Porosome Therapeutics Announces Groundbreaking Approach to Advance Diabetes Treatment

October 30, 2023 (BOSTON) – Porosome Therapeutics, Inc. (Porosome Therapeutics) has announced a new and distinctive therapy for Type 1 Diabetes (T1D) and Type 2 Diabetes (T2D) targeting the insulin secretory defects found in beta cells associated with the disease. Porosome Therapeutics’ approach addresses the cell's secretory machinery.

Porosome Therapeutics Founder and Chairman Professor Bhanu P. Jena discovered a new cellular structure called the porosome nearly three decades ago. After its discovery, the porosome was isolated and its structure and composition determined before porosomes were successfully inserted into cells to enhance secretion. This groundbreaking discovery provides a platform for diabetes treatments, as well as other secretory disorders such as cystic fibrosis, Alzheimer’s, and certain cancers. This approach is novel in that it provides the ability to target undruggable proteins, which make up almost 85% of the human proteome.

“Identifying effective approaches to find therapeutic solutions to undruggable proteins is our major focus,” said Jena. “By targeting beta cells and incorporating additional insulin-secreting porosomes, we are able to restore the cell’s ability to secrete insulin. Similarly, a major issue in treating T1D using beta cells derived from induced pluripotent stem cells (iPSC), is the inability of these beta cells to optimally secrete insulin in response to a glucose challenge. Consequently, a large number of such beta cells derived from iPSC are required for a transplant, a major issue. This can be overcome by reconstituting insulin-secreting porosomes to the iPSC derived beta cells prior to a transplant. Our solution is a promising advancement in treating diabetes.” 

Porosome Therapeutics' has two novel therapeutic approaches.  The first is the proprietary approach of “porosome-reconstitution therapy,” where insulin-secreting porosomes are introduced into the cell plasma membrane of stem cell-derived beta cells. This approach has been demonstrated in published studies to enhance glucose-stimulated insulin secretion.  The second proprietary approach is the use of a porosome-targeted small molecule capable of both insulin synthesis and secretion from beta cells. When combined with Metformin, a widely used medication for T2D, it could offer a powerful therapeutic approach to manage and treat T2D...Porosome Therapeutics' Press Release -

CSL : drug candidate in diabetes research breakthrough

27/09/2012 - CSL Limited has developed a new drug candidate that is able to prevent the development of type 2 diabetes and reverse its progression in animal models of the disease.

The drug candidate blocks signalling by a protein known as Vascular Endothelial Growth Factor B (VEGF-B) and this prevents fat from accumulating in the “wrong” places, such as in muscles and in the heart. As a result, cells within these tissues are once again able to respond to insulin and blood glucose is restored to normal levels.

This represents an entirely new approach to the treatment of type 2 diabetes and a paper outlining this breakthrough has just been published in the prestigious scientific journal Nature.

The research is a joint effort by an international team led by Professor Ulf Eriksson from the Karolinska Institute in Sweden, and involving scientists from CSL‟s research laboratories in Melbourne, The University of Melbourne and the Ludwig Institute for Cancer Research.

“The results seen in these laboratory studies are very promising for the millions of people around the world who are affected by type 2 diabetes,” said Dr Andrew Nash, Senior Vice President of Research at CSL... CSL's Press Release -

NGM and Daiichi Sankyo Collaborate to Discover and Develop Innovative Therapeutics for Diabetes

March 28, 2012) – Daiichi Sankyo Company, Ltd. (hereafter, Daiichi Sankyo) and NGM Biopharmaceuticals, Inc. (hereafter, NGM) announced that they have entered into a research collaboration and license agreement to discover and develop novel therapeutics that modulate beta-cell regeneration for the treatment of diabetes. The loss or decline of beta-cell function contributes to the pathogenesis of diabetes, a chronic disease that ultimately necessitates insulin therapy for the majority of sufferers. A therapeutic providing for beta-cell regeneration could potentially be disease-modifying and represent a significant advance for patients suffering from Type 1 or Type 2 diabetes.

As part of this collaboration, NGM will apply its integrated discovery technology and in vivo screening platform to identify and validate physiologically-relevant metabolic targets that modulate beta-cell growth and function. Daiichi Sankyo and NGM will jointly conduct research on selected targets with the goal of identifying and optimizing drug candidates for further development. Daiichi Sankyo will assume responsibility for preclinical studies, clinical development, manufacturing and commercialization on a worldwide basis.

Under the terms of the agreement, NGM will receive an upfront payment and committed research funding for the duration of the collaboration. In addition, NGM is eligible to receive payments upon the achievement of research, development, regulatory and commercial milestones, as well as royalties on product sales. Daiichi Sankyo will receive an exclusive worldwide license to develop and commercialize compounds resulting from the collaboration... Daiichi Sankyo's Press Release - [PDF] NGM Biopharmaceuticals' Press Release -

PhaseBio : Positive Clinical Results with its Once Weekly GLP-1 analogue, Glymera

November 15, 2011 - For the Treatment of Hyperglycemia in Patients with Type 2 Diabetes -

PhaseBio Pharmaceuticals, Inc., announced positive results from its Phase I/IIa single and multiple ascending dose clinical study with Glymera™, a recombinant glucagon-like peptide-1 (GLP-1) analogue for the treatment of hyperglycemia in patients with type 2 diabetes. In a dose dependent manner, Glymera™ demonstrated highly statistically significant reductions in fasting glucose glycemic load following meal tolerance testing, and average daily glucose measured through continuous glucose monitoring following 4 weeks of dosing.

“Currently approved GLP-1 analogues in the US need to be given at least once a day. Our intent was to develop a long acting product that would provide full 24/7 coverage and we are extremely pleased to have such robust results this early in the development of Glymera™ that supports a weekly dosing regimen and plan to aggressively move Glymera™ through the development process” said Lynne Georgopoulos, Senior Vice President Clinical Development at PhaseBio...PhaseBio Pharmaceuticals' Press Release -

AstraZeneca : Option Agreement to Acquire New Class of Diabetes Assets from Prosidion

20th December, 2011 – AstraZeneca and Prosidion Limited, a fully-owned subsidiary of Astellas Pharma Inc. (Tokyo: 4503,”Astellas”), announced that they entered into an option agreement, under which Prosidion grants to AstraZeneca an exclusive option to acquire the Phase II clinical and pre-clinical assets, PSN821 and PSN 842 respectively, for the treatment of type 2 diabetes. Both PSN821 and PSN842 are orally administered G protein-coupled receptor GPR119 agonists, a potential new class of medicines for diabetes.

PSN821 is currently in a Phase-II clinical trial for the treatment of type 2 diabetes. It has been shown in pre-clinical disease models to substantially lower blood glucose, reduce food intake and bodyweight and therefore has the potential to be a valued addition to the future treatments for type 2 diabetes. PSN842 is currently poised to enter clinical trials to treat type 2 diabetes.

Under the terms of the agreement, AstraZeneca will pay Prosidion an undisclosed, non-refundable option fee. The exercise of the option will be dependent upon the successful results of the Phase-IIa clinical trial of PSN821 and the evaluation of pre-clinical work. In the event that AstraZeneca exercises the option, AstraZeneca would acquire the assets from Prosidion and would pay an undisclosed, pre-specified upfront payment and milestone payments... AstraZeneca's Press Release - [PDF] Astellas' Press Release -

Servier : Type 2 Diabetes partnership with Canadian firm Prognomix Inc.

Nov. 8, 2011 - Les Laboratoires Servier, France (Servier) and Prognomix Inc., Canada (Prognomix) announced that they have entered into a research and development agreement aimed at identifying novel targets as part of programs meant to develop innovative type 2 diabetes and metabolic disease treatment.

This collaboration will rest on the discovery platform developed by Prognomix. This platform comprises genomic and bioinformatic technologies, a database of phenotypic and genotypic data and an assembly of results of the analysis of these data that are at the foundation of a knowledge base that will be exploited by the partners. This knowledge base was developed using, among other, the data collected during ADVANCE, the largest clinical study ever conducted on Type 2 diabetes and of which Servier was the main sponsor.

As part of the agreement, Servier will make a contract signature fee payment and will be granted options to obtain rights to use the results of the collaboration.

According to Dr. Pavel Hamet, President of Prognomix, « Closing of this agreement represents an important step in the development of Prognomix and confirms the value of the knowledge base that we have developed. We are happy to initiate this collaboration with Servier, a well known and very innovative pharmaceutical company and we are excited by the opportunities it represents ».

According to Dr. Emmanuel Canet, President of Research and Development at Servier, « This partnership confirms Servier interest for well validated biomarkers, allowing for the identification of the patients who will benefit the most from Servier therapeutic innovations »... [PDF] Prognomix's Press Release - Servier's Press Releases -

Poxel : New Clinical Results for an Anti-Diabetic Compound in Development

LYON, FRANCE - Oct. 26, 2011 - Poxel's Novel Compound Imeglimin Shows Significant Benefits in Type 2 Diabetes When Added to Metformin -

Poxel SA announced that Imeglimin, a novel compound in development for Type 2 diabetes, showed incremental efficacy as an add-on therapy to metformin, the reference first-line treatment, in patients inadequately controlled by metformin monotherapy. The study achieved its primary endpoint of superiority in HbA1c reduction versus placebo (p<0.001), and the decrease in FPG (Fasting Plasma Glucose) was also statistically significant (p<0.001). Reduction in HbA1c and FPG are two important measure of diabetes control.

Data from this Phase II trial assessing the clinical benefit of adding imeglimin to metformin demonstrate that in 12 weeks, patients in the imeglimin-metformin treatment group experience a -0.65 % reduction in HbA1c versus baseline. Moreover, the initial results indicated a trend towards reduced BMI (body mass index) and waist circumference, further indications of diabetes control. The overall safety and tolerability profile in the Imeglimin-metformin group was good.

Professor Valdis Pirags, Principal Investigator, commented, "I am pleased to see how positive these findings are. The results are exciting and we wait to further contribute to the development of this compound."

"The results from this add-on study are extremely encouraging, and I am confident that further development trials will reinforce the conclusion that Imeglimin is a safe and efficacious treatment option for diabetic people. There is still a need for new medications to control their disease," said Professor Harold Lebovitz, a distinguished member of Poxel's scientific advisory board... [PDF] Poxel's Press Release -

Boston Therapeutics : to Start Clinical Trial in Type 2 Diabetes

October 11, 2011 - Boston Therapeutics, Inc., a public company registered with the SEC and a developer of diabetes therapeutics, announced the initiation of its first clinical trial to evaluate the Safety and Efficacy of PAZ320 when added to oral agents or Insulin regimen in Patients with Type 2 Diabetes Mellitus.

“We have already seen significant reduction of post-meal elevation of glucose in preclinical models with PAZ320,” said David Platt, Ph.D., Chief Executive Officer of Boston Therapeutics. “We are excited about our collaboration with Endocrinologist Sushela Chaidarun, M.D., Ph.D. and Dr. Laura E. Trask at Dartmouth Hitchcock Medical Center and the possibility to help millions of people with high blood sugar and diabetes.” 

PAZ320 is a chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose. It is a proprietary polysaccharide designed to be taken before meals and works in the gastrointestinal system to block the action of carbohydrate-hydrolyzing enzymes which break down carbohydrates into glucose and release it into the bloodstream. This clinical study will evaluate the safety and efficacy of PAZ320 when added to oral diabetes agents or insulin. The study population will consist of adults aged 18-75 years with Type 2 diabetes, either on oral agents or insulin with a BMI of 25-35 kg/m2 and with A1c of less than 9.0%... [PDF] Boston Therapeutics' Press Release -

Merck : FDA Approves Merck's JUVISYNC™ (sitagliptin and simvastatin) Tablets, a Once-Daily Therapy for Patients with Type 2 Diabetes Who Need to Lower Blood Sugar and Cholesterol, Known Risk Factors for Cardiovascular Disease

Oct. 7, 2011 - Multiple National Guidelines Recommend that Patients with Type 2 Diabetes be Treated for Cholesterol - Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved JUVISYNC™ (sitagliptin and simvastatin), a new treatment for type 2 diabetes that combines the glucose-lowering medication sitagliptin, the active component of JANUVIA® (sitagliptin), with the cholesterol-lowering medication ZOCOR® (simvastatin). JUVISYNC is the first treatment option for healthcare providers to help patients who need the blood sugar-lowering benefits of a DPP-4 inhibitor and the cholesterol-lowering benefits of simvastatin, with the convenience of a single tablet once daily. "Although clinical guidelines put people with type 2 diabetes who need glycemic and lipid therapy at the same risk level as those with coronary heart disease, nearly 40 percent of eligible patients do not receive statin treatment," said Barry J. Goldstein, M.D., Ph.D., vice president, Diabetes and Endocrinology, Merck. "We are proud to bring forward a treatment option that can help these patients who need both glycemic and lipid therapy."

Indications and usage for JUVISYNC

JUVISYNC is indicated in patients for whom treatment with both sitagliptin and simvastatin is appropriate. Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet... Merck' s Press Release -

Furiex Pharmaceuticals Confirms Takeda Launches LIOVEL® LD and LIOVEL® HD, a Fixed Dose Combination of NESINA® and ACTOS® for Type 2 Diabetes in Japan

September 20, 2011 - Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) confirmed that Takeda Pharmaceutical Company Limited ("Takeda") has launched two dosages of LIOVEL®, a fixed dose combination tablet of NESINA® (alogliptin) and ACTOS® (pioglitazone HCL), in Japan for the treatment of Type 2 diabetes.

Furiex developed NESINA, which is a member of the dipeptidyl peptidase IV (DPP-4) inhibitor class, in collaboration with Takeda's wholly-owned subsidiary, Takeda San Diego, Inc. LIOVEL LD and LIOVEL HD contain 25 mg alogliptin/15 mg pioglitazone and 25 mg alogliptin/30 mg pioglitazone, respectively.

"We are very pleased with Takeda's launch of LIOVEL in Japan, a new product using the drug NESINA," said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. "This launch adds to Furiex's revenue stream and confirms our strategy of partnering drug candidates in return for royalty payments." 

Under Furiex's agreement with Takeda, this launch does not trigger a milestone payment to Furiex. However, Furiex is entitled to receive royalty payments on sales of LIOVEL... Furiex Pharmaceuticals' Press Release - Takeda Pharmaceutical's Press Release -

Bristol-Myers Squibb and Ambrx : Collaboration for Novel Biologics Programs in Diabetes and Heart Failure

September 22, 2011 - Bristol-Myers Squibb Company (NYSE: BMY) and Ambrx, Inc. announced a collaboration under which Bristol-Myers Squibb will receive exclusive worldwide rights to research, develop and commercialize biologics based on Ambrx’s research surrounding the Fibroblast Growth Factor 21 (FGF-21) protein, for potential use in treating type 2 diabetes, and the Relaxin hormone, for potential use in treating heart failure. Derivatives of FGF-21 and Relaxin were developed using Ambrx’s unique ReCODE™ platform technology to modify the native proteins with amino acid building blocks beyond the common 20 to engineer enhanced versions for investigation for therapeutic use.

Under the terms of the agreement, Bristol-Myers Squibb will make an upfront payment of $24 million to Ambrx. In addition, Bristol-Myers Squibb will make potential milestone payments and royalty payments on worldwide sales for both programs. Bristol-Myers Squibb and Ambrx will also enter research collaborations for both programs.

FGF-21 is a naturally occurring protein that has been characterized as a potent metabolic regulator, and has been shown to lower blood glucose, elevate good cholesterol and promote weight loss in preclinical studies. The lead compound in this program, ARX618, or PEG-FGF-21, is in the final stages of preclinical development.

Relaxin is a naturally occurring hormone known for its role in pregnancy and childbirth. Preclinical studies suggest Relaxin may aid in the treatment of heart failure by improving cardiac function. This program is in preclinical development... Bristol-Myers Squibb's Press Release - Ambrx's Press Release -

Amarantus BioSciences and Generex Biotechnology : Collaboration on Cell Therapy for Late Stage Diabetes

Aug. 4, 2011 - Amarantus BioSciences (OTCBB: AMBS), a biotechnology company developing a first-in-class anti-apoptosis therapeutic protein known as MANF, and Generex Biotechnology Corporation (OTCBB: GNBT), a biotechnology company developing a buccal insulin spray technology known as Generex Oral-lyn™, currently in a Phase III trial, are making public the details of their intended third joint diabetes research collaboration. In this third research project, the companies will use Amarantus' proprietary PhenoGuard cell immortalization process to develop beta cell replacement therapies to aid diabetes therapy. The two companies are currently planning to develop a MANF-based diagnostic test to identify a sub-population at risk of developing Type 1 or Type 2 diabetes as well as a MANF-based therapeutic to be administered using the RapidMist™ delivery system for the treatment of diabetes and impaired glucose tolerance.


"The potential of Amarantus' proprietary PhenoGuard cell immortalization process to create a stable source of representative beta cells that can be used in cell replacement therapy in patients who have lost virtually all beta cell function represents a potential major breakthrough for the treatment of chronic, late-stage diabetes," said Dr. James Anderson, Senior Scientific Advisor and Director of Generex. "Patients whose beta cell function is most impaired are the ones most at-risk of developing life-threatening complications of diabetes. Beta cell replacement therapy taken together with the development of a diagnostic test able to track the progression of beta cell dysfunction, and the ability to administer MANF prophylactically and therapeutically to alter the course of beta cell apoptosis and dysfunction in patients with diabetes and pre-diabetes disorders, these three research collaboration programs represent major research and development initiatives that could dramatically alter the course of treatment in the diabetes space. The breadth and scope of this research collaboration provides Generex with an incredible opportunity to position itself as a long-term market leader in the treatment of diabetes-related metabolic disorders."... [PDF] Amarantus BioSciences' Press Release - Generex Biotechnology 's Press Release -

Axxam and Polyphor : Research Partnership for the Treatment of Type-2 Diabetes Funded by the EU

July 27, 2011 - The partnership between Axxam Spa and Polyphor Ltd receives a three-year EU grant under the Eurostars Program for the generation of innovative GLP-1R modulators - Axxam Spa and Polyphor Ltd announced a joint discovery research project for the generation of GLP-1R modulators. The partnership will receive funding from the EU as part of the Eurostars Program aimed at supporting innovation within the European Union.
The two companies will undertake a three-year research project with the objective of identifying and developing different classes of molecules as novel therapeutic agents to modulate the activity of the Glucagon-like-peptide 1 receptor (GLP-1R) for the treatment of Type-2 Diabetes.

“Axxam has developed several innovative technologies for drug discovery research of GPCRs including new functional readout systems, like Photina® and chAMPion that set the ground to develop smart screening assays for the identification of GLP-1R modulators,” said Dr. Chiara Liberati, Head of Discovery at Axxam.
Tailored functional assays will be developed to address the different mode of actions offered by the GLP-1R pharmacology like agonists, allosteric modulators as well as molecules reducing receptor desensitization and internalization.
“Polyphor’s innovative technology platforms, PEMfinder® and MacroFinder®, have proven to generate promising PEMdrug candidates and highly potent and selective novel molecular entities, even on challenging biological targets such as protein-protein interactions, GPCRs, ionchannels and the like... [PDF] Axxam's Press Release - [PDF] Polyphor's Press Release -

Sirona Biochem : Scale Up of Compounds to Accelerate Development of Diabetes Program

January 12, 2011 – Sirona Biochem Corp. (TSX-V: SBM) (the “Company”), a biotechnology company specializing in carbohydrate-based molecules, including therapeutics for diabetes and obesity, announced it has contracted Roowin to scale up a key intermediate for its lead diabetes drug candidate, a sodium glucose transporter (SGLT) inhibitor. Roowin is a privately owned Contract Research Organization (CRO) headquartered in Paris, France. Its core business is in high value-added fine chemistry. Roowin will bring expanded capabilities to Sirona Biochem’s research and help accelerate the preclinical development of its lead candidate for Type 2 diabetes.



“Recent positive preclinical data of our lead SGLT-2 inhibitor demonstrates that we are on the right track in developing a new Type 2 diabetes treatment and by scaling up this key intermediate we can speed up our preclinical process... Sirona Biochem's Press Release -

Metabolic Solutions Development : Launches Phase 2a Trial of its Second Compound to Treat Type 2 Diabetes

March 29, 2011 – Metabolic Solutions Development Company (MSDC), a drug discovery and development company exploiting novel molecular targets to treat metabolic diseases, announced that it has launched a Phase 2a trial for MSDC-0602, the company’s second drug candidate for the treatment of type 2 diabetes. The 28-day, randomized, double-blind, comparator- and placebo-controlled clinical trial will involve approximately 125 patients at 15 planned sites throughout the United States.
MSDC-0602 is a selective modulator of mitochondrial metabolism that modifies nutrient-sensing pathways leading to improved insulin action without direct activation of nuclear transcription factors. “Because this novel mechanism of action does not depend on direct activation of nuclear transcription factors, type 2 diabetic patients treated with MSDC-0602 are not expected to experience fluid retention or weight gain as do patients treated with the currently marketed PPARγ agonists,” said Dr. Jerry Colca, president and chief scientific officer of MSDC.
In addition to gathering additional safety and tolerability data, the Phase 2a trial will evaluate the reduction in fasting plasma glucose following once-daily dosing for 28 consecutive days in patients with type 2 diabetes. Patients taking MSDC-0602 will be compared to those taking 45 mg of pioglitazone and placebo... [PDF] Metabolic Solutions Development's Press Release -

Stempeutics Research : DCGI nod to start Phase II clinical trial...

January 20 th, 2011 – Stempeutics Research a group company of Manipal Education & Medical Group announced that Drug Controller General of India (DCGI) has granted clearance of the company’s Investigational Medicinal Product “Stempeucel” for conducting Phase II clinical trials in patients with Osteo Arthritis, Diabetes Mellitus – Type 2, Liver Cirrhosis and Chronic Obstructive Pulmonary Disease. Stempeucel product is developed from allogeneic mesenchymal stem cells derived from donated bone marrow using Stempeutics proprietary technology. Earlier the company has received approval from DCGI for Phase I/II clinical trial for Acute Myocardial Infarction and Critical Limb Ischemia in March 2009. Stempeutics is funded by Manipal Group and Cipla...


[...]

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Diabetes Mellitus – Type2

Diabetes mellitus Type2 is a disease in which a person has high blood sugar, either because the body does not produce enough insulin, or because cells do not respond to the insulin that is produced. Current therapies for diabetes include oral hypoglycaemic drugs and insulin injections in addition to dietary management. They do not address the root cause i.e. lack of functional cells in pancreas and peripheral insulin resistance. This study is planned to see if stem cells injected into patients with diabetes, can trigger pancreatic resident stem cells / progenitors to form new cells. If successful, stem cell therapy possibly may result in permanent cure for diabetes. The objective of this study is to evaluate the safety and efficacy of a single intravenous dose of “Stempeucel” in type 2 diabetes mellitus and to find out the most suitable dose of stem cells... [PDF] Stempeutics Research's Press Release -

Diartis Pharmaceuticals : New Biotech Company Will Focus on Clinical Development of Novel Diabetes Drug

February 16, 2011 - INDEX VENTURES AND AMUNIX INVEST IN DIARTIS PHARMACEUTICALS – Diartis Pharmaceuticals, Inc., a newly founded biotechnology company, announced that it has received initial funding from Index Ventures, Amunix Inc., a U.S. based biotechnology company, and private investors. The company has also acquired a clinical-stage diabetes drug candidate from Versartis, Inc., VRS-859 (exenatide-XTEN), and with this initial funding will continue its development for type 2 diabetes mellitus (T2DM).

A Phase 1a multi-center, blinded, placebo-controlled, single-ascending dose study is ongoing to evaluate the safety and ability of VRS-859 to maintain glycemic control for one month in T2DM patients after a single dose. The results of the Phase 1a study are anticipated in Q2 2011. The Phase 1a study will be followed later this year by a repeat dose (3 month) Phase 1b study comparing VRS-859 to Byetta® (exenatide injection) in T2DM patients. VRS-859 is intended as a once-monthly form of the GLP-1 analog, exenatide.

Commenting on the investment, Kevin Johnson, London based partner at Index Ventures said, “We are delighted to invest in Diartis Pharmaceuticals Pharmaceuticals. The company will focus on moving this exciting compound rapidly through early clinical development. Given the dramatic rise in the number of people with type 2 diabetes, there is a significant market need for a longer acting form of the GLP-1 analog exenatide.”... Diartis Pharmaceuticals' Press Release -

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 -

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 -