Array and Amgen : Partner in Type 2 Diabetes

Dec 14, 2009 - Amgen to Pay $60 Million Up-front with Additional Potential Milestones and Royalties - Array BioPharma Inc. (NASDAQ: ARRY) and Amgen Inc.(NASDAQ: AMGN) announced that they entered into an agreement granting Amgen exclusive worldwide rights to Array's small-molecule glucokinase activator program, including ARRY-403, currently being tested in a Phase 1 clinical trial in patients with Type 2 diabetes.

Under the terms of the agreement, Array will receive an upfront payment of $60 million and additional contingent payments for certain clinical and commercial milestones. Array is responsible for completing the Phase 1 trial for ARRY-403. Amgen is responsible for future clinical development and commercialization for ARRY-403 and any resulting back-up compounds, with Array having an option to co-promote in the United States. Array will receive double digit royalties on sales of ARRY-403. In addition, Amgen will fund an agreed upon number of full-time Array employees as part of a two-year research collaboration intended to identify and advance second-generation glucokinase activators... Array BioPharma's Press Release - Amgen's Press Release -

Biocompatibles and AstraZeneca : Schedule of Phase I and Phase II Trials agreed for Type II Diabetes Drug

4 December 2009: Biocompatibles International plc is pleased to announce that it will initiate clinical trials for CM3, a type II diabetes drug, under development with AstraZeneca, in January. Biocompatibles entered into an agreement with AstraZeneca in December 2008 to develop CM3. The agreement included pre-clinical, Phase I and Phase IIa activities managed by Biocompatibles’ subsidiary, CellMed. Phase I studies are scheduled to start early in 2010 and Phase II studies are expected to start later in 2010. The pre-clinical phase of the programme was completed ahead of schedule with positive results.


A further €4.3m instalment of a schedule of payments of €8.8m, first announced by Biocompatibles on 22 December 2008, will be paid by AstraZeneca in January.

CM3 is a glucagon-like peptide-1 (GLP-1) analogue invented and developed by CellMed and is part of a new family of GLP-1 analogues. The first of the relevant patents has recently been granted. This GLP-1 compound has the potential to be an important treatment for diabetes and obesity and may offer patient benefits not currently available from other GLP-1 drugs on the market.

The agreement also provides AstraZeneca with an exclusive option to license relevant patents for further exploitation, at any time during the course of the development programme, which is expected to be completed in 2012... Biocompatibles' Press Release -

GI Dynamics' EndoBarrierTM Gastrointestinal Liner : Significant HbA1c Reduction in Obese People Living with Type 2 Diabetes

November 11, 2009 – GI Dynamics, a leader in non-surgical treatments for type 2 diabetes and obesity, announced data which demonstrate that obese patients with uncontrolled type 2 diabetes using the EndoBarrier™ Gastrointestinal Liner achieved near normalization of glycemic control in just one week, as compared to a sham control group. In addition, patients treated with EndoBarrier achieved a mean reduction of 2.4% in HbA1c glucose levels versus 0.8% for the sham arm at 24 weeks. Patients treated with EndoBarrier also achieved reductions in other diabetic factors including fasting blood glucose and weight. The results of the pilot study were published today in the current advance online issue of Diabetes Technology & Therapeutics.



“Studies show that every one percent decrease in HbA1c reduces health risks by 21 percent and as the rates of obesity and type 2 diabetes continue to reach epidemic proportions around the globe, patients are in urgent need of new therapeutic solutions that overcome the limitations associated with pharmaceutical regimens and invasive surgery,... GI Dynamics' Press Release -

First Diabetes Patient Adherence Program for Foot Ulcer Treatment

November 3, 2009 – Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine and the maker of Dermagraft®, launched during American Diabetes Month the Heal2gether Partnership Program for diabetes patients and their physicians. Focused on patient adherence, Heal2gether aims to increase awareness and proper care of diabetic foot ulcers (DFUs), enhance the effective use of living cell technologies in treating DFUs, and encourage patients to take an active role in their healing process... Advanced BioHealing's Press Release -

Compugen : Discovery of Genetic Biomarker for Predisposition to Type 2 Diabetes

November 9, 2009 - Compugen Ltd. (NASDAQ: CGEN) announced the discovery and experimental confirmation of a genetic biomarker, CGEN-40001 for predisposition to type 2 diabetes, the most common form of diabetes. This new biomarker was discovered using Compugen’s GeneVa® platform, which consists of an in silico database of approximately 350,000 predicted genetic variations in the human genome, with each predicted variation consisting of multiple consecutive nucleotides.

Predisposition markers are of particular value in diseases like type 2 diabetes, where specific lifestyle and health factors are known to play an important role. Following diagnosis, high-risk patients may benefit from more aggressive management either through lifestyle modification or drug treatment. There are an estimated 24 million people in the U.S. with diabetes, 90% of whom are affected by type 2 diabetes.During the past few years, extensive efforts by others searching for genetic markers for type 2 diabetes have utilized numerous genome-wide association studies, involving thousands of patients globally. Several validated genetic markers have been found; however, combining all the discovered biomarkers still explains only a small fraction of the heritability of the disease, so the need for additional markers continues to exist... Compugen's Press Release -

Ossulin, a Novel Oral Insulin : Promising Bioavailability for Advancing Diabetes Therapy

9th November 2009 - New data from Puredel Limited, presented at the 9th Annual Diabetes Technology Meeting in San Francisco, California, suggest that higher blood levels of insulin were achieved by Ossulin than had been prevously demonstrated by other products. In a series of experiements in a range of doses and models, Ossulin consistently delivered around 20% of the insulin dose into the bloodstream.

The authors concluded that:

'Ossulin provides an efficient way to deliver insulin to the body by oral administration, resulting in blood levels higher than those previously observed with other oral insulin products.'... CM&D Pharma' Press Release -

CPEX’s Nasulin Insulin Therapy Featured in an Oral Presentation and Four Abstracts at the Ninth Annual Diabetes Technology Meeting

November 05, 2009 -CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) announced that its intranasal insulin product candidate, NasulinTM, will be featured in an oral presentation and four abstracts at the Ninth Annual Diabetes Technology Meeting, November 5-7, 2009 at the Hyatt Regency Airport in San Francisco, California. Dr. Lance Berman, Senior Vice President and Chief Medical Officer, is scheduled to deliver an oral presentation entitled “The Technology and Clinical Aspects of Nasal Insulin Therapy” at 9:30 a.m. PST on Saturday, November 7. Further details on the abstracts are provided below.
A Randomized 6-Way Crossover Study of NasulinTM, Saline and Lispro in Subjects with Type 2 Diabetes to Determine Optimum Dose Timing
A similar glucose-lowering effect may be achieved by administering Nasulin either just before or at the end of the meal offering more flexibility of dosing than with injectable insulins.
Two Randomized Crossover Glucose Clamp Studies of NasulinTM and Lispro
In both Type1 diabetic patients and healthy volunteers, peak glucose metabolism rates occurred earlier with ultra-rapid acting Nasulin than with rapid acting lispro. The pharmacodynamic profile indicates Nasulin has optimum activity when glucose levels rise during a meal with less potential for hypoglycemia in the hours after the meal has ended.

Dose-Exposure for Single and Dual Nostril Administration of Nasal Insulin (NasulinTM)
The findings from this study demonstrated significantly enhanced insulin absorption when a 50 IU dose is administered as 2 sprays of 25 IU given in the same nostril rather than one spray in each nostril. In addition, the study also demonstrated that nasal administration of up to 200 microliters per nostril was well tolerated allowing the administration of doses up to 100 IU. Together these findings provide an improved dosing methodology and a higher maximum dose for evaluation in future clinical trials.

Dose-Exposure for Two Dose Strengths of Nasal Insulin (NasulinTM)
These data demonstrated that the original Nasulin concentration (1.0%) and the new concentration (0.7%) revealed proportional dose-dependent increases in insulin exposures... [PDF] CPEX Pharmaceuticals' Press Release -

GlycoMimetics : Awarded NIH Grant to Study Drug Candidate in Diabetes

August 16, 2009 -- GlycoMimetics, Inc., a clinical-stage biotechnology company that is developing a new class of glycobiology-based therapies for a broad range of indications, announced it has been awarded a grant from The National Heart, Lung, and Blood Institute (NHLBI) of The National Institutes of Health (NIH) to evaluate its E-selectin small molecule antagonists in animal models of vascular complications of diabetes.

The grant is based upon substantial data in the scientific literature suggesting an important role for E-selectin in the chronic inflammation associated with diabetes. The company has developed a family of potent small molecule E-selectin antagonists which it is currently optimizing for oral availability... GlycoMimetics' Press Release -

EXSULIN : PUBLICATION OF PHASE 2 TRIAL RESULTS FOR NOVEL ISLET REGENERATION TREATMENT IN TYPE 1 & TYPE 2 DIABETES

(August 18, 2009) – Exsulin Corporation announced milestones achieved and immediate plans to move forward as a well supported Minnesota-based company dedicated to the development of regeneration therapies for the treatment of diabetes mellitus. Exsulin’s focus is on development of a drug with potential to become a breakthrough therapy for patients suffering from type 1 (T1DM) and type 2 diabetes (T2DM). Phase II human clinical trial data of ExsulinTM (INGAP peptide), a peptide drug product aimed at restoring the ability of the pancreas to produce insulin normally in people with diabetes mellitus, have just been published online by Diabetes/Metabolism Research and Reviews.




Exsulin Corporation, founded by diabetes industry professionals, is supported by a proven clinical, development and regulatory management team and is advised by globally recognized diabetes experts. To follow on and support the results documented in the recent trial data publication, Exsulin has received clearances for a trial in patients with established (not newly diagnosed) T1DM, a population subset with no other currently active clinical trials. Other milestones achieved by Exsulin include reformulation and procurement of drug product, support of key independent laboratory research, and securing regulatory authorization to initiate a new clinical trial... Exsulin's Press Release -

Lexicon : Phase 1 Clinical Trial and Phase 2 Clinical Trial of LX4211 in Patients with Type 2 Diabetes

September 15, 2009 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, obtained favorable results from recently completed Phase 1 studies of LX4211 and announced that it has initiated a Phase 2 clinical trial of the drug candidate in patients with type 2 diabetes mellitus. LX4211 is an orally-delivered, small molecule drug candidate that inhibits the sodium glucose transporter 2 (SGLT2). LX4211 is Lexicon’s fourth drug candidate currently being tested in Phase 2 clinical trials... Lexicon Pharmaceuticals' Press Release -

Intarcia Therapeutics : Enrollment of ITCA 650 Phase 2 Study in Type 2 Diabetes

September 17, 2009 - Intarcia Therapeutics, Inc. announced the start of enrollment for a phase 2 study comparing its proprietary drug candidate ITCA 650 (DUROS continuous delivery of exenatide) with Byetta, an FDA-approved twice-daily injection form of exenatide. Building upon the successful completion of a 28-day phase 1b study of ITCA 650 in May of this year, the phase 2 study is intended to evaluate the doses achieving the best results in the phase 1b in a larger study population and for a longer duration of treatment. In addition, an extension phase of the phase 2 study will evaluate dose response of ITCA 650. Patients receiving Byetta for the first 12 weeks will be switched from Byetta to one of two doses of ITCA 650 to evaluate the potential for improving treatment effect... Intarcia Therapeutics' Press Release -

Medarex : Milestone Payment from FibroGen for the Initiation of a Phase 2 Study of FG-3019 in Patients with Diabetic Kidney Disease

Jul. 13, 2009-- Medarex, Inc. (NASDAQ:MEDX) announced it will receive a milestone payment of an undisclosed amount from its licensing partner, FibroGen,Inc., in connection with a recently initiated Phase 2 clinical trial of FG-3019 in patients with type 2 diabetes and advanced kidney disease as announced by FibroGen on June 15, 2009.



FG-3019 is a fully human monoclonal antibody generated using Medarex's UltiMAb(R) technology against connective tissue growth factor(CTGF). Under the agreement with FibroGen, Medarex could receive future milestone payments and sales-based royalty payments... Medarex's Press Release -

Kineta : Novel Drug Candidates from Airmid for Potential Treatment of Multiple Sclerosis, Type 1 Diabetes and other Autoimmune Diseases

July 7, 2009, – Kineta, Inc. of Seattle and Airmid Incorporated of Redwood City, CA jointly announce an agreement in which a Kineta subsidiary has acquired exclusive commercial rights to a portfolio of novel therapeutic compounds from Airmid. The array of compounds holds extraordinary potential for the treatment of multiple sclerosis, type 1 diabetes mellitus and numerous other autoimmune diseases...

...


Kineta, Inc. is a Seattle-based privately held biotechnology company specializing in clinical advancement of drugs that modulate and enhance the human immune system. Our world class scientists are pioneers, developing life-changing classes of drugs that harness the power of the immune system to fight disease. Kineta seeks to improve the lives of millions of people suffering from autoimmune and viral diseases... [PDF] Kineta's Press Release -

Andromeda Biotech Consummates Deal with Teva for the Commercialization of DiaPep277, its Late Stage Development Drug for Type 1 Diabetes

June 22, 2009 -- Teva completes $13.5 million investment in Andromeda and receives a worldwide exclusive license to commercialize DiaPep277 -- Andromeda Biotech Ltd. , announced that Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) has decided to exercise its option to complete a $13.5 million investment and license Andromeda’s DiaPep277 for the treatment of Type 1 diabetes. Pursuant to the agreements, Teva is receiving worldwide marketing rights for the DiaPep277 product...


... About Andromeda Biotech
Andromeda Biotech Ltd., a subsidiary of Clal Biotechnology Industries Ltd. (TASE: CBI), is focused on the development of an innovative treatment for autoimmune diabetes. Andromeda’s DiaPep277, currently in Phase III Clinical Studies, is a novel therapeutic approach in treating Type 1 diabetes. It is a unique peptide derived from the human protein, HSP60, which immunomodulates the immune system, prevents the destruction of pancreatic cells that secrete insulin and preserves their natural function... Andromeda Biotech's Press Release -

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 -