Mark Schobel, MonoSol's CEO, holds a PharmFilm that the company uses to deliver medicine under the tongue.
MonoSol Rx is on a roll.
During the span of a month this summer, the tiny Warren-based company announced that two of its drugmaker partners had received regulatory approval to sell reformulated versions of their medicines on the quick-dissolving film strips made by MonoSol Rx.
“From our perspective, this not only validates our ability to bring technology through the (regulatory) approval,’’ said Mark Schobel, the company’s chief executive officer.
“It clears the way for us to explore other drugs.’’
MonoSol Rx, which typically spends about three years developing a product, has its sights set on even bigger targets, including a couple of migraine medicines, a top-selling asthma drug and the possibility of putting a treatment for Alzheimer’s disease on the company’s patented under-tongue strips. Although it hasn’t developed a single new drug, MonoSol Rx is on the cutting edge of the pharmaceutical industry.
The business of drug delivery — or the way a patient is administered medicine — moved beyond mere pills and needles years ago with the introduction of more novel methods, such as patches, sprays, time-release medications and film strips.
The idea of using a postage stamp-sized piece of film to give patients medicine isn’t really so far-fetched when you consider the concept took off years ago when Listerine PocketPaks were introduced, allowing consumers to freshen their breath anywhere.
Schobel said Listerine breath strips helped to inspire the technology that eventually led to the development of the company’s PharmFilm product.
PharmFilm, the brand name for MonoSol Rx’s film strips, consists of pharmaceutical-grade polymers capable of delivering medicines in a range of doses. The strips, which are placed on or under the patient’s tongue, are made to dissolve within seconds.
“This is pharmaceutically elegant and it’s a better way to take medications,’’ Schobel said, That may be particularly true for medicines aimed at children or treatments for specific conditions, such as nausea, which make it more difficult for a patient to swallow a pill.
The company’s first prescription drug product addressed that very issue. Par Pharmaceuticals partnered with MonoSol Rx to put Zuplenz, a drug for chemotherapy-induced vomiting, on a film strip that could be placed under a patient’s tongue. MonoSol Rx is in line to receive millions of dollars in milestone payments as a result of the collaboration.
Last month, the company said federal drug regulators had approved Reckitt Benchkiser’s proposal to sell its opioid-addiction treatment Suboxone on MonoSol Rx’s film strip.
Todd Brady, a principal with the venture capital firm Domain Associates, said there is strong demand for both of MonoSol’s initial products.
“There is a large market for antiemtic (anti-nausea) and a large market for treatments for addiction,’’ Brady said. “Any delivery system that is more convenient than swallowing something is going to be compelling for both patients and physicians.’’
MonoSol Rx is counting on that.
It is working on a reformulation of Singulair, Merck’s top-selling asthma and allergy drug. Singular will face generic competition beginning in 2012, creating a market opportunity for prospective rivals intent on capturing teen users of the asthma medicine.
The company, which has 85 employees, is also working on reformulating a pair of migraine medicines and an osteoporosis drug.
“We’re going to continue to look for high-value targets, opportunities where the technology creates a competitive advantage for the drug maker,’’ said Keith Kendall, MonoSol’s executive vice president. “We feel we have a lot of opportunities in front of us.’’
The 6-year-old company started building its business with a handful of non-prescription, film-strip products, including one for snore-relief and another for colds. The strategy helped to prove its technology worked, Schobel said.
The company isn’t required to publicly disclose its financial results because it is privately held, but Kendall said MonoSol Rx, which makes the bulk of its money from royalties and milestone payments, is on track to show a profit next year.
As Kendall put it: “We’re gaining traction.’’