Steve Freed, Publisher, Diabetes in Control: When do you think you might be able to submit to the FDA?
Joe Cook, Jr: Having developed a number of medicines, they all have their own character. It’s like children. They all come with different presentations.
If the data from this study are very clear and point to one of the arms being outstanding compared to metformin, then I think that might be a basis on which the FDA would allow us to immediately move into phase 3. If we need to refine the dose one more time, then there would be a phase 2b study that we would conduct, followed by a phase 3 study. If we go to the full phase 2b and phase 3 study, then we are probably talking about submitting a NuSirt application in 2017.
SF: How do you foresee this as being formulated? As a pharmacist, I’m always interested. I know you can’t be 100% sure, but I would assume this would be combined with metformin. You would not make people take two different drugs.
JC: No, we would not. It would be combined to a single form, probably a tablet formulation, although we haven’t ruled out capsules, yet. We are still in the formulation stage, to determine the size of the tablet and other details. There is still work to be done, but we expect it would be combined in a fixed ratio in a single oral dosage form.
SF: Do you foresee this, maybe, as a one-tablet timed release, or would this be a twice-a-day dosage
JC: I think it will, very likely, be twice a day. While there is some evidence that the extended-release form of metformin works adequately, our first product would not rely on that technology.
SF: One of the major concerns when it comes to new drugs is the cost. Most new drugs start at around $250. And you are taking a $3 drug and turning it into a more expensive drug. Where do you think this new drug will be priced?
JC: We haven’t established a price yet. I do not believe that our cost to develop this medicine will require us to introduce it at the same price level as recently advanced technologies. NuSirt is seriously examining a pricing strategy between the generic drugs and newly released branded technologies in diabetes.
SF: I do not want to keep you too much longer. One of my final questions is dear to my heart. You see all these drugs on television having patients making requests of their doctors. Obviously it has been successful because you wouldn’t see this otherwise. It will be interesting to see how you put this together as far as the marketing campaign, but more importantly, I do not think there is a drug for diabetes that will ever reduce A1c significantly enough to call it a successful drug, without the education that goes with it. I am a diabetes educator, so obviously I’m interested in the education part.
JC: I couldn’t agree more with you!
SF: You can’t eat 10 Big Macs and take metformin.
JC: There is no magic pill. There are multiple factors, including behavioral change, psychological change, environmental change, and education that are key here. If you are going to the question, are we going to advertise on TV, I can tell you we will not launch the drug that way. I do not think it’s necessary. I think metformin is so well known by the treating physicians that what will be important is educating physicians, diabetes educators, nurse practitioners, and all others who take care of patients with diabetes. NuSirt may be a new way to administer metformin with potentially improved side effects – I think that message, alone, will cause people to use it in appropriate patients.
SF: The education process, even to the physicians, is going to be hugely important. This is really a whole new paradigm of treating patients with a drug, because they understand metformin, but they pretty much do not know anything about what you are producing. That is one of the reasons I’m doing this interview, because I really felt that what you are doing is kind of a new forefront in the field of treating diabetes, by adding a nutraceutical that makes a current drug more effective.
JC: We had a physician at the recent ADA meeting say exactly what you just said. He said that we didn’t need any more solutions — we need a better way to use all the solutions we already have. I asked him, “What if I could improve one of those existing solutions?”He replied, “All the better.” He said he is driven by the notion that we have advanced the technology really dramatically in the last decade, but we haven’t seen a corresponding improvement in A1c. I think part of that is that we haven’t executed well. Educating the physician is going to be important. At this time, we are not contemplating hiring a full-fledged sales force. We think there are different ways of educating physicians. We think physicians are being informed about new advances with a variety of means today, including your very enterprise. One of the things we want to do is expand the number of physicians who have clinical trial experience with NuSirt technology and metformin, and we’ll do that as we continue our clinical trials.
SF: As a diabetes educator, I’ve just seen too many patients who get on these miracle drugs, and they expect miracles to happen, and it just doesn’t happen because they don’t know how to read a food label. They don’t know what a carbohydrate is. As you get closer to production, I’m hoping that you will consider tying it into some kind of patient education.
JC: I’m all ears. I’ve always been a fan of AADE because I think that’s where science actually meets the ground. The whole concept of diabetes educators is one I’ve been very familiar with. At Amylin, we used certified diabetes educators extensively because of the important value and advice they brought to us as to how clinical trials should be designed. I am totally open to this notion of a new way to educate patients. Television works, but it’s expensive, and it implies a message and a visual that is kind of entertainment-oriented versus education-oriented. You need to find the medium that is more consistent. Today, social media is becoming a much more powerful tool. We are using that in some of our businesses, and we’re seeing a lot of progress.
SF: I do not want to keep you any longer. I want to congratulate you. You are only at the first step. I’m sure you are aware that with most medications that are going through research in phase 1 trials, probably 80-90 percent don’t make it.
JC: I think our odds are higher here because we are dealing with two components. Leucine is a part of our natural diet and found in dietary proteins, and we already know a good deal about metformin. What we don’t know, Steve, and you are exactly right, is can we find a lower dose of metformin with leucine that will give us the same glucose control without side effects? If we can, I’d say we might make a difference in the curve of people getting diabetes. I’ve enjoyed our conversation.
SF: I’ve enjoyed it, too. Hopefully, your product will get approved for diabetes and maybe pre-diabetes.
JC: Yes, given the numbers for pre-diabetes, exactly. Thank you very much for your time.
SF:Thank you, as well.
Joe Cook, Jr.:
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