June 14, 2016
By Alex Keown, BioSpace.com Breaking News Staff
BOSTON – As Intarcia Therapeutics nears to filing for U.S. regulatory approval of its diabetes drug, the company is moving into a new space in South Boston, the Boston Business Journal reported this morning, something the company had been planning since last year.
Intarcia is taking over a 47,000 square-foot space for its new headquarters in the Fan Pier building, which is next to the Vertex headquarters, the Journal said. The new space is much larger than its previous location, which is a good thing as the company looks to expand its number of employees to approximately 800 by the end of 2017. Intarcia’s expected growth will be supported by its, as of yet unapproved diabetes treatment, ITCA-650, that will be delivered to diabetes patients in a once-per-year subcutaneous injection. Earlier this month Intarcia revealed the delivery device, called the Medici Drug Delivery System. The device, about the size of a matchstick, combines three technologies; an osmotic mini-pump that is placed just beneath the skin to deliver a continuous and consistent flow of medication; a placement technology designed for a simple, relatively quick and highly reliable user experience; and a stabilization technology for proteins, peptides, antibody fragments, and other high-potency small molecules.
Shortly after revealing its new drug delivery device, Intarcia unveiled results of its late-stage trial for ITCA-650, a glucagon-like peptide-1 (GLP-1) receptor agonist. During the American Diabetes Association meeting in New Orleans, Intarcia said ITCA-650 demonstrated superior efficacy to Merck’s blockbuster diabetes drug, Januvia, in reducing HbA1c and body weight in patients with poorly controlled type 2 diabetes on metformin following one year of treatment.
If approved by the U.S. Food and Drug Administration, Intarcia’s ITCA-650 would enter a crowded type 2 diabetes field and face competition from established drugs such as Januvia and AstraZeneca’s Symlin. However, Symlin and other injectables require daily dosages, while ITCA-650 would dole out the proper dosage all year long before a new one would need to be inserted into the body. According to the U.S. Centers for Disease Control, the number of Americans diagnosed with diabetes is expected to double or triple by 2050. The CDC projects as many as one-third of the U.S. population, more than 100 million people, could develop diabetes within that time frame. Currently, about one in 10 Americans has been diagnosed with the disease, the CDC said.
In August, Intarcia was emboldened by trial results showing the company’s lead product had a much stronger showing against Merck’s Januvia in a head-to-head competition. Intarcia’s ITCA-650 pump led to greater weight loss and lowered blood glucose levels over a one-year period. The study showed that Intarcia’s pumps and exenotide combination reduced glucose levels by 1.5 percent, compared to .8 percent reduction in Januvia patients. Also, those who used the Intarcia combination showed an average weight loss of about nine pounds, compared to about four pounds for Januvia patients.
If the drug receives approval from federal regulators, ITCA 650 would represent the first injection-free GLP-1 therapy that can deliver up to a full year of treatment from a single placement. That is something that would significantly improve diabetes treatment, Intarcia Chief Executive Officer Kurt Graves told BioSpace in September. He said the Itca-650 platform delivers medication to the body throughout the year, which means patients developing complications due to forgetting their medication regimen should decline.“There’s tons of literature that shows patients don’t stick with their routine of taking medicine. On average 70 percent of people stop taking their medicine. It’s why the bad things happen,” Graves told BioSpace in an earlier interview.
