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Nanobio on market in 2013-2014!!!

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NanoBio® Awarded New Patent Covering its Nanoemulsion-based Anti-infective Product Candidate for the Treatment of Cold Sores

http://www.marketwatch.com/story/nanobior-awarded-new-patent-covering-its-nanoemulsion-based-anti-infective-product-candidate-for-the-treatment-of-cold-sores-2010-08-03?reflink=MW_news_stmp

ANN ARBOR, Mich., Aug 03, 2010 (BUSINESS WIRE) -- NanoBio Corporation announced today that it has been awarded a seventh U.S. patent covering its novel nanoemulsion technology. The new claims encompass methods of treating Herpes Simplex I infections, including herpes labialis (commonly referred to as cold sores), using NanoBio's proprietary anti-infective nanoemulsion product candidates.

This new patent covers NanoBio's NB-001, a novel topical therapy for the treatment of cold sores that has been licensed to GlaxoSmithKline plc (GSK) in the United States and Canada for over-the-counter (OTC) use. NanoBio and GSK are currently preparing to initiate two Phase 3 clinical trials to confirm the efficacy and safety of 0.3% NB-001 and are targeted to launch the product in 2013 - 2014.

"The issuance of this patent further demonstrates the novelty of NanoBio's nanoemulsion platform for use in treating dermatological conditions," said James R. Baker, Jr., MD, chief executive officer and founder of NanoBio. "Given the remarkable safety profile of NB-001 and the clear efficacy demonstrated in our prior clinical trials, we expect NB-001 will make a meaningful contribution to the well being of the millions of people who suffer from cold sores."

The development of the nanoemulsion platform began in the 1990s at the University of Michigan, and has since been supported by over $110 million in grants, investments and partnership funding. The newly issued patent (U.S. #7,767,216) is licensed from the University of Michigan to NanoBio Corp. on an exclusive, worldwide basis. With this new patent, NanoBio now holds seven U.S. patents and has filed over 30 additional U.S. and International applications.

About NanoBio

NanoBio Corporation is a privately held biopharmaceutical company focused on developing and commercializing dermatological products, anti-infective treatments and intranasal vaccines derived from its patented NanoStat technology platform. The company's lead product candidates are treatments for herpes labialis (licensed to GSK in the U.S. and Canada), onychomycosis, acne, cystic fibrosis and a broad platform of intranasal vaccines. The company's headquarters and laboratory facilities are located in Ann Arbor, Michigan.

SOURCE: NanoBio Corporation

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Denise 07

Good to know that things are starting to get together in finding better treatments for herpes. Seems like progress is getting further along and eventually maybe a cure in the works!

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herpesufferer

Here's some more info on how NB-001 works and what makes it better than all current topical acyclovir-based treatments. I highlited the most important pieces of information:

http://www.nanobio.com/News/documents/xconomy07.15.10.pdf

NanoBio, With Glaxo as Big Partner, Sees Market in Treating and (Maybe) Preventing Cold Sores

By Luke Timmerman

NanoBio has spent a decade of R&D working on nanotech formulations that might help drugs and vaccines be better absorbed, more effective, or more convenient. Now the Ann Arbor, MI based company is plowing ahead with its first big application—for the treatment and possibly the prevention of cold sores. This story has been unfolding for some time, but NanoBio gained some additional cash and credibility for the idea last December when it formed a partnership with GlaxoSmithKline. London-based Glaxo, the world’s fourth-biggest pharma company by revenue, makes the only FDA-approved topical over-the-counter treatment for cold sores, docosanol (Abreva). The deal provided NanoBio with $14.5 million in upfront cash, plus milestone payments worth as much as $40 million, and a single digit royalty on sales if the new drug reaches the marketplace. There’s both business strategy, and some cool science, to explain how the startup and the drug giant came together. For one thing, Glaxo’s patent expires on its existing drug in 2014. If things break right in the development plan for NanoBio’s NB-001, then Glaxo could be in position to sell a “new and improved” treatment for cold sores a year earlier, in 2013, says NanoBio chief operating officer David Peralta. Having cold sores isn’t a life-threatening condition that puts people in the hospital, and Abreva doesn’t generate enough sales to show up on Glaxo’s quarterly earnings reports. Still, an estimated 136 million people in the U.S are said to get herpes simplex virus-1 infections (cold sores). The Abreva pump sells on drugstore.com for $16.99, so even if Glaxo only captures a small slice of the market, there’s real money to be made.

But besides the business, there’s some interesting science at work here. For starters, NanoBio is led by CEO James Baker Jr., the prolific inventor and director of the Michigan Nanotechnology Institute for Medicine and Biological Sciences at the University of Michigan. Baker’s team wondered if it could come up with a localized, dab-on lotion for cold sores that would work better than traditional oral pills that circulate through the entire bloodstream. Topicals often haven’t worked well in the past, because older formulations didn’t penetrate deep enough into the nerve where the herpes simplex virus resides, Peralta says. The nanotech formulation that NanoBio developed is designed to penetrate deeper, and kill the pathogen before it can replicate and cause the fever blister that’s the visible symptom of a cold sore, he says.

It took a long time to get the particle size right, so it’s not too big or too small to do the job, Peralta says. What NanoBio has settled on, after a battery of animal tests and a pair of controlled, mid-stage clinical trials, is a lotion that can be dabbed onto the spot of infection as many as five

times a day for 10 days, or until the sore is healed, Peralta says.

The NanoBio drug “definitely accelerates healing” when compared with a placebo, based on the clinical trial results thus far, Peralta says. A less definitive, but intriguing result, suggested that the NanoBio treatment could do more than just heal the sore, but actually prevent it from forming in a subgroup of patients. No company has ever been able to claim that a drug can prevent cold sores.

“They licensed our product to be the new improved Abreva when it comes off patent 2014,” Peralta says. “There’s an opportunity for us there.” What happens next in development of NB-001 is the big story for NanoBio, but that’s really only part of what the 21-person venture has on its plate these days. The company has raised about $60 million in equity, and another $40 million in various grants, plus the roughly $15 million from Glaxo so far. Taken together, that gives the company about two years worth of operating cash in the bank, Peralta says.

That financial cushion has allowed NanoBio to pursue a broader strategy of treatments for the skin, and for which you want a potent, locally delivered drug, that doesn’t circulate through the bloodstream and potentially cause unwanted side effects. A potent drug for killing tough-to-treat nail fungus (onychomycosis), called NB-002, falls into this category. That drug has passed an interim analysis of a 443-patient clinical trial, demonstrating safety and effectiveness compared to a placebo, Peralta says.

NanoBio is preparing its game plan for a Phase III clinical trial required to get the drug approved for sale by the FDA, and it is in conversations with potential development partners, Peralta says. There is no competitor on the market today with an effective topical, and an estimated 6 to 8 percent of the adult population has this kind of nail fungus infection, usually in the toes.

There was a whole range of other things Peralta wanted to mention when we spoke a few weeks back, including an inhalable antibiotic for nasty lung infections found in cystic fibrosis patients. NanoBio also envisions creating new formulations of vaccines, particularly so they can be given via nasal sprays for people who want to avoid needles. Much of that stuff is still in its very early days, so I figured such things would be better to cover when more evidence of their effects emerges. But I took it as a good sign that Peralta was willing to talk about so much in the pipeline, not just one lead asset.

“We think we really have some positive news flow to come,” Peralta says.

Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle.

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no good herpes

ive read somewhere on here that nanobio is due to come on the market by the end of 2012. is this true? any thoughts or comments on this?

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herpesufferer
ive read somewhere on here that nanobio is due to come on the market by the end of 2012. is this true? any thoughts or comments on this?

It was supposed to come on market by the end of 2012 according to an older statement by the company CEO. Nowadays it is an out-of-date statement as the latest statement by Nanobio says that NB-001 will be available on market in 2013/2014. Anyway, whether that will be in December 2012 or in January 2013 doesn't make a difference. The main thing is that the product will be made available to the public at last!

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Tronixo

Don't omit another possible pharm

There's also "Nanoviricides," who, despite their 1990's-era website, seem to have better technological luck in the lab, if these stories are founded (seem not too well sourced):

"The nanoviricides® mechanism of action is believed to mimic a natural host cell receptor by which the virus binds and infects cells; binding of a nanoviricide nanomicelle to the virus renders it non-infectious."

Link 1

http://www.masshightech.com/stories/2010/08/16/daily7-NanoViricides-hits-on-encouraging-study-of-Herpes-treatment.html

Link 2

http://www.marketwatch.com/story/nanoviricides-reports-that-its-drug-candidates-demonstrated-significant-inhibition-of-herpes-virus-infection-2010-08-16?reflink=MW_news_stmp

snip:

NanoViricides Inc., a Connecticut developer of drugs to fight challenging infectious diseases, has reported almost complete inhibition of the Herpes virus following a study of the company’s anti-Herpes drug targets.

The West Haven, Conn.-based company plans to develop an ointment form of a treatment for cold sores or genital herpes simplex virus infections. Its nanoviricides nanomicelle drug is designed to bind to the virus and break it down, making it non-infectious.

The cell culture studies took place at Northeastern Ohio Universities’ Colleges of Medicine and Pharmacy and was carried out using with the virulent H129 strain of herpes, as opposed to the simplex virus type 1 (HSV-1).

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