Some Interesting Developments
Just because there were no earnings calls today doesn’t mean there isn’t news. First and foremost comes word that Novo Nordisk (NYSE:NVO) has begun laying off sales reps. This may seem like odd timing for layoffs given the company just received FDA approval for their once-daily GLP-1 Victoza®. Guess the folks at Novo might just see the same competitive landscape as Diabetic Investor does, simply that they’ll have a tough time selling a drug that comes to market with a black box warning especially when once-weekly Byetta LAR is set to be approved on March 5th.
This feeling could have been reinforced by a report by Decision Resources issued Tuesday that projects Byetta and Byetta LAR achieving clinical gold standard status in 2013. According to the report, Byetta LAR has advantages over current and emerging therapies in terms of efficacy and delivery and would likely earn a 40% patient share, according to surveyed U.S. endocrinologists, while European endocrinologists said it would earn a 20% share. Diabetic Investor doesn’t want to gloat but it seems like we’ve been saying this for some time. We knew LAR was a winner long ago and based on the moves made by Novo and the report by Decision Resources it looks like the LAR fan club is growing.
Also under the radar this week was the approval of the Finesse™ insulin patch – pen device from Calibra Medical. The Finesse is one of growing number of devices that is supposed to make insulin delivery easier. According to the company; “Finesse represents a new category of simple mechanical devices intended to make insulin therapy adherence easier for patients to achieve at an affordable price point.” Calibra is not alone in their quest to market a patient friendly insulin delivery device but is the first to receive FDA approval.
According to the company; “Measuring roughly 2″ long, 1″ wide and i” thick, Finesse is a small plastic device designed to adhere comfortably to a patient’s skin. Finesse is able to hold and deliver prescribed amounts of insulin over multiple days while remaining firmly in place throughout a patient’s daily activities, including showering, exercising and sleeping. Finesse is operated discreetly through a patient’s clothing and is designed to quickly deliver many common dose amounts.” Basically think OmniPod without the mechanics or PDM.
Based on the study that was published this week in Diabetes Care which found that 57% of patients on insulin therapy skip insulin injections, and 20% skip injections a regular basis, Diabetic Investor believes there is a need for this type of device. The fact is there are patients who for a variety reasons do not want to move from insulin injections to insulin pump therapy. It is also a well known fact that even though insulin pens are very patient friendly patients often feel uncomfortable injecting in public. Diabetic Investor has noted this “vanity” factor before, a factor which was identified in the study as well.
Although it was not stated in the study, per se, one of the biggest factors for skipping injections is what we call diabetes fatigue. While it’s true that needle technology has improved dramatically and that many would argue it is actually more painful to monitor glucose levels than to take insulin injections, this does not mean constant, daily insulin injections are enjoyable. Diabetic Investor has noted on several occasions that with all the fingersticks and injections patients on insulin therapy perform each and every day they are basically human pin cushions. It’s a wonder these patients don’t leak given the numerous times they are poking or pricking their bodies.
Frankly this constant pricking and poking takes its toll on patients and it’s hardly surprising that patients would skip injections. This is the same reason why LAR has such great potential; the less frequent a therapy needs to be delivered the better. The same principal applies to insulin using patients, better to poke yourself once every three or so days then to inject each day and for many patients multiple times per day.
Based on what Diabetic Investor has seen from the many who seek to enter this patch-pen area the Finesse is the best of the bunch. The issue for Calibra isn’t whether or not there is a need for the Finesse; the issue will be competing against the growing popularity of insulin pens and the huge companies who make them.