Thought Leader: Room for Improvement - Pharmaceutical Executive

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Thought Leader: Room for Improvement


Pharmaceutical Executive


You have developed a drug technology that helps protect against overdosing. How do you expect this to be received?

The reason our analysts are so excited about NRP-104 is because it's a molecule that is completely inert, inactive, and nontoxic. It does absolutely nothing at all until it's absorbed through a mammalian digestive system. That's when it becomes a bioactive, and almost no other method will liberate that bioactive. What we engineered into this molecule is a dose-limiting feature. While obviously you can't do overdose studies on humans, our rat data shows that we've never been able to kill a rat, no matter how many doses we have given it.

And with 15 million Americans now admitting to abusing prescription pharmaceuticals—according to recent government data—there is a clear opportunity for us to really do something socially and medically meaningful and offer consumers an advantage. Frankly, physicians are inhibited from writing for this drug category because they fear that the patient will abuse it. So we're able to reduce that concern and allow more consumers who really need these medicines to get them.

Pain specialists, for example, believe that opioid narcotics are significantly underutilized. Physicians know they could write you a prescription for Lortab (hydrocodone bitartrate/apap) for a sprained ankle and basically eliminate your pain for the next five days. But they usually don't do it because they're scared.

Can this overdose-protection technology work for several therapeutic categories?

It depends on the type of product. In the chronic pain space, it's really difficult to figure out how to use our technology appropriately because one person's therapeutic range would be another person's toxic range. So it's not really possible to think about—in the case of a chronic drug—something that a terminal cancer patient may be on for the last years of his or her remaining life.

Plus, there is an opioid-tolerance effect, so they end up having to take more and more of the medication. Our technology is less useful in that area. There certainly are medical applications for walloping doses of opioids, and certainly people who really need them, and clinicians who need to provide them. So, if you have an overdose-protection technology, then they wouldn't be able to get the therapeutic advantage. We've been struggling with this issue because one of our pipeline drugs is actually a carrier with oxycodone. As we learned that a lot of people really do need very high doses, we think we identified what is the real problem that is worth fixing, which is opioid tolerance. It's not really a question of, what's the therapeutic range or what's the therapeutic dose of opioid for a given patient. It's the fact that opioids have a tendency to induce the patient to require more and more to get the same level of analgesis.

How would you describe your interactions with the DEA?

People are so cynical about the government that sometimes they forget that you don't really need to know anybody. Our tactic is to go in the front door and talk to them and tell them what we want to do. And if they think that what we're trying to do benefits society, they'll work with us. Because we went to them early with a technology that offered some promise and asked them what kinds of tests they'd like to see for them to be comfortable with the drug, they were receptive.

Would you ever consider partnering with Big Pharma?

I can't rule it out, but it would require something more than somebody just writing a check and licensing out a drug. We're not interested in validation. But that's not to say that there couldn't be a relationship with Big Pharma on some product in the future, like we experienced with the Shire deal. It would have to be a situation where the other company is contributing more than it's taking out.

We're really not interested in empire building—we're mostly focused on our value per share. When you have that focus, it's going to change how you analyze these opportunities. We would have to evaluate each opportunity in terms of what such a transaction really does for our shareholders.

Randal J. Kirk is founder of New River Pharmaceuticals. He has served as the company's director since August 1996, as chairman of the board since 1996, and as president and CEO since October 2001. He has over 20 years of experience in the healthcare industry. Previously, in 1983, he co-founded General Injectables & Vaccines, a pharmaceutical distributor, and served as chairman of the board until the company was sold in 1998. He also was a member of the board of directors at Scios (recently acquired by Johnson & Johnson), between February 2000 and May 2002.


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