NewGen BioPharma Corp. (NEWG)

[Big Brother]

Beyond the NanoCannabinoids they have a very strong pipeline of products with serious potential.

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 fasted 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 NewGen 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 pin relief through lidocaine. We plan to initiate a head-to-head clinical study of MNP Acyclovir + lidocaine combination versus Zovirax in Q2/Q3 2017.

Cosmeceuticals

MNP Minoxidil transdermal Nanoemulsion Lotion: A significant improvement over the current Rogaine solution and foam formulations. Contains less than 10% alcohol as opposed to 30-50% for Rogaine and no Polyethylene Glycols (which have been clinically documented to cause scalp irritation and hinder long-term compliance). Our formulations have excellent spreadability, are moisturizing and do not require an approval in the USA as Minoxidil is an OTC product for up to 5% concentration. We expect to begin a worldwide launch in Q3/Q4 2017 beginning with India and other Emerging Markets and will also be conducting a Phase IV head-to-head study with Rogaine to document MNP Minoxidil benefits over Rogaine.

MNP Minoxidil + Finasteride Transdermal Nanolotion: Combination of Transdermal Minoxidil and Transdermal Finasteride presents a superior solution for hair re-growth comparative to current solutions of Topical Minoxidil or oral Finasteride. Finasteride is an inhibitor of type I, 5 alpha-reductase and has been shown to be effective in treating AGA or baldness, when given orally. However, it can have significant side-effects when given orally including erectile dysfunction, lowered libido and impotence. Oral Finasteride (1mg tablet) has been approved by the USFDA and by most countries for treatment of male androgenic alopecia. No Transdermal Finasteride or its combination with Minoxidil are being sold in the Regulated Markets or are in development presently, and therefore present a significant market opportunity for NewGen. MNP Finasteride, MNP Finasteride + MNP Minoxidil transdermal nanoformulations have been successfully developed. We are now initiating the process of generating cGMP data for clinical trials. NewGen expects to initiate clinical trial with MNP Finasteride 1% and MNP Finasteride 1% + MNP Minoxidil 5% combination therapy in Q3 2017.

MNP Anti-wrinkle cream and lotion: These are moisturizing nanoemulsions of phytoestrogen-like molecules which laboratory research has shown to be effective. We expect to launch them through marketing partners in India in Q3 2017.