Headquarters: Coralville
Website: www.kempharm.com
Ticker symbol: KMPH
Employees: 28

It may surprise many people that drug overdoses take more lives in the United States every year than car accidents or homicides. 

On average, 46 Americans die each day from prescription opioid overdoses, a rate of about two deaths every hour, or 17,000 annually, according to the American Society of Addiction Medicine. Looked at another way, deaths from prescription painkillers account for nearly 40 percent of the more than 44,000 drug overdoses that occur annually. 

An Iowa-based startup company, KemPharm Inc., is working in what it hopes is the pole position in the entrepreneurial race to bring abuse-resistant versions of widely prescribed — and abused — pain medications and other prescription drugs to market. 

The Coralville-based clinical stage specialty pharmaceutical company expects to receive approval later this year for a proprietary drug that provides a fast-acting alternative to hydrocodone that’s difficult for users to abuse or overdose on. 

KemPharm has developed a molecular structure for the drug that prevents the release of the opioid upon crushing, physical manipulation or other commonly employed extraction techniques. Instead, the so-called prodrug must undergo a chemical transformation in the body to release the active parent drug. 

KemPharm’s president and CEO, Travis Mickle, anticipates that after nine years of hard work, the company will obtain government approval of its hydrocodone substitute drug, now known simply as KP201, later this year. 

The company also has several other prodrug candidates in its development pipeline, among them safer prodrug alternatives for the painkiller oxycodone as well as a popular attention deficit hyperactivity disorder drug, methylphenidate.

Mickle, an Iowa native, launched the company in 2006 with his wife, Christal Mickle, with financial backing from several Iowa angel investors. 

With a Ph.D. from the University of Iowa, Mickle cut his research teeth with New River Pharmaceuticals Inc., a Virginia-based company, where he helped develop the ADHD drug that is now marketed as Vyvanse, a safer alternative to amphetamines. 

That work spurred him to think about launching his own company, which became publicly traded with an initial public offering in April 2015.  

“The entrepreneurial spirit is something that I’ve always had,” Mickle said, noting that he also learned an important lesson or two from his father, who had his own construction business, including that failure is not necessarily a bad thing. 

“I learned not be afraid of failure,” he said. 

Q & A with Travis Mickle, president, CEO and chairman of KemPharm

Age: 42
Education: Bachelor of Arts, Simpson College; Doctorate in chemistry from University of Iowa
Hometown: Coralville
Family: He and his wife, Christal, have four children

How difficult is it to find investors? 
It’s probably the biggest single issue, especially being a scientist, it’s not my nature to be that social or overly communicative. We were lucky to work with some smart individuals to help us through that process. All of our early finance was done with angel investors, mostly in the state of Iowa. It wasn’t until the (investment fund Deerfield Management Co. LP) financing and the subsequent IPO that we were introduced to institutional investors.  

Are institutional investors easier to work with?  
There are pluses and minuses to both types of investors. Angel investors are more likely to let you run the company, but the regulatory hurdles are greater. But institutional investors can write bigger checks, and they certainly have connections to other investors and CEOs in the industry that would be of strategic interest for the company. 

What were the advantages and disadvantages of starting up in Iowa? 
I think for us during that time the one big advantage was the access to a group of investors who hadn’t really had the opportunity to invest in these types of early-stage pharmaceutical companies in the past. Also, the resources were there (in Iowa) as far as the lab space. It provided a great way to bootstrap the first few years of our existence. Our first lab space was in North Liberty and was a private lab that the KemPharm team set up and used initially. Eventually we did use space at the University of Iowa Bioventures Center but have since moved to our own lab and office suite at the research park in Coralville. 

Was attracting the talent needed to advance the company difficult in Iowa? 
That has been a big hurdle and has forced us to look outside of the state however we can, either working from satellite offices or working from home. We currently have about 28 employees in total, and all but two of them are out of state. That includes my wife and myself; we live near our Florida office outside of Orlando. 

There’s a lot of discussion about the high cost of prescription drugs. How costly is your first new drug likely to be? 
Our products that we’re focused on, especially KP201, are trying to replace products like Vicodin. So if you command too much of a premium, there’s no way it will work. We’re very cost-minded. 

Do you anticipate government mandates to require use of tamper-resistant drugs when they become available?  
I think the day will come when that happens. More people die from drug overdoses than vehicle crashes (in the United States), so political pressures will be in place to take care of our citizens. The (U.S. Food and Drug Administration) has even said they envision a day when this will happen. In the interim until that happens, pricing is something we’re very focused on. There are so many prescriptions written for pain medication; we don’t need to command a huge premium to do well. 

How intense is the competition for getting tamper-resistant pain drugs on the market? 
There are a lot of people claiming to work on tamper-resistant prodrugs, Many of those are within the extended-release products, being made so you can’t extract the active ingredient to abuse it. Because of our technology, we’re able to focus on quick-release products as well, so we’re able to fit into that niche space where we’re the only immediate-release product.

Overall, how do you view the past year and the outlook in 2016? 
Certainly 2015 was a huge year for the company. … We think 2016 will be even bigger with approval of our first product and the launch of two other products — we think these products have a big potential to make a difference in what is a big problem right now.