By Toni Clarke
May 4 (Reuters) - When Noah Minskoff's mother died of lungcancer in 2007, e-cigarettes were just entering the U.S. market.Minskoff, who had just started medical school in Utah, wonderedwhether the devices might have saved his mother's life byhelping her quit smoking. Later, he sent some samples to hisboyhood friend Nathan Terry, a mechanical engineer, and askedfor his opinion.
Terry, who was working in Germany for the French industrialfirm Areva, took apart the products to see how they were made.What he found disturbed him: at the heart of the devices wereheater wires of unknown quality wrapped around bundles of glassfibers and surrounded by steel wool, silicon, plastic, tape andadhesives.
Wires between the heater, circuit board and batteries wereconnected with lead solder and also housed in tape and plastic.Everything was close to the heat source, meaning consumers wereat risk of inhaling fiber and metal particles as well as toxicfumes from hot plastic and lead.
"There were red flags everywhere," Terry said.
Still, he liked the concept and decided to design a versionof his own, avoiding the use of fiberglass, plastic and solderand sourcing his materials entirely in the United States. In2009 he reunited with Minskoff in California and formed acompany, Thermo-Essence Technologies, to sell the product.
At $300 a piece, the e-cigarette serves a niche market,albeit one with a loyal following among medical marijuanapatients and smokers looking for a high-end e-cigarette. As manyas 30,000 have been sold.
But what began as a quest to develop a better e-smoke hasbroadened into an ambitious effort to design a new medicaldevice: an inhaler that delivers measured doses of nicotine tohelp people quit smoking. The technology could also eventuallybe used as an abuse-resistant delivery device for other drugs,including opioid painkillers.
If successful, the inhaler could become the first newsmoking-cessation product to emerge from the e-cigarette fieldand would compete with products such as GlaxoSmithKline Plc's nicotine gum and Pfizer Inc's antismoking drug,Chantix.
A STARTUP WITH BIOTECH FUNDING
To develop the inhaler, Terry formed a second company,Minusa LLC, which is based in Newtown, Connecticut. Minskoffleft Thermo-Essence for family reasons and is not involved inMinusa. Terry himself is leaving Thermo-Essence, which iscurrently being sold, to concentrate on Minusa.
The new company obtained initial funding from MichaelBreede, a commercial real-estate-turned-biotech investor whosefather suffered from drug and alcohol addiction and who is eagerto see an abuse-resistant painkiller device.
"This is in my wheelhouse," he said. "I think we can put aserious dent in this problem."
When Terry developed his e-cigarette he assumed the U.S.Food and Drug Administration would begin regulating theindustry, as it has recently done, proposing a ban on sales topeople under the age of 18 and requiring companies to register.Later it could impose product standard and quality controls.
Terry wanted to create a product that would pass any FDAinspection. He used a pure metal wire wrapped around a rod madefrom magnesia-stabilized zirconia, a highly durable ceramicmaterial. Instead of meshes, tape and plastic he used novelporous ceramics and surgical-grade alloys, and instead ofsoldering parts together he connected them mechanically, fittingcomponents together like Legos to complete the circuits.
He built on that design to create his drug-delivery device,known as Envi, a single-user, tamper-resistant, metered-doseinhaler.
Envi is about the size of a short cigar and comes with aspare in a case the size of a deck of playing cards.
The nicotine or other drug will come in a sealed cartridgethat the patient will insert into the inhaler. To activate thedevice, the user will have to enter a code. The inhaler will beprogrammed to deliver a certain amount of drug and then turnoff.
When the device is returned to the case, which is requiredafter each dose to activate it for the next dose, data on thepatient's usage will be downloaded and available to be viewedelectronically by the prescribing physician.
"It will only let you take your prescription," Terry said."It will log your usage and transmit it in real time, and makeit easier for the doctor to monitor and interact with thepatient."
BUILDING A BETTER INHALER
Terry, 37, who grew up on an organic farm in Ohio to "hippycommune" parents and studied mechanical engineering at theUniversity of Idaho, faces multiple challenges.
Inhalers are typically more expensive to develop than pills,and ensuring patients get the right dose is more complicated.
"I can see a lot of barriers, but the idea is certainlyinteresting," said Dr. Ben Forbes, a Reader in Pharmaceutics,broadly the equivalent of a U.S. professor, at King's CollegeLondon who specializes in inhaled medications.
There needs to be a good reason to target a drug to thelungs, Forbes said. Drugs that are inhaled may work faster thanpills, so a device that offered quick pain relief in anabuse-resistant form would be "brilliant" if it could beproduced economically, he added.
"Changes in inhaler technology have been very incrementalover the years, so maybe something like this would have aplace."
In the meantime, big tobacco companies are developingalternative nicotine products they hope one day will carry a"modified risk" of harm. Some are dispensed through an inhaler.
Unlike Terry's smoking-cessation device, which he plans tofile with the FDA's drug division, these products would bemarketed as less risky alternatives to smoking and be processedthrough the FDA's tobacco division.
However smokers end up using the new products will be thesubject of intense research by the FDA.
Terry believes he is creating a product that will surviveany market configuration. Minusa has a long way to go, and humantrials may be two years off. Eventually he hopes to partner witha big drug company.
"I think we can change how drugs are delivered." (Reporting by Toni Clarke in Washington; Editing by MicheleGershberg and Prudence Crowther)
Glaxosmithkline (GSK)