In-situ forming gel/implant
Subcutaneous, Intra-articular
Risperidone
Phase III
NDA pending approval at the FDA (2022)
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.
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.
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.
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.
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.
No delivery device
Small molecules are best suited for formulating. Compatibility needs to be determined on a case-by-case basis.
Case by case basis. Complex biomacromolecules like therapeutic proteins have inherent challenges that need to be tackled specifically during formulation development
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0.1-60%
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No proprietary excipient used
Confidential information
No residual solvent used
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.
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.
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.
Our technology may allow long-term storage at room temperature with shelf life well above 1 year.
Room Temperature storage possible. Cold chain is not mandatory, except in instances where the drug substance requires refrigeration for long term storage.
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Depending on product, once weekly up to once annually, Weekly, Monthly, Bi-yearly, Yearly, Once every 8 weeks
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Unspecified
Unspecified
Unspecified
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antipsychotic
Phase III
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Schizophrenia
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1 or 2 months
NDA pending approval at the FDA (2022)
anti inflammatory
Phase II
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post-operative pain and inflammation
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Once every 12 weeks
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Malaria Transmission prevention
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Single intervention per year (3 months action duration)
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Christophe Roberge, Jean-Manuel Cros, Juliette Serindoux, Marie-Emérentienne Cagnon, Rémi Samuel, Tjasa Vrlinic, Pierre Berto, Anthony Rech, Joël Richard, Adolfo Lopez-Noriega
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.
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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
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
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
No sponsor indicated
More information available at : https://www.medincell.com/en/