Sanofi Aventis Reports
Yesterday while Diabetic Investor was visiting our nation’s capital, Sanofi-Aventis (NYSE:SNY) reported 2010 full year results and provided a glimpse of what 2011 will look like. Looking strictly at the numbers their diabetes unit, Lantus® in particular, continues to perform well. According to the company sales for the unit increased 9.2% in 2010.
While Lantus sales in the US are slowing somewhat, growing a little over 6% in the fourth quarter, a more astonishing number is the growing importance of the SoloStar® insulin pen. According to the press release which accompanied the call; “The contribution from Lantus®SoloSTAR® in the fourth quarter 2010 represented 40.2% of total Lantus® sales in the U.S., an increase of 7.9 percentage points versus Q4 2009.” This number also falls in line with a trend that started a few years ago as insulin pens are capturing an increasing share of the insulin delivery market.
Looking to capture an even greater share of the insulin market with advanced insulin pen delivery systems the company is developing an insulin pen that communicates with their new line of glucose monitors and/or smartphones. Patients using the iBGStar monitor, which attaches to iPhone, can then use the app for the IBGStar to determine how much insulin to dose. This bolus calculator feature is commonly found on insulin pumps and is one of the more helpful features for effective insulin therapy.
Just when the IBGStar and BGStar are available in the US market here is another story. Back at JPM the company noted these systems would be launched in the second quarter of 2011. According to the earnings press release; “BGStar® and iBGStarTM, the first range of blood glucose monitoring systems (BGMs) co-developed by sanofiaventis and its partner AgaMatrix were approved in Europe. BGStar® was also approved in the U.S. where a dossier for iBGStarTM was submitted in Q4 2010. The Group expects to launch BGStar® and iBGStarTM in 2011.” During the call yesterday the company further clarified this by stating the systems would be available in Europe in the second quarter with the US launch coming later.
It should come as no surprise that the US launch is being held up by the FDA. While there are no structural issues with either system the FDA has asked the company for additional information for the iBGStar. Since this product attaches to an iPhone the FDA, in their never ending zest for overkill, is concerned that the blood drawn for a glucose test could end up on the iPhone and that blood would somehow be transferred to someone other than patient who just happens to share their iPhone with someone else. As we have noted in the past the FDA seems to believe that patients with diabetes are like heroin addicts who share their needles.
Making sure they cover every possible contingency, even one that happens once every million years, the FDA wants to make sure patients are properly cleaning the iPhone so that blood does not become transferred to a patient who just happens to borrow another patient’s iPhone right after this patient has performed a glucose test.
Diabetic Investor also understands the FDA is also considered a new requirement that all BGM companies cover the contingency of what effect the Chicago Cubs winning the World Series will have on glucose monitoring. Although it has been over a century since the Cubs won a World Series the FDA wants to make sure they cover every possible scenario even one as unlikely as the Cubs actually winning the World Series. In actuality the Cubs stand a better chance of winning a World Series than a diabetes patient somehow transferring blood to another person after they monitor their glucose. If this is not a prime example of just how screwed up the FDA is and how crazy things have become at the agency, Diabetic Investor does not know what is.
Getting back to Sanofi, the company also continues to move forward rounding out their diabetes drug offerings with their once-daily GLP-1 lixisenatide, which is currently in Phase 3 trials. This move into the GLP-1 space fits perfectly into the company’s overall diabetes strategy of providing diabetes management systems rather than just individual diabetes products. Like everyone else in diabetes Sanofi understands that you cannot be a player in the market without offering a GLP-1. The big question is whether lixisenatide will be able to gain traction in the market as it will be the third drug in the category and will come to market after the introduction of Bydureon which is administered once-weekly.
The bottom line for Sanofi continues to remain the same, will the company be able to execute on their aggressive diabetes strategy. They are accumulating all the pieces to the puzzle but no one is quite sure if they can put all the pieces together and come out with a nice picture. While they have the resources they need, resources alone won’t make this happen. Still, Sanofi also remains the company to watch in diabetes as their aggressive plans for the space are already altering how their competitors are moving forward.