8/6/2019
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`Sanofi's SoloStar hits US market despite patent suit
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`Sano's SoloStar hits US market despite patent suit
`By Anna Lewcock
`30-Jul-2007 - Last updated on 19-Jul-2008 at 16:56 GMT
`
`RELATED TAGS: Sano-aventis, Insulin glargine, Sano
`
`Sano-Aventis' disposable insulin pen SoloStar has been launched
`across the US for use with the company's 24-hour basal insulin
`Lantus (insulin glargine), despite patent infringement claims
`emanating from fellow insulin pen manufacturer, Novo Nordisk.
`
`The disposable pen was rolled out in France and Germany earlier this year, but a cloud formed over the
`company's US plans for the product when reports emerged that Danish rm Novo had led a patent
`infringement suit against the company to prevent the pen's availability on the US market. On July 10 Novo led
`a suit with the US District Court of New Jersey against Sano with regard to the Lantus SoloStar product, but
`Sano has yet to be ocially served with the complaint, and says it's understanding of the allegations is still
`preliminary. Novo's allegations pertain to the mechanisms for injection and dose-setting, features which
`Sano emphasises as advantages of its product but which Novo claims infringe on its NovoPen 4 insulin
`delivery system. Sano states that the dose-setting mechanism on the Lantus SoloStar is somewhat unique, in
`that it is the only pre-lled disposable insulin pen that allows patients to administer from one up to 80 units in
`single-unit increments with a single injection. The pen oers a 25 per cent higher capacity than other insulin
`pens, according to the company, capable of holding 300 units of insulin. The average Lantus dose is 35 units a
`day. Sano also highlights the reduced injection force used with its SoloStar product, with the pressure
`required to administer the insulin 31 per cent less than Novo's FlexPen device and 54 per cent less than Eli
`Lilly's Humulin/Humalog pen. A further advantage of the Lantus version of the pen product is that Lantus is
`currently the only 24-hour insulin approved exclusively for once-daily treatment of hyperglycaemia in patients
`with Type I or Type II diabetes. It also eliminates the problem of the 'peak-of-action' eect common with other
`insulins, where the insulin reaches a point of maximum eect in the body. Lantus, on the other hand, has no
`such pronounced peak and is released into the bloodstream at a relatively constant rate throughout the day.
`The cost of the pen on the US market is similar to other pen format analog insulins, according to Julissa Viana
`of Sano, coming in at around 10 cents a unit or $30 (€22) per injection device. With insulin pens still
`somewhat under-utilised in the US compared to other regions such as Europe and Japan, Sano will be hoping
`to wean the American diabetic population onto the SoloStar pen, emphasising its ease of use and convenience
`over traditional needle-based injection systems. Although reluctant to disclose information regarding the
`potential share of the market that the company could garner with the Lantus SoloStar product, Viana said that
`Sano does "feel condent that [it] will increase the percentage of patients initiating on Lantus in pen format above
`the national average of 12-14 per cent over the next two years." The company is also awaiting approval for the use
`of the SoloStar pen with Apidra (insulin glulisine), the company's fast-acting prandial insulin. Until approval is
`granted, Apidra will be continue to be available with the company's reusable insulin pen, OptiClik, which will
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`also remain available for use with Lantus should patients prefer a reusable pen option.
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`https://www.in-pharmatechnologist.com/Article/2007/07/31/Sanofi-s-SoloStar-hits-US-market-despite-patent-suit
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`Mylan Ex.1080
`Mylan v. Sanofi - IPR2018-01675
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`Sanofi's SoloStar hits US market despite patent suit
`8/6/2019
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`https://www.in-pharmatechnologist.com/Article/2007/07/31/Sanofi-s-SoloStar-hits-US-market-despite-patent-suit
`
`2/2
`
`Mylan Ex.1080
`Mylan v. Sanofi - IPR2018-01675
`
`