GlaxoSmithKline : positive CHMP opinion for new non-prescription weight loss treatment – alli® – to help in the fight against obesity across Europe

23 October 2008 - GlaxoSmithKline (GSK) announced that alli ^® (orlistat 60mg) has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) as a non-prescription product. As a result, approval of alli (orlistat 60mg)could be granted by the end of the year across all 27 EU member countries with an anticipated launch in 2009 as the first licensed weight loss treatment available without a prescription. The product would be indicated for adults who are overweight and have a body mass index (BMI) of 28 or more... GlaxoSmithKline's Press Release -

Novo Nordisk : Levemir® demonstrates a 24-hour duration of action and significant weight loss in obese patients – new studies announced

10 September 2008 -Data released at the European Association for the Study of Diabetes (EASD) Annual Meeting concludes that Levemir® (insulin detemir [rDNA origin] injection) is a once-daily treatment for diabetes patients after demonstrating a 24-hour duration of action in both type 1 and type 2 diabetes.1,2 Results from two other studies announced reveal that Levemir® can lead to significant weight loss for insulin-naïve patients with type 2 diabetes3, and provides a similar blood glucose response as glargine with no significant difference in daily average consumption (DACON) or diabetes-related pharmacy costs4... Novo Nordisk's Press Release -

BioServe : Customizable DNA Panels for Genetic Research

September 11, 2008 - BioServe announced a more affordable pricing plan for its vast bank of DNA with comprehensive, de-identified, covariate data that includes age, gender, diet, body mass index (BMI), and race. In addition, each sample has data on the complete diagnostic and treatment history of the donor. BioServe's DNA represents a wide range of disease states including cancers (breast, prostate, lung, colon, others), diabetes, heart disease, hypertension, arthritis, obesity, as well as some rarer diseases. The repository also includes over 14,000 control subjects that are free of major illnesses. DNA is available in quantities from a few nanograms to hundreds of micrograms per subject to suit customer needs. Customized DNA panels and case-control studies can be designed based upon the investigators’ needs, taking into consideration the specific data points available for each individual DNA sample. Another useful function of these DNAs is for investigators to utilize them as second group of samples to validate data generated from their studies... BioServe's Press Release -

Merck Discontinues Development of Investigational Medicine Taranabant for Obesity

Oct. 2, 2008 - Merck & Co., Inc. will not seek regulatory approval for taranabant, an investigational medicine, to treat obesity and is discontinuing its Phase III clinical development program for taranabant for obesity.

"Available Phase III data showed that both efficacy and adverse events were dose related, with greater efficacy and more adverse events in the higher doses. Therefore, after careful consideration, we determined that the overall profile of taranabant does not support further development for obesity... Merck & Co's Press Release -

Amylin Pharmaceuticals : Novel Data on Promising Obesity Pipeline at 2008 Annual Scientific Meeting of The Obesity Society

Oct. 1, 2008 - Data support the therapeutic potential of Amylin's integrated neurohormonal approach to obesity pharmacotherapy - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) announced that new data for its pipeline obesity candidates will be presented at the 2008 Annual Scientific Meeting of The Obesity Society in Phoenix October 3-7. The Obesity Society's annual meeting is one of the largest and most comprehensive scientific conferences in the field of obesity.

Amylin will present scientific data through 11 oral and poster presentations, showcasing progress in the company's obesity pipeline. In addition to Amylin's lead clinical-stage programs in obesity, pramlintide/metreleptin and AC2307, new findings will also be presented on various preclinical programs, including a new Y-family mimetic and Amylin's peptide hybrid (phybrid) platform. Additional information will be presented during two corporate-sponsored symposia focused on the emerging peptide hormone approach to the treatment of obesity and the new science and therapeutic research that shows promise to reduce the risk of cardiovascular disease associated with obesity and type 2 diabetes... Amylin' Press Release -

Interleukin Genetics and Geisinger : Collaboration on Genetic Tests to Predict Weight Loss Success

Sep. 18,2008 - Interleukin Genetics, Inc. (Amex: ILI - News), and Geisinger Health System, announced a research collaboration to explore the role of genetics in obesity. The goal of the collaboration is to develop a series of genetic tests that will help physicians better understand an individual's inherited resistance to weight loss and, more specifically, gauge a patient's likelihood of success with diet and other weight loss techniques.

Geisinger and Interleukin Genetics will engage in a case-control retrospective study involving the analysis of DNA to better understand genetic links to obesity. The study will focus exclusively on variations of perilipin, interleukin 1 and a select number of other genes... Interleukin Genetics' Press Release -

Obecure : First Patient in Phase II Obesity Study in Pre-Menopause Women

08.09.2008 - Obecure has commenced a Phase II clinical trial to evaluate the efficacy of Histalean^TM in obese patients. This study, encoded BET-207, is a follow-up to the Company's post-hoc findings in a prior Phase II study, suggesting that treatment with a 48 mg/day dose of the drug provides significant weight reduction in obese women up to the age of 50. The current study is a double-blinded, placebo-controlled, multi-center, dose ranging study to confirm the efficacy of a 12 week treatment with the drug in obese but otherwise healthy premenopausal females aged 18-50. The study will randomize about 180 obese women, with a body to mass ratio (BMI) ranging from 30 - 40 kg/m², into three study arms: 60 women will be treated with 48 mg/day Histalean^TM, 60 women will be treated with 96 mg/day Histalean^TM and 60 women will receive matching placebo. The study will be carried out in about 12 investigation sites in Europe and regulatory approval has already been received in Belgium and the Netherlands... Obecure's Press Release -

Aragon Surgical LapCap : FDA Special 510(K) Clearance For Use With Longer Needles Used In Morbidly Obese Patients

January 23rd, 2008—Aragon Surgical, Inc., a developer of surgical devices, announced that it has received FDA Special 510(k) Clearance allowing laparoscopic surgeons to use the company’s novel LapCap with any length needle, allowing the LapCap to be used across the patient obesity spectrum, including in morbidly obese patients.
The initial step in laparoscopic surgery requires instillation of gas into the abdominal cavity, creating the space in which the surgeon operates (the pneumoperitoneum). In order to instill the gas, the surgeon blindly passes a 14 gauge needle through the abdominal wall, attempting to position the needle tip within the abdominal cavity without injuring intestines or blood vessels based on subtle tactile feedback. Blind needle passage is an inconsistent maneuver associated with risk of needle injury to intestines and vessels, failure to correctly position the needle, and anxiety for the surgeon... [PDF] Aragon Surgical's Press Release -

Corcept Therapeutics and Lilly : about Collaboration With Eli Lilly and Company

Sep 3, 2008 - Corcept Therapeutics (CORT) announced that Eli Lilly and Company (Lilly) has agreed to fund studies to test the effectiveness of Corcept's selective GRII receptor antagonist, CORT 108297, in rat models of olanzapine induced weight gain.
Corcept has previously published the results of studies in rats that demonstrated that CORLUX, a potent GRII (cortisol) receptor antagonist, both reduced the weight gain associated with the ongoing use of olanzapine and mitigated the weight gain associated with the initiation of treatment with olanzapine. In August of 2007, Corcept also announced that the results of a clinical trial in healthy men indicated that CORLUX mitigated the weight gain associated with the initiation of treatment with olanzapine.

Lilly supplied olanzapine and provided the funds for this human proof of concept study... Corcept Therapeutics' Press Release -

Anthill Technologies : Agreement with Zafgen

August 25, 2008 - Anthill Technologies, Inc. announced that it has entered into an agreement with Zafgen, Inc. to apply its high-speed chemistry technologies and capabilities to Zafgen’s obesity program. Zafgen, Inc. is a Boston-based biopharmaceutical company which develops obesity therapy based on the vascular targeting of adipose tissue.
Under the agreement, Anthill will use its ACOS™ high-speed synthesis and on-demand purification capabilities to assist Zafgen in the development of lead compounds for its obesity therapy programs...
Anthill Technologies' Press Release -

GlaxoSmithKline and the Harvard Stem Cell Institute : unique collaboration to enable the discovery of new medicines

24th July 2008 - GlaxoSmithKline (GSK) and the Harvard Stem Cell Institute (HSCI) announced that they have entered into a five-year, $25 million-plus collaborative agreement to build a unique alliance in stem cell science, leading to the development of new medicines.

GSK’s investment, one of the largest by a pharmaceutical company in stem cell science, will support innovative research at Harvard University and in at least four Harvard-affiliated hospitals in the areas of neuroscience, heart disease, cancer, diabetes, musculoskeletal diseases and obesity. In addition, GSK will fund an annual grant, which supports early stage research in stem cell biology, as part of HSCI’s seed grant program

This agreement marks the beginning of an exciting collaboration with multiple researchers at multiple Harvard institutions, making it possible for academic and industrial scientists to work side-by-side to develop treatments in areas of unmet medical need... GlaxoSmithKline's Press Release -

MDRNA : Phase 2 Trial of PYY(3-36) Does not Meet Weight Loss Endpoint

July 31, 2008-MDRNA, Inc. (Nasdaq: MRNA) announced results from a Phase 2 clinical trial evaluating PYY(3-36) Nasal Spray (PYY) for the treatment of obesity. The data indicate that PYY did not meet the primary efficacy endpoint of a dose response of weight loss vs. PYY dose, nor did PYY meet the secondary efficacy endpoint of greater weight loss than the active control, sibutramine (Meridia(R))... MDRNA's Press Release -

Alkermes : Positive Data on Proprietary Molecules Targeting Opioid Receptors

July 1, 2008 - Alkermes, Inc. (NASDAQ: ALKS) announced positive preclinical results for three proprietary molecules targeting opioid receptors, including ALKS 33. Data from two preclinical studies demonstrated that the three molecules showed statistically superior oral efficacy as well as evidence for improved metabolic and pharmacokinetic profiles compared to an active control. The data were presented at the 2008 Research Society on Alcoholism/International Society for Biomedical Research on Alcoholism (RSA/ISBRA) Joint Scientific Meeting in Washington, D.C.

"We are encouraged by the compelling preclinical profiles emerging for this series of orally active, proprietary molecules, which represent multiple opportunities to advance novel drug candidates into our pipeline," stated Daniel Deaver, Ph.D., vice president, non-clinical development of Alkermes. "These findings support the continued development of next-generation therapeutics to treat a broad range of diseases, including central nervous system disorders and brain reward disorders, such as addiction, obesity and other impulse-control disorders.".. Alkermes' Press Release -

EnteroMedics : ISO 13485:2003 Certification for the Maestro(TM) System

Jun 27, 2008 - EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, announced that it has received ISO 13485:2003 certification from KEMA Quality B.V. for the design, manufacture and distribution of surgical implants and associated accessories for nervous impulse modulation for the purpose of regulating gastrointestinal and metabolic disorders. EnteroMedics is in pivotal testing of VBLOC(TM) vagal blocking therapy, delivered via the Maestro(TM) System, for the treatment of obesity... EnteroMedics' Press Release -

Palatin Technologies : AMENDMENT EXPANDING ASTRAZENECA OBESITY COLLABORATION

July 1, 2008 – Palatin Technologies, Inc. (AMEX: PTN) announced that AstraZeneca and Palatin have amended their exclusive global licensing and research collaboration agreement to discover, develop and commercialize compounds that target melanocortin receptors. The original agreement was effective in January 2007.
Under the amendment, Palatin has agreed to license additional compounds and associated intellectual property to AstraZeneca. Palatin will receive development and regulatory milestone payments if any additional compound advances into human clinical trials, and sales target milestone payments and stepped royalties if any additional compound is commercialized.


Research scientists at AstraZeneca and Palatin are working to complete election of a lead drug candidate for initial clinical evaluation. Under the agreement, AstraZeneca is responsible for product commercialization, product discovery and development costs... Palatin Technologies' Press Release -

Elixir Pharmaceuticals : Exclusive Sirtuin Intellectual Property License Agreement with Boston University.

July 1, 2008 - Elixir Pharmaceuticals, Inc., announced the Company has entered an exclusive license agreement with Boston University to key intellectual property covering discoveries regarding the use of modulators of SIRT1, a member of the sirtuin class of protein deacetylase enzymes. SIRT1 is the human equivalent of Sir2, a gene identified in yeast that has been recognized to play a key role in the control of lifespan, metabolism, resistance to stress and other cellular regulatory pathways. Th agreement with Boston University encompasses therapeutic applications for SIRT1 modulators in metabolic diseases, including obesity and diabetes, as well as therapeutic modulation of SIRT1 for anti-angiogenic activity to treat cancer... [PDF] Elixir Pharmaceuticals' Press Release -

AstraZeneca and Columbia University Medical Center : strategic research collaboration to develop novel therapeutics for diabetes and obesity

June 17, 2008 - AstraZeneca (NYSE: AZN) and Columbia University Medical Center announced that they have entered into a strategic research collaboration in metabolic related diseases, to develop novel therapeutics primarily in type 2 diabetes and obesity and, with a secondary focus on atherosclerosis (hardening of the arteries)/dyslipidemia (abnormal blood lipid levels).

The preclinical and clinical research will focus on discovering mechanisms and identifying new biological targets for intervention that have the potential of being starting points for successful and commercially viable treatments to tackle these diseases that are major risk factors for cardiovascular morbidity and mortality... AstraZeneca's Press Release -

Amarillo Biosciences Files Patent to Treat Obesity with Oral Interferon

June 11, 2008 — Amarillo Biosciences, Inc. (OTCBB: AMAR), a specialty pharmaceutical company focused on low-dose orally administered interferon as a treatment for a variety of conditions, announced that a patent has been filed with the United States Patent and Trademark Office on the oral use of interferon to treat obesity.

The company recently conducted a review of clinical data from four studies that it had conducted wherein 582 women were treated for autoimmune diseases or fibromyalgia syndrome over three to six months with one of 5 different low daily doses of oral interferon or placebo. This review found that a significantly greater proportion of women given two specific doses of oral interferon experienced at least a 5% weight loss, compared to the women given placebo. This surprising benefit occurred in the women given oral interferon without a significant increase in adverse events... Amarillo Biosciences' Press Release -

OSI Pharmaceuticals : Clinical Development Program for Anti-Obesity Candidate, PSN602

June 19, 2008- OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced that it has initiated the first-in-human clinical study of its development compound PSN602. Discovered by OSI's diabetes and obesity team, PSN602 is an oral dual serotonin and norepinephrine reuptake inhibitor and 5-HT1A agonist, being developed for the treatment of obesity. PSN602 is the first clinical candidate to emerge from the Company's research efforts in obesity.

"Our research efforts are focused on designing innovative, next-generation, small molecule compounds to provide safer or more effective options for the treatment of type 2 diabetes and obesity," stated Anker Lundemose, M.D., Ph.D., President of (OSI) Prosidion. "We believe that not only does PSN602 have the potential to have a favorable side-effect profile relative to current therapies for obesity, but also the potential to provide greater efficacy."

The double-blind, placebo-controlled, ascending, single and multiple, oral dose study is designed to provide preliminary information on the safety, tolerability and pharmacokinetics of PSN602 in healthy lean and overweight/obese subjects, as well as on the effects of PSN602 on appetite and food intake in healthy overweight/obese subjects... OSI Pharmaceuticals' Press Release -

MDS Pharma : Therapeutic Focus on Respiratory and Metabolic Disorders

May 20, 2008 - MDS Pharma Services, a leading provider of innovative drug discovery and development solutions, has named two experienced medical professionals to lead its late stage clinical trial management activities related to respiratory ailments and metabolic disorders. Dr. Bernard Tisserand and Dr. Jonny L. Salyer have been named Executive Medical Directors for Respiratory Disorders and Metabolic Disorders, respectively. These therapeutic areas represent serious global public health concerns and are key areas of focus for MDS Pharma Services' customers. Respiratory disorders include conditions such as asthma, allergic rhinitis, chronic obstructive pulmonary disease (COPD), and community acquired pneumonia (CAP), while metabolic disorders include diabetes, dyslipidemia, obesity and metabolic syndrome, which is defined as a cluster of conditions that damage the cardiovascular system... MDS Pharma Services' Press Release -

Amylin Pharmaceuticals : Promising Data From Diabetes and Obesity Programs at ADA 2008

June 2, 2008, 2008 - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) announced that the company will present new data for its FDA-approved diabetes drugs, BYETTA(R) (exenatide) injection and SYMLIN(R) (pramlintide acetate) injection, and its pipeline diabetes and obesity drug candidates at the American Diabetes Association's 68th Annual Scientific Sessions (ADA) being held in San Francisco, CA from June 6 to 10. The company will also host an investor presentation on Sunday, June 8, at 7:45 PM PT (10:45 PM ET) that will be available by webcast. ADA is one of the largest scientific meetings for endocrinologists and other health care professionals involved in diabetes research and the delivery of diabetes care. Amylin will be introducing data through over 20 posters and eight oral presentations at the meeting. The data will demonstrate significant progress in key research and clinical programs that include studies of BYETTA, SYMLIN, and Amylin's early and late-stage pipeline candidates... Amylin's Press Release -

Daiichi Sankyo : AZOR Reduces Blood Pressure in Difficult to Treat Special Populations

May 15, 2008 - Daiichi Sankyo, Inc., announced that data presented at the American Society of Hypertension's Twenty-Third Annual Scientific Meeting (ASH 2008) in New Orleans demonstrated that the powerful combination drug AZOR™ (amlodipine and olmesartan medoxomil) safely and effectively helped patients across several major subpopulations lower their blood pressure (BP). An analysis of patient subgroups from the pivotal registrational trial demonstrated the efficacy of AZOR in several key difficult to treat patient groups including people of African and Hispanic/Latino decent, people with high body mass index (BMI) and those with diabetes... [PDF] Daiichi Sankyo's Press Release -

Theratechnologies ; Tesamorelin in Growth Hormone Deficient Abdominal Obesity

May 15, 2008 - Theratechnologies (TSX:TH) announced a strategic agreement with both the Massachusetts General Hospital ("MGH") and Dr. Steven Grinspoon to explore the use of tesamorelin in relative growth hormone deficient abdominally obese (GHDAO) subjects. MGH, under the direction of Dr. Grinspoon, will sponsor and conduct a clinical trial with tesamorelin in subjects that have excess visceral adipose tissue (VAT) with a moderate growth hormone deficiency and who are abdominally obese.The combination of these factors is now being recognized as an important contributor to increased risk of cardiovascular disease. Therefore, one of the reasonable approaches to lower the cardiovascular risk in these subjects is to decrease VAT levels with tesamorelin to replenish growth hormone secretion, and to measure certain key markers of cardiovascular risk. Theratechnologies has demonstrated in various Phase 2 and 3 clinical trials that tesamorelin significantly and specifically reduces VAT in certain patient populations... Theratechnologies' Press Release -

NESTLÉ SCIENCE AND RESEARCH AND GE : COLLABORATION TO EXPLORE NEW FRONTIERS IN DIAGNOSTICS FOR HEALTH AND NUTRITION

May 14, 2008 – The Nestlé Research Center, Lausanne, Switzerland and GE Global Research, the General Electric Company’s (NYSE: GE) centralized research and development organization, announce an innovative collaboration to scientifically assess associations between body composition, metabolic status, diet and lifestyle habits...

...“The use of GE’s diagnostic tools will provide Nestlé scientists with more information on how diet and lifestyle measures can be optimized to help people lead healthier lives and ultimately make healthcare systems more efficient by more effectively managing and treating obesity.”... GE's Press Release -

Elixir Pharmaceuticals : Issuance of SIRT Patent Covering Development of New Therapies Based on Breakthrough Science.

04.28.08 - Elixir Pharmaceuticals, Inc., announced today issuance of U.S. Patent No. 7,351,542, which covers the discovery of new and existing chemical entities that modulate the activity of a human sirtuin, SIRT 2. Elixir's rights to this patent were made possible through an exclusive license.
Sirtuins are a class of enzymes believed to play a significant role in diseases of aging, including type 2 diabetes and obesity. SIRT 2 is one of the seven human SIRT (or sirtuin) enzymes. Elixir co-founder Dr. Lenny Guarente of MIT and others have shown that the down-regulation of SIRT 2 elicits positive effects on metabolism. Therefore, pharmaceutical compounds that block the activity of this enzyme could have clinical utility to treat a range of metabolic diseases, such as diabetes and obesity. This new patent adds to Elixir's broad portfolio of issued patents and patent applications related to the development of sirtuin-based therapeutics... [PDF] Elixir Pharmaceuticals' Press Release -

Pfizer : Research Consortium to Expand Understanding of Diabetes and Obesity Pathobiology

April 25, 2008 - Pfizer has entered into a collaboration agreement with four major research universities – University of California, Santa Barbara (UCSB); Caltech; the Massachusetts Institute of Technology; and University of Massachusetts – and Entelos, a physiological modeling company, to re-examine the regulatory mechanisms of human energy metabolism.
Pfizer is funding the three-year and $14 million Insulin Resistance Pathway (IRP) Project to look at insulin signaling in adipose (fat) cells to increase understanding of diabetes and obesity, inextricably linked conditions that affect 7 percent of the U.S. population... Pfizer's Press Release -

VIVUS : Third Phase 3 CONQUER (OB-303) Trial

Apr 22, 2008 - VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, announced that it has completed enrollment in the final of three phase 3 studies of Qnexa(TM) in overweight and obese patients with co-morbidities including hypertension, dyslipidemia, or type 2 diabetes. The CONQUER study (OB-303) enrolled patients with a Body Mass Index ("BMI") ranging from 27 to 45 and at least two additional co-morbidities. The co-primary endpoints for this study are the mean percent weight loss and the percentage of subjects achieving weight loss of 5% or more... VIVUS' Press Release -

Amylin Pharmaceuticals : Phase 2B Dose-Ranging Clinical Study of Pramlintide/Metreleptin Combination Treatment in Obesity

May 5, 2008 - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) announced the initiation of a Phase 2B clinical study evaluating various dosing combinations of pramlintide, an analog of the natural hormone amylin, and recombinant human leptin (r-metHuLeptin; metreleptin) for the treatment of obesity. The objective of this dose-ranging study is to support dose selection for Phase 3, and to inform the ongoing development of a convenient delivery system for this combination regimen. The six-month, randomized, double-blind, placebo-controlled multi-center study will enroll approximately 600 overweight and obese subjects and is expected to complete in mid-2009.

"There is a tremendous medical need and market demand for a weight loss product that meets both safety and efficacy expectations of patients and physicians, and we believe that our integrated neurohormonal approach to obesity holds great promise for achieving this profile... Amylin Pharmaceuticals' Press Release -

Orexigen Therapeutics : Completion of Enrollment in Second of Four Phase III Clinical Trials for Contrave

Apr 22, 2008 - Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of central nervous system disorders, including obesity, today announced completion of enrollment in NB-301, the largest of its Phase III clinical trials, for Contrave(R), its lead obesity product candidate. This represents completion of enrollment in the second of four Phase III trials of Contrave.

The NB-301 clinical trial is a placebo-controlled, 56-week study intended to analyze the efficacy, safety and tolerability of two doses of Contrave in generally healthy obese patients. This trial is taking place at 34 centers nationwide and has randomized approximately 1742 patients... Orexigen's Press Release -

Znomics : Drug Discovery Program in Obesity Using Proprietary In Vivo Screening Model

Apr 15, 2008 - Znomics, Inc. (OTCBB:ZNOM), a pioneer in the development of the zebrafish as a vertebrate genetic platform to accelerate drug discovery, announced today the launch of a program to find lead drug compounds for the treatment of obesity.

Znomics obtained from Oregon Health & Science University (OHSU) an exclusive biological license to a genetic model of obesity using the zebrafish developed in the OHSU laboratory of Znomics' co-founder Roger Cone, Ph.D., a leading international researcher in the field of weight regulation. Under the direction of Stephane Berghmans, director of drug discovery at Znomics, the company intends to refine Dr. Cone's obesity model for use in the screening of small molecule compounds. The company aims to identify pre-clinical drug candidates for obesity and to partner with a pharmaceutical or biotechnology company to advance these candidates into human clinical studies... Znomics' Press Release -

Pacific Biometrics : Research Contracts as Part of Global Phase I and II Diabetes and Obesity Programs

April 3, 2008 - Pacific Biometrics, Inc. (PBI) (OTCBB: PBME) has been awarded a series of contracts with a top multinational pharmaceutical company (the “Sponsor”) to provide essential laboratory data for a global Phase I and Phase II metabolic disease program. These contracts are part of a series of seven contracts related to clinical trials that form part of a global development program for an innovative approach for the treatment of type 2 diabetes and obesity.
PBI will provide the Sponsor with testing of metabolic markers and gut hormones on samples collected to support the Sponsor’s clinical development program. Testing has already commenced and is anticipated to be completed by the end of the first quarter of calendar 2009, although additional studies may be added to the program. PBI estimates total revenue over the expected life of these contracts at over $800,000... Pacific Biometrics' Press Release -

University of Virginia : DiaKine's Lisofylline Reduces Obesity-Related Inflammation and Insulin Resistance

April 16, 2008 - -DiaKine Therapeutics announced that its developmental drug Lisofylline (LSF), significantly reduced indicators of inflammation in visceral fat tissue that are predictive of heart disease and diabetes risk, according to results of a pre-clinical study presented at the Arteriosclerosis, Thrombosis and Vascular Biology Annual Conference 2008.

“This study using ‘Western’ type high-fat, diet fed obese mice, suggests that medications with the actions of LSF could reduce inflammation and insulin resistance associated with central obesity – therefore providing a novel opportunity to treat heart disease and prevent type 2 diabetes development... [PDF] DiaKine's Press Release -

SCN, Scandinavian Clinical Nutrition : diagnosis and research in the field of virus‐induced obesity

April 8, 2008 - SCN has signed a world‐wide license agreement for the patent rights to the obesity related virus adenovirus 36 (AD36). The agreement is signed between SCN and the internationally renowned researcher and Professor Richard L. Atkinson. In conjunction with the agreement, SCN has initiated additional research cooperation with Karolinska Institutet in Stockholm, one of Europe’s leading medical universities, and Professor Atkinson. SCN aims for a commercial launch of its first diagnostic tests within six to twelve months.
Professor Atkinson comments; “The results from a number of research projects indicate that between 30 and 57 percent of obese people and as much as 18 percent of lean people could be infected by the human adenovirus AD36.” Results from animal testing show that nearly all individuals infected by the virus had significantly more fat compared with a control group of lean animals, even though their food intake was in fact less... [PDF] Scandinavian Clinical Nutrition's press Release -

Memory Pharmaceuticals : Advance Development and Clinical Programs

March 12, 2008 - Memory Pharmaceuticals Corp. (Nasdaq: MEMY) announced that it has realigned its operations, reallocated its resources and extended the preclinical research portion of its PDE10 collaboration with Amgen. The Company will focus its near-term and mid- term efforts on two partnered programs, its nicotinic alpha-7 receptor agonist collaboration with Roche and the PDE10 collaboration with Amgen, and two proprietary programs, its PDE4 inhibitor and 5-HT6 antagonist programs...(...)
- 5-HT6 Antagonist Program. 5-HT6 antagonists are potential treatments for Alzheimer's disease, schizophrenia, attention deficit disorder and obesity. Memory Pharmaceuticals has generated a portfolio of novel, potent and selective 5-HT6 antagonists and is evaluating several lead compounds as potential development candidates. The Company plans to advance the program into clinical trials by the end of 2008... Memory Pharmaceuticals' Press Release -

Genaera Corporation : MSI-1436 Data Presented at Society of Neuroscience Meeting

March 28th, 2008 - Genaera Corporation (NASDAQ: GENR) announced that preclinical data was presented Thursday at the Chicago Chapter of the Society of Neuroscience by Mitchell F. Roitman, Ph.D., a Genaera collaborator and investigator with the University of Illinois at Chicago. The abstract titled “A novel anti-obesity drug MSI-1436 does not alter the rate of dopamine uptake via the dopamine transporter,” demonstrates that MSI-1436 does not inhibit the dopamine transporter in vivo by directly measuring dopamine levels in the brain of rats after MSI-1436 administration.
Dopamine is a neurotransmitter found in the brain which can have affects on locomotor function and addictive behavior. Many drugs that reduce food intake and body weight affect the rate of dopamine reuptake by inhibiting the dopamine transporter (DAT), such as amphetamine and bupropion. Such compounds, which inhibit the dopamine transporter, are considered undesirable as weight-loss drugs since they affect locomotor behavior and may have high addictive potential... Genaera 's Press Release -

Merck : Phase III Data Showed Taranabant, its Investigational Medicine to Treat Obesity, Led to Statistically Significant Weight Loss

March 31, 2008 - Fifty-two week results of a two-year Phase III study of taranabant, Merck's investigational cannabinoid-1 receptor (CB1R) blocker, showed patients experienced statistically significant weight loss when taking the drug in combination with diet and exercise. These findings were presented today at the 57th annual scientific session of the American College of Cardiology... Merck's Press Release -

VIVUS : Enrollment in Phase 3 EQUIP (OB-302) Tria

March 27, 2008--VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, announced that it has completed enrollment in the first of two pivotal phase 3 studies of Qnexa(TM) in obese patients. The EQUIP study (OB-302) has enrolled over 1,250 morbidly obese patients with a Body Mass Index ("BMI") that equals or exceeds 35. The co-primary endpoints for these studies are the mean percent weight loss and the percentage of subjects achieving weight loss of 5% or more... VIVUS' Press Release -

Sanofi-aventis : NICE Recommends Acomplia to be included in the NHS Guidance

March 26, 2008 - Sanofi-aventis announced that the National Institute for Health and Clinical Excellence (NICE) has issued its Final Appraisal Determination (FAD) on Acomplia® (rimonabant) which proposes guidance recommending the use of the drug in England and Wales, within its licensed indications, as an adjunct to diet and exercise for adults who are obese or overweight and who have had an inadequate response to, are intolerant of, or are contraindicated to other antiobesity agents that have previously been reviewed by NICE.
Sanofi-aventis is delighted that the Institute has recommended that Acomplia® should be made available for the management of obese and overweight National Health Service (NHS) patients, and believes that Acomplia® is a valuable addition to the limited treatment options currently available... [PDF] Sanofi-aventis' Press Release - [PDF] Communiqué de Presse Sanofi-aventis -

deCODE Obesity Genetics study merck

March 16, 2008 – In a paper published online today in the journal Nature, a team of deCODE scientists detail a major mechanism through which genetic factors contribute to major public health problems. In its work on the inherited components of dozens of common diseases, deCODE has discovered gene variants that significantly affect individual susceptibility or protection against disease...
...In today’s paper, the deCODE team and collaborators from Merck demonstrate one of the principal ways in which the activity of biological pathways is functionally perturbed in a quintessentially complex condition: obesity. Through analysis of adipose tissue from some 1700 Icelandic participants in obesity research cohorts, the deCODE team showed in data derived from primary human tissue that variations in gene expression – in the up-regulation or downregulation of how genes are translated into proteins – have a major impact on several parameters of clinical obesity... deCODE 's Press Release -

Arena Pharmaceuticals' Lorcaserin for Obesity

March 17, 2008 - Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced that following a planned review by an independent Echocardiographic Data Safety Monitoring Board (EDSMB) it is continuing BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), a pivotal trial evaluating the efficacy and safety of lorcaserin hydrochloride for the treatment of obesity. The EDSMB's review of unblinded echocardiographic data performed after patients completed 12 months of dosing in the trial confirmed that differences, if any, in the rates of Food and Drug Administration (FDA)-defined valvulopathy in patients treated with lorcaserin and in the control group did not meet the EDSMB's predetermined stopping criteria. Based on the EDSMB's review of the rate of FDA-defined valvulopathy, Arena has been able to confirm that the statistical power calculations used in the design of the Phase 3 trial program to monitor patients for increased risk of developing valvulopathy are justified. The findings from the month-12 review build on the EDSMB's September 2007 review that evaluated echocardiograms after 6 months of dosing.

"This critical milestone assessing month-12 echocardiographic data strongly supports lorcaserin's cardiovascular safety profile. We believe that this exposure duration, even under a conservative interpretation of the literature, would have been sufficient to observe a fenfluramine like effect on heart valves if present. BLOOM's primary echo endpoint is based on the month-12 data," said Jack Lief, Arena's President and Chief Executive Officer. "We are committed to continued efforts to develop a robust database for submission to the FDA in our efforts to provide patients a novel, safe and effective obesity treatment."... Arena 's Press Release -

VIVUS, Enrollment in EQUATE (OB-301) Trial completed

March 4, 2008--VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, announced that it has completed enrollment in the EQUATE study (OB-301). This trial, initiated in December 2007, will study the effects of Qnexa, an investigational drug, in obese patients with and without co-morbidities over 28 weeks. The EQUATE study has enrolled over 700 patients with Body Mass Index ("BMI") ranging from 30 to 45 in 35 clinical sites. The co-primary endpoints for these studies will evaluate the differences between treatments in mean percent weight loss and in the percentage of subjects achieving weight loss of 5% or more... Vivus' Press Release -

Thiakis, Novel therapy for treatment of obesity enters clinical trials

12 March 2008 – Thiakis Limited, the biopharmaceutical company focused on the development of peptide hormones for the treatment of obesity, announced that it has successfully commenced dosing in a clinical trial of TKS1225, the Company's novel oxyntomodulin analogue, for the treatment of obesity. The trial will initially focus on safety and tolerability before investigating the effects of TKS1225 on appetite and food intake.
TKS1225 is a potent, long acting analogue of oxyntomodulin, a naturally occurring peptide hormone involved in regulating food intake. Preclinical models have demonstrated TKS1225 to be highly efficacious, ameliorating glucose intolerance as well as causing a significant reduction in body weight... [PDF] Thiakis' Press Release -

Alizyme's cetilistat,Phase III development programme, for type 2 diabetes as well as for obesity

6 March 2008 - Alizyme plc (“Alizyme”) (LSE: AZM) announces that FDA has agreed
the remaining two protocols for its Phase III development programme for cetilistat under the Special Protocol Assessment (“SPA”) procedure and recommended that Alizyme open a separate diabetes IND.
Cetilistat is Alizyme's metabolic product under development for the treatment of obesity and associated comorbidities, including type 2 diabetes. It is a gastrointestinal lipase inhibitor that blocks fat digestion and absorption, leading to reduced energy intake, and thus weight loss.
Following successful end of Phase II discussions, FDA approved Alizyme’s outline plan for the Phase III clinical development programme of cetilistat... [PDF] Alizyme's Press Release -

Merck, Innovative Research Method to Identify Changes in Gene Networks Linked to Obesity

March 17, 2008 - Merck & Co., Inc. announced the publication of two studies providing evidence that genetic susceptibility to obesity involves changes in entire networks of genes and is not limited to mutations in several specific genes. The work also showcases how genomic techniques may be used to understand the complex changes at the root of common diseases where multiple complex genetic changes are thought to be involved. The studies were published online in the peer-reviewed journal Nature.
Scientists at Merck Research Laboratories (MRL) and their collaborators performed genetic and gene expression analysis of tissues from a model of metabolic syndrome (a group of conditions that increases the risk of cardiovascular disease and diabetes) and a human population known to be susceptible to obesity. The resulting data were analyzed using powerful computational methods that integrate data from several sources to identify networks of gene interactions altered in individuals susceptible to obesity... Merck's Press Release -

Marcadia Biotech and Merck, strategic collaboration

March 6, 2008 – Marcadia Biotech, Inc., a privately held drug development company, announced a strategic collaboration with Merck & Co., Inc. to jointly discover, develop and commercialize novel biopharmaceutical therapies targeting the glucagon and related receptors for the treatment of diabetes and obesity.

“Merck is a world leader in the discovery of breakthrough medicines and has proven expertise in the development and commercialization of drugs that treat metabolic diseases,” said Fritz French, CEO of Marcadia. “We are excited about the opportunity to significantly leverage the research we have accomplished to date through this collaboration with Merck.”... [PDF] Marcadia Biotech's Press Release -