August 29, 2014 +33 467 419 Global Health Delivered

Best in Class Products for Global Populations

Unprecedented Level of Controlled Release
nce_modelMedinCell always targets 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. MedinCell’s injectable technology forms an in situ depot after administration. Burst and duration rates 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 to compete in multi-generic markets
Optimized Drug Release
controlled-release-concept-largeBy minimizing the initial burst (Cmax) of drug molecules post-administration, MedinGel 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 MedinGel Cmax.

In addition to patient tolerability and comfort, keeping a drug at within an optimal therapeutic range in bloodstream helps prevent API waste, thereby reducing treatment costs.

Contact MedinCell to learn of example pain control formulations in which Cmax was substantially reduced, such as Buprenorphine (both 4 day and 1 month durations).

Enabling Localized Delivery
Localized Delivery
Arthritis of the knee, X-rayIn addition to systemic delivery via subcutaneous injection, MedinCell develops long-acting, controlled release formulations for intra-articular administration (i.e., injection into the synovial cavity of the knee). Initial studies confirm that significantly higher concentrations can be maintained with local delivery, which subsequently reduces the overall API required for osteoarthritis treatments.

Pain associated with arthritis can be debilitating, and current palliative treatments are not ideal for chronic treatment: viscosupplementation can lead to painful inflammation, opioid-based drugs may induce physical dependency, and NSAIDs can lead to long-term gastrointestinal side effects. Tremendous potential exists for controlled-release osteoarthritis therapies that can be delivered directly to the site of pain or inflammation for improved efficacy and lower systemic toxicity

Contact MedinCell to learn more about our experience with delivering small molecules and antibody APIs via intra-articular injection, as well as recent studies on intra-peritoneal (oncology) and intra-ocular applications of our technology.

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Accommodating Fragile & Short-lived APIs
API Types

MedinCell 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, our MedinGel technology 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 dose-sparing nature of MedinGel, 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 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. Break through the peptide delivery barrier with MedinCell’s novel technology and expand the potential of your peptide products!

Contact MedinCell to explore results for a 1-month antidepressant peptide formulation project, and to hear about our promising experience for protein and antibody delivery.

MedinGel Benefits

API Protection

MedinCell’s polymers protect small molecule, peptide, and protein APIs during release (days, weeks, months—even up to a year); this proprietary technology also guards against competitors.

Rapid Formulation

MedinCell offers an extremely rapid formulation development process. This means faster validation of the extended release capacity for key drug compounds in development.

Improving Compliance

By tailoring the initial release of drug molecules, MedinGel can reduce Cmax and limit off-target effects for improved patient compliance and safety.

Optimize Drug Products for Compliance and Affordability

Increased Patient Compliance and Treatment Adherence
compliance-dose-frequencyExtending Dose to Improve Compliance
Novel, controlled-release delivery technology can improve treatment compliance and patient retention. Plus, with dramatically reduced API requirements you 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 MedinGel formulations last weeks or months, we expect compliance improvements even over weekly dosing. Extending duration is especially critical in pathologies like schizophrenia, dementia, contraception, and for dependent patients across senior populations.

Adjusting Route of Administration for Patient Preference
Shifting from intramuscular 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, nearly 50% non-compliance rate has been reported. For patients that lack the awareness of their condition, 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 years lost because of disability.

MedinCell is actively targeting medical indications that damage global productivity and world economies.

Low Cost of Goods for Globally Available Medicine
The Netherlands Access to Medicine Index estimates “that more than a billion people do not have access to the medicine they need.” A significant component of this issue is the absence of drugs that are affordable for emerging market countries.

The MedinCell team maintains a global perspective for our business and humanitarian goals. To this end, we endeavor to make products that are as efficacious, convenient, and cost-effective as possible. We share a population-focused view of the world, and strive to develop Best-in-Class treatments for all markets, regardless of local economic conditions.

MedinCell's worldview is based upon patient populations

Enabling best-in-class treatments for developing countries

The MedinGel technology has been refined by years of continuous improvements. Our polymers utilize low-cost components, and avoid scale-up issues common to nano- and microparticles. The 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, the MedinGel technology relies on low-cost, safe components. And through its API-sparing nature, the overall treatment costs can be extremely lower. In fact, we are currently developing several products that—fully packaged—will cost less than their generic oral counterparts!

For Enabling humanitarian collaborations (6 and 12 month Ivermectin for River Blindness), and Malaria NCEs

Beyond Formulation, MedinCell Serves as Pharma Think Tank
MedinCell’s scientific and business development experts work with our partners to evaluate the API selection, delivery and market strategy before embarking on a formulation development program. With the dramatic reduction of internal pharmaceutical R&D staff, MedinCell serves as an efficient drug product think tank, expediting and de-risking reformulation of high-potential actives.
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Please contact us with any questions on our company or technology.