Some quotes from the transcript...
"So our two approved products Qsymia and STENDRA. We'll start with Qsymia and spend most of our time today speaking about it. This is our label and this is class label in the obesity category, specifically the indication as an adjunct to reduce calorie diet and increase physical activity for chronic weight management in adults with a BMI 30 or greater or 27 or greater with a co-morbidity of some nature and the safety information of course is listed there.
And the beauty of this agent is that we are really checking these three boxes in a very meaningful way. You've probably seen these data, these are our two pivotal data from our two pivotal trials, EQUIP and CONQUER. On the left the EQUIP study conducted in the more obese, the morbidly obese category and folks able to achieve clear double-digit weight loss, the purple line approaching 37 pounds on average and even on the starting dose or low dose achieving 18 pounds of weight loss. And over on the right in CONQUER, folks with obesity and an attendant co-morbidity, clearly the green and the purple lines showing nice consistent effect and consistent weight loss overtime.
Within the Qsymia label is a very specific treatment algorithm, what we're guiding prescribers is to watch their patients over the first three months of therapy and you have a choice with Qsymia that's the beauty of this drug. We've got multiple doses and we're expecting that folks essentially will follow this algorithm. If you're seeing a patient should be on treatment for about 12 weeks and checking to see whether or not they're achieving at least 3% weight loss, 3% of their body weight after 12 weeks of treatment on the recommended dose. And then if that's not happening you have a choice of either discontinuing or titrating up to our top dose for another round of therapy.
And if after 28 weeks folks have not lost at least 5% of their weight they're probably a non-responder and should be discontinued. Well, interestingly our clinical data has demonstrated that we can go back to our prescribers and say look, you put a 100 patients on this drug, you can expect based on our clinical data, nearly 84% success rate on recommended dose. And on top there was nearly 90% success rate based on this treatment algorithm. These are the data that prescribers and payers are looking for.
So blood pressure, positive effect, see reactive protein and marker of inflammation of positive effect, cholesterol liver function and glycemic control. All of these positives of being on Qsymia are what prescribers and insurers are looking for being on therapy. So, clearly the investment is paying off putting their patients on. We've had some clear clinical and regulatory successes and some commercial successes to talk about. So, we've seen specifically over the last six months increases in prescription prescribers in patients which we'll talk about. We've had some pharmacoeconomic data published in the major journal that folks look to for these types of reports.
Medco has initiated coverage of Qsymia. We've been able to achieve FDA approval to modify our REMS system and allow dispensing at retail pharmacies, instead of the of being limited only to our existing mail order system. VA, a very conservative organization, has adopted Qsymia and added it to its formulary. And finally the American Association of Clinical Endocrinologists, the thought leaders has in fact identified medical obesity pharmacotherapy as a treatment option in managing obese and diabetic patients.
So let's talk about these for just a minute. We've spoken most recently I believe on our quarterly call, about our steady growth in prescriptures, prescriptions, prescribers and patients. We've seen a nearly 100% quarter-on-quarter growth between the fourth quarter of 2012 and the first quarter of 2013. And we are proud to say that since launch through the end of March of this year, we've generated nearly 90,000 prescriptions."
http://www.earningsimpact.com/Trans...-Research-and-Economics-Healthcare-Conference
"So our two approved products Qsymia and STENDRA. We'll start with Qsymia and spend most of our time today speaking about it. This is our label and this is class label in the obesity category, specifically the indication as an adjunct to reduce calorie diet and increase physical activity for chronic weight management in adults with a BMI 30 or greater or 27 or greater with a co-morbidity of some nature and the safety information of course is listed there.
And the beauty of this agent is that we are really checking these three boxes in a very meaningful way. You've probably seen these data, these are our two pivotal data from our two pivotal trials, EQUIP and CONQUER. On the left the EQUIP study conducted in the more obese, the morbidly obese category and folks able to achieve clear double-digit weight loss, the purple line approaching 37 pounds on average and even on the starting dose or low dose achieving 18 pounds of weight loss. And over on the right in CONQUER, folks with obesity and an attendant co-morbidity, clearly the green and the purple lines showing nice consistent effect and consistent weight loss overtime.
Within the Qsymia label is a very specific treatment algorithm, what we're guiding prescribers is to watch their patients over the first three months of therapy and you have a choice with Qsymia that's the beauty of this drug. We've got multiple doses and we're expecting that folks essentially will follow this algorithm. If you're seeing a patient should be on treatment for about 12 weeks and checking to see whether or not they're achieving at least 3% weight loss, 3% of their body weight after 12 weeks of treatment on the recommended dose. And then if that's not happening you have a choice of either discontinuing or titrating up to our top dose for another round of therapy.
And if after 28 weeks folks have not lost at least 5% of their weight they're probably a non-responder and should be discontinued. Well, interestingly our clinical data has demonstrated that we can go back to our prescribers and say look, you put a 100 patients on this drug, you can expect based on our clinical data, nearly 84% success rate on recommended dose. And on top there was nearly 90% success rate based on this treatment algorithm. These are the data that prescribers and payers are looking for.
So blood pressure, positive effect, see reactive protein and marker of inflammation of positive effect, cholesterol liver function and glycemic control. All of these positives of being on Qsymia are what prescribers and insurers are looking for being on therapy. So, clearly the investment is paying off putting their patients on. We've had some clear clinical and regulatory successes and some commercial successes to talk about. So, we've seen specifically over the last six months increases in prescription prescribers in patients which we'll talk about. We've had some pharmacoeconomic data published in the major journal that folks look to for these types of reports.
Medco has initiated coverage of Qsymia. We've been able to achieve FDA approval to modify our REMS system and allow dispensing at retail pharmacies, instead of the of being limited only to our existing mail order system. VA, a very conservative organization, has adopted Qsymia and added it to its formulary. And finally the American Association of Clinical Endocrinologists, the thought leaders has in fact identified medical obesity pharmacotherapy as a treatment option in managing obese and diabetic patients.
So let's talk about these for just a minute. We've spoken most recently I believe on our quarterly call, about our steady growth in prescriptures, prescriptions, prescribers and patients. We've seen a nearly 100% quarter-on-quarter growth between the fourth quarter of 2012 and the first quarter of 2013. And we are proud to say that since launch through the end of March of this year, we've generated nearly 90,000 prescriptions."
http://www.earningsimpact.com/Trans...-Research-and-Economics-Healthcare-Conference