Valeritas FDA 510(k) Clearance for the V-Go™ Disposable Insulin Delivery Device

December 8, 2010 - V-Go provides Type 2 diabetic patients a simple option for basal-bolus insulin therapy - Valeritas, Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, announced that the US Food and Drug Administration has cleared the company's V-Go Disposable Insulin Delivery Device for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing for adult patients requiring insulin. V-Go devices will be available in a preset basal rate to deliver 20, 30 or 40 Units of insulin in one 24-hour period (0.83 U/hr, 1.25U/hr or 1.67U/hr respectively) and on-demand bolus dosing in 2 Unit increments (up to 36 Units per one 24-hour time period).

"The V-Go Disposable Insulin Delivery Device is the first fully disposable, non-electronic basal-bolus device that is specifically designed with the Type 2 population in mind," said Valeritas CEO Kristine Peterson. "We believe that the simple user features of the V-Go will allow more patients with diabetes to adhere to their insulin regimen, which ultimately may lead to better control." ... Valeritas' Press Release -

Merck to Acquire SmartCells, Inc.

Dec. 2, 2010 - Merck & Co., Inc., (NYSE:MRK) and SmartCells, Inc., announced that they have entered into a definitive agreement under which Merck will acquire SmartCells, a private company developing a glucose responsive insulin formulation for the treatment of diabetes mellitus.

"Maintaining control of blood glucose levels represents a daily challenge for people living with diabetes," said Nancy Thornberry, senior vice president and head, diabetes and obesity franchise, Merck Research Laboratories. "Through the acquisition of SmartCells we have obtained innovative technology that may enable us to develop glucose-responsive insulins. If this investigational technology is ultimately approved for use with patients, it could provide an important new therapy for the treatment of diabetes. This holds the potential to significantly impact the treatment of this disease."

Under the terms of the agreement, Merck will acquire all outstanding stock of SmartCells, Inc. In return SmartCells shareholders will receive an upfront cash payment and be eligible to receive clinical development and regulatory milestones for products resulting from the transaction for potential aggregate payments in excess of $500 million. Sales-based payments for products resulting from the transaction will also be payable. SmartCells' board of directors has unanimously approved the transaction... Merck & Co's Press Release -

Questcor : Interim Results From Independent Study of H.P. Acthar® Gel in Patients With Advanced Diabetic Nephropathy

DENVER, Nov. 22, 2010 - New data suggest Acthar may represent a novel pathway for the treatment of proteinuria due to diabetic nephropathy - Diabetic nephropathy represents the most common cause of end-stage renal disease in the U.S. - On November 20 at the American Society of Nephrology (ASN) 43rd Annual Meeting, interim results presented from an ongoing, randomized prospective study conducted independently by James A. Tumlin, MD, at the University of Tennessee College of Medicine Chattanooga indicated that 9 of 15 patients (60%) with advanced diabetic nephropathy who are currently enrolled in the study and have completed or are still undergoing a six month course of treatment with H.P. Acthar ® Gel (repository corticotropin injection) have exhibited a clinically significant decrease in proteinuria and achieved stabilized renal function. Excessive proteinuria, or urinary protein loss, is a known high risk factor for end-stage renal disease (ESRD).

Acthar is not currently indicated for the treatment of proteinuria associated with diabetic nephropathy.

"Our interim analysis suggests that Acthar may reduce proteinuria and stabilize renal function in patients with advanced diabetic nephropathy," stated Dr. Tumlin. "The use of Acthar could represent a novel pathway for the management of proteinuria associated with diabetic nephropathy. Given the very limited number of treatments available for these patients, further clinical evaluation of Acthar in patients with diabetic nephropathy is needed."

This is an exploratory, investigator-initiated study -- conducted independently by Dr. Tumlin but sponsored through a research grant from Questcor. The study currently has 15 patients enrolled. These patients have either completed or are still undergoing a six month course of Acthar therapy, and so far 9 have exhibited either a complete or partial response to therapy... Questcor's Press Release -

Freedom Meditech : Benefits of Non-invasive Diabetes Screening and Glucose Monitoring in the Eye

Freedom Meditech Presents Data Showing Benefits of Non-invasive Diabetes Screening and Glucose Monitoring in the Eye at London Conference
January 25, 2010 – People with diabetes or at risk of developing the disease – now estimated at over 400 million globally - could reduce complications, improve quality of life and reduce healthcare costs by using new non-invasive technology to screen for and monitor the illness, according to a presentation by Freedom Meditech at the 6th Annual Diabetes and Diabetic Retinopathy Conference in London, England.
“We believe that our proprietary technologies, which non-invasively measure changes in the eye to detect and monitor diabetes, could identify the presence of the disease earlier, and once found, reduce the pain and inconvenience barriers currently required to maintain optimal glycemic control,” said Craig Misrach, President & CEO of Freedom Meditech. “Early disease detection and maintaining tight glucose control are two important keys to reducing the proliferation and associated costs of diabetes complications such as diabetic retinopathy, macular degeneration, and blindness.” Diabetes complications directly attribute to over $120 billion in excess medical expenditures in the United States annually (American Diabetes Association, 2007).
Freedom Meditech is developing two products that non-invasively scan the eye with light to screen for diabetes and monitor glucose levels. The diabetes screening product, which targets an estimated $2 billion untapped market, is designed for use by ophthalmic care practitioners – a market entry point where diabetes can first present in patients. In clinical studies, the device has demonstrated the ability to detect diabetes rapidly, without a blood draw, and before complications become advanced. The company’s glucose monitoring technology targets a $10 billion market and is designed as a handheld device that a person with diabetes gazes into for a reading. Both devices are in the development stage... [PDF] Freedom Meditech's Press Release -

Wound Management Technologies : CellerateRX® Effectively Manages Diabetic Ulcers…

November 10, 2010 - New CDC Report Indicates Type 2 Diabetes on the Rise… Diabetes Projected to affect up to 1 in 3 Americans by 2050 - Wound Management Technologies, Inc., (WNDM: OTCQB) a leader in advanced wound care solutions, is meeting the challenge of a rise in type 2 diabetes in the US, as chronicled by a new report by the Center for Disease Control (CDC). The report published in the October 22, 2010 journal Population Health Metrics recommends that proper diet and physical activity can prevent type 2 diabetes and reduce its complications, among the most severe of which are diabetic ulcers and amputations. Wound Management, exclusive worldwide licensee and distributor of CellerateRX® wound care powder and gel, further recommends that existing diabetic patients who suffer from moderate to heavily exudative wounds should ask their doctor whether CellerateRX® may be an effective treatment for them. CellerateRX® is the only activated Type 1 collagen-based product reimbursed by Medicare and has been shown to effectively manage diabetic ulcers.... Wound Management Technologies' Press Release -

Epinex Diagnostics : Patent Granted for Revolutionary Diabetes Test

March 01, 2010 – The United States Patent and Trademark Office (USPTO) granted Epinex Diagnostics the patent for its primary technology, the G1A™ Rapid Diabetes Monitoring Index Test. The patent (US7659107B2) is for the first ever rapid glycated albumin test and instrument, which could redefine the way diabetes is monitored for over 250 million diabetics worldwide.

The G1A™ test provides a monthly diabetes-monitoring index by measuring damage caused by excess sugar to albumin, the most abundant serum protein. Albumin is an ideal monthly marker as it is replaced in the body every 2-3 weeks. Using only a pinprick of blood, the test will simultaneously and rapidly measure glycated albumin and total albumin. Researchers at the Wake Forest University School of Medicine have described glycated albumin as a “more robust” and “more accurate” indicator of long-term glycemic control... [PDF] Epinex Diagnostics' Press Release -

Repros Therapeutics : Randomization Of Subjects In Androxal® Type II Diabetes Phase II Trial

October 25, 2010 - New FDA Ruling On Potential For Development Of Diabetes Due To Castrating Effects Of GnRH Administration Reinforces Company Strategy For Androxal - Repros Therapeutics Inc.® (NasdaqCM:RPRXD) announced it has commenced randomization of subjects into its Phase II Androxal® study in the treatment of type 2 diabetes (T2DM) in men with low testosterone. Low testosterone and T2DM are co-morbid conditions in a significant number of men. The study is being conducted at nine sites across the US including both academic and private practices and will enroll up to 150 patients. The five private practices are located in the metropolitan New York area, San Antonio and Houston and were selected based on their current data base of patients that meet the inclusion criteria. These private practices have already begun to enroll and randomize subjects. Four academic sites were selected based on the same criteria, but were further assessed based on the expertise they bring to the study. The academic sites will require individual institutional review board approval, which can take a few months, before enrolling subjects... Repros Therapeutics' Press Release -

Biocon and Pfizer : Global Commercialization Agreement

Oct. 18, 2010 - Creates Global Alliance Well Positioned to Deliver Essential Insulin Treatments to Diabetes Patients Worldwide - Biocon, Asia's premier biotechnology company, and Pfizer Inc. (NYSE: PFE), the world's leading biopharmaceutical company, announced that they have entered into a strategic global agreement for the worldwide commercialization of Biocon's biosimilar versions of Insulin and Insulin analog products: Recombinant Human Insulin, Glargine, Aspart and Lispro. Pfizer will have exclusive rights to commercialize these products globally, with certain exceptions, including co-exclusive rights for all of the products with Biocon in Germany, India and Malaysia. Pfizer will also have co-exclusive rights with existing Biocon licensees with respect to some of the products, primarily in a number of developing markets.



Biocon will remain responsible for the clinical development, manufacture and supply of these biosimilar Insulin products, as well as for regulatory activities to secure approval for these products in various geographies. Biocon's Recombinant Human Insulin formulations are approved in 27 countries in developing markets, and commercialized in 23, while Glargine has been launched in its first market, India... Pfizer's Press Release - [PDF] Biocon's Press Release -

Dynavax Technologies : New HEPLISAV(TM) Data in Diabetics

Oct 11, 2010 - Dynavax Technologies Corporation (NASDAQ: DVAX) said that Dr. William L. Heyward, Vice President, Clinical Development, will make an oral presentation of new data from a subset of diabetes subjects evaluated as part of the company's previously reported multicenter, observer-blinded phase 3 study. The PHAST (Phase 3 HeplisAv Short-regimen Trial) study compared two doses of HEPLISAV (20ug HBsAg combined with 3000ug 1018 immunostimulatory sequence, Dynavax's Toll-like receptor agonist) given at 0 and 4 weeks (placebo at 24 weeks) to three doses of Engerix-B given at 0, 4 and 24 weeks. The presentation will be made in a late-breaker session on October 23, 2010 at the Annual Meeting of the Infectious Diseases Society of America (IDSA) in Vancouver, British Columbia.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has been studying the hepatitis B infection rates among diabetics and in long-term care facilities for quite some time. Later this month, ACIP will consider a recommendation for hepatitis B vaccination of adults with diabetes. Diabetics are at risk for hepatitis B infection and once infected, their disease frequently results in more severe chronic illness. Multiple outbreaks of hepatitis B among diabetics have occurred over the last several years in long-term care facilities, but prevention by vaccine has been complicated by the fact that diabetics are not routinely immunized and commonly do not respond well to currently licensed hepatitis B vaccines... Dynavax Technologies' Press Release -

TransPharma Medical : Successful Completion of Phase 1a Clinical Trial of ViaDerm-GLP1 Agonist Indicated for the Treatment of Type II Diabetes Study

September 14, 2010 - endpoints of pharmacokinetic profile, safety and tolerability successfully met - Phase 1b clinical study in patients has been initiated – TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced the successful completion of a Phase 1a trial of ViaDerm-GLP1 agonist which is being developed for the treatment of diabetes mellitus type II. The Phase 1 study was a three-way cross over study designed to evaluate the pharmacokinetic (PK) profile and assess safety and tolerability of two doses of ViaDerm-GLP1 agonist in healthy volunteers, as compared to a subcutaneous injection of Exenatide (Byetta). Each volunteer received all three treatments with a washout period of one week between treatments.

The results of the study demonstrate ViaDerm-GLP1 agonist to be safe and well-tolerated with a preferable extended PK profile compared to an injection of Exenatide (Byetta). Transdermal application of ViaDerm-GLP1 agonist resulted in therapeutic GLP1 blood levels for approximately 13 hours compared to 6 hours of the injected form. In addition, ViaDerm-GLP1 agonist was demonstrated to be biologically active based on changes in glucose levels during the treatment. TransPharma has initiated enrollment of Type II diabetic patients to a phase 1b clinical trial using its dry form, extended release state-of-the-art patch formulation of GLP1 agonist... TransPharma Medical's Press release -

Janssen and European Foundation for the Study of Diabetes will jointly fund research into the kidney’s role in diabetes

September 24, 2010 - Janssen and the European Foundation for the Study of Diabetes (EFSD) will jointly contribute up to a €500,000 pool to fund a three-year research program into the role of the kidney in type 2 diabetes mellitus. EFSD is the research arm of the European Association for the Study of Diabetes (EASD).
The research initiative - which will begin in 2011 and run until 2013 - was officially announced on 24 September 2010 during the 46th EASD Meeting in Stockholm.
“EFSD is proud to join forces with Janssen to thoroughly explore type-2 diabetes which, despite being one of the defining health problems of the 21st century, remains insufficiently understood... Janssen's Press Release -

Sanofi-aventis : innovative blood glucose monitoring self-management of diabetes devices to enhance

September 21, 2010 - Patient-centric approach and new mobile health technology – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced the upcoming launch of the blood glucose monitoring (BGM) devices BGStar® and iBGStarTM, developed by sanofi-aventis and its partner AgaMatrix. Due to their convenience, accuracy and ease-of-use, BGStar® and iBGStar[TM] will help the decision-making process for people with diabetes and their healthcare professionals, with the aim of improving patient self-management. iBGStarTM connects to the iPhone® or iPod touch®. This is an important step towards sanofi-aventis’ vision of becoming the leader in global diabetes care by integrating innovative monitoring technology, therapeutic innovations, personalized services and support solutions.

BGStar® and iBGStar™ are planned to be made commercially available in the first markets in early 2011.
“Our patient-centric approach means we truly understand the challenges faced by people with diabetes,”... [PDF] Sanofi-aventis' Press Release -

Advinus Therapeutics : novel molecule for treatment of diabetes, completes Phase 1 Single Ascending Dose study

September 7 2010 - Advinus Therapeutics, the research-based pharmaceutical company promoted by the TATA Group has discovered a novel molecule for the treatment of type II diabetes - GKM -001. The molecule is an activator of glucokinase; an enzyme that regulates glucose balance and insulin secretion in the body.

GKM-001 is the completely indigenously developed molecule and the initial clinical trials have shown excellent results for both safety and efficacy.

"Considering past failures of other companies on this target, our discovery program primarily focused on identifying a molecule that would be efficacious without causing hypoglycemia. The Phase I data indicate that GKM - 001 is a liver selective molecule that has overcome the biggest clinical challenge of hypoglycemia. GKM-001 is differentiated from most other GK molecules in development due to this novel mechanism of action... Advinus Therapeutics' Press Release -

Cellonis Biotechnologies : Novel stem cell therapy can help children with diabetes get back their normal lives

August 23, 2010 - Cellonis Biotechnologies, a Beijing and HK-based medical research and application company, has recorded some remarkable results in the treatment of a twelve-year-old boy with diabetes using their stem cell therapy in a Beijing partner hospital. He has completely regained his normal life, enjoying sports and school activities just like every other person his age, and has been free from injections and drugs for more than half a year.

"Our whole family is delighted with this outcome," his mother commented in a Cellonis interview. "He is now no different from any other child at his school. There is no sign of diabetes anymore. He previously coughed a lot in spring and winter, but after the therapy we haven't seen him coughing at all. We are very pleased."... Cellonis Biotechnologies' Press Release -

ZenBio : Awarded Phase I SBIR Grant to Develop Adipose Stem Cells into Insulin Producing Cells

July 1, 2010 - ZenBio, Inc. announced that it has been awarded a Phase I SBIR grant to identify and characterize an adult stem cell population from human fat stroma that has the therapeutic potential to differentiate into insulin-secreting “beta-like” cells.
Human adult stem cells derived from adipose tissue are a practical source of stem cells from which to launch work on deriving beta-like cells for autologous transplantation. The medical need for new therapies to manage type 1 and type 2 diabetes is well known and appreciated by physicians and patients alike. A plentiful and convenient source of cells that release appropriate amounts of insulin in response to changes in glucose would be a major advancement for diabetes therapy, particularly if the cells were provided by the patient (i.e. autologous transplantation). “In type 1 and long-term type 2 diabetes, the failure of the beta cells in the pancreas to produce sufficient insulin results in eventual insulin dependence for survival.”... [PDF] ZenBio's Press Release -

OM Pharma : New article published in Diabetes presents insights on the mode of action calcium dobesilate in diabetic retinopathy

23rd July 2010 - A paper titled “Calcium dobesilate inhibits the alterations in tight junction proteins and leukocyte adhesion to retinal endothelial cells induced by diabetes” will be published in the August issue of Diabetes.

Diabetes is the reference journal for the physiology and pathophysiology of diabetes mellitus. The latest impact factor for Diabetes is 8.261, it is ranked 3rd of 92 publications in the field of endocrinology/metabolism and 2nd among journals publishing original research in that field.

The paper presents results of preclinical research conducted with calcium dobesilate - the active principle of Doxium® by a research team of the AIBILI centre in Coimbra, Portugal in collaboration with OM Pharma... OM Pharma's Press Release -

Prodigy : syringe-filling system for blind and low-vision diabetics

March 16, 2010 – Prodigy Diabetes Care, LLC, is launching its new Prodigy® Count-a dose™ April 1, a precise and safe syringe-filling device for the blind and visually impaired.
The Prodigy® Count-a-dose™ offers diabetics a device which can easily measure and mix two insulins at one time. The device had been pulled from the market a year ago by another company, prompting an outcry from blind and low-vision diabetics. Prodigy® is coming to their rescue as of April 1.
The initial version uses touch and sound to allow diabetics to measure out dosages. Prodigy® plans to release a fully audible version in the future, which mirrors the company’s commitment to providing audible medical devices.
“We’ve perfected the device to make it simple for the blind or low-vision patient to easily and, above all, safely fill their own insulin syringes,”... [PDF] Prodigy Diabetes Care's Press Release -

Forest Laboratories and Gedeon Richter : Results from a Phase II Study of Radiprodil for the Treatment of Diabetic Peripheral Neuropathic Pain

June, 29, 2010-- Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc. announced top-line results from a Phase II placebo and positive comparator-controlled, parallel-arm, double-blind, dose-response clinical trial of the novel, investigational NR2B-selective NMDA (N-methyl D-aspartate) receptor antagonist, radiprodil (RGH-896), for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPNP). Treatment with radiprodil did not show statistically significant or clinically meaningful reductions in mean daily pain scores, the primary endpoint, compared to placebo for any of the dosages studied.

The companies will review the complete study database over the coming weeks to determine the appropriate next steps regarding the development of radiprodil.

About the Study

This was a randomized placebo and active-controlled parallel-arm, double-blind, dose-response study in patients with diabetic peripheral neuropathic pain (DPNP) who were clinically diagnosed with painful polyneuropathy (greater-than or equal to 6 months) due to type I or type II diabetes mellitus. Patients had a minimum daily pain rating of at least four at screening, and an average daily pain rating of at least four (on an eleven-point scale) during the one week before baseline.



Following a five-week screening/washout period during which all analgesic medications used for DPNP were discontinued, a total of 458 male or female outpatients between 18 and 75 years of age were randomized to one of three radiprodil doses (15mg, 30mg, 45mg), an active comparator (100mg pregabalin), or placebo given three times a day (TID) for 14 weeks... Forest Laboratories' Press Release -

Johnson & Johnson Pharmaceutical Research & Development : Phase 2b Clinical Trial Results Evaluating Canagliflozin to Treat Type 2 Diabetes

June 26, 2010 – Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced that canagliflozin, an investigational, oral, selective sodium-glucose transporter-2 (SGLT2) inhibitor, improved glycemic control, and was also associated with a decrease in body weight, in a Phase 2b dose-ranging trial in patients diagnosed with type 2 diabetes who were concurrently treated with metformin. The data were presented at the 70th American Diabetes Association (ADA) Annual Scientific Sessions.

Canagliflozin is a member of a new class of antihyperglycemic therapies under development to treat type 2 diabetes. Blood glucose filtered in the kidney is mainly reabsorbed into the blood stream by SGLT2. Inhibiting SGLT2 is believed to reduce blood glucose levels by increasing the amount of glucose excreted in the urine, which may also lead to a loss of calories... Johnson & Johnson's Press Release -

Novo Nordisk : Victoza® to be launched in Japan

2 June 2010 - Novo Nordisk announced that it has received approval of the price of Victoza®, a once-daily human GLP-1 analogue for the treatment of type 2 diabetes, from Japan’s Central Social Insurance Medical Council (Chuikyo), the advisory committee to the Minister of Health, Labour and Welfare.

The price approval allows Novo Nordisk to commercially launch in Japan shortly after Victoza® is officially posted on Japan’s National Health Insurance price list 11 June.

Victoza® is the first GLP-1 to achieve regulatory approval and commercial availability in Japan. It is indicated for the treatment of type 2 diabetes when used as monotherapy or as an add-on to sulphonylurea (SU)... Novo Nordisk's Press Release -

Vitae Pharmaceuticals Receives $14 Million Milestone Payment as Boehringer Ingelheim Advances Lead Compound into Phase I Clinical Trials

June 28, 2010 - Program Targets 11beta-HSD-1 for the Treatment of Diabetes and Other Metabolic Syndrome Disorders - Vitae Pharmaceuticals, Inc., an integrated discovery and development company, announced that it has earned a $14 million clinical milestone payment from Boehringer Ingelheim, one of the world’s 20 leading pharmaceutical companies. Vitae’s 11beta-hydroxysteroid dehydrogenase (HSD)-1 is targeted for the treatment of diabetes and metabolic syndrome-related diseases in a strategic alliance with Boehringer Ingelheim. The payment recognizes Boehringer Ingelheim’s recent advancement of a small molecule inhibitor of 11beta-HSD-1 into Phase I clinical trials.

“Inhibition of 11beta-HSD-1 represents an important new mechanism of action for treating diabetic patients,”... [PDF] Vitae Pharmaceuticals' Press Release -

Servier : Launch of IMIDIA, an Innovative Medicines Initiative (IMI) project to fight diabetes

June 14, 2010. IMIDIA (“Innovative Medicines Initiative for Diabetes”), a public private consortium funded by the Innovative Medicines Initiative (IMI), announced the launch of a project focusing on pancreatic islet cell function and survival. Academia, biotech and pharma industry have joined forces to develop biomarkers and tools to pave the way for improved disease management and ultimately provide a cure for diabetes.


Leading European experts from 14 academic institutions, 8 pharmaceutical research organizations and 1 biotech company in the area of pancreatic ß-cells (= the body’s own insulin producing cells) officially launched the IMIDIA project. The project is supported by the Innovative Medicines Initiative (IMI). IMI a unique Public Private Partnership between the pharmaceutical industry (represented by the European Federation of Pharmaceutical Industries and Associations / EFPIA) and the European Union. The EU contributes a total of EUR 1 billion over ten years, which is matched in-kind by the EFPIA member companies...

[...]

...About IMIDIA:

The IMIDIA team, led by sanofi-aventis, Servier and the University of Lausanne is working on the generation of novel, patient centric tools, biomarkers, and fundamental knowledge on ß-cell organization to accelerate the path to improved diabetes management... Servier's Press Release -

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...

[...]

...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 -

Home Diagnostics, Inc. and Cellnovo : Strategic Alliance

May 6, 2010 – Building on a shared vision to simplify diabetes management worldwide, Cellnovo, a London-based medical device company, and Home Diagnostics, Inc., a leader in diabetes products, announced a strategic alliance that involves integrating technologies and developing distribution opportunities for Cellnovo’s insulin patch pumps.

The partnership allows both companies to accelerate their growth and has the potential to transform the pump industry. The first phase of the agreement calls for the inclusion of Home Diagnostics TRUE™ blood glucose technology in the Cellnovo wireless mobile handset. The companies will also begin exploring ways to leverage Home Diagnostics’ distribution network to expand Cellnovo’s presence in the United States and other countries... [PDF] Home Diagnostics' Press Release -

IRIDEX : First Commercial Shipment of New IQ 532(TM) Laser Systems

April 30, 2010 - IRIDEX Corporation, (Nasdaq: IRIX) announced the commencement of commercial shipment of the IQ 532 laser systems. The IQ 532 is a high-power, 532 nm, dual port multi-purpose laser system for use by ophthalmologists to treat sight-threatening eye diseases such as diabetic retinopathy, age-related macular degeneration and glaucoma; and for use by otolaryngologists to correct certain types of conductive hearing loss.

"The time and effort we invested to perfect our core system platform and obtain regulatory approval for a family of laser products has made it possible to introduce the IQ 532 green laser within one year of shipping the IQ 577 yellow laser... IRIDEX's Press Release -