This article first appeared in the St. Louis Beacon, March 18, 2012 - Ed Timm has heard the rap on orphan drugs before.
“Understand that it is enormously difficult to get a new drug approved in this country,” he said, noting that the average manufacturer can spend many millions of dollars and perhaps a dozen years on research for a pharmaceutical with a limited audience. “If you look at an orphan drug designation where you have a small number of patients, the cliché is that the hill ain’t worth the view.”
But Timm, president of Mobius Therapeutics, is liking the view well enough these days. As soon as next month, his company’s initial product, Mitosol, may finally be on the market, the culmination of a dream Timm has been nursing since he founded Mobius in Israel in 2006.
In some sense, Mitosol is based on an already proven therapy, an ingredient known as mitomycin, a variety of fungus used in treatment after certain types of eye surgery, particularly one to treat glaucoma or a pterygium.
Mitomycin works, but the logistics involved with its application to the eye can be something of a nightmare. It’s unstable and has to be refrigerated and shielded from light to preserve what is already an especially short shelf life. Normally, the substance is used in chemotherapy where it is applied in huge doses, yet for ophthalmologic indications only a tiny amount is required.
“Up to this point, if you wanted to get an ophthalmologic formulation of mitomycin, there wasn’t one available so you had to call the oncology pharmacy and say, ‘I need one cc of mitomycin 0.2 milligrams per ml,’” he said. “If it’s in a 40-milligram vial that means that 99.5 percent of it is being thrown away.”
That’s where Mobius enters the picture. Timm was determined to find a better way of serving up the uncooperative substance. This wasn’t just a matter of putting it in a smaller bottle. In tiny enough amounts, the interaction between the water and the active ingredient would become unstable causing a runaway reaction.
“It sounds simple, but it’s not. The tiny dose we needed to supply was so small it’s ultimately freeze dried,” he said. “The amount of liquid to be put into the vial was so small that the tolerance of the nominal fill volume associated with that liquid fill was less than the tolerances of the filling equipment.”
Working out the bugs was a long road but Timm and Mobius have finally made it. Mobius now has a product with a shelf life that’s sterile, easier to store and lasts a year and a half instead of weeks. The regulatory green light has just come on and he expects to go to market by April.
“We have a tremendously unique value proposition that we’re bringing to the customer,” he said proudly. “We didn’t just take mitomycin, slap ‘FDA approved’ on it and say, ‘OK, now you can use it on the eye.’ On the contrary, we completely optimized the product for use on the surgical field. And we did that in a way so that the surgeon's routine... is totally unchanged.”
Like any entrepreneur, Timm is a realist who can click over to the lingo of business and speak it as fluently as he does the language of science.
“It’s an appealing demographic strictly from a marketing perspective,” he said of patients who suffer from ailments like glaucoma. “It’s an aging demographic so there is a growing population. The other thing is that there is an overabundance of needs associated with it. It’s an underserved subspecialty. It seemed like the perfect opportunity to jump in.”
The shift in verbiage from medicine to markets is heard often in the industry and it’s one that shows this isn’t Timm’s first startup. The Gary, Ind. native was previously a key player at Synergetics (now Synergetics USA), an O’Fallon-based microsurgical device company which today is publically traded on NASDAQ.
But after leaving that venture he wanted something new.
“I can’t stop,” he laughed. “I know that sounds silly but I’ve been in the surgical devices/life science business my whole career. I love what I do. We find our opportunity by improving patient care. If we don’t do that, whatever we’re creating will never be adopted. At the end of the day, that’s not a bad thought to have in your head as it hits the pillow.”
The fact that his head hits the pillow in St. Louis is no accident. He’s proud of his adopted hometown’s position in biotech. What about those who say the coasts are where it’s at for precision tools and equipment?
“Baloney,” he said, tapping the desk for emphasis. “It’s right here. All of that competency is right here.”
He argues that everyone from Cardinal Health to Bausch & Lomb to Aesculap have a presence in town.
“This is the cradle of the industry as it relates to microsurgical device manufacturing,” he said. “You’ve heard of robotic surgery? All of those instruments are made here.”
Timm likes knowing that if a piece of equipment or an injection mold has a problem, he doesn’t have to get on a plane to Boston or Seattle. He can just hop in the car and drive across town.
It’s an idea he hopes other biotech startups take notice of as well.
“We are unabashedly, unashamedly homers,” he said. “We’re going to try and keep all of our business here at home because in so doing, we can utilize our best qualities, which we believe are product innovation, creativity and commercialization and take advantage of existing resources so the whole ocean rises, raising all the boats.”
Timm plans for the company to be busy well beyond its current product. There’s a reason his enterprise is called Mobius, a geometric term that refers to an endlessly looped strip. He wants to apply the same innovative process that produced Mitosol to other difficult-to-use medical treatments.
“We believe we can make this an endless model, that we can replicate this model,” he said.