We have designed an exclusive enabling delivery system for human medicine.
BEPO™ applications cover any medical need: neurology, cardiology, urology, gastro-enterology, oncology, metabolic and immune diseases, pain management, and inflammation. In many situations, we can develop multiple duration prototypes to provide partners with greater strategic flexibility.
Adding Value to Off-Patent APIs
Flexible Product Development
We identify pharmaceutical partners that aim to significantly impact an illness with best-in-class products, while also sharing our goal of providing treatments to patients regardless of local economic conditions. BEPO™ delivers value across a wide range of medical applications, including chronic conditions such as type II diabetes, short-duration pain control, psychiatric disorders and oncology therapies.
We enable all types of pharmaceutical companies to develop higher value drug products based on patent-free APIs that feature significantly longer durations.
With more expensive molecules (peptides and larger), controlled-release strategies can translate into significantly lower drug cargos. This reduces cost and allows flexible repositioning for emerging global markets. This represents a better route to profits than horizontal acquisitions.
Our scientists work alongside API development and formulation teams, across indication and API types. We help partners select ideal candidates for successful controlled-release programs, and have proprietary knowledge of modifications that can be leveraged to achieve unheralded delivery ranges.
BEPO™ Platform Power
We are continuously enhancing the capabilities our delivery platform. With each new study, we refine BEPO™ ability to permit compatibility with wider ranges of physicochemical properties and molecule classes (small molecule, peptide and biologic APIs), while further improving the ability of the platform to govern burst and duration for application-specific formulations.
For example, we are expanding the potential for local delivery through alternative routes of administration. For osteoarthritis, intra-articular delivery can trap and slowly release NSAID drugs at the site of pain within the synovium of the knee, adressing the substantial drug dosing and clearance challenges of traditional administration routes. Our intraarticular potential can bring dramatic improvements to efficacy, reduce treatment cost, administration frequency, and the long-term safety profile for a treatment.
Leveraging Delivery for Multiple Durations
Through our efficient formulation discovery phase, we often identify multiple duration prototype formulations. This enables our partners to design a cluster of products around an indication with different release characteristics. We are also exploring combination therapies for simultaneous delivery of multiple APIs.
Supergenerics (SGx), Value Added Generics and New Therapeutic Entities (NTE) are recent generic product categories that are differentiated by improved pharmacokinetics, delivery, patient convenience and/or an improved manufacturing process. They require a lower financial investment than the traditional pharma NCE development. And, due to shorter development timelines, they offer lower failure risk while maintaining some potential for market exclusivity.
Market drivers for Supergeneric programs:
- Indications with high unmet clinical needs
- Patent expirations / Freedom to Operate for a specific indication and therapy area
- Aging populations and corresponding rise in age-related conditions
- In emerging markets, drug supplies have historically been government-controlled. But with increased economic standing, these populations are now looking for the improved treatment quality that supergenerics offer
The generic industry is focused upon the following indication areas: CNS/Pain, Anti-Infectives, Cardiovascular, Oncology and Respiratory. As competition intensifies with multiple generic products serving each indication, MedinCell enables generic drug makers a path towards true market differentiation.
Instead of defending generic brands through marketing programs, contact MedinCell to design a supergeneric formulation with better duration, burst control and PK profile.
Significant advantages for peptide APIs
Over 60 peptide APIs have reached regulatory approval, and more than 700 are moving through pharmaceutical pipelines. Surpassing the overall pharma growth rate, the peptide market will reach $15 bilion 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.
- 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 our formulations, decreasing total treatment cost
- Avoids pitfalls associated with PLGA microparticle scale-up
- Compatible with hydrophilic and hydrophobic molecules
Drug life cycle management & optimization
Generics have already had an impact of $137 billion on pharma revenue. With our controlled-release platform, a well-timed product extension with extended release can keep your a pharmaceutical brand strong.
- We offer unique opportunities for Life Cycle Managers to design follow-on products, extending action duration and reducing drug cargo for strongly branded APIs.
- Life cycle acquisitions are also gaining traction with the VC community as a way to manage late-stage products, as they often couple validated APIs with defining drug delivery technologies and a rapid development timeframe.
A broader view of optimizing the life of a pharmaceutical product is also gaining ground. Drug Life Optimization (DLO) views the entire product lifespan – not just the marketing lifecycle – to make better strategic decisions. DLO is an all-encompassing approach to manage the complete set of product information, processes, and resources in order to maximize the longest, full-life potential of a drug.
Drug Life Optimization
MedinCell has been incorporated into DLO programs as a parallel option to chemical optimization of early stage candidate APIs. This often occurs after Phase II results yield suggested dosing.