Roche Update

Roche Update

Yesterday I had the pleasure of attending Roche Diagnostics investor’s day. First the good news, the new Aviva blood glucose meter looks like a winner. Designed to replace the aging Advantage meter, the Aviva will put Roche on equal footing with the OneTouch Ultra from LifeScan (LifeScan is a unit of Johnson and Johnson NYSE:JNJ) and FreeStyle (FreeStyle made by Therasense which is part of Abbott NYSE:ABT) meters. Like the Ultra and FreeStyle, the Aviva requires a small blood sample, has fast test results, is approved for alternate site testing and has a large memory.

Where Diabetic Investor sees the Aviva having an edge comes in the design of the test strip. The test strip is larger and easier to handle than test strips for the Ultra or FreeStyle and has a larger area to apply the blood sample. Look for Roche to aggressively market the Aviva in attempt to regain lost market share.

Unfortunately the same cannot be said for the Accu-Chek Spirit insulin pump. The Spirit, which recently received 510K approval from the FDA, will mark Disetronic’s (Roche acquired Disetronic two years ago) return to the US pump market once the FDA lifts the import ban they imposed on the company two years ago. According to Heino von Prondzynski, the CEO of the Diagnostics division, the company has a meeting set with the FDA next week to clarify when the FDA will inspect Disetronic’s plant in Switzerland, the last remaining step before the import ban is lifted. According to Prondzynski, it is unlikely the inspection will take place within the next few months and it will take another 6 to 8 weeks after the ban is lifted to finally get the Spirit on the US market.

This delay has provided a large window of opportunity for pump newcomer Insulet, who’s set to introduce their OmniPod System at the AADE conference in August. With its unique design the OmniPod will gain the lion’s share of attention in the pump community this summer. Not having the Spirit around is just icing on the cake for Insulet as they won’t have the added burden of coming to market at the same time as the Spirit.

After seeing the Spirit its unlikely Insulet would have much of problem gaining attention even if the two pumps were introduced simultaneously. With the pump market becoming increasingly crowded one might think that Roche would have made the Spirit something special or at least come back with a pump that meets the competition head on matching them feature for feature. Sadly the Spirit fails to match the competition and in many ways is a step backwards in pump technology. With the new Aviva meter set to hit the market in August it would seem like a no-brainer that the Aviva and Spirit would communicate. Not unlike the CoZmonitor from Smiths or MiniMed’s Paradigm link system and with those two systems the meter and pumps are made by two different companies. It also seems like another no-brainer for the Spirit to contain a bolus calculator on the pump that helps patients determine how much insulin they need during meals and snakes. Today the Paradigm 515 and 715, Cozmo and Animas 1200 and 1250 pumps all have this feature.

Instead Roche has adopted a strategy called the Circle of Care. With the Circle of Care approach readings from the Aviva meter are downloaded to a smart phone or PDA which has Roche’s software on it. The software allows the patient to track glucose levels and make bolus calculations. Using this system the patient would enter expected carb intake into the software which then makes a dosage recommendation. The patient then enters the bolus amount into the pump which in turn delivers the insulin. Compare that approach with MiniMed’s Paradigm Link system which automatically delivers the glucose level to the pump. The patient then pushes a button on the pump which brings up the Bolus Wizard, another button push and the last glucose level appears, one more push and the patient enters expected carb intake, next the pump recommends a dosage level which the patient can accept with one more push of a button. All of the software is contained smartly on the pump itself. Why Roche would add the extra piece of equipment is difficult to understand. Pump therapy is already costly enough and not every patient will have a smart phone or PDA. Not to mention using the Circle of Care requires that the patient have their PDA or smart phone with them at every meal or snack.

The Spirit does have one unique feature, a reversible screen which makes operating the pump simpler no matter which side the pump is worn on. Other than that the Spirit offers nothing new and on several fronts is actually a step backwards.

With the pump market getting more competitive each day the company should take advantage of the FDA’s delay and go back the drawing board. This product is hardly worthy of carrying the Accu-Chek brand name.

David Kliff
Diabetic Investor
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