NewGen BioPharma Corp. (NEWG)

[Big Brother]

Article from 2013 mentioning NewGen's FDA approved MNP platform. This seems to be where the real value of the company is, not as much with Estrasorb itself, I'm not sure there are any profits in Estrasorb as it seems to have high manufacturing costs.

http://pharmaceuticalcommerce.com/manufacturing-and-packaging/transdermal-drug-delivery-looks-for-new-frontiers/

Passive technologies
Nanotechnologies

Nanotechnologies seem to hold some hope of expanding the transdermal market. In 2010, NewGen BioPharma (Titusville, NJ) bought a transdermal platform, Micellar Nanoparticulates (MNP), from Novavax. That company had developed one transdermal product using MNP, Estrasorb (estradiol), which is currently on the market for treatment of symptoms of menopause. The platform improves the solubility and bioavailability of topically delivered products. Providing an increased residence time for an active pharmaceutical ingredient (API), the technology can reduce the dosage or the number of applications per day.

MNP offers a solution for delivery not only of systemic transdermal products but also of topical local, oral, injectable, and ophthalmic products. Navdeep Jaikaria, NewGen’s CEO, indicates that MNP gives NewGen the ability to reformulate 60% of all small-molecule drugs. The company also has a platform for delivery of inhaled products and is developing a technology for large-molecule peptides. These peptides must have a stable conformation that withstands the high pressure under which formulations are produced; Jaikaria adds that only GRAS-listed (Generally Recognized As Safe) additives are used.

Jaikaria has indicated that NewGen’s MNP platform holds promise for transdermal technology because it may improve patient acceptance of transdermal products. While common and well accepted in Asia, transdermal products such as patches can cause irritation and itching, and US consumers have not been as tolerant. NewGen’s nanoformulated, medicated lotions are nonirritating and are moisturizing rather than dehydrating, unlike patches in the first instance and gels in the second.

NewGen is developing its own pipeline of drugs, currently 20 APIs that it has reformulated using the MNP platform. This year NewGen plans to launch an ophthalmic and a topical drug in India as well as a reformulation of Estrasorb that keeps estrogen in the skin longer. NewGen has used its technology to develop cosmeceutical products as well, one for hair regrowth and an anti-aging cream.

The company will work with partners as a contract service provider, developing drugs using the platform. Jaikaria indicates that hormonal (steroidal) conditions, pain, urinary incontinence, erectile dysfunction, and smoking cessation are examples of the types of conditions that drugs using the platform can treat. The technology primarily permits delivery of small-molecule drugs, but Jaikaria says that it also will function with small peptides as long as conformation is not an issue. He says that any drug listed as BCS Class 2 (a measure of drug absorption), or that is poorly water-soluble, is a possibility for delivery.