Breathing a sigh of relief

With the GLP-1 market continuing to explode many including us here at Diabetic Investor had high hopes for the Intarcia exenatide micropump. Hopes which were dashed as the FDA has now rejected the device twice which likely put an end to the device and may well put an end to Intarcia. The company put out a statement yesterday which said;

“We are extremely disappointed with the receipt of a Complete Response Letter (CRL) from the FDA. We remain steadfast in our belief that ITCA 650 holds important potential as a new treatment option for people managing type 2 diabetes. We anticipate meeting with the Division for our end of review meeting to make sure we understand the situation and the path forward.”

What made the case for ITCA 650 so compelling wasn’t the drug itself but the delivery system which was implanted in the patient’s body effectively solving the biggest challenge in diabetes, patient compliance.

The GLP-1 market has grown as we long ago predicted. First came Byetta which was a twice daily injection, then came Victoza a once daily injection then Trulicity a once weekly injection and now Rybelsus taken orally once a day. We anticipated if approved ITCA 650 would open a new chapter in GLP-1 growth expanding the market even further. There is no doubt in our minds that properly manage ITCA 650 had blockbuster potential.

The two leading GLP-1 companies Lilly and Novo Nordisk must be breathing a sigh of relief as unlike their insulin franchises which continue to struggle their GLP-1 franchise are growing quite nicely. It’s still way too early to know how Rybelsus from Novo, the first orally delivered GLP-1 is doing and frankly we really won’t know much until the second and possibly third quarter results come in. As we have noted the drug when dosed properly works just fine it’s the complex dosing regimen which concerns us.

No matter as Novo has Ozempic to compete with Trulicity in the once weekly space and from all indications both drugs are doing quite nicely. Novo also in a stroke of brilliance has repositioned Victoza from a diabetes treatment to Saxenda as a treatment for obesity. Novo had nothing to lose and everything to gain by this move and while Saxenda isn’t knocking the cover off the ball it’s added some nice incremental revenue to Novo’s bottom line.

Diabetic Investor has reached out to Intarcia for additional information but has yet to hear from the company as the FDA’s decision will have ramifications beyond ITCA 650 as there are other companies developing similar platforms. But for the time being the GLP-1 category belongs to Lilly and Novo. The only issue they have is keeping this space from following the same path as insulin and becoming a commodity.

Commodization will eventually come but for now GLP-1’s are a bright light in an otherwise dark space. As we noted back when Novo reported results insulin is now somewhat of an afterthought for both Novo and Lilly while GLP-1 is driving growth. Even if Intracia can come back from the dead both Novo and Lilly have to be breathing a sigh of relief knowing that their biggest franchises won’t face a serious threat in the near future.