It’s a fine line between the nose and the brain. Actually, it’s called the olfactory nerve, where researchers believe can serve as an ideal way to deliver drugs to the central nervous system (CNS).
MedInvent LLC is certainly intrigued. The White Bear Lake, Minn.-based start-up hopes to ride the strong initial sales of its nasal drug delivery device for sinusitis sufferers to eventually target neurological diseases like Alzheimer’s and epilepsy.
Founded in 1998, MedInvent has developed an irrigation system that can deliver specialty drugs like steroids into the nasal cavity to treat polyps, small non-cancerous growths on the lining of nasal passages and sinus that cause infections.
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“We address the underlying medical conditions” of diseases like sinusitis, said Bill Flickinger, a former marketing executive at Transoma Medical who founded the company along with Dr. Steven Isenberg, an ear, nose and throat (ENT) specialist in Indianapolis.
ENT has attracted considerable interest from medical device investors in recent years. Last December, Johnson & Johnson acquired Acclarent Inc., a company that developed a balloon catheter system to treat sinusitis, for $785 million. Maple Grove, Minn.-based Entellus Medical, which is working on a similar balloon catheter that’s inserted through an incision in the upper lip, recently raised $30 million.
Experts say MedInvent faces plenty of competition in nasal drug devices.
“I would guess that if someone with sinus issues used [the device] religiously, they may be able to relieve their daily symptoms and slow or halt progression toward chronic sinusitis,” said Ben Arcand, a recent graduate of the University of Minnesota’s Medical Device Fellows Program who’s launching a start-up to treat sinusitis. “But that is probably true of most irrigation, which there are quite a few other models out there. So if it’s convenient to use a better irrigator, I think it would definitely be good for someone with sinus problems.”
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Flickinger says the company’s patented two-spray pressurized system can deliver larger drug particles more fully throughout the entire nasal cavity. MedInvent has already generated an operating profit and expects to sell 15,000 to 20,000 units of the $219.95 device in 2010 compared to 2,500 units in 2009.
“We’ve brought the company to a position where it’s really poised for growth,” Flickinger said.
What’s really helped MedInvent is its distribution partnerships with specialty pharmacies like ASL Pharmacy. Specialty drug sales, including high-end biopharmaceuticals, grew 15.4 percent in 2008 compared to just 1.5 percent for traditional drugs, according to a report by Express Scripts, a top pharmacy benefits manager.
That’s why MedInvent is eying ways to position its device as a way to deliver neurological drugs. Researchers have long puzzled over ways to administer drugs that can successfully cross the blood-brain barrier, a defensive mechanism meant to block harmful particles from entering the brain.
One promising avenue is the olfactory mucosa in the nose; its nerve cells are in direct contact with the central nervous system.
“For long, the blood-brain barrier (BBB) has impeded the development of many potentially interesting CNS drug candidates due to their poor distribution into the CNS,” according to a research paper published in Drug Delivery Technology in 2004.
“Owing to the unique connection of nose and the CNS, the intranasal route can deliver therapeutic agents to the brain bypassing the BBB,” the paper said. “Via intranasal delivery, many abandoned potent CNS drug candidates are promising to become successful CNS therapeutic drugs. Recently, several nasal formulations, such as ergotamine (Novartis), sumatriptan (GlaxoSmithKline), and zolmitriptan (AstraZeneca) have been marketed to treat migraine.”
Flickinger said he believes MedInvent’s technology can successfully deliver drugs through the blood-brain barrier via the olfactory nerve with little modification to the device it sells today.
But first, the company wants to conduct a clinical study to prove the device’s benefits to ENT patients. Eventually, MedInvent wants to sell globally, develop a more portable device, or even package drugs with the device.
