Orexo signs license agreement with Mundipharma, which obtains ex-US global rights to Zubsolv®
2016年6月30日 - 3:23PM
ビジネスワイヤ(英語)
Regulatory News:
Orexo AB (publ.) today announced an agreement granting
Mundipharma’s network of independent associated companies´
exclusive global (ex-US) rights to Zubsolv® (buprenorphine and
naloxone) sublingual tablet (CIII), for treatment of opioid
dependence. Under the terms of the agreement Orexo receives an
upfront payment of 7 million euros. Pending marketing
authorizations and commercial milestones Orexo is also entitled to
receive further milestone payments and up to low double digit
royalties on future net sales. Orexo will also be compensated for
specific expenses related to the work required to prepare Zubsolv
for markets outside the US.
In addition, the launch of Zubsolv outside the US will increase
production volumes and over time this could considerably improve
Orexo’s gross margin.
Zubsolv is licensed in the US for the treatment of opioid
dependence and used as part of a comprehensive treatment plan,
which includes counselling and psychosocial support. It is expected
to be submitted to the EMA (European Medicine Agency) 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. Around 20 million people outside the
US are suffering from opioid dependence.1 This new partnership
builds on the ambition to provide a greater choice of therapies to
those patients and the clinicians managing addiction.
Nikolaj Sørensen, CEO and President 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. Together with the anticipated
increase of physicians prescription rights in the US this year and
an exciting pipeline with non-disclosed projects this important
commercial collaboration with Mundipharma, will further drive
business value.”
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.”
About Orexo
Orexo is a specialty pharmaceutical company commercializing its
proprietary product Zubsolv® for treatment of opioid dependence in
the US. Zubsolv is an advanced formulation of buprenorphine and
naloxone using Orexo’s unique knowledge and expertise in sublingual
drug delivery. R&D is focusing on reformulation of known
substances to new improved products that meet great unmet medical
needs by using its patented proprietary technologies. Orexo’s
share is listed on Nasdaq Stockholm Exchange Mid Cap (STO:ORX) and
is available as ADRs on OTCQX (ORXOY) in the US. Orexo’s global
headquarters and R&D are based in Uppsala, Sweden.
For more information about Orexo please visit www.orexo.com
Orexo AB (publ.) discloses the information provided herein
pursuant to the Financial Instruments Trading Act and/or the
Securities Markets Act. The information was submitted for
publication at 08:00 am CET on June 30, 2016.
1 World Drug Report 2015 (United Nations Office on Drugs and
Crime)
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version on businesswire.com: http://www.businesswire.com/news/home/20160629006602/en/
Orexo AB (publ.)Nikolaj Sørensen, CEO and PresidentTel: +46
(0)18 780 88 00email: ir@orexo.comorHenrik Juuel, EVP and
CFOTel: +46 (0)18 780 88 00email: ir@orexo.com
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