A tiny, matchstick-size pump, which could be implanted for up to a year in diabetics, is showing promise as a replacement for self-administered shots.
Intarcia Therapeutics Inc., backed by venture-capital firms including New Enterprise Associates Inc. and Venrock, developed the device. It continuously delivers a diabetes drug known as a GLP-1 receptor agonist, currently marketed as an injection.
CEO Kurt Graves is betting that by reliably delivering a full dose of the drug, the pump could help Boston-based Intarcia take market share from AstraZeneca Plc, Novo Nordisk A/S and Eli Lilly and Co.’s shots, since patients often struggle to keep up self-injections.
Indianapolis-based Lilly launched its first GLP-1 product, Trulicity, in November after it received FDA aproval in September. Analysts predict the drug could eventually bring in $700 million to as much as $1.3 billion annually in revenue.
Patients with type 2 diabetes who used the Intarcia Therapeutics pump along with standard oral drugs for 39 weeks saw their blood glucose levels and weight decline in a final-stage study presented last week at the American Diabetes Association’s annual conference.
While the potential is great, multiyear data is needed to ensure the safety of the pump, said Robert Ratner, chief scientific and medical officer of the American Diabetes Association.
Graves also plans to undercut the pharmaceutical giants on price. Before insurance kicks in, the list price of GLP-1 injections is about $6,000 a year, according to the American Diabetes Association. Newer oral medications like Merck & Co.’s Januvia list at about $3,500 a year.
“If you’re injection-free, and you show you’re superior, do you have the ability to not price yourself out of the market?” Graves said. “That’s what will make it disruptive.”
Injections are mostly used by diabetics who can’t control their blood sugar with just a pill. In addition to going after that market of self-injectors, Intarcia is also aiming for patients who take pills but might consider an implant to ward off the need for injections in the future.
Intarcia stands out in the biotech field because it hasn’t gone public or formed an alliance with a large pharmaceutical company, even though it’s running four final-stage trials covering 5,000 patients.
Graves, 46, has instead chosen to rely on venture-capital backing and $225 million in convertible notes issued in April. The financing assumed an equity valuation of $5.5 billion after U.S. regulatory approval of the pump.
There were about 29 million Americans age 20 or older with diabetes in 2012, according to the U.S. Centers for Disease Control and Prevention, and the total has been rising quickly as obesity rates increase and the population ages.
The diabetes market has grown accordingly. Novo Nordisk reaped $2.39 billion in sales of its GLP-1 injection Victoza in 2014. Merck & Co.’s diabetes pill Januvia is its top seller, accounting for $3.93 billion in 2014.
Unlike an insulin pump, which is carried on a belt or in a pocket and delivers insulin through a catheter inserted under the skin, Intarcia’s device is designed to be implanted entirely, in a simple procedure that takes less than a minute. The company aims for the device to be implantable by a nurse or physician’s assistant, not requiring a doctor.
The pump is often implanted in the stomach area, where there’s ample skin, though it can go elsewhere, such as the upper arm. Once it’s under the skin, the patient doesn’t need to take any action. The pump must be removed after six months to a year and replaced with a new one.
“I think it’s going to be very quickly taken up, and the cost is reasonable,” said Robert Henry, a professor of medicine at the University of California at San Diego who ran a final- stage trial for Intarcia.
The pump’s duration — whether it lasts six months or a year — will be a key factor, the diabetes association’s Ratner said. When an old pump is taken out, the new one needs to be placed in a new location because of scar tissue formed in the old site, he said. More frequent applications would mean the need for more implantation sites on a patient’s body.
Ratner said he’s waiting to see the results of a trial pitting Intarcia’s pump against Merck’s Januvia, an oral drug with a different mechanism. Those results are coming in September. Intarcia may also face additional competition if Novo Nordisk’s oral version of a GLP-1 is approved.
Graves says he wants to show that his pump can beat any class of diabetes treatment. Besides Januvia, Intarcia is planning a study that will compare the pump to three classes of drugs.
His ambitions don’t end there. Studies have shown that GLP-1 shots may be able to delay the onset of diabetes. The CDC estimates about 86 million people in the U.S. are pre-diabetic.
“We’re not just trying to change the treatment market,” he said. “At the end of the day, I want to show we can use it, once a year, to prevent and delay onset of diabetes.”