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Thursday, December 8, 2011

Grove Instruments : Noninvasive Glucose Monitor

Grove Instruments
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]

Wednesday, November 23, 2011

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

Tandem Diabetes Care
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 -

Thursday, November 10, 2011

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

Prognomix
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.

Servier

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 -

Thursday, November 3, 2011

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

Poxel
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 -

Monday, October 24, 2011

Boston Therapeutics : to Start Clinical Trial in Type 2 Diabetes

Boston Therapeutics
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 -

Friday, October 14, 2011

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

Merck
Oct. 7, 2011 - Multiple National Guidelines Recommend that Patients with Type 2 Diabetes be Treated for CholesterolMerck (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 -

Monday, October 3, 2011

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

Furiex Pharmaceuticals
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.

Takeda Pharmaceutical

"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 -

Monday, September 26, 2011

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

Ambrx
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.

Bristol-Myers Squibb Company  bms

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 -

Monday, September 19, 2011

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

Kuros Biosurgery
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 -

Monday, September 12, 2011

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 Pharmaceuticals

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 -

Tuesday, September 6, 2011

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.

Lpath

"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 -

Tuesday, August 30, 2011

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

TelcareAugust 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 -

Monday, August 22, 2011

Echo Therapeutics : Symphony tCGM Demonstration Video

Echo TherapeuticsAug. 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 -

Friday, August 12, 2011

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

Amarantus BioSciencesAug. 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.
Generex Biotechnology

"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 -

Tuesday, August 9, 2011

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

PolyphorJuly 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
“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 -

Tuesday, August 2, 2011

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

LupinJuly 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.

Eli Lilly
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 -

Thursday, July 21, 2011

Concert Pharmaceuticals : Advancement of Novel Drug Candidates in Kidney Disease and Spasticity

June 20 , 2011 - Concert Pharmaceuticals, Inc. announced the advancement of two programs from its DCE Platform™ (deuterated chemical entity platform). CTP-499 is progressing into Phase 2 clinical trials for diabetic nephropathy and C-21191 has been selected as a lead candidate for spasticity.

CTP-499 is a novel anti-inflammatory, anti-oxidant and anti-fibrotic agent that Concert is developing for the potential treatment of diabetic nephropathy associated with chronic kidney disease (CKD). The company has successfully completed two Phase 1 clinical trials and expects to report results at a future scientific meeting. Concert intends to advance the CTP-499 clinical program into an approximately 170 patient Phase 2 proof-of-concept clinical study by year-end.

Concert also announced that C-21191 has been selected as a lead candidate. C-21191 is a non-sedating subtype-selective GABAA modulator that represents a new therapeutic modality for the potential treatment of spasticity, neuropathic pain and anxiety. Recently, the U.S. Patent and Trademark Office issued a notice of allowance for Concert’s patent application claiming C-21191 and other deuterium-containing GABAA modulators as novel compositions of matter. Concert expects to complete preclinical dose ranging studies during 2011 to support the potential advancement of C-21191 into human clinical testing... Concert Pharmaceuticals' Press Release -

Thursday, July 14, 2011

Regeneron and Bayer HealthCare : Start of Phase 3 Clinical Program in Diabetic Macular Edema

Regeneron PharmaceuticalsApril 8, 2011 -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare announced that they have initiated the first of two Phase 3 clinical trials evaluating the efficacy and safety of VEGF Trap-Eye (aflibercept ophthalmic solution), an investigational new agent for the treatment of certain eye diseases, in the treatment of Diabetic Macular Edema (DME). The companies are extending their development program for VEGF Trap-Eye in DME after promising results in the global Phase 2 DME program.

The first Phase 3 trial in DME, named VIVID-DME, is being led by Bayer HealthCare and has started in Australia. The trial will also be conducted in Europe and Japan. A second study led by Regeneron, named VISTA-DME, is expected to begin later in 2011 in the United States, Canada, and other countries.

Bayer HealthCare
"Clinically significant DME is a leading cause of vision loss in adults under the age of 50 suffering from diabetes," said Dr. Kemal Malik, Head of Global Development and member of the Bayer HealthCare Executive Committee. "After reporting positive results from our global Phase 3 program (VIEW 1 and VIEW 2 studies) for the treatment of the neovascular form of age-related macular degeneration (wet AMD), we are pleased to start a Phase 3 program with VEGF Trap-Eye in DME which may help to address this significant unmet medical need."

The Phase 3 program in DME expands the companies' global development collaboration for VEGF Trap-Eye. The companies announced positive data for two Phase 3 studies in patients with wet AMD in November 2010 and for the first of two Phase 3 studies in patients with Central Retinal Vein Occlusion (CRVO) in December 2010... Regeneron Pharmaceuticals's Press Release - Bayer HealthCare's Press Release -

Monday, July 11, 2011

Arcion Therapeutics : data from the Phase 2b trial of ARC-4558 for the treatment of pain associated with painful diabetic neuropathy (PDN)

Arcion TherapeuticsJune 14, 2011 -...Arcion previously announced positive top-line results from a Phase 2b double-blind, randomized, placebo-controlled clinical trial of ARC-4558 in adult patients with PDN. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to ARC-4558 for the treatment of pain associated with PDN. The Company also held an End of Phase 2 meeting with the FDA and the ARC-4558 program is now poised to enter Phase 3 studies.

About ARC-4558

ARC-4558 is a 0.1% gel formulation of clonidine hydrochloride (HCL) for topical administration to the painful area in order to manage the neuropathic pain associated with painful diabetic neuropathy (PDN). Topical clonidine, through its agonist effects on (a2)-adrenergic receptors, is believed to reduce pain in PDN via local actions on the nociceptors that innervate the affected skin. Based on the results of clinical trials to-date, Arcion believes that ARC-4558 has a level of efficacy comparable to systemic therapies in the target population, but with substantially fewer side effects. The 0.1% gel formulation avoids the treatment area limitations and undesirable aesthetic and skin reaction issues associated with analgesic patches. Furthermore, the ARC-4558 gel has been shown to provide analgesia without numbing or anesthetizing the skin... [PDF] Arcion Therapeutics' Press Release -

Monday, July 4, 2011

Cebix : Long-Acting C-Peptide Ersatta Has Potential in Multiple Chronic Complications of Diabetes

CebixJune 24, 2011 – Cebix Incorporated announced that preclinical data for its long-acting form of C-peptide, ErsattaTM (CBX129801), demonstrated a half-life of three days as compared to one hour for native C-peptide. Ersatta halted the impairment in nerve conduction velocity, a measure of the rate at which electrical signals travel through the nerves, in an animal model of diabetic peripheral neuropathy. Additionally, clinical data showed that native C-peptide replacement therapy improved erectile function in 46% of type 1 diabetes patients as compared to 9% of patients receiving placebo. These preclinical and clinical data will be presented during two poster sessions at the 71st Annual Meeting of the American Diabetes Association in San Diego starting on Saturday, June 25.

“C-peptide replacement therapy is a clinically-validated approach to treating multiple serious long-term complications of diabetes, including erectile dysfunction, peripheral neuropathy, and nephropathy,” said John Wahren, M.D., Ph.D., Chief Scientific Officer of Cebix. “We see tremendous potential in Ersatta to treat all of these diseases, because its biological activity is comparable to that seen in the native peptide, and the long-acting form will require less frequent dosing, thereby improving patient convenience and compliance.”

Cebix has an established database of 19 clinical studies evaluating native C-peptide in more than 300 patients with type 1 diabetes. These studies demonstrate that C-peptide replacement therapy increases nerve blood flow and mitigates peripheral and autonomic neuropathy and nephropathy, as well as improves erectile function. To date, native C-peptide replacement therapy has an excellent safety profile... Cebix's Press Release -

Monday, June 27, 2011

ActiveSite Pharmaceuticals : Small Molecule Protease Inhibitor Blocks Retinal Blood Vessel Damage in Rodent Model of Diabetes

ActiveSite PharmaceuticalsMarch 28, 2011 - ActiveSite Pharmaceuticals, Inc., announced the online publication of a study in the journal Diabetes that describes the effectiveness of its novel plasma kallikrein inhibitor ASP-440 in reducing blood-retinal barrier breakdown in a rodent model of diabetes. Diabetes-induced breakdown of the blood-retinal barrier results in leaky blood vessels in the eye, and the gradual buildup of fluid in the retina from the leakage can result in diabetic macular edema (DME), the primary cause of vision loss in diabetic individuals. DME affects more than 1 million individuals in the U.S. alone, and no FDA-approved medicines are currently available for its treatment.

In the study, co-authored by scientists from the Joslin Diabetes Center, an affiliate of Harvard Medical School, and ActiveSite Pharmaceuticals, the integrity of the blood-retinal barrier in diabetic rats was measured using a well-established technique that measures the leakage of the plasma protein albumin from the vascular compartment into the retina. Compared to non-diabetic healthy rats, diabetic animals demonstrated a 2.6-fold increase in the rate of albumin leakage into the retina. Treatment of diabetic animals with systemically-administered ASP-440 for four weeks reduced the excess rate of albumin leakage by more than 80%, without affecting blood glucose.

ASP-440 was also effective in preventing blood-retinal barrier breakdown in hypertensive rats, reducing excessive albumin leakage into the retina by 90% following systemic treatment for seven days, without affecting blood pressure. Hypertension is a known risk factor for development of DME... ActiveSite Pharmaceuticals' Press Release -

Wednesday, June 22, 2011

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

Sirona BiochemJanuary 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.

Roowin

“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 -

Wednesday, June 15, 2011

The Juvenile Diabetes Research Foundation and Selecta Biosciences : Research Collaboration for Vaccines for Type 1 Diabetes

Selecta BiosciencesJune 9, 2011 – The Juvenile Diabetes Research Foundation (JDRF) and Selecta Biosciences, Inc. announced that they have established a research collaboration to support Selecta's development of a vaccine technology, which may subsequently help to better treat and potentially prevent type 1 diabetes.

Through the research partnership, JDRF will provide milestone-based financial support and expertise, with the goal of applying Selecta's vaccine technology toward the development of vaccines for type 1 diabetes.

Selecta's vaccine technology would ultimately be applied to create a therapeutic that would halt or prevent the autoimmune response that causes type 1 diabetes. Known as antigen-specific tolerogenic vaccines, these vaccines are designed to specifically stop the autoimmune response that causes the disease without damaging the immune cells that provide protection against infection. Antigen-specific therapies have shown promise to date in animal models of type 1 diabetes.

In addition to their potential in preventing type 1 diabetes, tolerogenic diabetes vaccines could have other benefits. For example, they could be used in conjunction with other therapies to preserve remaining beta cell function in individuals recently diagnosed with type 1 diabetes. This type of vaccine could also help with regeneration and replacement therapies, and be used to protect newly regenerated or transplanted insulin-producing beta cells in established type 1 diabetes. In addition, this class of vaccines may also have applicability for other autoimmune diseases... Selecta Biosciences' Press Release - The Juvenile Diabetes Research Foundation's Press Release -

Wednesday, June 8, 2011

LCT and Otsuka of Japan : Common DIABECELL ® Vision

 Otsuka Pharmaceutical FactoryApril 12, 2011 ― Otsuka Pharmaceutical Factory, Inc. (head office: Naruto City, Tokushima, Japan; President: Ichiro Otsuka) (“OPF”) entered into a share subscription agreement on April 12, 2011 with Living Cell Technologies Limited (head office: Auckland, New Zealand, Managing Director & CEO:Ross Macdonald) (“LCT”) with respect to subscription for LCT’s new shares.
Under the agreement, OPF will invest AUD3 million in LCT for 25 million ordinary shares (A$0.12 per share). This investment will result in OPF holding 8.2% of LCT’s outstanding shares.
In addition to subscription for LCT’s new shares, OPF has earned an exclusive right to negotiate with LCT for research and development toward commercialization of LCT’s pancreatic islet “DIABECELL” and exclusive license and distribution right in Japan and other Asian countries (except for China).

Living Cell Technologies Limited lct
It is OPF’s objective, through obtaining the rights for development and commercialization of this pancreatic islet DIABECELL, to offer additional therapeutic options for patients with diabetes, and to strengthen its R&D in the field of regenerative medicine and further actively expand its business not only in Japan but also on the international stage... [PDF] Otsuka Pharmaceutical Factory's Press Release - [PDF] Living Cell Technologies' Press Release -

Thursday, May 26, 2011

Derma Sciences : Continued Healing at 24 Weeks in Patients with Diabetic Foot Ulcers Treated with DSC127 in Phase 2 Trial

Derma Sciences IncMay 25, 2011 - Healing spread widens between DSC127 0.03% group and placebo group compared with 12-week data - Wounds up to five times more likely to heal at 24 weeks with DSC127 0.03% versus placebo - Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, announced that in the follow-up portion of its Phase 2 clinical trial in patients with diabetic foot ulcers, the percentage of patients treated with the therapeutic (0.03%) dose of DSC127 with complete healing at 24 weeks following trial enrollment was 73% in the intent-to-treat (ITT) population and 85% in the per-protocol population (PP), a difference of 27 and 33 percentage points, respectively, compared with patients treated with placebo/standard of care (placebo). DSC127 is a patented, topically applied novel angiotensin analog that targets receptors that are up-regulated upon injury to tissue.

Healing was defined as 100% epithelialized with no drainage. The Company previously announced that the 0.03% dose of DSC127 exceeded the trial's goal of an improvement of 15 percentage points in complete healing of wounds at 12 weeks for both the ITT (21 percentage point increase) and PP (27 percentage point increase) populations, compared with placebo. With today's announcement, the improvement at 24 weeks between patients treated with DSC127 0.03% and patients treated with placebo is even more pronounced. There were no drug-related adverse safety events during the entire 24-week study period.

The double-blind, placebo-controlled, multi-center Phase 2 clinical trial randomized 80 patients to receive one of two dose strengths of DSC127 (0.03% or 0.01%) or vehicle placebo control. After 14 days of best standard-of-care to evaluate ulcer healing and ensure the wounds were chronic, those patients randomized into the study received four weeks of active treatment followed by eight weeks of observation and assessment. Although the primary endpoint of the trial was healing at 12 weeks, patients continued to be followed for an additional 12 weeks to gain further information on the drug and its effects. Consistent with what was seen at week 12, the 0.01% dose of DSC127 continued to be comparable to placebo at week 24, and therefore non-therapeutic. The table below shows the percentage of patients healed at weeks 12 and 24, with the 0.03% dose of DSC127 and placebo... Derma Sciences' Press Release -

Monday, May 16, 2011

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

Metabolic Solutions Development CompanyMarch 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 -

Wednesday, May 4, 2011

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

Stempeutics ResearchJanuary 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...

cipla
[...]

...
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 -

Monday, April 18, 2011

Asante Solutions : CE Mark for Pearl™ Insulin Pump

asante solutions.April 12, 2011 – Asante Solutions, Inc. (Asante), a medical device company focused on diabetes care, announced it received the CE mark for its Pearl Insulin Pump, the only insulin pump that uses a pre-filled insulin cartridge. The CE mark is a European proof of conformity that certifies the product meets EU safety, health and environmental requirements. Asante has begun discussions with potential distribution partners in Europe.
“This important regulatory milestone brings us one step closer to our goal of delivering a sensible solution to the growing but underserved insulin pump market,” said Phil Hopper, Asante CEO and President. “Once available, we believe the small and sleek Pearl will be the simplest-to-operate pump on the market. The Pearl is a fully featured insulin pump addressing the imperatives of safety, reliability, and ease of use required to meet the needs of people with diabetes using intensive insulin therapy.”

The Pearl Insulin Pump is designed to simplify diabetes care for the more than 500,000 people worldwide who use an insulin pump and those considering insulin pump therapy. Unlike the insulin pumps currently available, which require users to manually fill an insulin reservoir using a vial of insulin and syringe, the Pearl Insulin Pump uses a 300-unit, pre-filled insulin cartridge that simplifies the process of loading the pump and filling the infusion set by reducing the number of steps required and thereby creating a less time-consuming and more convenient process... [PDF] Asante Solutions' Press Release -

Monday, April 11, 2011

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

Diartis PharmaceuticalsFebruary 16, 2011 - INDEX VENTURES AND AMUNIX INVEST IN DIARTIS PHARMACEUTICALSDiartis 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).

Versartis
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.

amunix
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 -

Tuesday, April 5, 2011

Genentech : Second Lucentis Phase III Study Meets Primary Endpoint for Improved Vision in Patients with Diabetic Macular Edema (DME)

GenentechMarch 25, 2011 - -- Results Consistent with Data Released Last Month Showing Patients with DME Who Received Lucentis Achieved Significant Improvement in Vision - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the second of two Phase III trials evaluating Lucentis® (ranibizumab injection) in patients with diabetic macular edema (DME) met its primary endpoint. The primary endpoint of the study, known as RIDE, showed that after 24 months a significantly greater number of patients who received Lucentis, compared to those who received placebo (sham) injections, were able to read at least 15 additional letters on an eye chart than they could at the start of the study. The safety results were consistent with previous Lucentis Phase III trials and no new significant safety findings were observed. Further analyses of the data are ongoing. Topline results from the RIDE study will be presented at the EURETINA Congress in London on May 29, 2011.

Roche
DME is an eye condition characterized by swelling of the retina, which can occur in patients with type 1 or type 2 diabetes and can cause blurred vision, severe vision loss and blindness.1 DME is a leading cause of blindness among the working-age population in most developed countries,2 and there are currently no U.S. Food & Drug Administration (FDA) approved medications to treat DME.
"This data adds to the considerable body of clinical evidence showing that patients with DME who received Lucentis had significant improvement in vision," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "Lucentis may provide physicians and patients with a potential option for DME, and we look forward to sharing the data from this study and a previous Phase III trial with the FDA and medical community."... Genentech's Press Release -

Tuesday, March 29, 2011

Mylan Pharmaceuticals : Approval for Generic Version of Precose® Tablets

Mylan PharmaceuticalsJan. 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 -

Wednesday, March 23, 2011

Biocrates Life Sciences : Metabolomic biomarker research for the early detection of diabetes

BIOCRATES Life Science13 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 -

Tuesday, March 15, 2011

NeuroMetrix Announces New Strategic Direction : Primary Focus on Diabetes

NeuroMetrix, Inc. 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 -

Wednesday, March 9, 2011

Sanofi-aventis Acquires from Ascendis Pharma Worldwide Rights on Drug-Delivery Technology in Diabetes and Related Disorders

Ascendis PharmaDecember 21, 2010 – Innovative technology designed for sustained release of peptides and proteinsSanofi-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.

Sanofi-aventis
“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 -

Tuesday, March 1, 2011

Evotec : Metabolic disease alliance with MedImmune

Evotec15 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.

Develogen
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.

MedImmune
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 -