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Based on public information

Technology name

Last update: Jul 2026

BEPO®

Developer(s)

Sponsor(s)

Not specified

export_notes
Based on public information

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

Marketed

Regulatory Approval

FDA approved (UZEDY)

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.

Developer(s)

MedinCell
Originator
France

MedinCell

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. BEPO® technology makes possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months. At the time of the injection, the BEPO technology forms a deposit of polymers of a few millimeters under the skin for a systemic action, or locally for a targeted action. The deposit diffuses the active ingredient by resorbing for the desired duration, like a mini pump that would be injectable and bioresorbable.

Illustration(s)

Technology main components

Three core components: a- A combination of diblock (DB) and triblock (TB) copolymers containing hydrophilic and water-soluble blocks (polyethylene glycol – PEG) linked with hydrophobic and amorphous blocks (Poly(D,L-lactic acid) – PLA) which precipitate in forming a depot when exposed to an aqueous environment. 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. The API is entrapped within the polymer matrix and is released thereafter by diffusion and following polymer degradation.

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.

Safety, Efficacy and Evidence Summary

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.

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided

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

1 single API :

LogP

Min: -2.5 Max: 6.1

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 & delivery device(s)

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

Delivery device(s)

No delivery device

Additional features

Other features of the technology
  • Biodegradable
  • Room temperature storage
  • At least 1 year shelf life
  • Drug-eluting
  • Non-removable
  • Single-use
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. The hygroscopy and consequently the API release kinetics from the depots can be fine-tuned by adjusting the hydrophilicity of the DB and TB and their relative ratio.

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.

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
  • Disease agnostic
  • COVID 19
  • Pain management
  • Mental Health Disorders (incl. schizophrenia, bipolar disorders, Schiz. Aff. Dis.)
  • TB
Use case(s)
  • Treatment
  • Prevention

Potential associated API(s)

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, Every 6 months, Yearly, Every 2 months

User acceptance
Not provided

Targeted user groups

Age Cohort
  • Adults
  • Older Adults
Genders
  • All
  • Male
  • Female
  • Cisgender female
  • Cisgender male
  • Transgender female
  • Transgender male
  • Intersex
  • Gender non-binary
Pregnant individuals

Unspecified

Lactating individuals

Unspecified

Healthy individuals

Unspecified

Comment

Not provided

Class(es)

antipsychotic

Development stage

Marketed

Clinical trial(s)

,

Foreseen/approved indication(s)

Schizophrenia

Foreseen user group

UZEDY (risperidone) extended-release injectable suspension is a prescription medicine used to treat schizophrenia in adults.

Foreseen duration between application(s)

1 or 2 months

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

FDA approved (UZEDY)

Celecoxib

Class(es)

anti inflammatory

Development stage

Phase III

Clinical trial(s)

, ,

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

Class(es)

Not provided

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

Malaria Transmission prevention

Foreseen user group

persons at risk of malaria and their communities

Foreseen duration between application(s)

Single intervention per year (3 months action duration)

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Not provided

Progestin

Class(es)

Not provided

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

contraception

Foreseen user group

persons desiring contraception use

Foreseen duration between application(s)

6 months

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Not provided

Olanzapine

Class(es)

Not provided

Development stage

Phase III

Clinical trial(s)

, , , ,

Foreseen/approved indication(s)

schizophrenia management

Foreseen user group

Adults with schizophrenia

Foreseen duration between application(s)

1 month

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Not yet approved

Macozinone

Class(es)

antimycobacterial

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

Not provided

Foreseen user group

Not provided

Foreseen duration between application(s)

Not provided

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Not provided

Progestin

Class(es)

contraceptive

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

Not provided

Foreseen user group

Not provided

Foreseen duration between application(s)

6 months

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Not provided

All sponsors

No sponsor indicated

Additional information

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