Monday, January 04, 2010

Intelliject Twins Profile in RTD

Twins start firm to help allergy sufferers
Richmond Times-Dispatch
Jan 4, 2009

Millions of people at risk of severe allergic reactions to certain foods and bee stings rely on pen-size syringes that contain a life-saving dose of the drug epinephrine administered in an emergency.

As lifelong allergy sufferers, twin brothers Eric S. Edwards and Evan T. Edwards, co-founders of the Richmond-based specialty pharmaceutical firm Intelliject Inc., keep their epinephrine auto-injectors close by.

Accidental ingestion of peanuts, tree nuts and shellfish can cause them to go into anaphylactic shock, a potentially fatal allergic reaction. Tongue and throat tissues swell, making breathing difficult. A person may break out in hives and blood pressure may drop, causing fainting.

Injecting the drug epinephrine into the thigh quickly reverses the symptoms.

As grateful as the brothers are to have the existing injector technology available, from their own experiences they've concluded there has to be a better injector system.

The 29-year-old brothers and their management team have built Intelliject around the goal of creating a more intuitive, compact and safer emergency epinephrine delivery system.

Their result: a credit-card-size device that "talks" users through administering epinephrine.

"It's user-centered design," said Evan Edwards, vice president of product development at Intelliject.

"We really started with the patient and worked our way backwards," he said. "A lot of companies don't really think about how, in the moment of truth, when [people] are actually having to use the injector, what are the scenarios involved."

In the hands of a babysitter or parent who has never used an epinephrine injector, for instance, precious seconds could be lost trying to figure it out, he said.

A month ago, Intelliject moved into the big leagues, announcing a multimillion licensing deal with pharmaceutical giant Sanofi-Aventis U.S., which will manufacture and market Intelliject's novel epinephrine injector.

"Evan and I are just a small part of that" deal coming to fruition, Eric Edwards said. "We really have been blessed with an extraordinary management team."

That team includes President and Chief Executive Officer T. Spencer Williamson IV, who has been with the firm since 2006; Vice Presidents Kristopher D. Ford, Ronald D. Gunn, Neil D. Hughes and Mark J. Licata; and Chief Financial Officer Christopher T. Schools.

Sanofi-Aventis U.S. is an affiliate of Sanofi-Aventis, one of the world's largest pharmaceutical firms, with annual sales worldwide of about $40 billion in 2008. Sanofi-Aventis' U.S. product lineup includes blockbuster medications such as the allergy drug Allegra, the sleep aid Ambien and the clot-buster Plavix.

The agreement with Sanofi-Aventis U.S. calls for $25 million up front to Intelliject. In addition, Intelliject is eligible for up to $205 million more over time as development and commercial milestones are reached, plus royalties on sales associated with the licensure.

In announcing the deal, Sanofi-Aventis' Brent Ragans said: "This agreement complements our strong presence in the U.S. as a leader in the allergy arena and is a great example of our company's transformation into a provider of health-care solutions."

Intelliject retains licensing and marketing rights for their auto-injector delivery system in the rest of the world and is shopping around for other partners.

"The $25 million is being used to invest in our business and to realize the potential of Intelliject's portfolio across a range of therapy areas," Eric Edwards said. "We have over 70 patents pending, issued or granted and have multiple other platforms that can be utilized with a variety of pharmaceuticals across many therapy areas."

. . .

Not bad for two young men raised in Chesterfield County who have spent the past decade balancing school, starting families and building a firm they say is "all about relationships."

"Our faith is of extraordinary importance in everything we do," Eric Edwards said. "Some would say this is a faith-based company."

Explained Evan Edwards: "When you have the management team and everyone in the company that shares a similar culture, when you go through some difficult times, it really tests you, and that's when you have to really rely on faith to get over those hurdles. . . . We have seen that time and time again. This whole idea of us having allergies and living with it all our lives and turning it into an opportunity, we feel is very divinely led. It's not just by chance that all these individuals have come into our lives and helped us make an impact."

The sons of Linda and Gary Edwards went to Monacan High School, but their paths diverged for college -- Evan heading off to the University of Virginia to study engineering and Eric to Virginia Commonwealth University for biology and pre-med.

"We pretty much shaped our education around this idea of creating a better delivery system," Eric Edwards said.

A grant from the National Collegiate Inventors and Innovators Alliance started Intelliject, which in the early days was a family company, Evan Edwards said.

"We had our father be the CEO and our older brothers be a part of it," Evan Edwards said.

The brothers realized that to get to the next stage, they needed expertise they didn't have.

The Virginia BioTechnology Research Park, with its business incubation centers, offered a place to fine-tune their idea.

"We asked them to tell us their story," recalled David R. Lohr, executive director and vice president of business development at the park's Biosciences Development Center. "What are you trying to accomplish? What are you looking for in the way of help? We also shared with them our program, how it works, what it does and perhaps what it doesn't do. . . . We don't invest, but we can help them raise capital."

Lohr said his first impression of the brothers is that they had a unique and revolutionary idea -- they probably didn't realize how revolutionary.

"Not only did I see the potential to put epinephrine in this device, but I saw the potential to put a lot of other drugs into the device," said Lohr, who had run a drug-delivery company before. "Especially the newer biotech drugs that typically have to be injected anyway, they are very expensive, they would be more affordable if they could be self-administered, and the whole compliance issue would be better.

"We helped them to think about this as a drug-delivery company and not just a single-product company," Lohr said.

Over the next three to four years, the incubation center provided mentoring, networking, help with the business plan and financial model development, fundraising and help identifying a chief executive.

"Why are these guys successful? They had a great idea rooted in their personal understanding of an unmet medical need," Lohr said.

"The thing that differentiated them is these guys listened and took the advice they were given from this myriad of advisers. They processed it, integrated it, and they just kept redoing their thinking."

. . .

Now ensconced in Intelliject's modern offices in Shockoe Slip, Eric Edwards and Evan Edwards talked about what's next for them.

Evan Edwards is preparing to move to Indianapolis temporarily. The brothers are limited in what they can say about product development, so he will not say what he will be doing specifically.

"As Spencer [Williamson] likes to say, it's really the end of the beginning," Evan Edwards said. "Because there is so much more work to do."

Success, for them, will be when their auto-injector is in the hands of people, like themselves, at risk of severe allergic reactions, Eric Edwards said. That is at least a year or more down the road.

"With this partnership, Intelliject is responsible for finishing the development of the product through [Food and Drug Administration] approval," Eric Edwards explained. "It's a late-stage product. We will be filing our new drug application with the FDA [in 2010]. . . . Within the next couple of years this product should be on the market."

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