BEPO, our biodegradable polymer controlled release technology offers a balanced approach and multiple benefits to create best-in-class products. 

 


BEPO: unprecedented level of controlled release

We always target best-in-class formulations from novel entities (NCEs) and proven, off-patent drugs (Supergenerics), with the goal of providing market leading therapies across the globe. BEPO™ forms an in situ depot after administration by injection. By varying the formulation characteristics, we significantly alter a drug’s release profile, injectability and therapeutic duration. Burst can be tailored for specific medical indications and drug types. The following advantages help us design superior controlled-release formulations:

  • Extended duration release, API-conservation, and lower materials costs allow for more economical treatments – potentially at lower-than-oral-generic treatment costs!
  • Shifting administration routes (IM vs subcutaneous) and final dosage forms (surgical implant vs bioresorbable, injectable depot) to improve compliance.
  • Formulating Supergeneric and Life Cycle products designed with improved usage of off-patent API to compete in multi-generic markets

 

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BEPO: optimized drug release

By minimizing the initial burst (Cmax) of drug molecules post-administration, BEPO™ formulations should demonstrate a commensurate reduction in off-target effects, such as nausea and vomiting. We have observed the burst level of saline formulations to be 25-fold higher than the same molecule (and amount) formulated using BEPO™. In addition to patient tolerability and comfort, keeping a drug within an optimal therapeutic range in the bloodstream helps prevent API waste, thereby reducing treatment costs.

BEST-IN-CLASS-02

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BEPO™: accommodating fragile and short-lived APIs

BEPO™ offers significant advantages for peptide APIs. In addition to our extensive experience with small molecule formulation, MedinCell is dedicated to helping biotech and pharmaceutical companies realize the promise of therapeutic peptides by overcoming half-life and manufacturing challenges. With a single administration, a BEPO™ can be used to release peptides over days, weeks – even multi-month -therapeutic durations. And, due to the protective nature of the polymer depot, less API is required per day than other delivery methods.

  • No PEGylation or covalent conjugation required
  • No need to requalify drug substance
  • in situ depot protects peptides from serum peptidases
  • Soluble system using low-cost, safe materials
  • Injected through a fine gauge needle
  • Cargo accommodates active peptide doses
  • API maximized through the dose-sparing nature of BEPO™, decreasing total treatment cost
  • Avoids pitfalls associated with PLGA microparticle scale-up
  • Compatible with hydrophilic and hydrophobic molecules

Over 60 peptide APIs have been approved globally, and more than 700 are currently moving through pharmaceutical pipelines. Surpassing the overall pharma growth rate, the peptide market is predicted to reach $15 billion by 2015. Peptides demonstrate limited off-target activation of molecular receptors (greater specificity than small molecules). And due to their short half-life, they promise to minimize risks related to toxic accumulation. However, high synthesis costs and frequent injections have limited the widespread acceptance of peptides in drug regimens.

 

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BEPO: rapid formulation development

BEPO™ offer an extremely rapid formulation development process. This means faster validation of the extended release capacity for key drug compounds in development. See how we work with our partners

 

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Low manufacturing cost

BEPO has been refined through years of continuous improvements. Our polymers utilize low-cost components, and avoid scale-up issues common to nano and micro particles. Our BEPO technologic platform offers partners a low-risk growth engine to develop novel, competitive therapies. MedinCell’s cGMP partner can produce hundreds of millions of doses per year, and can scale rapidly to meet any market need.

At its core, BEPO relies on low-cost, safe components. And through its API-sparing nature, the overall treatment costs can be much lower. In addition to reducing the frequency of administration, BEPO™ formulations can reduce API requirements by up to 80%. This translates into substantially lower production costs and reduces environmental impact.

 

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BEPO™-: increased patient compliance and treatment adherence

Extending dose to improve compliance
Our controlled-release delivery technology can improve treatment compliance and patient retention. Plus, with dramatically reduced API requirements, our partners can preserve product revenue. A recent report shows that a shift from 4 doses/day to 1 dose/day drove compliance from 51% to nearly 80%. Since most BEPO formulations last weeks or months, we expect compliance improvements even over weekly dosing. Extending duration is especially critical in pathologies like schizophrenia, dementia, or contraception, and for dependent patients across senior populations.

 

Adjusting route of administration for patient preference
Shifting from intra-muscular to subcutaneous injections can substantially reduce pain of administration and reduce patient anxiety.

 

Reducing societal burdens
In addition to improving patient lifestyle, a reduced dosing regimen means fewer trips to the clinic and less time off work for patients. In the case of severe illnesses like schizophrenia, a nearly 50% non-compliance rate has been reported. For patients who lack the awareness of their condition, the non-adherence impact is especially clinically disruptive. The total yearly cost of short-term hospital admissions for relapsing schizophrenia patients is over $2 billion in the USA; in fact the WHO ranks schizophrenia as a Top10 cause of lost work-years because of disability.

 

We are actively targeting medical indications that damage global productivity and world economies.

 

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BEPO: reduced environmental footprint

In many countries, government agencies have identified chemical waste such as steroids, prescription drugs, antibiotics and hormones in water collected from streams that are connected to urban and livestock-related wastewater. By reducing the amount of active chemicals needed for treatment in human healthcare, MedinCell’s technology will help minimize the environmental impact from pharmaceutical manufacturing and sewage contamination. By developing best-in-class products, our environmental goal is to reduce:

  • Exposure of aquatic organisms to antibiotics
  • Trace concentrations of drugs in drinking water
  • Potential for pathogen resistance to antibiotics
  • Chemical waste due to more efficient usage of peptide actives

 

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