Hawthorne, NY-based Acorda Therapeutics (NASDAQ: ACOR) held its first R&D day for Wall Street analysts in six years today, and when CEO Ron Cohen was asked ‘why now?’ his answer was simple. The company had been focused all those years on getting its multiple sclerosis drug dalfampridine (Ampyra) approved, Cohen says. “Until all of that was done, we really didn’t have the bandwidth to do much else.”
While Acorda didn’t announce any news at the meeting today, which was held at the Four Seasons Hotel in New York City, its executives had plenty to review about the company’s pipeline, which has grown considerably in the two years since dalfampridine was cleared for sale. The company continues to study dalfampridine, having launched studies in both stroke and cerebral palsy. Acorda has also struck a few deals to fill out its mid-to-late-stage pipeline. Last summer it acquired an experimental drug to treat spinal cord injuries from Medtronic (NYSE: MDT). More recently, in February of this year, the company announced an agreement with Neuronex to acquire a late-stage product to treat epileptic seizures.
Prior to today’s meeting, Cohen (who is also one of our Xconomists) sat down with Xconomy to answer some questions about Acorda’s pipeline, its focus on developing treatments for neurologic disorders, and its growth strategy.
Xconomy: You’re starting new trials of dalfampridine in new indications, including cerebral palsy. What’s attractive to you about the CP market?
Ron Cohen: There’s a tremendous unmet need in CP. People with CP have primarily the same issues as people with MS have: motor weakness, sensory weakness, spasticity, cognitive issues, walking issues, and so forth. Right now there’s nothing really that’s specifically indicated to approve neurological function in those people. Our hope is if it works, it will improve function to help them walk better and to use their arms and legs better.
X: What was the thinking behind the Neuronex deal?
RC: Fundamentally we’re interested in innovative products. One definition of innovative is a product that meets a serious unmet need in medicine. The Neuronex drug, a diazepam nasal spray, falls in that category. It’s an old drug—a well-known drug—but the method of the delivery is so novel, and that in itself constitutes an innovation that is beneficial to patients. Diazepam is highly effective at stopping seizures. For patients with epileptic disorders who have seizures periodically, and in particular those who are not perfectly controlled on anti-epileptic drugs, many times they can have repetitive seizures, which can be quite dangerous. They need a way of immediately breaking the cycle. Typically they have to go to the emergency room to get an IV of diazepam. The oral form isn’t good because it takes too long to work, and if someone is seizing, you don’t want to give them something to swallow. One of the needs of these people is to have something they can use at home. This is a nasal spray. You can just take it out and put two puffs in your nose, and you’re done.
The plan is to apply to the FDA for a new drug application (NDA) this year. We took an option to close the deal with Neuronex. So we paid $3.2 million, which includes research funding, and that will take us through the pre-NDA meeting with the FDA. Once we go through that with the Neuronex folks, we’ll make the determination of what we think the prospects are. If we like it, we’ll close the deal.
X: Will you be out looking for other acquisition targets?
RC: We’re always alert to potential opportunities out there. Our plate is pretty full given our current size and capabilities. For us to bring in something now, it would have to be even more compelling than usual. We’re looking more in the commercial realm, where we can leverage our sales team in neurology. If we had opportunities that were going to be on the market soon or in the market now, that would be attractive. That was the impetus for the deal with Neuronex.
X: Acorda recently debuted a website for MS patients called Ampyra Journeys, which is a direct appeal to patients. How much direct-to-consumer marketing has Acorda done, and why did you choose this approach?
RC: We’ve always had a strong focus on the patient. The whole company started as a virtual company. There was no lab for the first five years. The office was my second bedroom. The company was a network of laboratories and patient advocacy groups that I knitted together. Our roots are there. We’ve kept that. We have very strong ties with all the MS advocacy groups. Our view is that to develop drugs most effectively, you have to have the patient’s voice constantly in your ear. Up until lately we didn’t have the wherewithal to express that as fully as we are now on the Amypra Journeys website. It’s entirely patient focused. The idea there is to humanize it. It’s to give patients a voice and a place to go for information on MS in general, and information about the impact it has on people’s lives. We’re going to keep building in functionality as we go forward.
What we’ve done until now is targeted print advertising. We advertise in the National MS Society journal. We advertise in selected magazines, such as women’s health magazines. We’ve had a growing online presence. Right now it’s intensifying. We do search-engine optimization, key word searches, all designed to drive traffic to the various websites we set up. That’s a major part of our outreach now. So many people are online now that we think it’s the current and future wave of marketing. We’ve been really pleased with the initial interest in the site.
X: What are you most excited about in Acorda’s early-stage pipeline?
RC: Chondroitinase is very early but it’s still my favorite program. It’s an enzyme that degrades a powerful inhibitor of regeneration in the nervous system. That correlates with improved function after injury. It has, in my view, the best chance to increase plasticity of the injured central nervous system—brain, spinal cord. At least six labs worldwide, as well as our lab, have done work in spinal cord injury models. A group in Italy has restored sight to rats with cortical blindness. We’ve shown restoration of walking and bladder function in animal models of spinal cord injury. The science is well understood. My dream is for us to get this into the clinic for spinal cord injury.