** PENDING MERGER WITH NEWGEN BIOPHARMA CORP(Private), EXPECTED TO CLOSE ON OR ABOUT JANUARY 31, 2017, MERGER IS NOT OFFICIALLY COMPLETE AS OF YET ** Website: http://newgenbiopharma.com Facebook: http://www.facebook.com/newgenbiopharma/
OTC Markets: http://www.otcmarkets.com/stock/NEWG/profile
Nevada SOS: http://nvsos.gov/SOSEntitySearch/CorpDetails.aspx?lx8nvq=Khquk4Zw0j%252b7L421uY5zzA%253d%253d&nt7=0
NewGen BioPharma (OTC: NEWG), is an innovative, clinical-stage and revenue-generating developer of nanotherapeutics. The Company combines proprietary nanotechnologies with structural biology to generate superior solutions by (a) reformulating FDA approved drugs that are sub-optimal and (b) by developing novel therapies. NewGen is committed to the development of nano-cannabinoid candidate products targeting transdermal delivery, increased bioavailability, and reduced psychotropic effects. Our aim is to safely deliver large dose therapies as an alternative to many traditional medicines such as opiates, which are currently considered over prescribed and potentially life-threatening.
We intend to be a leading global nanomedicine company. We have developed near term and global strategies to achieve that goal.
Our near term focus has been to:
(a) formulate Cannabinoids to generate ophthalmic, neural and transdermal formulations to address large unmet medical needs and,
(b) reformulate underperforming FDA approved drugs that are sub-optimal due to poor water solubility and low bioavailability.
A key component of our strategy and focus is to generate revenues via MNP Technology-based products in India and related emerging markets from the outset, while conducting proof-of-concept (POC) clinical trials for US and other regulated markets in low-cost geographies such as India.
Revenue generation via product marketing partnerships in India and emerging markets is already underway.
Proof of concept, Phase II clinical studies are expected to begin in Q2 2017.
We project revenues from emerging markets to top several $million over the next few years.
Our key areas of focus for NanoCannabinoids are:
- TransNanoCannis: Transdermal delivery for pain relief and anti-inflammatory indications: Some cannabinoids (THC) are powerful anti-inflammatory agents with 2 times the power of steroids and 20 times that of aspirin (Russo, E.B., 2011, British Journal of Pharmacology, 2011, 163 1344-1364; Evans F, 1991, Planta Med, 57: 560-567). MNP Cannabinoid formulations entail individual as well as multiple synergistic cannabinoids in one formulation. These are designed to provide local as well as systemic therapeutic effects and are ideal transdermal formulations because of excellent skin penetration and spreading capabilities. Target indications include Rheumatoid arthritis, pain, psoriasis, eczema. We expect to file our first IND in the US by mid-2018.
- OPNanoCannis: For Ophthalmic Indications: We have developed several MNP formulations for ophthalmic indications including MNP Cyclosporine for dry eye. We are now developing MNP Cannabinoids for treatment of dry eye as well as glaucoma. We expect to file our first IND in the US by mid-2018.
- CNSNanoCannis: Delivery of Cannabinoids to the brain: Delivering Cannabinoids across the blood-brain barrier remains a key hurdle. We have demonstrated our nano-formulations to cross the blood brain barrier in a significantly superior manner versus the conventional non-nano formulations. We are currently working on developing formulations of Cannabinoids to treat neural indications such as Alzheimer’s, and other disorders. We are focused on developing oral nanoformulations of cannabinoids that have (1) enhanced bioavailability compared to current therapeutics such as Epidolex and (2) ability to readily cross the blood-brain barrier.
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.
Transdermal Drug Delivery Looks For New Frontiers PATENTS http://www.google.com/patents/WO2014028587A1?cl=en https://www.google.com/patents/US20130224268?dq
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.
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.
Founder and Chairman Dr. Navdeep Jaikaria
Dr. Navdeep Jaikaria is the Founder and Chairman of NewGen BioPharma Corp., US and its Indian subsidiary, New India BioPharma in 2010. Dr. Jaikaria has successfully raised multi-million dollars in investment capital and has transformed NewGen into a commercial stage company with a marketed product and a strong pipeline of products in various stages of clinical and pre-clinical development.
He has been at the forefront of cutting-edge biotechnologies in his various professional roles and has trained at some of the finest institutions in India and the US and with leading scientists of his times. Dr. Jaikaria has successfully used his scientific acumen and expertise to consistently identify and value ground-breaking therapies and biopharma technologies as successful investment opportunities in his Wall Street career spanning over 8 years. He has a broad knowledge base in the health care industry. During his career, he has successfully assembled & managed competent teams of scientific experts and business professionals in high-pressure, productivity-focused environments.
Navdeep’s industry and investment perspectives have been widely cited in the print & broadcast media including The Wall Street Journal, Financial times, Businessweek, Forbes. He has periodically appeared as a guest commentator on CNNfn, CNBC and CNN India. He has provided policy input to the US senate health committee on biodefense.
Navdeep was named as one of the five best stock-pickers in Biotechnology in the Wall Street Journal's annual "Best on the Street" Analysts survey in 2007. He was consistently ranked as a top analyst and as high as #3 by Starmine in 2006. Navdeep won many academic awards throughout his career, including the Martha Lucas Pate, Ph.D. Memorial Award for academic excellence & leadership at the New York Medical College & the Naval Research Scholarship to conduct research at Stanford University. He was ranked #2 overall at the All India Institute of Medical Sciences and was awarded the prestigious National Talent Search Scholarship – the highest scholastic award in India after high school.