2017 was already shaping up to be a pivotal year for Intarcia Therapeutics before the company announced late last month that it is to collaborate with the Bill and Melinda Gates Foundation as part of a strategic initiative to prevent the spread of HIV. More immediately, Intarcia's lead product – the implantable diabetes treatment ITCA 650 – could secure FDA approval by year-end and provide payers an opportunity they can't get anywhere else, CEO Kurt Graves told FirstWord in San Francisco.
It is Intarcia's Medici drug delivery technology which attracted attention of the Bill and Melinda Gates Foundation about a year ago, says Graves. Medici allows various drugs to be stabilised at or above human body temperatures for up to three years or more and administered through a matchstick-sized osmotic mini-pump placed just under the skin. Intarcia's most advanced product – ITCA 650 – was submitted to the FDA in November for the treatment of type 2 diabetes (Spotlight On Interview: FirstWord discusses Intarcia Therapeutics' revolutionary diabetes treatment ITCA650 with CEO Kurt Graves).
Graves and Trevor Mundel, who heads up the foundation's R&D division, worked together for a decade at Novartis. In March of last year Graves received a call from Mundel asking whether he could discuss the Medici technology for the purpose of developing an effective HIV prevention therapy that could be administered once or twice a year.
Although improved drugs and better access to HIV treatments in sub-Saharan Africa have had a dramatic effect in reducing morbidity, mortality and mother-to-baby transmission rates over the past 10 to 15 years, there is now considerable risk that without an effective prevention strategy all successes on this front could be wiped out over the next two decades. "Sometimes success can become the next challenge," says Graves in reference to a young population which has grown in size but is exposed to the risk of any new HIV epidemic.
Mundel had found no other technology offering the opportunity to develop a preventive treatment offering the adherence rate that Medici can provide. "The initial question focused on whether the drugs in question were potent enough to be used with our technology but it quickly became apparent that this could work," says Graves. He met with Bill Gates in Boston during the summer where the Microsoft co-founder "completely understood the technology and identified this approach as one of the most important things we could do to improve prevention of HIV."
Graves concedes that when he was presenting at last year's JP Morgan conference, HIV was not a priority in terms of potential therapeutic expansion for the Medici technology beyond its initial use in diabetes. "I didn't appreciate the unmet need in HIV over the next 10 to 20 years for prevention of the disease in the developing world. Had I done, HIV would have been a priority," he says. Furthermore, Intarcia "may be on the only company in the world that can do this right now. How can we walk away from that."
Intarcia's collaboration with the Bill and Melinda Gates Foundation may go beyond the parameters of a typical business deal but on that front the relationship also benefits the company, particularly as Intarcia has had to remain very secretive about Medici in order to protect its intellectual property. "If you are going to have someone endorse your technology I can't think of anyone better than Bill Gates," says Graves. Furthermore, Intarcia has always wanted to showcase its technology as a platform for both treatment and prevention of chronic diseases, says the CEO; "if successful this could save millions of people's lives."
In the near term, Intarcia hopes to secure approval for ITCA 650 in late 2017 when focus will shift quickly to the company's launch and pricing strategies. Graves is obviously reluctant to give too much away but is willing to argue that in achieving the holy grail of outcomes-based pricing for a chronic disease, Intarcia is "the only company in the diabetes market who can have a legitimate conversation with payers," when discussing adherence as a means to ensure that any outcomes-based deal will work.
Success to date has been elusive as neither drug manufacturers or payers want to assume the risk that patients won't keep taking their medicine, says Graves, and with good reason; on average just 20 percent of patients across all diseases are "militant," in terms of their drug adherence. Intarcia, on the other hand, "doesn't have to worry about people not taking our drug," says Graves.
Intarcia Therapeutics will present at the 35th JP Morgan Annual Healthcare Conference on Monday
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