Sanofi-Aventis Gets FDA Approval for Disposable Insulin Pen

Sanofi Aventis said the FDA has approved its disposable insulin pen, SoloStar, for once-daily use in treating hyperglycemeia in Type 1 or 2 diabetes. The pen incorporates the company's 24-hour basal insulin Lantus, and its ease of use will make it a potent competitor against rival products. Sanofi says SoloStar's heightened sensitivity to a combination of user needs differentiate it from other disposable insulin devices such as Eli Lilly's Humulin/Humalog pen and Novo Nordisk's FlexPen. The company's strategy was to retain the best features of existing pens while addressing unmet or unsatisfied needs, including simplicity of use, injection force, dial extension (how far the pen extends when a dose is dialed), robustness, maximum dose deliverable in one injection, and the ease of distinguishing between different types of insulin carried in the same pen. Sanofi says its drive mechanism requires 30-50% less force than either FlexPen or the Lilly Pen; injection force and dial extension are important, considering about 58% of diabetics have limited joint mobility of the hand and significantly weakened grip strength. Pens account for 56% of all insulin units delivered worldwide; 94% in Japan and 86% in Europe but only 14% in the U.S.

Sources: Press release (.pdf), MarketWatch, in-Pharma
Commentary: 7 Companies Searching to Treat or Cure Parkinson's • Novo Nordisk: Set to Conquer the Insulin Market - Barron's • Top Pharma Innovations In 2006
Stocks/ETFs to watch: sanofi-aventis (SNY), Eli Lilly and Company (LLY), Novo Nordisk A/S (NVO). ETFs: Pharmaceutical HOLDRs (PPH), iShares Dow Jones US Pharmaceuticals (IHE)
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