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Developed by 
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Supported by 
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BEPO®
Verified by the innovator, on Feb 2022Main developer(s)
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MEDINCELL www.medincell.comFrance MedinCell® is a pharmaceutical company at premarketing stage that develops innovative long-acting injectable medicines in many therapeutic areas. Products of our portfolio are based on our BEPO® technology and aim to ensure patient compliance, improve the effectiveness and accessibility of treatments, and reduce their environmental footprint. |
Sponsor(s)
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No sponsor indicated |
Partnerships
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TEVA Pharmaceuticals www.tevapharm.com |
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Arthritis Innovation Corporation (AIC) www.aic.com/about-us |
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UNITAID www.unitaid.org |
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The Bill and Melinda Gates Foundation www.gatesfoundation.org |
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CORBION www.corbion.com |
Technology information
Type of technology
In-situ forming gel/implant
Administration route
Subcutaneous, Intra-articular
Development state and regulatory approval
Risperidone
Phase III
NDA pending approval at the FDA (2022)
Description
BEPO® is a simple yet flexible technology based on MedinCell®'s custom proprietary copolymers, which forms a fully bioresorbable depot once injected. BEPO® technology has the potential to control regular delivery of an API at an optimal therapeutic dose for several days, weeks or months. BEPO® can be administered subcutaneously for systemic exposure of APIs or locally for targeted treatments.
Technology highlight
From systemic to local delivery, BEPO® is a clinically advanced proprietary long acting injectable technology that enables the controlled delivery of various active ingredients, to address a broad range of therapeutic needs.
Technology main components
Three core components: a- Two block copolymers, bioresorbable, made of Polyethylene glycol and poly(Lactic acid). They are functional excipients, ensuring the controlled drug release. b- A pharmaceutically acceptable organic solvent, e.g. DMSO, to dissolve the copolymers and make the entire system injectable. c- An API to ensure pharmacological activity. The API can be a small molecule, a peptide or a therapeutic protein.
Information on the raw materials sourcing, availability and anticipated price
The core functional copolymer excipients are exclusively manufactured and supplied through a joint Venture made between Medincell and Corbion, called CMB. Corbion manufactures the copolymers with the appropriate quality standards and scale to ensure sufficient availability.
Delivery device(s)
No delivery device
APIs compatibility profile
API desired features
Small molecules
Small molecules are best suited for formulating. Compatibility needs to be determined on a case-by-case basis.
Proteins
Case by case basis. Complex biomacromolecules like therapeutic proteins have inherent challenges that need to be tackled specifically during formulation development
Additional solubility data
Not provided
Additional stability data
Not provided
API loading: Maximum drug quantity to be loaded
0.1-60%
API co-administration
Not provided
Scale-up and manufacturing prospects
Scale-up prospects
Not provided
Tentative equipment list for manufacturing
Not provided
Manufacturing
Not provided
Specific analytical instrument required for characterization of formulation
Not provided
Clinical trials
Not providedExcipients
Proprietary excipients used
No proprietary excipient used
Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration
Confidential information
Residual solvents used
No residual solvent used
Additional features
Other features of the technology
- Biodegradable
- Room temperature storage
- At least 1 year shelf life
- Drug-eluting
Release properties
BEPO® technology has the potential to control regular delivery of an API at an optimal therapeutic dose for several days, weeks or months. The technology can provide a sustained release profile of an API with low initial burst.
Injectability
BEPO® drug products are liquid and can be injected using standard injection device with standard 21 gauge needle or even thinner depending on the formulation characteristics.
Safety
We currently have 3 clinically advanced drug products based on BEPO® technology, including one at NDA stage with TEVA pharmaceuticals. The RISE clinical phase III study completed in November 2020 did not raise any safety signals that were inconsistent with the known safety profile of other risperidone formulations.
Stability
Our technology may allow long-term storage at room temperature with shelf life well above 1 year.
Storage conditions and cold-chain related features
Room Temperature storage possible. Cold chain is not mandatory, except in instances where the drug substance requires refrigeration for long term storage.
Potential application(s)
Therapeutic area(s)
Use case(s)
Not provided
Use of technology
Ease of administration
- Administered by a nurse
- Administered by a specialty health worker
- To be determined
Frequency of administration
Depending on product, once weekly up to once annually, Weekly, Monthly, Bi-yearly, Yearly, Once every 8 weeks
User acceptance
Not provided
Targeted user groups
Age Cohort- Adults
- Older Adults
- Male
- Female
- Cisgender female
- Cisgender male
- Transgender female
- Transgender male
- Intersex
- Gender non-binary
- All
Pregnant individuals
Unspecified
Lactating individuals
Unspecified
Healthy individuals
Unspecified
Comment
Not provided
Potential associated API(s)
Risperidone
Class(es)
antipsychotic
Development stage
Phase III
Clinical trial number(s)
Not provided
Foreseen/approved indication(s)
Schizophrenia
Foreseen user group
Not provided
Foreseen duration between application(s)
1 or 2 months
Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals
NDA pending approval at the FDA (2022)
Celecoxib
Class(es)
anti inflammatory
Development stage
Phase II
Clinical trial number(s)
Not provided
Foreseen/approved indication(s)
post-operative pain and inflammation
Foreseen user group
Not provided
Foreseen duration between application(s)
Once every 12 weeks
Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals
Not provided
Ivermectin
Class(es)
Not provided
Development stage
Not provided
Clinical trial number(s)
Not provided
Foreseen/approved indication(s)
Malaria Transmission prevention
Foreseen user group
Not provided
Foreseen duration between application(s)
Single intervention per year (3 months action duration)
Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals
Not provided
Patent info
Technology patent families
Patent informations
| Patent description | Representative patent | Categories | Patent holder | Licence with MPP | Patent source |
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Biodegradable drug delivery composition covering BEPO® technology
Expiry date: 2031-12-29 A biodegradable drug delivery compositions comprising a triblock copolymer containing a polyester and a polyethylene glycol and a diblock copolymer containing a polyester and an end-capped polyethylene glycol, as well as a pharmaceutically active principle is disclosed. |
WO2012090070 | Long-acting platform | Medincell | Yes |
Patent status
| Patent status/countries | Low, Low- middle and upper-middle | High income |
|---|---|---|
| Granted | Brazil, China, Russian Federation, Kazakhstan, Bulgaria, Türkiye, Mexico, Malaysia, Ukraine, South Africa, India, Indonesia, Viet Nam | Australia, Canada, Chile, Liechtenstein, Italy, Norway, Denmark, Belgium, United Kingdom, Greece, Netherlands, Hungary, Croatia, Switzerland, Spain, Slovenia, Austria, Romania, Iceland, Cyprus, Finland, France, Slovakia, Poland, Latvia, Ireland, Estonia, Germany, Luxembourg, Portugal, Czechia, Lithuania, Sweden, Israel, Japan, Korea, Republic of, New Zealand, Singapore, United States of America, Hong Kong |
| Filed | Bulgaria, Türkiye, North Macedonia, Thailand | Liechtenstein, Italy, Norway, Malta, Denmark, Belgium, United Kingdom, Greece, Netherlands, Hungary, Croatia, Switzerland, Spain, San Marino, Slovenia, Austria, Romania, Iceland, Cyprus, Finland, France, Slovakia, Poland, Latvia, Ireland, Estonia, Germany, Luxembourg, Czechia, Monaco, Sweden, United States of America |
| Not in force | World Intellectual Property Organization (WIPO), Colombia, Cuba, Tajikistan, Belarus, Azerbaijan, Moldova, Republic of, Turkmenistan, Armenia, Kyrgyzstan, Albania, Serbia, Bosnia and Herzegovina, Montenegro, Bulgaria, North Macedonia, Morocco, Tunisia, Algeria, Costa Rica, Egypt, Nigeria | World Intellectual Property Organization (WIPO), Liechtenstein, Norway, Malta, Denmark, Belgium, Greece, Hungary, Croatia, Switzerland, San Marino, Slovenia, Austria, Romania, Iceland, Cyprus, Finland, Slovakia, Latvia, Ireland, Estonia, Luxembourg, Portugal, Czechia, Lithuania, Monaco, Sweden, United States of America, United Arab Emirates, Qatar, Brunei Darussalam |
MPP Licence(s)
MPP/MedinCell licence on a long-acting formulation of ivermectin developed using BEPO® technology
https://medicinespatentpool.org/licence-post/long-acting-technology-for-malaria-vector-controlPatent informations
| Patent description | Representative patent | Categories | Patent holder | Licence with MPP | Patent source |
|---|---|---|---|---|---|
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Biodegradable drug delivery composition comprising triblock polymer and diblock polymer
Expiry date: 2033-06-27 A biodegradable drug delivery compositions comprising a triblock copolymer containing a polyester and a polyethylene glycol and a diblock copolymer containing a polyester and an end-capped polyethylene glycol, as well as at least one pharmaceutically active principle or hydrophobic active principle such as medroxyprogesterone acetate, levonorgestrel, cyclosporine, progesterone or bupivacaine is disclosed. |
WO2014001904 | Composition | Medincell | Yes |
Patent status
| Patent status/countries | Low, Low- middle and upper-middle | High income |
|---|---|---|
| Granted | Brazil, China, Russian Federation, Kazakhstan, Serbia, Bosnia and Herzegovina, Montenegro, Bulgaria, Türkiye, North Macedonia, Mexico, Tunisia, Ukraine, South Africa, Indonesia, Malaysia, Viet Nam | Australia, Canada, Chile, Liechtenstein, Italy, Malta, Denmark, Belgium, United Kingdom, Greece, Netherlands, Hungary, Croatia, Switzerland, Spain, San Marino, Slovenia, Austria, Romania, Iceland, Cyprus, France, Slovakia, Poland, Latvia, Ireland, Estonia, Germany, Luxembourg, Portugal, Czechia, Monaco, Israel, Japan, Korea, Republic of, Singapore, Brunei Darussalam |
| Filed | Costa Rica, India, Algeria, Egypt, Nigeria, Thailand | Spain, Hong Kong, United States of America, United Arab Emirates, Qatar |
| Not in force | World Intellectual Property Organization (WIPO), Colombia, Cuba, Tajikistan, Belarus, Azerbaijan, Turkmenistan, Armenia, Kyrgyzstan, Albania, Morocco | World Intellectual Property Organization (WIPO), Norway, Finland, Lithuania, Sweden, United States of America, New Zealand |
MPP Licence(s)
MPP/MedinCell licence on a long-acting formulation of ivermectin developed using BEPO® technology
https://medicinespatentpool.org/licence-post/long-acting-technology-for-malaria-vector-controlPatent informations
| Patent description | Representative patent | Categories | Patent holder | Licence with MPP | Patent source |
|---|---|---|---|---|---|
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Method for morselizing and/or targeting pharmaceutically active principles to synovial tissue
Expiry date: 2036-11-16 A method of targeting to the synovial tissue biodegradable drug delivery compositions or morselizing biodegradable drug delivery compositions are described. The biodegradable drug composition comprises a triblock copolymer containing a polyester and a polyethylene glycol and a diblock copolymer containing a polyester and an end-capped polyethylene glycol, as well as at least one pharmaceutically active principle is disclosed. |
WO2017085561 | Process | Medincell | Yes |
Patent status
| Patent status/countries | Low, Low- middle and upper-middle | High income |
|---|---|---|
| Granted | China, India | Australia, Japan |
| Filed | Albania, Serbia, Bulgaria, Türkiye, North Macedonia | Canada, Liechtenstein, Italy, Norway, Malta, Denmark, Belgium, United Kingdom, Greece, Netherlands, Hungary, Croatia, Switzerland, Spain, San Marino, Slovenia, Austria, Romania, Iceland, Cyprus, Finland, France, Slovakia, Poland, Latvia, Ireland, Estonia, Germany, Luxembourg, Portugal, Czechia, Lithuania, Monaco, Sweden, Korea, Republic of, United States of America |
| Not in force | World Intellectual Property Organization (WIPO), Morocco, Bosnia and Herzegovina, Montenegro, Moldova, Republic of | World Intellectual Property Organization (WIPO), United States of America |
MPP Licence(s)
MPP/MedinCell licence on a long-acting formulation of ivermectin developed using BEPO® technology
https://medicinespatentpool.org/licence-post/long-acting-technology-for-malaria-vector-controlSupporting material
Publications
<p>Christophe Roberge, Jean-Manuel Cros, Juliette Serindoux, Marie-Emérentienne Cagnon, Rémi Samuel, Tjasa Vrlinic, Pierre Berto, Anthony Rech, Joël Richard, Adolfo Lopez-Noriega</p><p><br></p><p><a href="https://www.sciencedirect.com/science/article/pii/S0168365920300304" rel="noopener noreferrer" target="_blank">BEPO®: Bioresorbable diblock mPEG-PDLLA and triblock PDLLA-PEG-PDLLA based in situ forming depots with flexible drug delivery kinetics modulation, Journal of Controlled Release, Volume 319, 2020, Pages 416-427</a></p><p><br></p><p>https://www.sciencedirect.com/science/article/pii/S0168365920300304</p><p><br></p>
This article presents BEPO®, an in situ forming depot (ISFD) technology mediated by a solvent-exchange mechanism. The matrix of the in situformed drug delivery depot is composed of the combination of a diblock (DB) and a triblock (TB) polyethylene glycol-polyester copolymer. This combination offers a broad capability to tune the release of a wide variety of drugs to the desired pharmacokinetics. The work described in the present article demonstrates that the delivery rate and profile can be adjusted by changing the composition of either TB or DB or the relative ratio between them, among other parameters. It has been shown that the polymeric composition of the formulation has a substantial impact on the solvent exchange rate between the organic solvent and the surrounding aqueous medium which subsequently determines the internal structure of the resulting depot and the delivery of the therapeutic cargo. This has been demonstrated studying the in vitro release of two model molecules: bupivacaine and ivermectin.
Formulations releasing these drugs have been administered to animal models to show the possibility of delivering therapeutics from weeks to months by using BEPO® technology.
Additional documents
No documents were uploaded
Useful links
Access principles
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Collaborate for developmentConsider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology Not provided |
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Share technical information for match-making assessmentProvide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit Not provided |
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Work with MPP to expand access in LMICsIn the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing Not provided |
Comment & Information
More information available at : https://www.medincell.com/en/
Illustrations
To be determined
To be determined