We have developed stable formulations of over 10 approved but off-patent Active Pharmaceutical Ingredients that are the active substance of drugs addressing large markets.
Two formulations that we expect to move into the clinic this year:
- MNP-Cyclosporine for dry eye – approved and already marketed in India. Filing for approval in other emerging markets. Currently initiating head to head proof-of-concept Phase II study versus Restasis. MNP Cyclosporine has demonstrated faster drug release and 4x more binding versus standard of care Restasis of Allergan. If these pre-clinical differences lead to superior clinical benefits versus Restasis, such as an earlier onset of action, and less corneal irritation, then we expect MNP-Cyclosporine to have a multi-hundred million dollars in peak sales potential and to drive significant value for SGN in the next two years.
- MNP Acyclovir + Lidocaine is the first ever combination product for treatment of genital and oral herpes that provides pain relief and viral clearance simultaneously. Zovirax is the current market leader and the market size is projected to be ~$500 MM worldwide. We have demonstrated in pre-clinical skin permeation studies that our MNP formulations retain up to 10 times more drug in the skin when compared with Zovirax, and delivers several-fold more drug across the skin. We therefore expect this formulation to improve the dosing regimen from the current 5-7 times a day to 1-2 times a day, in addition to providing pain relief through lidocaine. We plan to initiate a head-to-head clinical study of MNP Acyclovir + lidocaine combination versus Zovirax in Q2/Q3 2017.