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 -