The End of AZ Diabetes - Intarcia has a job for you

[anonymous]

Intarcia Therapeutics has submitted its new drug application to the FDA for the ITCA 650, the matchstick-size pump that delivers microscopic size doses of exenatide to patients with type 2 diabetes (T2D). The tiny pump, which is inserted just below the surface of the skin and replaced once or twice a year, has been shown in early trials to improve glycemic control in patients with previously uncontrolled T2D, largely because it overcomes the chief challenge in diabetes care—medication adherence. Kurt Graves, president and CEO of Intarcia, said in a statement that the company was excited to submit it new drug application so close to World Diabetes Day, which was November 14. “During the past decade over 40 new pills and injections were approved for diabetes; however, the scary reality is that the majority of patients with type 2 diabetes still have poor glycemic control and poor adherence to their pills and injections over time,” he said. “These trends and the alarming amount of diabetes complications, costs, and lives lost on a daily basis have to be addressed with a real sense of urgency.” Graves called the ITCA 650 a “disruptive” technology that would change diabetes care with “built-in compliance and adherence.” In presentations at the American Diabetes Association (ADA), leading researcher Julio Rosenstock, MD, brought the same message in presenting clinical trial results: “Persistence means that people don’t just start the medication, but they stay on the medication,” he said at the ADA meeting in June. In a trial that compared patients taking a daily 60 mcg dose of exenatide with those taking 100 mg of sitagliptin (with both groups taking background metformin), the group taking the exenatide through the ITCA 650 device saw their glycated hemoglobin (A1C) drop 1.5%, on average, compared with 0.8% for the sitagliptin arm. All the patients started with A1C between 7.5% and 10.5%; of those using ITCA 650, 61% achieved an A1C of less than 7%, compared with 42% for the sitagliptin arm. The ITCA 650 patients lost 8.8 pounds, compared with 2.8 pounds for the sitagliptin arm. Intarcia has also announced topline results showing it has met targets in a cardiovascular (CV) safety trial, but it has not yet presented the results at a major scientific meeting. Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist, and another GLP-1, lixisenatide, has announced CV safety results that show no harm but no benefit, while liraglutide (Victoza) has been shown to have some CV benefits. - See more at: http://www.ajmc.com/newsroom/intarc...o-market-diabetes-device#sthash.wEcPSDtB.dpuf

 

[anonymous]

Oh how damn tacky to spew fantasies here.

So what do you say about this Mr. Customer Experience Jay?

LOL - if you bozos can pass PAI but who will be the fall guy for Kurt the CEO and his cronies? Take your pick - Hayward plant in front of concrete recycler with on-going micro contaminations, DS CMO AKA Chinese sweat shop CS Bio with the CALOSHA, fire dept and FDA after them and pill packing house Safecor who failed sterilization validation TWICE and taken out/removed from lame NDA.

Add to this Kurt touting 1-yr implant that does NOT exist on CNBC hosted by bozo Cramer.

And get this the Achilles heel - 1st year the patient needs THREE implants (3, 6 then 9 months), 3 placement kits, 3 insertion and 2 removal SURGERIES in the tunes of $20 to $30k! And biggest concern is well known (but hidden) and documented nausea side effect? So who will pay if the patient wants the damn implant removed due to nasty nausea?