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 -