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 -

Midatech and MonoSol Rx : Positive Phase 1 Clinical Results for their Novel Transbuccal Oral Insulin Film Product

3 May 2012 – Midatech Ltd., a global leader in the design, synthesis and manufacture of nanomedicines based on its passivated gold-nanoparticle technology, and MonoSol Rx LLC, the developer of PharmFilm® drug delivery technology, announced positive bioavailability and pharmacokinetic results from a first-in-human Phase 1 clinical study of their Midaform™ Insulin PharmFilm product in 27 healthy volunteers. The companies have licensed to their joint venture company, MidaSol Therapeutics LLC, a proprietary nanoformulated transbuccal insulin film product, which delivers monomeric insulin through the use of a rapidly dissolving mucoadhesive film that is placed onto the inside of the cheek.

Insulin, stabilized on a nanoparticle and delivered transbuccally, has the potential to offer diabetic patients a viable oral alternative to injectable insulin. The Phase 1 study established Midaform Insulin PharmFilm as a safe, novel, non-injectable insulin delivery system, which closely mimicked the delivery characteristics of monomeric insulin from the pancreas. Importantly, MidaSol’s product showed a faster onset of action compared to subcutaneous insulin. Top-line results, including PK and bioavailability elements, from the study will be presented at the European Summit for Clinical Nanomedicine (CLINAM) in Basel, Switzerland by Prof.Dr. med. Fritz R. Bühler, Chief Medical Officer and member of the Board of Midatech Ltd... [PDF] Midatech's Press Release - MonoSol Rx's Press Release -

Orgenesis : Agreement to Commence Advanced Studies for Proposed Diabetes Treatment

Apr 11, 2012 - Orgenesis Inc. (OTCBB: ORGS), a development stage company with a novel therapeutic technology dedicated to convert a patient's own liver cells into functional insulin-producing cells as a treatment for diabetes, is pleased to announce entry into an agreement to commence a comprehensive research study into the efficacy of its treatment in order to more efficiently move the technology towards future human clinical trials.

Effective March 22, 2012, Orgenesis Inc. has entered into an agreement with Tel Hashomer - Medical Research, Infrastructure and Services Ltd. ("THM"). In exchange for certain fees, licensing rights and other considerations, THM is to perform a study at the facilities and using the equipment and personnel of the Chaim Sheba Medical Center of Israel under the direct supervision of Orgenesis Chief Science Officer, Prof. Sarah Ferber.

THM will conduct the study, through the services of the Medical Research Infrastructure Development and Health Services Fund established by the Sheba Medical Center pursuant to the Research Program under the direct supervision of Prof. Ferber, who will conduct and supervise the study with the assistance of the employees, researchers and/or associates of the Hospital and/or the Fund. The study itself shall be performed pursuant to the laws, regulations and guidelines as applicable in Israel with respect to clinical research on human subjects... Orgenesis' 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 -

ADOCIA : positive phase IIa clinical results on its fast-acting human insulin, HinsBet®

28th of February 2012 - The first clinical results are confirmed on diabetic patients - The main results of this clinical trial are a rapid reduction of glycemia, an excellent local tolerance and an inter-patient and intra-patient variability, all comparable to NovoLog® (Novo Nordisk) -

ADOCIA (ISIN: FR0011184241, Ticker: ADOC), a biotechnology company specialized in the formulation of therapeutic proteins for treating diabetes and chronic wounds (diabetic foot ulcers, venous ulcers), announces positive results from a Phase IIa clinical trial evaluating the safety and efficacy of HinsBet®, its fast-acting human insulin, in type 1 diabetic patients. This program is supported by OSEO.

This phase IIa study was a single center, double-blinded, randomized, cross-over trial conducted on 20 type 1 diabetic patients under euglycemic clamp procedure. The aim of the study was to compare pharmacokinetics, pharmacodynamics and safety of HinsBet® to the fast-acting insulin analog NovoLog®, after 3 consecutive injections of each study medication to each patient.

The hypoglycemic effect of HinsBet® is as rapid as the one of NovoLog®, one of the modern prandial insulins. Furthermore, neither serious adverse event nor clinically significant change in laboratory safety parameters occurred in this study. On local tolerance, HinsBet® was as good as NovoLog®. Finally, the inter and intra patients variabilities of the two medications after 3 consecutive injections are also similar on pharmacological parameters... [PDF]ADOCIA's Press Release - PDF du communiqué de presse ADOCIA -

Medistem : Exclusive Worldwide License With Yale University for Treatment of Type 1 Diabetes Using Stem Cells

March 7, 2012 - Medistem Inc. (MEDS.PK) and Yale University have signed an exclusive worldwide licensing agreement covering the generation of pancreatic islets from stem cells such as the Endometrial Regenerative Cell (ERC). These pancreatic islets have effectively treated diabetes in animal models.

Professor Hugh Taylor of Yale University, inventor of the technology, made international headlines in September 2011 when he published his findings in the peer-reviewed journal Molecular Therapy.

“Medistem is the first company to develop clinical-grade endometrial-derived stem cells and initiate trials in humans,” said Professor Taylor. “Since Medistem’s Endometrial Regenerative Cells are manufactured inexpensively, can be used as an ‘off the shelf’ product, and to date appear safe in human subjects, I am very excited to see diabetes added to the list of diseases that can potentially be treated with Medistem’s ERCs.”... Medistem's Press Release -

China Nuokang Bio-Pharmaceutical Inc. Broadens Product Portfolio by Acquiring Alpha Lipoic Acid Capsule for Diabetic Patients

Jan. 11, 2012 - China Nuokang Bio-Pharmaceutical Inc. (Nasdaq:NKBP) ("Nuokang" or the "Company"), a fully integrated, China-based biopharmaceutical company focused on the research, development, manufacture, marketing and sales of hospital-based medical products, announced that it has acquired from Shandong Qidu Pharmaceutical Co., Ltd. ("Qidu Pharma") for a cash consideration of RMB18 million the manufacturing license and marketing rights for Alpha Lipoic Acid Capsule ("ALA"), also known as Thioctic Acid, an antioxidant product that addresses diabetic neuropathy. Upon the transfer of the manufacturing license from Qidu Pharma, the Company will be one of the two pharmaceutical companies in China licensed to manufacture ALA. ALA will be in the new drug monitoring period through October 2014, during which period there will be no additional market entrants due to current Chinese government regulations.

The Company expects to begin manufacturing ALA in its production facilities in Penglai, China in 2014 when the transfer of the ALA manufacturing license is expected to be completed. Until that time, Qidu Pharma has agreed to fulfill the full production needs for ALA for the Company on a contractual basis at a pre-determined, fixed price. The Company has begun to actively participate in provincial tendering processes for the drug and expects to begin recognizing meaningful revenues from it in the second half of 2012... China Nuokang Bio-Pharmaceutical's Press Release -

Actavis and Bioton : new alliance to shake up diabetes market

30 JAN 2012 - Global managed-care offering to help bring down treatment costs for 366 million diabetics -

Actavis and Bioton (WSE:BIO) announced today that they have formed a joint venture company for the development and registration of insulins, including analogue insulins. Within the framework of the joint-venture, Bioton will be responsible for the development and manufacture of insulin products, while Actavis will be granted an exclusive licence to commercialise those products under the Actavis brand throughout the European Union and the United States of America, as well as in Albania, Bosnia & Herzegovina, Croatia, Iceland, Japan, Kosovo, Lichtenstein, Macedonia, Montenegro, Norway, Serbia and Switzerland. In Poland, both companies will offer the insulin products under their respective brands, Bioton being a Polish company.

The announcement, at a press conference in Warsaw today, was made jointly by Ryszard Krauze, Chairman of the Supervisory Board of Bioton, and Claudio Albrecht, CEO of the Actavis Group and Chairman of the Actavis Board of Directors.

Actavis has agreed to remunerate Bioton with the aggregate amount of EUR 55.5 million, of which EUR 22.25 million at signing today. The remainder (EUR 33.25 million) will be paid in instalments in accordance with agreed milestones relating to the registration process involving recombined human insulin (RHI)...Actavis' Press Release -

Roche : clearance from the U.S. Food and Drug Administration for the new ACCU-CHEK® Nano SmartView blood glucose monitoring system

01.11.2012 - Innovative, small, no code device will be available to people with diabetes in the U.S. in first half of 2012  

Roche announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its ACCU-CHEK® Nano SmartView blood glucose monitoring system.The new ACCU-CHEK Nano meter, which is smaller than a standard credit card, employs a large brilliant backlit display and does not require any manual coding or code key for enhanced ease of use. It also offers improved functions such as customizable test reminders, pre- and postmeal markers and average glucose calculation. The ACCU-CHEK Nano meter uses ACCU-CHEK® SmartView test strips and will be available to customers in the first half of 2012.

“We are very excited to bring this latest blood glucose monitoring technology to the United States,” said Luc Vierstraete, Global Head of Roche Diabetes Care. “The ACCU-CHEK Nano meter is the newest advancement in Roche’s more than 35-year commitment to bring state-of-the-art innovations to people with diabetes and their caregivers, and continues our promise to enabling optimal diabetes management. This new system will help us to further leverage and enhance our position in this important market.”... Roche's Press Release -

Eisai and EIDIA : Launch of LIFE CHECK, a Self-monitoring Blood Glucose Meter That is Easy for Elderly Diabetes Patients to Use

January 19, 2012 - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) and its diagnostics subsidiary EIDIA Co., Ltd. (Headquarters: Tokyo, President & CEO: Keisuke Watanabe, “EIDIA”) announced that EIDIA will launch LIFE CHECK, a self-monitoring blood glucose meter manufactured by Gunze Limited (Headquarters: Osaka, President & CEO: Hiroshi Hirata, “Gunze”), on January 27, 2012.

LIFE CHECK is a personal self-monitoring blood glucose meter with which diabetes patients can monitor their own blood glucose level by simply inserting a dedicated sensor known as the LIFE CHECK SENSOR into the meter. The meter was developed as a next-generation model of the blood glucose monitor G-CHECK currently manufactured by Gunze and marketed by EIDIA. While Gunze received approval to manufacture and market LIFE CHECK in August 2011, the system will be distributed and marketed by EIDIA and co-promoted by Eisai.

The LIFE CHECK meter employs a color liquid crystal screen that displays step-by-step operational instructions and easy-to-read graphs of measured data. After measurement, the dedicated sensor can be easily and safely removed from the meter with the push of a button without the patient having to touch the part to which their blood has been applied... Eisai's Press Release -

GE Selects Bionime to Launch Innovative Diabetes Solutions

17 January 2012 - Bionime will offer innovative GE-branded clinical and home-based patient care products for the rapidly growing global diabetes population -

GE (NYSE: GE) announced it has entered into a new worldwide licensing agreement with Bionime, a global leader in biotechnology medical testing, to provide new GE-branded solutions for the diabetes market.

According to the World Health Organization, an estimated 346 million people worldwide have diabetes. Type 2 diabetes is the fastest growing chronic disease in the world. Through this agreement, Bionime will deliver GE-branded blood glucose monitors, test strips, kits and related diabetes accessories.



The first product to be launched is the GE100 Blood Glucose Monitoring System, available now through durable medical equipment suppliers and on retail shelves in 2012. The GE100 utilizes advanced patented strip technology to achieve a high level of accuracy and precision and a unique, innovative strip design that makes it easier to use and more sanitary for the consumer than current similar offerings. In addition, patented True Auto Coding Technology eliminates the need to code each strip lot without sacrificing the accuracy of the readings. The GE100 provides an easy, clean and accurate way to test blood glucose levels of people living with diabetes... GE Healthcare's Press Release - Bionime's 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 -