Geron Scientists and Collaborators : Activity of Pancreatic Islet-like Cells Derived from Human Embryonic Stem Cells in Diabetes

October 28, 2008 - Geron Corporation (Nasdaq: GERN) announced the publication of data showing the successful engraftment of human embryonic stem cell (hESC)-derived pancreatic islet-like clusters (ILCs) in diabetic mice. After transplantation, the ILCs continued to express important pancreatic islet proteins, responded to high levels of glucose in the blood, and extended the survival of recipient animals.

Pancreatic islet cells normally secrete insulin in response to high levels of glucose in the blood to maintain steady levels. Type 1 diabetes is an autoimmune disease in which the insulin secreting islet cells are destroyed. Administering insulin is life-saving but does not truly mimic the body's natural response to blood glucose and can result in serious complications such as diabetic retinopathy, nephropathy and neuropathy... Geron Corporation's Press Release -

BioLife Solutions : HypoThermosol Adopted by MicroIslet for Processing Pancreatic Islet Cells to Treat Diabetes

October 24, 2008 - Preservation with BioLife’s Proprietary, Next Generation, Biopreservation Media Resulted in Increased Yield and Quality of Insulin-Producing Islet Cells – BioLife Solutions Inc. (OTCBB: BLFS), a leading developer and marketer of proprietary hypothermic storage and cryopreservation media products for cells, tissues, and organs, announced that MicroIslet Inc. (OTCBB: MIIS), a biotechnology company engaged in developing and commercializing cellular therapies for patients with diabetes, has adopted HypoThermosol for preserving, transporting, and storing pancreatic source material.

MicroIslet plans to isolate and encapsulate islet cells for the treatment of Type 1 diabetic patients under a planned investigational new drug application and subsequent clinical trial... BioLife Solutions' Press Release -

Convincing results of Solianis’ multisensor system in home-use trial

October 13, 2008: Solianis’ multisensor system for non-invasive Continuous Glucose Monitoring is currently being tested by diabetic patients in the home and work environment. 12 patients have completed a 10-day trial aimed at assessing system reliability. Results indicate that the system tracks glucose in home-use settings and is sensitive to hypoglycemic glucose excursions.
With this proof of concept Solianis can now proceed to producing the final prototype. The company expects to launch its first product in Europe in 2010 after CE approval, targeting this non-invasive device at the insulin dependent diabetes population. Later model variants will address patients with diabetes and impaired glucose tolerance... [PDF] Solianis’ Press Release -

Phenomix and Forest : Collaboration on Development and Commercialization of Dutogliptin in Diabetes

October 23, 2008 — Forest Laboratories, Inc. (NYSE: FRX) and Phenomix Corporation today announced that they have entered into a definitive collaboration agreement to develop and commercialize dutogliptin (PHX1149) in North America. Dutogliptin is Phenomix’ proprietary orally administered, small molecule dipeptidyl-peptidase-4 (DPP-4) inhibitor currently undergoing Phase 3 clinical development in Type 2 diabetes mellitus... Phenomix's Press Release - Forest Laboratories' Press Release -

Amylin and Lilly : Supply Agreement for Exenatide Once Weekly

Oct 21, 2008 - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced they have entered into a product supply agreement for exenatide once weekly, a development compound that, if approved, would become the first once weekly therapy to treat type 2 diabetes. Under terms of the agreement, Lilly will make an initial cash payment of $125 million to Amylin, and Amylin will supply product for sales in the U.S. and to Lilly for sales outside of the U.S. In addition to the $125 million upfront payment, Lilly will reimburse Amylin for its share of the more than $500 million capital investment in the West Chester, Ohio facility through the cost of goods sold for exenatide once weekly.


As part of the overall supply arrangement, Lilly will make available to Amylin a $165 million line of credit that Amylin can draw upon beginning in the fourth quarter of 2009 through the second quarter of 2011. Any debt from the credit facility will be due three years from the date that the full amount has been drawn or the second quarter of 2014, whichever occurs first... Amylin Pharmaceuticals' Press Release - Eli Lilly and Company's Press Release -

Novo Nordisk Assigns Inhaled Insulin Patent Portfolio to Aradigm

Oct 08, 2008 - Aradigm Corporation (OTCBB:ARDM) ("Aradigm" or "Company"), a specialty pharmaceutical company, announced that Novo Nordisk ("Novo") transferred to Aradigm, at no charge, a portfolio of inhaled insulin related patents pursuant to a license agreement between Aradigm and Novo that was terminated in May 2008. Novo purchased a significant portion of the portfolio from Aradigm in July 2006 and supplemented the portfolio with certain of its own related patents. The portfolio includes both U.S. and foreign patents. Aradigm assumes responsibility for the maintenance of this portfolio.


In addition to the patent portfolio, Novo will transfer to Aradigm a significant preclinical safety database that was developed during the Aradigm/Novo collaboration, the rights to a miniaturized second-generation electronic insulin inhaler and data from Novo's inhaled insulin clinical program, which included nine Phase 3 trials in Type 1 and Type 2 diabetes patients... Aradigm's Press Release -

Echo Therapeutics : Issuance of New Patent for Symphony™ Transdermal Continuous Glucose Monitoring System

October 16, 2008 – Echo Therapeutics (OTCBB: ECTE) announced the issuance of U.S. Patent 7,432,069 covering compositions and methods for the preparation of a polyethylene glycol (PEG)- based hydrogel as a key component of Echo’s Symphony™ Transdermal Continuous Glucose Monitoring (tCGM) System... [PDF] Echo Therapeutics' Press Release -

Hospira : EndoTool from MD Scientific

Oct. 13, 2008 – Hospira, Inc. (NYSE: HSP), a global specialty pharmaceutical and medication delivery company, announced that it has acquired the EndoTool^® business from MD Scientific, LLC. The EndoTool glucose management system, a highly sophisticated software system cleared by the U.S. Food and Drug Administration (FDA), helps establish and maintain glycemic control in acute, critical care and operating room settings by calculating the dose of intravenous (I.V.) insulin needed to effectively control blood glucose levels... Hospira's Press Release -

RXi Pharmaceuticals : Exclusive Worldwide License to Technology for the Oral Delivery of RNAi Therapeutics from the UMMS

10/14/08 - RXi Pharmaceuticals Corporation (Nasdaq: RXII), a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today announced that it has licensed exclusive worldwide rights from the University of Massachusetts Medical School (UMMS) to certain technology for the oral delivery of RNAi therapeutics...
... "The development of technology that potentially enables oral delivery represents a truly dramatic advance for the field of RNAi therapeutics, and could open up significant market opportunities for RXi. We view this license as a major step toward our goal of developing such drugs as it allows us to potentially target a new class of cells that cannot be accessed either by traditional RNAi delivery methods, local administration or injection. In particular, we believe that UMMS' oral delivery technology, which targets certain types of inflammatory cells called macrophages, may allow us to develop orally administered rxRNA compounds for the treatment of a variety of significant inflammatory diseases, including rheumatoid arthritis, asthma, Crohn's disease, atherosclerosis, psoriasis and Type II diabetes. Since some of the most advanced and successful anti-inflammatory drugs currently on the market require injection, an orally administered RNAi compound could have significant competitive advantages for both patients and physicians."... RXi Pharmaceuticals' Press Release -

DIAGNOS : New CARA (Computer Aided Retinal Analysis) Application

Oct. 7, 2008 - DIAGNOS inc. ("DIAGNOS" or the "Corporation") (TSX VENTURE:ADK), a leader in the use of artificial intelligence ("AI") and advanced knowledge extraction techniques, launches CARA (Computer Aided Retinal Analysis) application bringing to market an 18 month development effort. CARA is an automated system for the identification of diabetic retinopathy and other eye related pathologies.

"I am very pleased to announce this new development based on our Artificial Intelligence platform. The software will be used for screening patients in hospitals, as well as private and public clinics and practices. The World Health Organization estimates that by year 2030, 366,000,000 people will have diabetes. DIAGNOS' goal is to provide our open platform analysis tool, to expand the diagnostic capabilities of more than 200,000 digital retinal imaging systems which currently exist worldwide... [PDF] DIAGNOS' Press Release -

Array BioPharma : Positive Preclinical Data on Its Glucokinase Activators in Type 2 Diabetes

Sept. 25, 2008 - Array BioPharma Inc. (Nasdaq: ARRY) announced the presentation of preclinical data on a novel small molecule glucokinase activator (GKA), ARRY-403, a drug for the treatment of Type 2 diabetes. The data showed that ARRY-403 demonstrated potent, highly glucose-blood-level dependent, control of both fasting and non-fasting glucose concentrations. Based on these and other results, Array plans to advance ARRY-403 into human clinical studies in the first half of 2009. The data were presented at an annual metabolic diseases conference in London... Array BioPharma's Press Release -

Oxygen Biotherapeutics : License Agreement for Its Glucose Biosensor Technology

Sept. 22, 2008 - Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) announced that the company has reached an agreement to license its glucose biosensor technology to Glucometrics, Inc. for applications involving the measurement and monitoring of glucose levels in diabetes patients.

Oxygen Biotherapeutics, Inc. will receive stock in Glucometrics and running royalties on a sliding scale based on worldwide net revenues from products derived from the licensed technology. Under terms of the agreement, the companies are not disclosing the royalty formula... Oxygen Biotherapeutics' Press Release -

Biocon : Human Clinical Data on IN-105 (Oral Insulin) at the EASD Meeting in Rome

September 08, 2008 - The results indicate that IN-105 is safe and well tolerated by Type 2 diabetic patients and is able to significantly drop 2-hour post prandial glucose in a dose-related manner - Biocon Limited, India’s premier biotechnology company, announced the results of an ascending dose study with their oral insulin drug (IN-105) at the European Association for the Study of Diabetes (EASD) meeting in Rome on September 8, 2008. The study involved dosing Type 2 diabetes subjects with single doses of 0 mg (placebo), 10 mg, 15 mg, 20 mg and 30 mg tablets of IN-105 in 5 separate periods before a mixed 600 kcal breakfast. The outcome measurements were the safety and tolerability of IN-105, as well as the pharmacokinetics and pharmacodynamics of IN-105. The results showed that IN-105 was safe and well tolerated by patients... Biocon's Press Release -

DexCom : JDRF Study Results Show Continuous Glucose Monitoring Provides Significant Benefits in Management of Type 1 Diabetes

Sep 08, 2008 - New study data presented by the Juvenile Diabetes Research Foundation (JDRF) today at the 44th annual meeting of the European Association for the Study of Diabetes (EASD), showed the use of Continuous Glucose Monitoring (CGM) to be effective in the management of Type 1 Diabetes.

The JDRF initiated the study to help increase access to and reimbursement of this new technology, which has been heralded as one of the most significant advancements in diabetes self-management in the past decade. The 322 person, six-month, multi-center randomized trial included both pediatric and adult patients who used either insulin pumps or multiple daily injections to manage their diabetes. The study was conducted in the United States, and utilized all three commercially-available CGM systems, including the Seven(R) System -- developed by San Diego based DexCom(TM), Inc.... DexCom's Press Release -

Major Study Reinforces the Power of Medtronic Device for Better Diabetes Management

Sept. 8, 2008 - Personal Continuous Glucose Monitoring Further Validated by Independent Study – Results of the largest ever Continuous Glucose Monitoring (CGM) study were published online by the New England Journal of Medicine. The study demonstrated that Personal CGM therapy significantly reduced the average blood glucose levels (A1c) of adult patients with type 1 diabetes, validating the growing body of clinical evidence in support of Personal CGM therapy and its ability to substantially improve diabetes management and glucose control. Studies have shown that reducing A1c can result in reduced risk of long-term side effects associated with diabetes, including blindness and kidney disease.

The multicenter, 322-patient trial, funded by the Juvenile Diabetes Research Foundation (JDRF), found that after six months adults using Personal CGM realized a statistically significant 0.53 percent absolute reduction in A1c as compared to the control group. All patients in the study experienced statistically significant absolute reductions in A1c levels ranging from 0.5 to 0.7 percent when Personal CGM was used at least six days a week. Moreover, improvements in A1c occurred without an increase in severe hypoglycemia (low blood sugar)... Medtronic's Press Release -

Takeda : New Drug Application in the U.S. for Alogliptin (SYR-322) / ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes

September 24, 2008 - Takeda Pharmaceutical Company Limited (Takeda) announced that its wholly owned subsidiary, Takeda Global Research & Development Center Inc. (U.S.), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of alogliptin (SYR-322) and ACTOS^® (pioglitazone HCl) (“alogliptin/ACTOS”) in a single tablet for the treatment of type 2 diabetes.

Alogliptin was discovered by Takeda’s wholly owned subsidiary, Takeda San Diego, Inc. and is a member of the DPP-4 inhibitors class, which are newer oral agents for the treatment of type 2 diabetes. DPP-4 inihibitors slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). The incretins play a major role in regulating blood glucose levels and have the potential to improve pancreatic beta-cell function. GLP-1 and GIP are produced by the digestive tract in response to food and regulate glucose balance, primarily by stimulating glucose-dependent insulin secretion. In addition, GLP-1 suppresses pancreatic glucagon secretion and subsequent liver glucose production, enhances glucose disposal, slows gastric emptying, and elicits satiety, a feeling of fullness. Takeda is the originator of the thiazolidinedione (TZD) class of oral anti-diabetes medications. ACTOS is a TZD that directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels... Takeda's Press Release -

Sirtris : EXCLUSIVE LICENSE TO HARVARD’S SIRT3-BASED INTELLECTUAL PROPERTY

September 16, 2008 – Sirtris, a GSK Company focused on discovering and developing small molecule drugs to treat diseases of aging such as Type 2 Diabetes, announced that it has completed an agreement with Harvard University to exclusively license two patent applications covering SIRT3-based methods of treatments and assays.

Sirtuins are a family of enzymes which regulate the aging process and have been the subject of extensive research. While SIRT1 — the founding member of this class of enzymes — is currently the most studied in the group, considerable research is underway on other members in this family, SIRTs 2-7. A study by Sirtris Scientific Advisory Board members and Harvard University scientists, published in the journal Cell in September 2007, showed for the first time that activation of SIRT3 and SIRT4 protects against cell damage. The findings further validated sirtuins as important targets for treating diseases of aging. The two patent applications being exclusively licensed from Harvard include assays useful for identifying SIRT3 activators for diseases of aging... Sirtris' Press Release -

Oramed Pharmaceuticals : GLP1-Analog Program, Based on its Proprietary Drug Delivery Platform

September 16, 2008 – Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB), a developer of oral drug delivery systems, announced that it has launched pre-clinical trials of ORMD 0901, a GLP1-analog.
ORMD 0901 belongs to the Incretin family of drugs which helps to manage diabetes, including reduction in blood glucose levels and inhibiting glucagon secretion.
Incretins have been cited in causing regeneration of pancreatic insulin secreting cells, and in tissue protective properties including protection of the heart. GLP1 and analogs are associated with gradual weight loss, which is very desirable in diabetes patients... [PDF] Oramed's Press Release -

MannKind & Pfizer : Collaboration for Certain Exubera Patients to Transition to MannKind's Inhaled Insulin Therapy

Sep 16, 2008 - MannKind Corporation (Nasdaq: MNKD) and Pfizer Inc (NYSE: PFE) announced that MannKind will transition certain Exubera patients with a continuing need for inhaled insulin to MannKind's inhaled insulin product, Technosphere(R) Insulin. Technosphere Insulin is an investigational product that has recently completed Phase 3 clinical trials.

In October 2007, Pfizer announced that it would stop marketing Exubera (insulin human (rDNA origin)) Inhalation Powder because it did not meet customers' needs or Pfizer's financial expectations. Since that time, Exubera patients have been transitioning to other diabetes therapies, although there remains a small number of patients with a continuing medical need for inhaled insulin. Pfizer began discussions with MannKind to give these patients access to Technosphere Insulin. Pfizer will reimburse some of MannKind's costs relating to the transition of patients... Pfizer's Press Release - MannKind's Press Release -

MannKind : Positive Data from a Phase 3 Clinical Study of Technosphere Insulin in Type 1 Diabetes

Sept. 16, 2008 - MannKind Corporation (Nasdaq: MNKD) released preliminary top-line results from a Phase 3 clinical study of the Technosphere(R) Insulin System in patients with type 1 diabetes (Study 009). This study compared the safety and efficacy of prandial inhalations of Technosphere Insulin (the TI group) versus prandial subcutaneous injections of insulin aspart (the comparator group). Both groups also received daily subcutaneous injections of a basal insulin (insulin glargine).

Study Highlights
Technosphere Insulin, compared to a rapid-acting insulin analog, showed:

• Comparable reductions in A1C levels
• Comparable numbers of patients reaching pre-defined A1C goals
• Superior fasting blood glucose levels
• Better early post-prandial glucose control
• Fewer patients experiencing hypoglycemic events
• Weight loss versus weight gain
• No adverse effects on pulmonary function... MannKind's Press Release -

DiaMedica : First Patient in Phase IIa Clinical Trial for DM-99

August 11, 2008 – DiaMedica Inc. (TSX-V:DMA), a drug discovery and clinical development company focused on a novel approach to treating type 2 diabetes, announces enrollment of the first patient in the phase II proof of concept clinical trial with DM-99, the Company’s third drug candidate to enter phase II human trials.

The single-blinded clinical trial being conducted in the European Union, will demonstrate DM-99’s effectiveness at controlling blood glucose levels in 40 type 2 diabetes patients with HbA1c levels over 7.5%, after they have consumed a standardized meal. Change in insulin and/or glucose levels is the study’s primary endpoint. Each patient will be tested for both the effects of treatment with DM-99 as well as a placebo, and will therefore serve as their own control in this cross over study. Results are expected at the end of 2008... DiaMedica's Press Release -

Diamyd Medical : NTDDS Technology Effective against Diabetes Pain

September 1, 2008 - Diamyd Medical (Pink Sheets:DMYDY)(STO:DIAMB) reports that its Nerve Targeting Drug Delivery System (NTDDS) expressing enkephalin, is effective in preclinical models of diabetes pain - Dr. David Fink, published in the scientific journal “Journal of Neuroscience” that Diamyd Medical’s proprietary NTDDS platform, expressing enkephalin, effectively relieves pain due to diabetes in animals. The NTDDS platform allows focal delivery of the human enkephalin gene directly to nerves experiencing pain.

”These new data indicate that not only is the NTDDS platform with enkephalin effective at reducing pain, it reverses the root cause of diabetes related pain. This means that the approach is not just pain relief, but local pain prevention”, says Darren Wolfe, President of Diamyd Inc.

Elisabeth Lindner, President and CEO of Diamyd Medical, states “We have positioned Diamyd Medical as a diabetes company. These exciting results give us the opportunity to expand our product portfolio to include a third diabetes related product, NP2”... Diamyd's Press Release -

CV Therapeutics : Phase 1 Clinical Trial of CVT-3619, a Novel Potential Treatment for Cardiometabolic Diseases

Sept. 2 , 2008 - CV Therapeutics, Inc. (Nasdaq: CVTX) announced that the company has enrolled the first patient in a Phase 1 trial of CVT-3619, a novel oral compound for potential treatment of cardiometabolic diseases. The U.S. Food and Drug Administration recently accepted the Company's investigational new drug application for CVT-3619, a partial A1 adenosine receptor agonist.

This Phase 1 trial will assess the safety and pharmacokinetic profile of CVT-3619 in healthy volunteers. The Phase 1 program will provide early data on the compound's potential effects on circulating levels of free fatty acids, which are associated with high blood lipid levels, insulin resistance and other cardiometabolic risk factors...

..."CVT-3619 represents a first-in-class agent that appears to inhibit the release of free fatty acids from fat cells and has the potential to meet a tremendous unmet need by potentially treating both dyslipidemia and diabetes. We look forward to the clinical development of this innovative medication... CV Therapeutics' Press Release -

Roche NimbleGen CGH Arrays Enable Detection of the Genomic Disorder Resulting in Diabetes

July 30, 2008 — Chromosomal rearrangements leading to genomic disorders are often mediated by low-copy repeat regions of the genome (e.g. segmental duplications). Roche NimbleGen CGH arrays offer expanded probe coverage in these regions. Using this technique, the authors of a recently published paper¹ identified a recurrent reciprocal genomic rearrangement of chromosomal region 17q12 in fetal samples with congenital anomalies that is also associated with pediatric renal disease and epilepsy. The results emphasize the importance of evaluating de novo structural variation events in pediatric diseases other than mental retardation and the importance of duplication architecture as a predisposing factor for disease.

Genomic disorders result from nonallelic homologous recombination (NAHR) between low-copy repeat regions of the genome and occur in approximately 1 in 1,000 live births. The phenotypes of many of these known genomic disorders include developmental delay and mental retardation. Therefore, screening for novel genomic disorders has largely focused on patients with cognitive disability and/or peripheral nervous system defects... Roche NimbleGen's Press Release -

Lilly and Boehringer Ingelheim : New data show Duloxetine maintained pain reduction for more than six months in patients with DPNP

19 August 2008 – Duloxetine hydrochloride maintained pain reduction in the treatment of diabetic peripheral neuropathic pain (DPNP) for more than six months, according to new data presented at the 12th World Congress on Pain in Glasgow, Scotland.

The open-label study, which aimed to evaluate long-term maintenance of effect of duloxetine 60 mg once daily, is the first to assess the efficacy of duloxetine in DPNP beyond three months. The study enrolled 216 patients with DPNP who began eight weeks of treatment with 60 mg of duloxetine once daily. Over this initial eight-week period, 53 percent (N=115) of enrolled patients experienced clinically significant improvement in pain reduction (defined as at least 30 percent pain reduction) as measured by the Brief Pain Inventory (BPI) 24-hour average pain rating. This group of responders was maintained on duloxetine 60 mg (N=103) once daily for up to 26 weeks to evaluate sustained pain reduction. Results at study end showed that the reduction in pain was maintained in 74.8 percent (N=77) of the sustained responders with 60 mg duloxetine over the full study period.


“DPNP is a chronic, potentially disabling, condition requiring treatment over a long period of time,” said Vladimir Skljarevski, M.D., lead author of the study and a neurologist and medical fellow at Lilly Research Laboratories. “This study showed duloxetine reduced pain over a six-month period, making this the longest data analysis of duloxetine for the treatment of DPNP.”... Boehringer Ingelheim's Press Release -

Home Diagnostics: FDA Clearance for TRUE2go, TRUEresult No-Coding Blood Glucose Monitoring Systems

Aug 20, 2008 - TRUE2go(TM) is World's Smallest Blood Glucose Meter, Designed to Help Patients Better Manage Their Diabetes On-the-Go - Home Diagnostics, Inc. (NASDAQ:HDIX), a leading manufacturer and marketer of diabetes testing supplies, announced that it received 510(k) clearance from the U.S. Food and Drug Administration for the world's smallest blood glucose meter, TRUE2go(TM), and for TRUEresult(TM), the company's latest advanced performance, no-coding meter for at-home testing.

Small enough to twist and attach to the top of a vial of test strips, TRUE2go offers patients the convenience of anywhere, on-the-go testing to help them better manage their diabetes. TRUEresult, the latest state-of-the-art, high performance meter, offers patients advanced monitoring capabilities at an affordable price. In clinical testing, both systems achieved a high degree of accuracy and repeatability, and were considered to be easy to use by people with diabetes.

Both new meters are compatible with the company's new TRUEtest platform of blood glucose test strips featuring the company's patent-pending, state-of-the-art GoldSensor(TM) laser accuracy and TRUEfill(TM) beveled tip. These advanced features ensure highly accurate test results and first test success by allowing for greater sampling precision and consistency... Home Diagnostics' Press Release -

Activx Biosciences : Positive Phase Ib and IIa Clinical Trial Results for KRP-104, a Flexible Dosing DPP-4 Inhibitor for Type 2 Diabetes

August 20, 2008 — Activx Biosciences, Inc., a wholly owned subsidiary of Tokyo-based Kyorin Pharmaceutical Co., Ltd., announced topline results from their Phase Ib and Phase IIa clinical trials with KRP-104, a dipeptidyl peptidase-4 (DPP-4) inhibitor, for the treatment of type 2 diabetes. In Phase IIa, KRP-104 was shown to be well tolerated and efficacious in the treatment of hyperglycemia in patients with type 2 diabetes resulting in highly significant improvements in glycemic control compared to placebo.

The open labeled, cross-over, Phase Ib trial of KRP-104 in the US enrolled 28 patients with type 2 diabetes and showed equivalent efficacy on glucose-lowering to a competitive drug.

The randomized, double-blind, placebo-controlled, multi-center Phase IIa trial in the US and India enrolled 220 patients with type 2 diabetes inadequately controlled on metformin alone. The study evaluated the safety, tolerability, and efficacy of a total daily dose of 120 mg of KRP-104, administered either as a once daily (QD) dose or as a split dose of 60 mg (BID) added to stable metformin therapy for 12-weeks of treatment. Both dosing regimens provide greater than 95% inhibition of DPP-4 during daytime hours, but the BID dosing regimen provides this high level of inhibition continuously, whereas the QD dose results in considerably less DPP-4 inhibition overnight... Activx Biosciences' Press Release -

Amylin and Lilly : Context for FDA Alert for BYETTA

Aug. 26, 2008 - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) in a conference call provided context and additional information regarding the August 18, 2008 U.S. Food and Drug Administration (FDA) update to a prior alert for BYETTA(R) (exenatide) injection referencing pancreatitis. The companies were aware of the pancreatitis cases referenced in the alert, as well as others, and previously reported these cases to the FDA. The complete conference call replay will be available through Amylin's and Lilly's corporate websites after the call.

Since 2006, the U.S. prescribing information for BYETTA has included information about pancreatitis. A recent study has also shown that patients with type 2 diabetes were at nearly three times the risk of developing pancreatitis than those without diabetes.(1) While a definite causal relationship between BYETTA and pancreatitis has not been proved, to better understand the suspected relationship, Amylin and Lilly continue to pursue a comprehensive drug safety program that includes extensive internal and external review of individual cases, and clinical and epidemiologic studies... Amylin Pharmaceuticals' Press Release -

Intercept Pharmaceuticals Raises $25 Million, Funding Will Support Completion of INT-747 Phase II Clinical Trials...

July 29, 2008 - Intercept Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing therapeutics for the treatment of chronic fibrotic and metabolic diseases, announced the completion of a $25 million equity financing by Genextra S.p.A. This financing was in lieu of the previously contemplated $20.5 million second tranche investment under the Genextra-led $41 million financing announced in May 2006.
Mark Pruzanski, M.D., Intercept's founder, President and CEO, commented, "This financing is recognition of the progress we have made with our lead compound INT-747, as well as recent exciting milestones achieved in our preclinical programs. Genextra's strong backing will enable us to complete our Phase II clinical trials while continuing to advance our pipeline of internally discovered novel FXR and TGR5 agonists."


Patient enrollment is well underway in three Phase II clinical trials of INT-747, Intercept's first-in-class farnesoid X receptor (FXR) agonist. The clinical program of INT-747 consists of two studies in patients with primary biliary cirrhosis (PBC), a chronic autoimmune liver disease, and a third study in Type 2 diabetic patients with nonalcoholic fatty liver disease (NAFLD). INT-747 has been granted orphan drug designation by the U.S. Food & Drug Administration for the treatment of PBC... [PDF] Intercept Pharmaceuticals' Press Release -

SemBioSys submits IND for safflower-produced insulin to U.S. FDAn

July 29, 2008 - SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, announced that it has submitted an Investigational New Drug (IND) application for safflower-produced recombinant human insulin to the United States Food and Drug Administration (FDA). The IND application contains a physical, chemical and structural analysis of safflower-produced insulin to a reference standard, results from 28-day sub-chronic toxicology studies in two species of mammals, demonstration of pharmacodynamic function in animals and describes a cGMP process for the production of safflower-produced insulin. SemBioSys plans to initiate a Phase I/II clinical study of its safflower-produced insulin in the fourth quarter of 2008... SemBioSys Genetics' Press Release -

Silence Therapeutics to receive $1.9m Milestone Payment as Pfizer, Quark commence Phase II Trial

30 July 2008 – Silence Therapeutics plc (AIM: SLN), a leading European RNAi focused biotechnology company, announces that its partner, Quark Pharmaceuticals Inc (“Quark”) together with Pfizer, has commenced a Phase II clinical trial with RTP-801i-14 (PF-4523655), a small interfering RNA (siRNA) therapeutic product based on Silence’s AtuRNAi technology. Its initiation triggers a $1.9 million milestone payment to Silence from Quark.


The study is designed to evaluate the effectiveness of the candidate in improving visual acuity compared to laser treatment in patients with diabetic macular oedema. The Phase II study is being funded and is conducted by Pfizer Inc in collaboration with Quark.
Pfizer in-licensed RTP-801i-14 from Quark in a deal announced in 2006 for the treatment of age-related macular degeneration (AMD) and other ophthalmologic and non-ophthalmologic indications... Silence Therapeutics' Press Release - Quark Pharmaceuticals' Press Release -

Formation of GlycoMark, Inc., a Joint Venture to Develop and Commercialize Novel Biomarkers for Diabetes

July 17, 2008 - Toyota Tsusho America, Inc. (New York, NY) and Nippon Kayaku Co., Ltd. (Tokyo, Japan) announced the formation of a new joint venture company, GlycoMark, Inc., dedicated to the discovery and commercialization of novel biomarkers for diabetes. The company is located in New York, NY and the Piedmont Triad Research Park in Winston-Salem, NC.


Toyota Tsusho America, Inc., Nippon Kayaku Co., Ltd., and the BioMarker Group (Kannapolis, NC) have worked together as partners to commercialize the GlycoMark(R) diabetes blood test over the past few years prior to establishing the new company.

With increasing clinical acceptance and commercial success of the GlycoMark(R) blood test, a solid foundation has now been built to position GlycoMark, Inc. as a leader in the field of diabetes diagnostics... [PDF] GlycoMark's Press Release -

Eisai China : License Agreement in China for alpha-Lipon 300 STADA for Diabetic Neuropathic Pain

July 30, 2008 - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced that Eisai China Inc. (Headquarters: Suzhou, President: Yukio Akada, “ECI”), a wholly-owned subsidiary of Eisai Co., Ltd., has entered into license agreement with Health Vision Enterprise Ltd. (Headquarters: Hong Kong, Directors: Alex Leung and Zona Yim, “Health Vision”), a sales subsidiary of STADA Arzneimittel AG (Headquarters: Germany, “STADA”), for sales and repack of -Lipon 300 STADA® (generic name: -lipoic acid) in China. -Lipon 300 STADA® is a treatment for diabetic neuropathic pain developed by STADA.

With this agreement, ECI will take over sales promotion activities for -Lipon 300 STADA® in China from Health Vision from August 1. In addition, ECI will prepare for filing an application for repacking the product at its Suzhou plant. Upon approval, ECI will assume repacking and sales of -Lipon 300 STADA® in China.

-Lipon 300 STADA® is a therapeutic agent for diabetic neuropathic pains developed by STADA, and has been on the market in China since 2005. It relieves neuropathic pain associated with diabetes by its antioxidant effect, which reduces overproduction of oxygen species and normalization of glucose metabolism... Eisai's Press Release -