OTC lotion to treat cold sores NB-001 to enter US, Canada

NB-001, a novel topical over-the-counter (OTC) treatment for cold sores (herpes labialis), may soon hit the markets in US and Canada.

NanoBio Corporation, the developer of NB-001, has entered into an exclusive licensing agreement with GlaxoSmithKline plc (GSK) to market the cold sore drug in the United States and Canada over-the-counter.

Under the terms of the agreement, NanoBio will receive an upfront payment of $14.5 million, and is eligible to receive additional milestone payments of up to $40 million plus single digit royalties on future sales.

NB-001 provides significant antimicrobial activity against the virus that causes cold sores, herpes labialis.

NB-001, speeds healing of lesions as effectively as the leading oral systemic drugs but without safety or toxicity concerns.

Cold sores are a prevalent condition affecting approximately 20% of the adult population in the US.

GSK has established Abreva as the leading cold sore treatment with a greater than 50% share, gaining two share points in the prior 12 months. Abreva is the only OTC medicine approved by the US Food & Drug Administration that is proven to shorten cold sore healing time.

NanoBio has completed two Phase 2 clinical trials of NB-001, demonstrating clear efficacy and a good safety profile in patients and plans to enter Phase 3 testing soon.

Data from clinical studies using NB-001 show that the topical agent can attain equivalent efficacy rates to oral systemic drugs, according to the NanoBio scientists. Topical treatments are widely considered inferior to oral systemic treatments because they fail to penetrate to the site of infection with adequate drug levels required to subdue infections.

In the study of 482 patients, NB-001 healed lesions 1.3 days faster than placebo as measured by investigators. Results of the randomized, double-blind, placebo-controlled, phase 2b trial.

NB-001 was well tolerated, without safety concerns or adverse events, and was not systemically absorbed.

“NB-001 challenges the conventional wisdom that topical therapies are less effective, because NB-001 directly accesses the site of infection in the dermis and epidermis instead of remaining on top of the skin,” stated James R. Baker, Jr., M.D., founder and chairman of NanoBio Corp.

NB-001 employs a physical mode of action to disrupt the outer membranes of pathogens and prompt viral lysis, essentially killing on contact, he said.

The study also suggests that the physical mode of action of NB-001 significantly reduces the likelihood that pathogens will develop resistance to the biocidal effect of the topical lotion.

NanoBio scientists credit the topical lotion’s safety and robust anti-infective activity to NB-001’s novel technology platform.

The lotion is composed of an oil-in-water emulsion and a commonly used antimicrobial surfactant that are mixed at high speeds to nanosize the particles and infuse them with high levels of potential energy. The resulting nanodroplets easily penetrate hair follicles and skin pores to reach the site of infection without damaging skin or mucous membranes. Upon contact with the pathogen, the highly charged particles release their energy to the pathogen’s outer membranes, disrupting the viral particle.

Because the herpes simplex virus causes both cold sores and genital herpes, there is a strong potential that NB-001 will also be effective in treating genital lesions.

NanoBio is currently testing its pipeline of topical products against a wide range of skin infections including onychomycosis (nail fungus), tinea capititis (ringworm) and acne.

NanoBio Corp. is a privately held biopharmaceutical company focused on developing and commercializing anti-infective products and mucosal vaccines derived from its patented NanoStat technology platform.

NanoBio’s lead product candidates are treatments for herpes labialis (cold sores), onychomycosis (nail fungus), acne and a broad platform of mucosal vaccines. The company’s headquarters and laboratory facilities are located in Ann Arbor, Mich.