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 -

Grove Instruments : Noninvasive Glucose Monitor

September 2011 –  Grove has received $998K for an SBIR Phase II grant titled “Development of a Fiberless Transflectance Noninvasive Glucose Monitor” from the NIDDK NIH... Grove Instruments' news -

About Grove Instruments

Grove Instruments,Inc. is a privately held pre-market medical device company developing the world's first noninvasive glucometer with the potential to exceed the ISO standard for blood glucose meters.

Grove's patented technology is based on the seminal concept of the Optical Bridge and is unique among all NIR spectroscopic approaches to noninvasive blood glucose determination.

The Company has been recognized for its innovation, technology development and clinical results on 10 separate occasions by the NIH NIDDK with funded SBIR Grants.

In 2011, Grove was also recognized by the Massachusetts Life Sciences Center with an Accelerator Award – one of only 4 recipients out of all Boston-area life sciences companies applying in that round. [About Grove Instruments]

Tandem Diabetes Care : FDA Clearance of the t:slim™ Insulin Delivery System

November 16, 2011 - Tandem Diabetes Care Announces FDA Clearance of the t:slim™ Insulin Delivery System -


Smallest Insulin Pump System and First-Ever with a Touch Screen -

Tandem Diabetes Care, Inc. announced that the U.S. Food and Drug Administration has granted the Company clearance to market the t:slim™ Insulin Delivery System.—

Tandem Diabetes Care, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to market the t:slim™ Insulin Delivery System (t:slim). This new full-featured pump is the first-ever with a color touch screen, and is the smallest insulin pump system currently available. The t:slim is one of the first insulin pumps to be cleared under the FDA’s new Infusion Pump Improvement Initiative.

“With the clearance of t:slim, Tandem Diabetes Care has an opportunity to set a new standard in insulin infusion therapy,” said Kim Blickenstaff, president and CEO, Tandem Diabetes Care. “In creating t:slim, we spoke with more than 4,000 healthcare professionals and people with diabetes, and the clear message we heard was, ‘make it cool and make it uncomplicated to use. Give us access to the most advanced features without extra effort.’ The t:slim’s touch screen interface has been proven in extensive user studies to be easy to learn and to use by new and experienced pump users alike.”

Of approximately 1.5 million people in the U.S. with type 1 diabetes,1 industry estimates indicate that only 20 to 30 percent use an insulin pump, despite clinical evidence that pump use can improve glycemic control and quality of life2. Tandem Diabetes Care believes that enhanced ease of use and attractive design will encourage more patients to consider the clinical benefits of insulin pump therapy... Tandem Diabetes Care's 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 -