Monday, March 19, 2007

Coming Soon: New Insulin Pen for Apidra & Lantus Users

Until very recently, Apidra users who for whatever reason did not use an insulin pump had limited choices when it came to portable insulin delivery: either a predrawn syringe, or Sanofi-Aventis' clunky insulin pen, the OptiClik insulin pen device. Users of the OptiClick complain about that pen for a variety of reasons. Most notably, the pen is not as small as insulin pen devices from rivals Novo Nordisk or Eli Lilly and Company. Plus, a box (or a 3 month supply) of the insulin cartridges are significantly larger than rivals and take up a lot of real estate in the refrigerator. Another complaint (from someone who had their bag stolen last fall) is that the OptiClik pens can only be obtained from a physician, so if you should lose or somehow have a pen malfunction, its not like you can go to the nearest Walgreens and pick up a new one over the weekend, it requires a trip to your doctor's office and time off from work. If you don't have a vial of Apidra in the fridge and suffer a similar issue, you'll be hard-pressed to draw insulin from the OptiClik pen cartridges because they contain the mechanics of the piston built into the insulin cartridge itself, rather than the pen device. As a result, withdrawing insulin from the cartridge itself would leave a huge air bubble in the cartridge, so a word of advice is to ask your doctor for two! And then there's the inability to dose in 1/2 unit increments, which many parents of children with diabetes and type 1 adults alike complain is unacceptable dosing precision. I won't go into that here, but my posts on Lilly's Humapen Memoir have covered that issue in detail.

In Sanofi's recent investor presentation, the company announced plans to introduce a new, disposable insulin pen to be branded SoloSTAR®. While the rationale for this pen was never addressed, the fact that Sanofi is the only one of the "big 3" insulin manufacturers who does not offer a disposable pen, and perhaps some of the complaints I described previously may have contributed to this decision.

While American consumers may have a slightly longer wait, today, Sanofi-Aventis announced it would introduce the SoloSTAR pen in Europe starting in April. The first launch of SoloSTAR insulin pen is planned in Germany in April 2007. Lantus® SoloSTAR and Apidra® SoloSTAR previously received European Commission approval, although FDA status is still undetermined at this time. Sanofi-Aventis is reporting that the company is currently building significant manufacturing capability to support worldwide launches, so the U.S. is likely to be announced sometime later this year. The pens themselves are made by a Swiss company. The product is aimed squarely at the vast type 2 market, as the company's blockbuster Lantus will be the first insulin to see the new pen, and they are touting the fact that the pen has the highest dose range of any disposable pen on the market, going up to 80 units in a single dose. Most type 1 patients would probably die from such a large dosage, as the total daily dose for most type 1 patients is usually less than half that maximum. Regardless, the news is likely to be welcomed as a big convenience for Apidra and Lantus users everywhere (or those considering these insulins).

According to the press-release, "SoloSTAR is a new, easy-to-use disposable pen for administration of Lantus and Apidra. SoloSTAR reduces the injection force by 30% or more in comparison to other leading disposable pens. This is beneficial for all people with diabetes and in particular for those with lower grip strength and the estimated up to 58% of individuals with limited joint mobility of the hand. SoloSTAR has the highest dose range of any disposable insulin pen with doses up to 80 units adjustable in 1 unit steps. To help with correct insulin identification and differentiation SoloSTAR is also the only disposable insulin pen with a completely different pen colour for each different insulin."

The color-coding feature is quite useful, as similar-looking pen devices can be easily confused otherwise. While the SoloSTAR pen may not be the answer patients have always waited for, it does put Sanofi-Aventis' insulin portfolio on a more competitive footing with rivals Novo Nordisk and Eli Lilly and Company. Now, if anyone speaks French, perhaps they can work with me on contacting company headquarters in Paris about 1/2 unit dosing?!


Christine said...

I LOVE it! That looks a lot better than the Opticlik.

Anonymous said...

Scott, tomorrow I am attending a local 2-day diabetes education event, put on by the local hospitals and diabetes clinics, that will also be attended by some vendors. I, too, will pose the obvious question. Can any of you people say "HALF-UNIT" ??!!!


Anonymous said...

There is a 1/2 unit insulin pen. Novo Nordisk provides Novo Pen Jr for 1/2 unit dilaing upto 30 units at a time.

Scott S said...

Thanks, but this posting was about Sanofi Aventis' Apidra insulin and that company's new insulin pens. Its worth noting that pens from each manufacturer are no longer compatible (early versions were), so Novopen Junior will not work with any brand other than Novo Nordisk insulin, which may not be a preferred brand for some insurance plans. FYI, Lilly now also offers a pen that doses in 1/2 units, but again, that doesn't really help Sanofi Aventis' Apidra users.

Anonymous said...

Hi Scott -
I was wondering if you or any of your readers know when the SoloSTAR pen is making its debut? I'm a researcher following the diabetes field and recently came back from ADA in Chicago. I spoke with the Sanofi folks and they said the pen will be out sometime this summer. Later I heard it will be out in three weeks. Was wondering if any of your readers had any inkling?

Scott S said...

Sanofi Aventis only received FDA approval on April 30, 2007, but since like all pharmaceutical manufacturers, they rely on third-party U.S. distributors like McKesson and others to distribute the devices via retail pharmacies, its not possible to predict when it will necessarily be available. However, you may try contacting the people listed in the press release for more information:

U.S. Contacts:

Terri Pedone
Tel: (908) 981-6562

Amy Ba
Tel: (908) 981-6563

Anonymous said...

Pen will make out End of August according to S-A...

Scott, what do you mean by color of this pen will be different for each insulin...I am little confused of that because doesn't NOVO also have different colors for different pens? Please explain clearly.

Anonymous said...

To help the person that ask about debut of Solostar----> Market launch will be end of August.


What do mean by color difference of each insulin with Solostar? I mean doesn't Novo already have that with three different colors for each insulin? how does this make sense with SoloStar...can you comment on different color benifit for SoloStar?

Scott S said...

To j jones, according to the press release "SoloSTAR is also the only disposable insulin pen with a completely different pen colour for each different insulin", and what that means is that that the pen itself will have a different color for each type of insulin, so Apidra will have one color, and Lantus will have another color. As the photograph shows, the pen itself will be the same color (a beige color), but will have a different colored pen-top and color markings.

As for the inquiry regarding Novo's, these comments come from Sanofi's press release, so you would have to direct your inquiry to Sanofi Aventis, not me, but I believe that Novo's pens do not have different color markings for different insulins unless they have made changes recently.