered royalties on future net sales.
Mundipharma recognise that the worldwide burden of opioid dependence is not solved and are committed to developing alternative treatment options to help treat patients. The addition of this asset to the Mundipharma pipeline continues the growth of the company and builds on its ambition to provide a greater choice of therapies to patients and clinicians managing addiction to opioids, including heroin.
Zubsolv (buprenorphine and naloxone) sublingual tablet is licensed in the US for the treatment of opioid dependence and used as part of a comprehensive treatment plan, which includes counseling and psychosocial support. It is expected to be submitted to the EMA for marketing authorisation pending the completion of a registrational bioequivalence study compared to reference product Suboxone® tablet (buprenorphine and naloxone). Regulatory filings in other ex-US territories are also planned.
Antony Mattessich, President and CEO, Mundipharma International Limited commented on the partnership. “We’re very excited about this new collaboration and the opportunity to realise the potential of Zubsolv to help patients and healthcare professionals manage opioid dependence with a combination product that is designed to deter misuse. We share the hopes and concerns of patients and their families battling heroin addiction. Our ambition is to give people the best possible chance to overcome their challenges in this area of high unmet need.”
Nikolaj Sørensen, CEO of Orexo AB, said: “I am very pleased that Zubsolv® soon could have a more global reach. Mundipharma has shown a strong commitment to become a leader in the treatment of opioid dependence and I am proud they have selected to commercialize Zubsolv. I am looking forward to a successful partnership with Mundipharma and working together to hopefully make a new treatment option available to also benefit patients outside the US with opioid dependence.”
-Ends-
References:
1 World Drug Report 2015 (United Nations Office on Drugs and Crime).
For more information please contact:
Charlotte James
Corporate Communications Lead
email: communications@mundipharma.co.uk
Tel: +44 (0) 1223 397 162
Abi Dewberry
MHP Communications
email: abi.dewberry@mhpc.com
Tel: +44 (0) 20 3128 6447
About Mundipharma
Mundipharma and its network of independent associated companies are privately owned companies and joint ventures covering the world’s pharmaceutical markets. These companies are committed to bringing to patients the benefits of significant new treatment options in the core therapy areas of pain, respiratory, addiction, oncology and inflammatory conditions. Through innovation, design and acquisition, Mundipharma delivers important treatments to meet the most pressing needs of patients, healthcare professionals and health systems worldwide.
For further information please visit: www.mundipharma.com
