Memorandum

FDA accepts Intarcia’s ITCA 650 New Drug Application for active review – February 8, 2017

Intarcia announced that the FDA has accepted its New Drug Application (NDA) for GLP-1 agonist ITCA 650 (implantable exenatide mini pump) late last week. The company previously submitted the NDA (a whopping 1.3 million page document!) in November 2016. We wonder whether the FDA will convene an Advisory Committee, and considering the novel mechanism of delivery, we wouldn’t be surprised if the answer is yes. Assuming a standard review process, a regulatory decision is expected in 10 months, in December 2017. ITCA 650 will offer continuous, subcutaneous release of exenatide that lasts three or six months (initiation and maintenance doses, respectively), greatly reducing injection burden for patients. This is tremendously exciting, though we note that Intarcia’s product will enter a competitive commercial landscape, particularly with strong 4Q16 sales of Novo Nordisk’s GLP-1 agonist Victoza (liraglutide) and Lilly’s Trulicity (dulaglutide) – additionally, next-generation once-weekly GLP-1 agonist semaglutide from Novo Nordisk (which already boasts promising CV results) will likely reach the market around the same time as ITCA 650. That said, management has emphasized in the past how ITCA 650 will ensure better patient adherence, which will likely be attractive to payers (suggestions of lower list price for ITCA 650 compared to other GLP-1 agonists notwithstanding) and we imagine that commercial success will depend heavily on payer coverage. Moreover, we see plenty of room for multiple GLP-1 agonists to do quite well on the market, given that still only a small subset of type 2 diabetes patients are using the advanced agents, and many more stand to benefit. Expanded patient choice is always a good thing, in our view, and ITCA 650 would bring a unique patient experience to GLP-1 agonist therapy.

The company is poised to launch further clinical development projects for its GLP-1 agonist that could help toward better formulary positioning: (i) When he spoke to our team back in November, Intarcia CEO Mr. Kurt Graves announced a head-to-head trial comparing ITCA 650 vs. a sulfonylurea vs. an SGLT-2 inhibitor, slated to dose its first patient in 1Q17; (ii) Intarcia has plans to collect real world outcomes data once ITCA 650 is approved; (iii) The company is evaluating study design options for a follow-up cardiovascular outcomes trial (CVOT) to FREEDOM-CVO, which reported topline results of CV safety in May 2016. We eagerly await more information on all of these planned trials. Ex-US regulatory submissions for ITCA 650 are also expected in the first half of this year.

-- by Payal Marathe, Helen Gao, and Kelly Close