Braeburn Pharmaceuticals and Camurus Expand Collaboration and License Agreement

Braeburn Pharmaceuticals and Camurus (STO:CAMX) today announced the expansion of their collaboration and license agreement from 2014 to include buprenorphine combination products. The first drug candidate within the expanded scope, (CAM2058), is an extended release injectable combination of buprenorphine and granisetron in the FluidCrystal® injection depot technology. CAM2058 has completed formulation development and non-clinical evaluation and is being transferred to clinical development during the fourth quarter of 2016, initially being studied for the prevention and treatment of post-operative pain, nausea and vomiting.
“We are pleased to announce this extension of our successful partnership
with Camurus. This new product candidate has the potential to expand
Braeburn’s ability to offer relief across the continuum of
post-operative pain management, including addressing the often
co-occurring symptoms of nausea and vomiting,” said Behshad Sheldon,
President and CEO Braeburn Pharmaceuticals.
“We believe that CAM2058 has the potential to improve the wellbeing of
patients post-surgery and reduce the need for other medications
including oral opioid painkillers which are taken home and
self-administered by the patient. The partnership with Braeburn
Pharmaceuticals is a strong platform for the further global development
of this new asset,” said Fredrik Tiberg, President & CEO, Camurus.
”CAM2058 combines these two treatment modalities in a single, small
volume, sustained release injection which is made possible by using our
FluidCrystal® technology.”
“Postoperative pain, nausea and vomiting are real management concerns
for patients and their physicians. The concept of CAM2058 combining
prolonged pain relief with prophylactic and sustained treatment of
nausea and vomiting is unique. The opportunity to manage these
conditions during the critical post-operative phase with a single
injection is a compelling proposition for both patients and treatment
providers,” said Andrea Barthwell, MD, DFASAM, Addiction Specialist,
whose practice includes pain management.
About post-operative pain
Effective postoperative pain management is an indispensable component of
the continuum of care for the surgical patient. Inadequate pain control
may result in delayed mobilization and recovery, pulmonary and cardiac
complications, and an increased likelihood of the development of
neuropathic pain. Data available indicate that opioid therapy together
with neural blockade is among the most effective treatments of
postoperative pain. Given its safety and efficacy profile when compared
to full opioid agonists (e.g. morphine, oxycodone, and fentanyl),
buprenorphine should be considered for first line therapy for the
treatment of a wide range of acute as well as chronic pain conditions.
Ideal buprenorphine formulations would deliver rapid onset and
persistent plasma levels for extended duration as mono or combination
therapy. The advantages of effective pain management include better
patient comfort, satisfaction and earlier mobilization, which together
with a faster recovery may reduce cost of care.
About post-operative nausea and vomiting (PONV)
Postoperative nausea and vomiting (PONV) is defined as any nausea,
retching, or vomiting occurring within the first 24–48 hours after
surgery. PONV is one of the most common causes of patient
dissatisfaction after anesthesia, with approximately 30-50% incidences
of vomiting and nausea reported by post-operative patients. In a subset
of high-risk patients, the PONV rate can be as high as 80%. In addition,
PONV is regularly rated in preoperative surveys, as the anesthesia
outcome the patient would most like to avoid.
About CAM2058
CAM2058 consists of a combination buprenorphine and granisetron
subcutaneous extended release injection product in development for the
potential treatment of post-operative as well as other pain indications.
The unique properties of the FluidCrystal technology allow for the
durations that are specifically tailored to the target application,
allowing for both shorter and longer-term treatments. CAM2058 is
designed for low volume subcutaneous injection by healthcare personnel
to ensure proper delivery while reducing the need for take home
medication that are often associated the risk of diversion, abuse, and
misuse.
About the Agreement
Pursuant to execution of the Amendment to the License Agreement from
2014, Braeburn Pharmaceuticals has obtained exclusive rights to develop
and commercialize CAM2058 in North America. Camurus retains all rights
to CAM2058 in the rest of the world, except that Braeburn has an option
to the rights for China, Japan, South Korea and Taiwan. The current
amendment expands the scope of the ongoing partnership between Camurus
and Braeburn Pharmaceuticals, where Braeburn is responsible for the
development in its’ territories. In addition to the financial terms
already disclosed for the products under the License Agreement, Camurus
is also eligible to non-disclosed late stage development milestones for
CAM2058.
About Braeburn Pharmaceuticals
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a
commercial stage pharmaceutical company delivering individualized
medicine in neuroscience. Long-acting therapeutic treatment options can
be essential to improving patient outcomes and facilitating recovery in
neurological and psychiatric disorders, which are often complicated by
stigma and present significant public health challenges. Probuphine,
Braeburn’s long-acting buprenorphine implant, was approved by the FDA in
May 2016. Braeburn’s investigational product pipeline consists of
long-acting implantable and injectable therapies for serious
neurological and psychiatric disorders, including opioid addiction,
pain, and schizophrenia. Braeburn’s pipeline products are at various
stages of clinical development and include CAM2038, weekly and monthly
subcutaneous injection depot formulations of buprenorphine, being
investigated in opioid addiction and pain and a risperidone six-month
implant being investigated in schizophrenia. More information on
Braeburn, can be found at www.braeburnpharmaceuticals.com.
About Camurus
Camurus is a Swedish research-based pharmaceutical company committed to
developing and commercialising innovative and differentiated medicines
for the treatment of severe and chronic conditions. New drug products
with best-in-class potential are conceived based on the proprietary
FluidCrystal® drug delivery technologies and an extensive R&D expertise.
Camurus’ clinical pipeline includes products for treatment of cancer,
endocrine diseases, pain and addiction, developed in-house and in
collaboration with international pharmaceutical companies. The company’s
share is listed on Nasdaq Stockholm under the ticker “CAMX”. For more
information, visit www.camurus.com.
This information is information that Camurus AB is obliged to make
public pursuant to the EU Market Abuse Regulation and the Swedish
Securities Markets Act. The information was submitted for publication,
through the agency of the chief executive officer, 08.00 AM CET on 24
October 2016.
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