Technology

A Platform For Success

Worldwide Rights - Global Marketplace

A key challenge in successfully developing optimal small molecule drugs with the right efficacy & safety profile, is the delivery of Active Pharmaceutical Ingredient (API) in a form that delivers good API bioavailability at the site of action.

Since 1990, almost 60% of approved small molecule therapeutics, as well as those in development, are poorly water soluble leading in most cases to sub-optimal drugs.

To-date, there are only 13 Nanodrugs approved by the US FDA including one from our MNP Platform. The majority of these drugs are delivered in formulations where API’s have micron sized particles.

Conversion into Nanoparticles enhances the surface area for absorption at least a hundred-fold which leads to the beneficial effects seen with nanoformulations including lower doses, improved safety & efficacy, improved dosing regimens & bioavailability etc.

There are two central challenges with Nanoformulations which prevent their successful translation into marketable products:

  • Long-term stability as nano sized particles
  • Scaling up issues

MNP Platform:

Micellar Nanoparticle (MNP) Technology

The MNP Platform was originally developed by Novavax (Nasdaq listed; NVAX) which successfully developed and launched Estrasorb in the US from this platform. SGN in-licensed all worldwide rights to the MNP Platform from Novavax and Estrasorb marketing rights Ex-North America.

Over the last 6 years we have successfully refined the 1st generation MNP Technology from Novavax to a more stable 2nd generation MNP Technology and have applied it successfully to formulate over 20 compounds. The original Novavax technology had large particle sizes (~500nM) and the emulsions were unstable beyond 6 months.  The products had to be shaken to mix and emulsify before use.

The 2nd generation MNP technology developed by SGN leads to finer particle sizes (mean particle diameter ~200nM) and stable nanoemulsions. We have documented stability for over 2 years at room temperature for over 10 compounds and up to 5 years for 2nd generation estrasorb. Further we have successfully scaled up and launched a product in India and have approvals for several more.

With an established nanotechnology platform offering broad applicability, we now will focus on developing NanoCannabinoids immediately upon approval of our DEA application (expected Q2, 2017). Cannabinoids are a group of molecules with exciting medicinal properties but present stability and bioavailability concerns. Their bioavailability is so low, in some cases it is not possible to effectively harness their medicinal properties. We believe the marriage between MNP Technology and Cannabinoids to generate NanoCannabinoids would be a perfect solution and could help successfully overcome the delivery and low bioavailability issues.

Patents

We currently have two families of patents pending with the USPTO and anticipate additional filings this year.

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