Mundipharma and Orexo Announce EU Regulatory Submission for Zubsolv®
04 Outubro 2016 - 3:18AM
Business Wire
· Mundipharma and Orexo make first EU regulatory submission for
Zubsolv® (buprenorphine and naloxone) sublingual tablet
· Zubsolv was approved in the US in 2013 for the maintenance
treatment of opioid dependence, as part of a complete treatment
plan
· Opioid dependence represents a significant public health
problem; across Europe there are an estimated 1.3 million high-risk
opioid users
Regulatory News:
Orexo (STO:ORX)
Mundipharma and Orexo AB (publ.) have announced the submission
of a regulatory submission of a Marketing Authorisation Application
(MAA) for Zubsolv (buprenorphine and naloxone) sublingual tablet to
the European Medicines Agency (EMA), seeking approval for the
treatment of opioid dependence. If approval is received, the
buprenorphine and naloxone sublingual tablet would be the first
fast dissolving buprenorphine and naloxone product available in six
unique strengths for the treatment of opioid dependence in
Europe.
Mundipharma and Orexo have worked in partnership to complete the
submission and the required bio-equivalence study, comparing
Zubsolv to Suboxone® European buprenorphine and naloxone tablets.
The pre-submission meeting with the Rapporteur agreed that the
results of the bioequivalence study along with supporting data from
previous pharmacokinetic studies performed and Orexo’s extensive
clinical program, including data on more than 1,000 opioid
dependent patients, were suitable to move forward with the
regulatory filing. In addition, Zubsolv has been approved in the US
since July 2013 and has resulted in more than 37 million tablets
prescribed to date and greater than 44,000 patient year’s exposure,
providing additional reassurance of product efficacy and
safety.
Similar to previous studies comparing Zubsolv to Suboxone US
Tablet and film formulations the participants in the European study
showed strong preference for Zubsolv. When compared with the
Suboxone European tablet, Zubsolv was preferred by 77.0 percent
(low dose) and 79.4 percent (high dose) of the subjects and the
tablet dissolve times were faster for Zubsolv than for
Suboxone.
The submission will not trigger any new financial milestones.
However Mundipharma is compensating Orexo for specific expenses
related to the work required to prepare the submission. The next
milestones are pending marketing authorisations and
commercialisation of Zubsolv. Orexo is also entitled to receive
tiered royalties on future net sales.
Nikolaj Sørensen, CEO and President of Orexo AB, said: “With the
regulatory filing to EMA of Zubsolv, Orexo has met another major
milestone in the efforts to potentially make Zubsolv available for
patients world-wide. Opioid dependence is a growing concern
globally and with the unique novel product characteristics of
Zubsolv such as fast dissolve time, six unique strengths to suit
individual patients’ needs and strong patient preference, I am
certain Zubsolv could be a welcome alternative for European
physicians treating opioid dependence. I am very pleased with the
first concrete results of the collaboration with Mundipharma and I
am looking forward to working with them to make Zubsolv available
in many more countries globally.”
Rachel Gooch, Head of Addiction Therapy, Mundipharma
International Limited, said: “We are pleased to submit Zubsolv to
the EMA for marketing authorization and take a further significant
step in our collaboration with Orexo. Opioid dependency is a
chronic condition that places a disproportionately large burden on
individuals and societies across Europe as well as globally. We are
committed to working to support people living with opioid use
disorders to have the best possible chance to work towards positive
change.”
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
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
This information is information that Orexo AB (publ.) is obliged
to make public persuant to the EU Market Abuse Regulation. The
information was submitted for publication, through the agency of
the contact persons above at 8.00 am CET on October 4, 2016
This information was brought to you by Cision
http://news.cision.com
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version on businesswire.com: http://www.businesswire.com/news/home/20161003006687/en/
MundipharmaRachel GoochHead of Addiction TherapyTel: +44
(0)1223 397 453Email:
rachel.gooch@mundipharma.co.ukorOrexo AB (publ.)Nikolaj SørensenCEO
and PresidentTel: +46 (0)18 780 88 00Email: ir@orexo.comorMHP
CommunicationsMadeleine Harris SmithTel: +44 (0)20 3128
8810Email: madeleine.harrissmith@mhpc.com
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