Asante Solutions : CE Mark for Pearl™ Insulin Pump

April 12, 2011 – Asante Solutions, Inc. (Asante), a medical device company focused on diabetes care, announced it received the CE mark for its Pearl Insulin Pump, the only insulin pump that uses a pre-filled insulin cartridge. The CE mark is a European proof of conformity that certifies the product meets EU safety, health and environmental requirements. Asante has begun discussions with potential distribution partners in Europe.
“This important regulatory milestone brings us one step closer to our goal of delivering a sensible solution to the growing but underserved insulin pump market,” said Phil Hopper, Asante CEO and President. “Once available, we believe the small and sleek Pearl will be the simplest-to-operate pump on the market. The Pearl is a fully featured insulin pump addressing the imperatives of safety, reliability, and ease of use required to meet the needs of people with diabetes using intensive insulin therapy.”

The Pearl Insulin Pump is designed to simplify diabetes care for the more than 500,000 people worldwide who use an insulin pump and those considering insulin pump therapy. Unlike the insulin pumps currently available, which require users to manually fill an insulin reservoir using a vial of insulin and syringe, the Pearl Insulin Pump uses a 300-unit, pre-filled insulin cartridge that simplifies the process of loading the pump and filling the infusion set by reducing the number of steps required and thereby creating a less time-consuming and more convenient process... [PDF] Asante Solutions' Press Release -

Diartis Pharmaceuticals : New Biotech Company Will Focus on Clinical Development of Novel Diabetes Drug

February 16, 2011 - INDEX VENTURES AND AMUNIX INVEST IN DIARTIS PHARMACEUTICALS – Diartis Pharmaceuticals, Inc., a newly founded biotechnology company, announced that it has received initial funding from Index Ventures, Amunix Inc., a U.S. based biotechnology company, and private investors. The company has also acquired a clinical-stage diabetes drug candidate from Versartis, Inc., VRS-859 (exenatide-XTEN), and with this initial funding will continue its development for type 2 diabetes mellitus (T2DM).

A Phase 1a multi-center, blinded, placebo-controlled, single-ascending dose study is ongoing to evaluate the safety and ability of VRS-859 to maintain glycemic control for one month in T2DM patients after a single dose. The results of the Phase 1a study are anticipated in Q2 2011. The Phase 1a study will be followed later this year by a repeat dose (3 month) Phase 1b study comparing VRS-859 to Byetta® (exenatide injection) in T2DM patients. VRS-859 is intended as a once-monthly form of the GLP-1 analog, exenatide.

Commenting on the investment, Kevin Johnson, London based partner at Index Ventures said, “We are delighted to invest in Diartis Pharmaceuticals Pharmaceuticals. The company will focus on moving this exciting compound rapidly through early clinical development. Given the dramatic rise in the number of people with type 2 diabetes, there is a significant market need for a longer acting form of the GLP-1 analog exenatide.”... Diartis Pharmaceuticals' Press Release -

Genentech : Second Lucentis Phase III Study Meets Primary Endpoint for Improved Vision in Patients with Diabetic Macular Edema (DME)

March 25, 2011 - -- Results Consistent with Data Released Last Month Showing Patients with DME Who Received Lucentis Achieved Significant Improvement in Vision - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the second of two Phase III trials evaluating Lucentis® (ranibizumab injection) in patients with diabetic macular edema (DME) met its primary endpoint. The primary endpoint of the study, known as RIDE, showed that after 24 months a significantly greater number of patients who received Lucentis, compared to those who received placebo (sham) injections, were able to read at least 15 additional letters on an eye chart than they could at the start of the study. The safety results were consistent with previous Lucentis Phase III trials and no new significant safety findings were observed. Further analyses of the data are ongoing. Topline results from the RIDE study will be presented at the EURETINA Congress in London on May 29, 2011.

DME is an eye condition characterized by swelling of the retina, which can occur in patients with type 1 or type 2 diabetes and can cause blurred vision, severe vision loss and blindness.1 DME is a leading cause of blindness among the working-age population in most developed countries,2 and there are currently no U.S. Food & Drug Administration (FDA) approved medications to treat DME.
"This data adds to the considerable body of clinical evidence showing that patients with DME who received Lucentis had significant improvement in vision," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "Lucentis may provide physicians and patients with a potential option for DME, and we look forward to sharing the data from this study and a previous Phase III trial with the FDA and medical community."... Genentech's Press Release -