Medical Device Daily Contributing Writer
And MDDs

Sanofi-Aventis (Paris) has introduced a new line of disposable insulin injection pens to be launched in Germany in April and progressively rolled out in other European markets throughout 2007.

The new SoloSTAR line of pens is awaiting approval for distribution in the U.S.

Sanofi said at a mid-March press conference that it is building significant manufacturing capability to support worldwide launches.

SoloSTAR pens administer both of Sanofi-Aventis' popular insulins — Lantus, an analogue of human insulin designed for once daily dosing, and the fast-acting Apridra.

For those with either Type 1 or Type 2 diabetes, the pens require a reduced injection force and can be set by the patient in one-unit increments for a dosage from one to 80 units, the highest dose range of any disposable insulin pen, according to Sanofi.

Insulin injection pens are lightweight, shaped like a writing pen, and are prefilled with an insulin cartridge. They feature a microfine needle and a device to set the amount of insulin for each dose.

The strength required by a diabetes patient self-administering the dose is nearly a third less than the HumaPen from Eli Lily (Indianapolis) or the NovoLog FlexPen from Novo Nordisk (Copenhagen, Denmark), said Dr. Anna Radjanova of Sanofi.

"SoloSTAR is a very significant improvement, considering how many people with diabetes have reduced grip strength," she said, estimating that over half of patients have limited joint mobility of the hand or fingers.

More than 230 million people worldwide live with diabetes, a number that is expected to explode toward 350 million people within 20 years. Sanofi says it estimates that more than 20 million Americans have diabetes, including some 6.2 million who remain undiagnosed.

Where Europe is a mature market for injection pens at around 85% of insulin delivery, Sanofi said U.S. diabetes patients continue to prefer conventional vials.

"The market is simply not driven by pens, though that is changing," said Sanofi spokesman Jean-Marc Podvin. He said a competitor's estimate of a 20% market share for pens in the $2 billion American market for insulin seems exaggerated. Sanofi's supplier of its current line of OptiClik injection pens said the U.S. market share for insulin pens in 2006 was 15%.

Sanofi has been challenged with its OptiClik injection pens, its only FDA-approved insulin delivery device. Where sales of its insulin grew by 40% in the U.S., the manufacturer of the OptiClik pens, Ypsomed (Burgdorf, Switzerland), reported in November 2006, "the demand in the U.S. for the OptiClik is lower than originally assumed in the studies and surveys carried out by Sanofi-Aventis, although the potential for pen systems is huge."

The supply of the pens also was troubled last year by "unexpected difficulties in the complex manufacturing process," according to Ypsomed, who said it shut down production for eight weeks, leading to "delays in delivery and a reduction of sales in the pen system core business."

Sanofi has also been challenged by Novo Nordisk for a patent violation with OptiClik. The lawsuit, filed in Delaware in 2005, is scheduled to be heard in August of this year, Podvin said.

Asked if the introduction of SoloSTAR was motivated by the patent challenge, Radjanova said the new line was developed over four years, well before any intellectual property challenge to the technology.

She said the design of the new SoloSTAR pen also addresses concerns from the American Foundation for the Blind in its ratings for accessibility and usability of diabetes self-care devices. The OptiClik pen is one of three on the U.S. market featuring an electronic read-out screen for the user to measure dosages, a challenge for the visually-impaired.

The SoloSTAR line replaces the sophisticated screen with a "highly readable black-on-white number," Radjanova said, and each unit adjustment is accompanied by a pronounced click. The pens for rapid-action and slow-release each have a different color as a further visual aid.

Krell named GM of Abiomed in Europe

Abiomed (Danvers, Massachusetts) has named Paul Krell general manager for its European operations, based in Aachen, Germany. He joins Abiomed from ev3 Europe, where he most recently served as VP, Europe, in the Neurovascular Division.

Krell has more than 14 years of experience in the medical device industry, including a lengthy tenure at Guidant, where he held several management positions, including country manager in Germany for cardiac surgery products and European marketing manager for tachyarrhythmia products.

Abiomed manufactures products designed to assist or replace the pumping function of the failing heart, including the AB5000 Circulatory Support System and the BVS 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. The company also has developed the AbioCor Implantable Replacement Heart.

NHS waiting times decline

New statistics released earlier this month show that waiting times in the UK's National Health Service (NHS) are at record low levels, with more critical care beds than ever before and a record low number of cancelled surgical procedures since 1999.

The new figures showed that the number of people on the inpatient waiting list in January was 774,000, one of the lowest since the NHS began collecting data this way in September 1988, and a reduction of 2,000 from the previous month and 384,000 since 1997.

There were 3,359 critical care beds in January, compared with 2,362 in January 2000, a record 42% increase.

There were 2,191 fewer operations cancelled this January than at the same time last year; of those that were cancelled, almost 95% of patients were treated within 28 days of a cancellation, compared to 92% a year earlier.