access-principles-1access-principles-2access-principles-3backcarrierdevelopmentease_of_administrationexportimplantableinjectablenon-implantablenon_carriernon_injectableother_featuresprintroute_of_administrationtherapeutic_areatype_of_tech
To be determined
Verified by the innovator, on Feb 2022

Technology name

BEPO®

Main developer(s)

Sponsor(s)

Not specified

Verified by the innovator, on Feb 2022

Type of technology

In-situ forming gel/implant

Administration route

Subcutaneous, Intra-articular

Development state and regulatory approval

Active Pharmaceutical Ingredient (API)

Risperidone

Development Stage

Phase III

Regulatory Approval

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.

Main developer

MEDINCELL
France

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.

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.

Illustration(s)

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%

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

Excipients

Proprietary excipients used

No proprietary excipient used

Novel excipients or existing excipients at a concentration above Inactive Ingredient 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.

Therapeutic area(s)

  • Malaria
  • Contraception
Use case(s)

Not provided

Potential associated API(s)

  • Risperidone
  • Celecoxib
  • Ivermectin

Use of technology

Ease of administration
  • To be determined
  • Administered by a nurse
  • Administered by a specialty health worker
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

Not provided

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

Publications

Christophe Roberge, Jean-Manuel Cros, Juliette Serindoux, Marie-Emérentienne Cagnon, Rémi Samuel, Tjasa Vrlinic, Pierre Berto, Anthony Rech, Joël Richard, Adolfo Lopez-Noriega


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


https://www.sciencedirect.com/science/article/pii/S0168365920300304


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

There are no document

Collaborate for development

Consider 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

Share technical information for match-making assessment

Provide 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

Work with MPP to expand access in LMICs

In 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

All sponsors

No sponsor indicated

Comment & Information

More information available at : https://www.medincell.com/en/