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 -

Kuros : Patient Recruitment in a Phase IIb Clinical Trial With KUR-211 for Diabetic Foot Ulcers

01.09.2011 - Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications, announced that it has completed recruitment in a Phase IIb clinical trial designed to investigate KUR-211 (Viz.I-020201) in the treatment of diabetic foot ulcers.

 This Phase IIb clinical trial is a randomised, multi-center, controlled, parallel group dose-finding study to evaluate the efficacy and safety of KUR-211 used as an adjunct to standard of care in patients with diabetic foot ulcers. KUR-211 is a bioactive therapy intended for topical treatment of diabetic foot ulcers, stimulating the granulation tissue formation, that aids wound closure. The study evaluates the effects of KUR-211 applied twice a week for maximum 16 weeks in addition to standard of care versus standard of care (SOC) alone.

 KUR-211 consists of a modified variant of platelet-derived growth factor (PDGF) incorporated into a fibrin sealant and is applied to the wound as a foam. The innovative Kuros "TG-hook" technology enables the PDGF to be retained at the site for local exposure to migrating cells and for sustained delivery of PDGF on enzymatic cleavage of the matrix. It is believed that this novel approach may improve the frequency and speed of healing... [PDF] Kuros Biosurgery's Press Release -

KalVista Pharmaceuticals Launched with £8 Million in Series A Funding to Develop Novel Class of Drugs for Diabetic Macular Edema

23 August 2011 – KalVista Pharmaceuticals (“KalVista”), a new ophthalmology company with a focus on diabetic macular edema (DME), has raised £8 million in a series A round from leading life sciences investors Novo A/S and SV Life Sciences. The Company is developing novel, small molecule plasma kallikrein inhibitors, which represent a new approach to the treatment of DME, a leading cause of adult visual loss in developed countries and a major unmet medical need. KalVista’s advanced pre-clinical product pipeline is targeting both intravitreal injection and oral administration routes. KalVista acquired these inhibitors plus all relevant intellectual property from Vantia Therapeutics.

KalVista’s scientific founders include world-leading experts in ophthalmology, diabetes and diabetes-related complications, Dr Lloyd Paul Aiello and Dr Edward P. Feener. Dr Aiello is Professor of Ophthalmology at Harvard Medical School, Director of the Joslin’s Beetham Eye Institute and Inaugural Chair of the National Eye Institute Diabetic Retinopathy Clinical Research Network. Dr Feener is Associate Professor of Medicine at Harvard Medical School and an Investigator in Vascular Cell Biology at the Joslin Diabetes Center, where his team led the discovery of plasma kallikrein in the vitreous fluid from people with DME and has shown that inhibition of plasma kallikrein decreases pathological retinal vascular permeability in pre-clinical studies. Dr Aiello has guided the clinical development programs for a wide range of recent ophthalmology drugs, and has been a lead investigator in the trials determining the benefit of VEGF (vascular endothelial growth factor) inhibitors for the treatment of DME... KalVista Pharmaceuticals' Press Release -

Lpath Addresses Diabetic Neuropathic Pain With Financial Support by National Institutes of Health

Aug 15, 2011 - Lpath to Conduct In Vivo Studies in Diabetic Neuropathy With Lpathomab(TM), Its Monoclonal Antibody Against Lysophosphatidic Acid (LPA) -- Lpath, Inc. (OTCBB: LPTN), the industry leader in lipidomics-based therapeutics, announced the Type 1 Diabetes Preclinical Testing Program of the National Institutes of Health (NIH) will provide financial support for the further study of Lpathomab's efficacy in animal models of disease, particularly diabetic neuropathy.

"Bristol Myers Squibb's recent $325 million acquisition of Amira, whose lead program is an LPA-receptor antagonist with Phase 1 results, underscores the potential value of a compound that neutralizes the LPA signaling pathway," said Lpath's CEO Scott Pancoast. "With assistance from the NIH for neuropathic pain and from various partners/collaborators for other central-nervous-system disorders and for fibrosis, we believe we can generate compelling data that validates Lpath's unique approach to neutralizing LPA with Lpathomab." As a monoclonal antibody, Lpathomab functions like a 'molecular sponge' that binds to and neutralizes the bioactive lipid signaling molecule, lysophosphatidic acid (LPA), thus silencing LPA receptors associated with the transmission of pain through the nervous system. Lpathomab was generated using Lpath's proprietary ImmuneY2(TM) technology... Lpath's Press Release -

Telcare : First-in-class mHealth Connected Glucose Meter Cleared by FDA

August 03, 2011 - Telcare, Inc., an exhibitor at this year’s annual meeting of the American Association of Diabetes Educators, has just received clearance from the US Food and Drug Administration to market the Telcare BGM, the first cellular-enabled glucose meter, combined with an FDA-cleared database (Telserve) to aid in the management of diabetes. The device allows patients to transmit their blood glucose readings to caregivers and family members, and receive immediate coaching and clinical feedback relayed to the screen of the glucose meter. The patient does not have to take any additional steps to transmit the data and the cost of the wireless connectivity is included in the price of the device and its accompanying test strips. Thus, users will have a much richer clinical experience at no additional cost when compared to standard glucose meters.
Telcare’s objective is to transform the management of diabetes, from a condition where patients feel cut off from their caregivers and don’t know what to do from day to day, to a model in which the patient is continually empowered to manage his or her condition through continual feedback from caregivers, family members, and even other patients.
The Telcare glucose meter aims to bridge the last mile between patient and caregiver. Real time information is transmitted to the electronic medical record, personal health records, such as Microsoft HealthVault, and a variety of smartphone apps designed to connect patients to family members and to each other. While other marketplace solutions have relied on Bluetooth transmission to cellphones, connections of glucose meters to personal computers and cradles, or requiring the patient to manually enter results into a phone app, Telcare’s solution requires no additional steps on the part of the patient... Telcare’s Press Release -

Echo Therapeutics : Symphony tCGM Demonstration Video

Aug. 9, 2011 - Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing the Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude™ SkinPrep System for transdermal drug delivery, announced the unveiling of a much anticipated demonstration video on the Company's website. The new video showcases the features and ease of use of the Symphony continuous glucose monitoring system in a home setting. The Company has released this demonstration video as a result of increasing demands from patients and investors for information regarding how the Symphony tCGM System works.

The launch of the video coincides with the final steps in the planning and preparation of the upcoming clinical study testing the next generation Symphony tCGM System design, which will commence in the near-term... Echo Therapeutics' 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 -

Eli Lilly India and Lupin : Strategic Collaboration to Help Fight the Battle Against Diabetes

July 29, 2011 - Eli Lilly India (Lilly) and Lupin Limited (Lupin)announced they have entered into a strategic collaboration to promote and distribute Lilly's Huminsulin range of products, including Huminsulin R(TM), Huminsulin NPH(TM), Huminsulin 50/50(TM), Huminsulin 30/70(TM) and Humapen Ergo II. Lupin's India formulations business will promote and distribute the range of products in India and Nepal, virtually doubling the number of sales representatives behind the diabetes care product. This collaboration will double the current customer base; approximately 45,000 doctors will now be called on as a result of the new partnership.

For Lilly, a company whose history in insulin production dates to 1923, caring for diabetes patients in India is clearly a priority. The country has an estimated 51 million people with diabetes currently and will have an estimated 85 million by 2030, or nearly one-fifth of all patients with diabetes globally. Lilly hopes to increase access to Huminsulin(TM) products through its relationship with Lupin India, bringing one of the most basic and proven therapies for diabetes treatment to more patients.

Lupin's India formulation business will deploy a sales force of medical representatives to provide education and resources to physicians and patients. Lupin has a vibrant presence in the Indian pharmaceuticals market and has over the past several years made major strides in expanding its therapy portfolio. Lupin has a robust promotion and distribution setup along with a strong presence in various therapeutic areas, including the fast growing diabetes market. This strategic collaboration will achieve major synergy arising from the strength of the product portfolio of Lilly and the promotion and distribution capabilities of Lupin... Eli Lilly's Press Release - Lupin's Press Release -