Sanofi-aventis and Metabolex : Exclusive Worldwide Licensing Agreement for a Novel Oral Antidiabetic to treat Type II Diabetes

June 25, 2010 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Metabolex announced a global licensing agreement on MBX-2982, an oral agent, GPR119 receptor agonist, for the treatment of Type II Diabetes. GPR119 receptor agonists (or G-protein coupled receptor 119) are found to exert the effects on glucose metabolism by a dual mode of action affecting both insulin and GLP-1 (glucagon-like peptide-1) release. This innovative mechanism could offer improved glucose control over the existing oral diabetes therapies, with an additional potentially beneficial effect on weight.

Under this agreement, sanofi-aventis will receive an exclusive worldwide license to develop, manufacture and commercialize MBX-2982, currently in Phase II a, and related compounds.
“The new mechanism of action of MBX-2982 is very promising and we are excited to have identified Metabolex as our partner in this very competitive field”... [PDF] Sanofi-aventis' Press Release -

MannKind : Study Showing AFREZZA(TM) Provides Comparable Glycemic Control with Less Weight Gain and Hypoglycemia than Standard of Care

Jun 24, 2010 - American Diabetes Association/The Lancet Symposium Will Highlight Study Showing AFREZZA(TM) Provides Comparable Glycemic Control with Less Weight Gain and Hypoglycemia than Standard of Care - Findings on ultra rapid acting insulin also published in The Lancet - AFREZZA (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, investigational ultra rapid acting mealtime insulin, combined with basal insulin is comparable to standard insulin therapy in controlling post-meal blood sugar levels in adult patients with Type 2 diabetes, and offers the added benefits of significantly less weight gain and lower risk of hypoglycemia. These study findings will be presented on Saturday, June 26, at a special symposium co-hosted by The Lancet and the American Diabetes Association (ADA), at the American Diabetes Association's 70th Scientific Sessions(R). The study will also be published in the June 26 issue of The Lancet, one of the world's leading medical journals...

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...AFREZZA is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind Corporation for the treatment of adult patients with Type 1 and Type 2 diabetes for the control of hyperglycemia. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder pre-metered into single use dose cartridges and the light, discreet and easy- to-use AFREZZA Inhaler. Administered at the start of a meal, AFREZZA dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the release of meal-time insulin observed in healthy individuals. To date, the AFREZZA clinical program has involved 50 different studies and over 5,000 adult patients... MannKind Corporation's Press Release -

Diamyd Medical and Ortho-McNeil-Janssen Pharmaceuticals : Agreement for Diabetes Therapy

June 22, 2010 - Diamyd Medical AB has signed an agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), a Johnson & Johnson company, to develop and commercialize the Diamyd® diabetes therapy.
The agreement relates to the development and world-wide commercialization of the GAD65 antigen-based therapy (Diamyd®) for the treatment and prevention of type 1 diabetes and associated conditions.
OMJPI will make an upfront payment of USD 45 million, and under the terms of the agreement, Diamyd has the potential to receive additional development and sales milestone payments of up to USD 580 million, as well as tiered royalties on future sales. The parties will equally share costs for the development program until results from the ongoing EU Phase III study, expected in the first half of 2011. OMJPI has the right to fully assume responsibility for the development program upon reviewing the results.

Following its strategy, Diamyd has secured exclusive rights for commercialization in the Nordic countries. Diamyd also retains the rights to the therapeutic use of the GAD65 gene and derivatives, fragments and variants of the GAD65 protein... Diamyd's Press Release - Johnson & Johnson's Press Release -

Metabolex and Ortho-McNeil-Janssen Pharmaceuticals : TYPE 2 DIABETES DEVELOPMENT AND LICENSE AGREEMENT

June 22, 2010 — Metabolex, Inc. announced that they have entered into a global development and license agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) to further develop and discover compounds for the treatment of type 2 diabetes and other disorders. Under the agreement, OMJPI will receive an exclusive worldwide license to develop, manufacture, and commercialize several Metabolex programs that are currently at the preclinical stage.

Under the terms of the agreement, Metabolex will receive an upfront payment and could be eligible to receive development, regulatory, and commercial milestones up to $330 million. Metabolex is also eligible to receive royalties on worldwide sales of marketed products... Metabolex's Press Release -

Lexicon Pharmaceuticals : Data Describing LX4211 Positive Phase 2 Clinical Results and Novel Mechanism of Action for Type 2 Diabetes

June 21, 2010 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, presented clinical data and analysis from its Phase 2a clinical trial of LX4211 for patients with type 2 diabetes mellitus at ENDO 2010. The results reported included newly-obtained data showing a trend of increased total GLP-1 in both LX4211 treatment arms relative to placebo as measured in a post-trial analysis of blood samples.
The Phase 2a clinical trial demonstrated that administration of LX4211, a dual SGLT2 and SGLT1 inhibitor, produced rapid and significant improvement in multiple assessments of glycemic control as well as positive trends in cardiovascular and metabolic parameters after only 28 days of dosing in type 2 diabetes patients. Importantly, after only four weeks of dosing, average percent hemoglobin A1c (HbA1c), a measure of blood glucose levels over time, was significantly reduced by 1.15 in the 150 mg dose group (p=0.036) and by 1.25 in the 300 mg dose group (p=0.017), as compared with 0.49 in the placebo group. HbA1c levels were reduced to less than or equal to 7% for half the patients in both dose groups; baseline levels were 8.22%, 8.50% and 8.20% for the 150 mg, 300 mg and placebo groups, respectively. In addition, positive trends were observed in weight, blood pressure and triglyceride reduction... Lexicon Pharmaceuticals' Press Release -

Avid Radiopharmaceuticals : Clinical Trial Advances in Molecular Imaging...

June 2, 2010 – Avid Radiopharmaceuticals, Inc. announced that seven oral presentations and three poster presentations will be made about the company’s PET imaging programs in three focus areas — Alzheimer’s disease (“AD”), Dementia with Lewy Bodies (“DLB”) and Diabetes — at the upcoming 2010 Annual Society of Nuclear Medicine (SNM) meeting in Salt Lake City, Utah, beginning Sunday, June 6, 2010.
Avid is a leading company in the development of novel molecular imaging compounds intended for the early detection and monitoring of significant chronic human diseases. Avid has completed enrollment of a landmark “Image-to-Autopsy” Phase III study of florbetapir F 18 (18F-AV-45), its amyloid imaging agent for the detection of the hallmark pathology of AD... [PDF] Avid Radiopharmaceuticals' Press Release -

Wright Medical Group : Commercial Launch of the VALOR(R) Hindfoot Fusion Nail System

Jun 03, 2010 - Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical device company, announced the full commercial launch of the VALOR(R) Hindfoot Fusion Nail - the most comprehensive and advanced surgical product for fusion of the ankle joint. The system was designed in conjunction with world-renowned foot and ankle surgeons to facilitate ankle fusion in the treatment of skeletal deformity, late-stage arthritis, or complications resulting from diabetes (neuro-osteoarthropathy). Since its initial pre-market availability announced in November of 2009, the system has been limited to use in a few centers in the U.S. gathering early clinical results... Wright Medical Group's Press Release -

Home Diagnostics and Nipro Diabetes Systems : Plans to Merge to Become Nipro Diagnostics

June 9, 2010 –– Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. announced that the two companies will merge to become Nipro Diagnostics, Inc. Both companies are wholly-owned by Nipro Corporation, a multi-billion dollar company headquartered in Osaka, Japan and a world leader in providing medical products to the healthcare community.
Home Diagnostics, Inc., based in Fort Lauderdale, Florida, manufactures and markets the TRUE brand of quality, high-performance blood glucose monitoring systems. Home Diagnostics is the co-brand supplier of blood glucose monitoring systems for leading national retail pharmacies, pharmacy wholesalers, medical products distributors and mail-order suppliers. Nipro Diabetes Systems, located in Miramar, Florida, is the manufacturer and marketer of the Amigo® Insulin Pump.
The merger of the two companies results in a comprehensive diabetes monitoring and insulin management product portfolio, which few companies offer. This portfolio will help to ensure that patients and their healthcare professionals have easy access to the high-quality diabetes monitoring and management tools they need to improve quality of life... [PDF] Nipro Diagnostics Press Release -

Cyntellect And Boston University To Collaborate In Diabetes And Anemia Research

DECEMBER 2, 2009 — Cyntellect, Inc., a privately-held life sciences company commercializing products to advance life science and stem cell research, biopharmaceutical production, and drug discovery, announced it has entered into a research collaboration agreement with the Boston University School of Medicine. The agreement focuses on advancing research in the roles of mitochondrial oxidative damage in degenerative, aging and metabolic diseases, such as anemia and diabetes. Boston University scientists will use Cyntellect’s award-winning LEAP™ Cell Processing Workstation to analyze, purify and process cells with great precision and simplicity within microplates, right where they are grown in the lab... [PDF] Cyntellect's Press Release -

Zydus Cadila : novel orally administered GLP-1 agonist – ‘ZYOG1’ to treat Diabetes and Obesity enters Phase I clinical trial

June 21, 2010 - Zydus Cadila, a global healthcare provider and one of India’s leading healthcare companies has received Phase I clinical trial permission from the DCGI for ZYOG1 - a novel GLP-1 agonist. Designed and developed at the Zydus Research Centre using a unique platform technology, ZYOG1 is a novel, oral, antidiabetic molecule.
The new class of anti-diabetic drugs called Glucagon Like Peptide-1 (GLP -1) agonists came to the fore in May 2005 when the first molecule of this class was approved by the USFDA. Glucagon Like Peptide-1 agonists are being used to treat people with type 2 diabetes who have not been able to control their blood sugar levels with oral medicines. It is an injectible which acts like the natural hormones in the body that lowers blood sugar.
ZYOG1 would represent a next generation GLP-1 agents, as it would not have to be injected but can be taken orally. ZYOG1, when administered by oral route demonstrated beneficial effects in preclinical models on glucose reduction, HbA1c reduction and showed an added benefit of weight loss. Additionally, ZYOG1 has displayed a differentiated preclinical safety profile with no nausea-like symptoms in the preclinical studies... [PDF] Zydus Cadila's Press Release -

Omni Bio Pharmaceutical : FDA IND Clearance for Alpha-1 antitrypsin (AAT) Type 1 Diabetes Clinical Trial

June 8, 2010 - Screening Underway at Barbara Davis Center for Childhood Diabetes at University of Colorado Denver Anschutz Medical Campus - Management to Present at Jefferies 2010 Global Life Sciences Conference – Omni Bio Pharmaceutical, Inc.(“OMNI”), (OTCBB: OMBP) announced that the Barbara Davis Center for Childhood Diabetes has received IND regulatory clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial evaluating Alpha-1 antitrypsin (“AAT”) in Type I diabetics.
Dr. Charles A. Dinarello, Acting Chief Executive Officer of OMNI stated, “We are pleased to announce IND Clearance for a Phase I/II clinical trial in Type 1 diabetics. Although this is the first time AAT will be evaluated in humans with Type 1 diabetes, AAT already has an excellent safety track record as an FDA-approved biological. We are confident that this outstanding safety profile was a significant factor in the FDA’s IND clearance.”
AAT is an FDA-approved, off-patent drug currently indicated for the treatment of pulmonary emphysema among those with genetic deficiency of AAT. Preclinical studies demonstrate that AAT may be effective in treating a variety of medical disorders. The decision to pursue a clinical trial of AAT in Type 1 diabetics was based on promising animal study data... [PDF] Omni Bio Pharmaceutical's Press Release -

LifeScan Canada collaborates with country's first consumer ehealth service

May 31, 2010 - LifeScan Canada Ltd. announced a collaboration with Canada's first consumer ehealth service. LifeScan will be the first distributor supporting the diabetes arm of the TELUS health space™ platform, allowing its customers to track all information related to their diabetes and easily share it with any doctor or other healthcare provider they want over a secure Internet connection.

"As a leader in blood glucose monitoring, we are constantly working to improve the lives of Canadians living with diabetes by bringing patients and healthcare providers the next level in diabetes care... LifeScan's Press Release [JNJ] - TELUS health space's Press Release -

Forest Laboratories and TransTech Pharma : License Agreement for the Development and Commercialization of Glucokinase Activators with Deal Valued...

June 8, 2010 - TransTech Pharma, Inc and Forest Laboratories, Inc. (NYSE: FRX), announced that TransTech Pharma and Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc. have entered into a license agreement for the development and commercialization of small molecule compounds discovered and developed by TransTech Pharma. These compounds are functionally liver-selective Glucokinase Activators (GKAs), which represent a novel class of glucose-lowering agents for the treatment of diabetes.

Through the license agreement, Forest will provide to TransTech Pharma an upfront license payment of $50 million. TransTech Pharma could receive up to $1.105 billion in upfront and milestone payments for the successful development and commercialization of the GKA compounds. Forest will also pay TransTech Pharma royalties on worldwide product sales and will be responsible for development and commercialization costs. TransTech Pharma retains the rights to the Middle East and North Africa, while Forest receives exclusive rights to the rest of the worldwide market. The portfolio licensed by Forest consists of a lead compound, TTP399, which has completed Phase I studies and other compounds in Phase I and pre-clinical stages of development... TransTech Pharma's Press Release - Forest Laboratories' Press Release -

OrbusNeich : Effectiveness of OrbusNeich's Genous™ Bio-engineered R stent™ in Diabetic Patients

May 26, 2010 - Data Presented at EuroPCR 2010 Demonstrate Effectiveness of OrbusNeich's Genous™ Bio-engineered R stent™ in Diabetic Patients – OrbusNeich announced that 12-month follow-up data from a subset analysis of the global e-HEALING registry demonstrate that the company’s Genous Bio-engineered R stent is effective in diabetic patients.
Peter Damman, M.D., of the Academic Medical Center in Amsterdam presented the subset analysis from 1,236 diabetic patients, including 273 insulin dependent diabetics (IDD) and 963 non-insulin dependent diabetics (NIDD), from the e-HEALING clinical registry and found a target vessel failure (TVF) rate of 10 percent for diabetic patients, compared to 7.9 percent for non-diabetics at 12 months. Specifically, the TVF rate in IDD was 13.4 percent, compared to 9 percent in NIDD. The higher TVF rates in diabetic patients were mainly driven by a higher mortality hazard. The target lesion revascularization rate (TLR) was 6.4 percent in diabetics, which is comparable to a reported 5.4 percent in non-diabetic patients, and the definite or probable stent thrombosis rate at 12 months was similar with 1.2 percent in diabetics compared to 1.1 percent in non-diabetics... [PDF] OrbusNeich's Press Release -

GENFIT : Two major pre-diabetes clinical trials within the IT-Diab Program

May 31, 2010 – GENFIT (Alternext: ALGFT; ISIN: FR0004163111), a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and associated disorders, announces that it has received approval from the French medical agencies to initiate the enrollment of patients in two major clinical trials in pre-diabetes and the early stages of diabetes, as part of its IT-Diab program.
The DECODIAB (DEpistage et COmpréhension du préDIABète) study, where a cohort of 500 hyperglycemic subjects will be assessed prospectively over a 5 year period for their conversion to Type 2 Diabetes, is led by Pr. Bertrand Cariou (Endocrinology-Diabetology Department, Thorax Institute/U915 INSERM, CHU Nantes, France). It will offer the opportunity to identify and validate in humans new biomarkers of -cell dysfunction in a population prone to develop Type 2 Diabetes. Enrollment for the DECODIAB trial is expected to begin in June 2010... [PDF] GENFIT's Press Release -