BMS & AstraZeneca : Dapagliflozin Study Demonstrated Improved Glycemic Control In Type 2 Diabetes Patients Treated With High Doses of Insulin...

June 06, 2009 -Results from a 12-week study demonstrated that the investigational drug dapagliflozin, a novel, selective, sodium glucose co-transporter 2 (SGLT2) inhibitor, produced greater improvements across all key glycemic measures studied [glycosylated hemoglobin level (HbA1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG)] in type 2 diabetes patients who were treated with high doses of insulin and commonly used oral anti-diabetes medications (OADs), compared to placebo (placebo plus OADs plus insulin).

Overall adverse events across the dapagliflozin treatment arms were reported at a similar rate to placebo. The study also showed that individuals receiving dapagliflozin had greater reductions in body weight compared to individuals taking placebo, and support the findings from a previous 12-week, Phase 2b study. Results from the 12-week study were presented at the 69^th American Diabetes Association Annual Scientific Sessions.

Dapagliflozin is an investigational SGLT2 inhibitor currently in Phase 3 trials under joint development by Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) as a once-daily therapy for the treatment of type 2 diabetes. SGLT2 facilitates the reabsorption of glucose in the kidney, thereby returning filtered glucose to the circulation.. BMS' Press Releases -

Halozyme : Phase 2 Insulin-PH20 Study Demonstrates Faster Insulin Absorption and Superior Glucose Control in Type 1 Diabetic Patients

Jun. 6, 2009 - Insulin-PH20 combination significantly reduced post-meal blood glucose concentration relative to treatment target resulting in reduced hyperglycemia - Halozyme Therapeutics, Inc. (Nasdaq: HALO) announced Phase 2 results that demonstrated faster insulin absorption and increased peak insulin concentrations in type 1 diabetic patients after co-administration of its recombinant hyaluronidase enzyme (PH20) with Humalog® (insulin lispro), a mealtime insulin analog. Study results also showed a significant reduction in postprandial blood glucose levels following administration of a standardized test meal, with improvements in both peak glycemic response and total hyperglycemic exposure compared to Humalog alone. Mean glucose levels after the meal challenge remained within current treatment targets throughout the eight hour post meal observation period. The company presented these results at the American Diabetes Association (ADA) 69th Scientific Sessions today in New Orleans.

In addition, Halozyme announced that its first treatment study with three times per day mealtime dosing of Insulin-PH20 in type 1 diabetic patients began in May, ahead of the company’s previous guidance for a fourth quarter 2009 start date... Halozyme Therapeutics' Press release -

NOXXON : Initiation of First Clinical Trial with a Spiegelmer

June 08, 2009 - NOXXON Pharma AG (NOXXON) announced the successful initial dosing of healthy volunteers with Spiegelmer® NOX-E36 in the company’s first-in-human clinical trial. The Phase I program is currently underway in the United Kingdom following review and approval of the Clinical Trial Application by the Medicines and Health product Regulatory Authority (MHRA). The study will evaluate the tolerability, safety and pharmacokinetics in up to 72 individuals following intravenous and subcutaneous administration of anti-inflammatory Spiegelmer® NOX-E36. The results obtained in the Phase I trial will guide the Phase II program to be conducted in patients suffering from nephropathy...
...NOXXON is planning to develop NOX-E36 for the treatment of inflammatory kidney diseases including diabetic nephropathy. Diabetic nephropathy is a growing public health threat due to the high and continually growing incidence of type II diabetes. Approximately thirty percent of patients diagnosed with diabetes develop nephropathy; twenty percent of these patients suffer from end stage renal disease. Diabetic nephropathy is the leading cause for chronic kideny disease and dialysis treatment in the Western world... [pdf] NOXXON's Press Release -

Covidien : Nationwide Our Resolution Movement

Jun. 18, 2009- Initiative Focuses on Role of Gastric Bypass Surgery in Resolving Type 2 Diabetes - As the rate of Type 2 Diabetes soars to epidemic proportions worldwide, Covidien (NYSE: COV), a leading global provider of healthcare products, announced the launch of the Our Resolution movement, a collaboration of healthcare experts, nonprofit organizations, health agencies, patients and national spokespersons who share the goal of resolving Type 2 Diabetes.

According to the World Health Organization, the worldwide incidence of Type 2 Diabetes is projected to grow from 171 million cases currently to 366 million worldwide by 2030. In 2007, the overall economic cost of diabetes in the U.S. was estimated at $174 billion.

The Our Resolution movement specifically focuses on the discovery that gastric bypass surgery resolves Type 2 Diabetes in approximately 77 percent of morbidly obese patients. In fact, for many of these patients, their diabetes or need for medication is resolved within days of surgery. According to the American Society for Metabolic and Bariatric Surgery, approximately 220,000 people in the U.S. had bariatric surgery in 2008. Studies show that those who had surgery dramatically reduced their risk of dying from an obesity-related disease, including the risk of death from diabetes, (down 92 percent), cancer (down 60 percent) and coronary artery disease (down 56 percent)... Covidien's Press Release -

Geron Scientists and Collaborators : Activity of Pancreatic Islet-like Cells Derived from Human Embryonic Stem Cells in Diabetes

October 28, 2008 - Geron Corporation (Nasdaq: GERN) announced the publication of data showing the successful engraftment of human embryonic stem cell (hESC)-derived pancreatic islet-like clusters (ILCs) in diabetic mice. After transplantation, the ILCs continued to express important pancreatic islet proteins, responded to high levels of glucose in the blood, and extended the survival of recipient animals.

Pancreatic islet cells normally secrete insulin in response to high levels of glucose in the blood to maintain steady levels. Type 1 diabetes is an autoimmune disease in which the insulin secreting islet cells are destroyed. Administering insulin is life-saving but does not truly mimic the body's natural response to blood glucose and can result in serious complications such as diabetic retinopathy, nephropathy and neuropathy... Geron Corporation's Press Release -

BioLife Solutions : HypoThermosol Adopted by MicroIslet for Processing Pancreatic Islet Cells to Treat Diabetes

October 24, 2008 - Preservation with BioLife’s Proprietary, Next Generation, Biopreservation Media Resulted in Increased Yield and Quality of Insulin-Producing Islet Cells – BioLife Solutions Inc. (OTCBB: BLFS), a leading developer and marketer of proprietary hypothermic storage and cryopreservation media products for cells, tissues, and organs, announced that MicroIslet Inc. (OTCBB: MIIS), a biotechnology company engaged in developing and commercializing cellular therapies for patients with diabetes, has adopted HypoThermosol for preserving, transporting, and storing pancreatic source material.

MicroIslet plans to isolate and encapsulate islet cells for the treatment of Type 1 diabetic patients under a planned investigational new drug application and subsequent clinical trial... BioLife Solutions' Press Release -

Convincing results of Solianis’ multisensor system in home-use trial

October 13, 2008: Solianis’ multisensor system for non-invasive Continuous Glucose Monitoring is currently being tested by diabetic patients in the home and work environment. 12 patients have completed a 10-day trial aimed at assessing system reliability. Results indicate that the system tracks glucose in home-use settings and is sensitive to hypoglycemic glucose excursions.
With this proof of concept Solianis can now proceed to producing the final prototype. The company expects to launch its first product in Europe in 2010 after CE approval, targeting this non-invasive device at the insulin dependent diabetes population. Later model variants will address patients with diabetes and impaired glucose tolerance... [PDF] Solianis’ Press Release -

Phenomix and Forest : Collaboration on Development and Commercialization of Dutogliptin in Diabetes

October 23, 2008 — Forest Laboratories, Inc. (NYSE: FRX) and Phenomix Corporation today announced that they have entered into a definitive collaboration agreement to develop and commercialize dutogliptin (PHX1149) in North America. Dutogliptin is Phenomix’ proprietary orally administered, small molecule dipeptidyl-peptidase-4 (DPP-4) inhibitor currently undergoing Phase 3 clinical development in Type 2 diabetes mellitus... Phenomix's Press Release - Forest Laboratories' Press Release -

Amylin and Lilly : Supply Agreement for Exenatide Once Weekly

Oct 21, 2008 - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced they have entered into a product supply agreement for exenatide once weekly, a development compound that, if approved, would become the first once weekly therapy to treat type 2 diabetes. Under terms of the agreement, Lilly will make an initial cash payment of $125 million to Amylin, and Amylin will supply product for sales in the U.S. and to Lilly for sales outside of the U.S. In addition to the $125 million upfront payment, Lilly will reimburse Amylin for its share of the more than $500 million capital investment in the West Chester, Ohio facility through the cost of goods sold for exenatide once weekly.


As part of the overall supply arrangement, Lilly will make available to Amylin a $165 million line of credit that Amylin can draw upon beginning in the fourth quarter of 2009 through the second quarter of 2011. Any debt from the credit facility will be due three years from the date that the full amount has been drawn or the second quarter of 2014, whichever occurs first... Amylin Pharmaceuticals' Press Release - Eli Lilly and Company's Press Release -

Novo Nordisk Assigns Inhaled Insulin Patent Portfolio to Aradigm

Oct 08, 2008 - Aradigm Corporation (OTCBB:ARDM) ("Aradigm" or "Company"), a specialty pharmaceutical company, announced that Novo Nordisk ("Novo") transferred to Aradigm, at no charge, a portfolio of inhaled insulin related patents pursuant to a license agreement between Aradigm and Novo that was terminated in May 2008. Novo purchased a significant portion of the portfolio from Aradigm in July 2006 and supplemented the portfolio with certain of its own related patents. The portfolio includes both U.S. and foreign patents. Aradigm assumes responsibility for the maintenance of this portfolio.


In addition to the patent portfolio, Novo will transfer to Aradigm a significant preclinical safety database that was developed during the Aradigm/Novo collaboration, the rights to a miniaturized second-generation electronic insulin inhaler and data from Novo's inhaled insulin clinical program, which included nine Phase 3 trials in Type 1 and Type 2 diabetes patients... Aradigm's Press Release -

Echo Therapeutics : Issuance of New Patent for Symphony™ Transdermal Continuous Glucose Monitoring System

October 16, 2008 – Echo Therapeutics (OTCBB: ECTE) announced the issuance of U.S. Patent 7,432,069 covering compositions and methods for the preparation of a polyethylene glycol (PEG)- based hydrogel as a key component of Echo’s Symphony™ Transdermal Continuous Glucose Monitoring (tCGM) System... [PDF] Echo Therapeutics' Press Release -