Mylan Pharmaceuticals : Approval for Generic Version of Precose® Tablets

Jan. 18, 2011 -- Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Acarbose Tablets, 25 mg, 50 mg and 100 mg, the generic version of Bayer's Precose® Tablets, a treatment to be used with diet and exercise to improve glycemic control in adults with type 2 diabetes.

Acarbose Tablets had U.S. sales of approximately $23 million for the 12 months ending Sept. 30, 2010, according to IMS Health. The product is available for immediate shipment.

Currently, Mylan has 169 ANDAs pending FDA approval representing $99.5 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $24 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health... Mylan's Press Release -

Biocrates Life Sciences : Metabolomic biomarker research for the early detection of diabetes

13 January 2011 – Metabolomic biomarker research is a young research area that carries great hopes for both medicine and the nutritional sciences, particularly for the early detection of genetically determined diseases. [...] The Austrian biotech company BIOCRATES Life Sciences AG provides cutting-edge support to these new research areas by contributing valuable research results, making available state-of-the-art research products, and setting milestones in the early detection of diabetes and in the field of personalized medicine.
Metabolomics - a young research field
The metabolome is the entirety of metabolites of an organism. This full set of metabolites is a mirror of the metabolic state of a cell or tissue. Metabolomics allows the medical profile of an individual to be determined, thereby predicting disease risk or how the organism will react to a particular drug. “Research into the metabolome can provide important insights into diseases such as cancer, nervous system disorders, asthma, or diabetes,” says Professor Jerzy Adamski, Helmholtz Center Munich. “Metabolomics enables the risks of certain diseases to be predicted and new diagnostic and therapeutic procedures to be developed. By analyzing the interactions between the genome (i.e., the entirety of the hereditary information of an organism), the metabolome, and environmental conditions, preventive health measures can be devised.”... [PDF] Biocrates Life Sciences' Press Release -

NeuroMetrix Announces New Strategic Direction : Primary Focus on Diabetes

Jan 04, 2011 - NeuroMetrix, Inc. (Nasdaq: NURO) announced that it will shift its business focus to diabetes, specifically detection and monitoring of diabetic neuropathy which is a common complication of the disease. The Company will continue to support its neurodiagnostic business which it intends to manage to optimize cash flow.

"Diabetes represents the largest and fastest growing opportunity for our proprietary technology," said Shai N. Gozani M.D., PhD., President and Chief Executive Officer of NeuroMetrix. "This is a fast growing sector in health care as countries around the world struggle to cope with an epidemic of Type II diabetes. Neuropathy is a common and serious complication of the disease that may lead to foot ulcers and limb amputation. We have over a decade of experience in neuropathy detection and believe we are uniquely positioned to address the unmet need for a rapid, cost-effective, objective test for diabetic neuropathy. We are working towards a mid 2011 launch of NC-stat-SL, which is a modified version of our NC-stat device designed specifically for assessment of diabetic neuropathy at the point-of-care. In support of our efforts, we have assembled a scientific advisory board of international experts."... NeuroMetrix's Press Release -

Sanofi-aventis Acquires from Ascendis Pharma Worldwide Rights on Drug-Delivery Technology in Diabetes and Related Disorders

December 21, 2010 – Innovative technology designed for sustained release of peptides and proteins – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Ascendis Pharma (Ascendis) announced a global licensing and patent transfer agreement on Ascendis’ proprietary TransCon Linker and Hydrogel carrier technology, which allows for a drug compound to be released in the body in a precise, time-controlled fashion, creating a long-acting effect.
The technology creates transient bonds between larger molecules such as proteins and peptides, including insulin, and a carrier. This allows for tailor-made release profiles, with no initial burst and high drug load formulations. The TransCon Linker technology has shown promising results in preclinical studies in delivering insulin.

“We are excited about this promising technology to create next-generation products in the field of diabetes and related disorders,” commented Pierre Chancel, Senior Vice-President, Head of the Global Diabetes Division, sanofi-aventis. “Building on our achievements with Lantus®, our 24-hour insulin approved for use once a day, we hope to further improve the lives of people with diabetes by developing this innovative technology to offer biologicals that present an extended and controlled release of unmodified parent drugs, including insulin."... [PDF] Ascendis Pharma's Press Release - [PDF] Sanofi-aventis' Press Release -

Evotec : Metabolic disease alliance with MedImmune

15 December 2010 - Focus on innovative diabetes therapy - €5 million upfront payment, up to €254 million milestones and royalties - Evotec's first commercial agreement in the field of beta cell regeneration - Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX) announced that via its subsidiary Develogen AG it has entered into a license and collaboration agreement with MedImmune (the global biologics unit of AstraZeneca), in the diabetes therapeutic area, with a particular focus on the regeneration of insulin producing beta cells. The license gives MedImmune exclusive access to a portfolio of research programs and represents the first deal executed by Evotec on beta cell regeneration assets and capabilities.


The agreement triggers an upfront payment of € 5 million. Further on, additional deferred payments including potential milestone payments of up to € 254 million as well as royalties are agreed. The milestone payments will be due upon achievement of certain clinical as well as regulatory and commercial events.


Further milestone payments may be achieved with the approval of additional indications and programs. Evotec will also receive research payments to support further in vivo and in vitro pharmacology efforts conducted in collaboration with MedImmune... Evotec's Press Release -

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 -