Industry News and Innnovations

ANSYS Helps Pioneer Patient-Specific Treatment for Osteoporosis, Part of European VPHOP Project
ANSYS, Inc. (Canonsburg, PA), a global innovator of simulation software and technologies designed to optimize product development processes, announced its participation in the Osteoporotic Virtual Physiological Human Project (VPHOP), launched by a European consortium. VPHOP aims to develop a new generation of medical technologies designed to predict the patient-specific risk of osteoporosis and bone fracture, improving diagnosis and treatment as well, according to a news release. ANSYS software is being used to simulate the variety of structural and fluid flow dynamics within the human anatomy based on the project's collection of anatomical, physiological, and pathological data.

Current treatments for osteoporosis focus on fracture prevention through a risk assessment based on historical patient data from similar reference populations. VPHOP takes a different approach by personalizing risk assessment. The project will develop patient-specific computer models based on conventional diagnostic imaging methods, incorporating the results of engineering simulation studies using software from ANSYS, to predict the daily loading of the skeleton for normal and abnormal activities. The computer models will allow clinicians to predict the actual risk and location of fracture for each patient, currently and into the future.

"The current approaches to fracture risk assessment oversimplify what is an extremely complex and multifaceted problem," said Marco Viceconti, MD, coordinator of VPHOP. "These approaches are only 60% to 70% accurate. But by applying the latest technology and using the analysis procedures we are developing in conjunction with current approaches, we believe we will be able to substantially improve this figure."

For more information, please visit www.vphop.org or www.ansys.com.

GI Dynamics Receives ISO Certification, CE Mark For EndoBarrier GI Liner System
GI Dynamics (Lexington, MA), a medical device company pioneering the development of new approaches to treat obesity and metabolic disorders, announced that it has received ISO 13485:2003 certification for the company's Lexington facility. The company has also received European Conformitˇ Europˇene (CE) mark approval for the EndoBarrier, its novel, noninvasive device currently in clinical trials to treat obesity and type 2 diabetes.

"We are very pleased to announce that we have received both the ISO certification and the CE mark approval, which are important milestones as we continue to develop the EndoBarrier and lay the groundwork for future commercialization of the product," said Stuart A. Randle, Chief Executive Officer of GI Dynamics, in a news release.

"Promising data continue to emerge from our clinical development programs in both obesity and type 2 diabetes, and we look forward to conducting larger, longer-term trials with the EndoBarrier in the year ahead."

To date, more than 100 patients have received the EndoBarrier in clinical trials. In September 2008, GI Dynamics announced data from a multicenter, randomized clinical trial of 37 patients suggesting that the EndoBarrier is well-tolerated with promising short-term weight-loss results in obese patients. These data showed that 26 patients treated with the EndoBarrier lost on average, triple the weight of their diet control group counterparts (11 patients). Specifically, at 12 weeks, the device group lost 13.7 kg (30.2 lbs) versus 4.4 kg (9.7 lbs) for the control group. Also notable was evidence that a beneficial effect on type 2 diabetes was observed through lower blood glucose levels and/or a reduction in diabetic medication.

For more information, please visit www.gidynamics.com.

Vivus Initiates Avanafil Phase 3 Trials For ED
Vivus, Inc. (Mountain View, CA), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, announced it has initiated the first of several pivotal phase 3 studies of avanafil, an investigational product for the treatment of erectile dysfunction (ED). Avanafil is a next-generation, fast-acting, selective, investigational oral phosphodiesterase type 5 (PDE5) inhibitor, according to the company. The first study, REVIVE (TA-301), is a randomized, double-blind, placebo-controlled, efficacy and safety study of avanafil in men with a history of ED. Men will undergo a 4-week run-in period followed by 12 weeks of treatment. Patients will be randomized to placebo or one of three dose levels of active drug. The primary endpoints of the study will be improvement in erectile function as measured by the Sexual Encounter Profile and improvements in the International Index of Erectile Function score (IIEF).

"Previous studies of avanafil have shown very promising results, both in terms of efficacy and safety, for the treatment of ED," said Charles H. Bowden, MD, Director of Clinical Development at VIVUS. "We are now beginning the final phase of clinical development of avanafil with REVIVE (TA-301), the first of four planned phase 3 trials. Additional phase 3 studies will include treatment in diabetic males with ED and in males with ED following a postradical prostatectomy, each about 16 weeks in duration. We also plan to initiate a 12-month safety study in the first half of 2009. In total, the pivotal phase 3 studies should enroll over 1,200 subjects."

For more information, please visit www.clinicaltrials.gov or www.vivus.com.

Finalists Announced for American Diabetes Wholesale's Educator of the Year
American Diabetes Wholesale's esteemed panel of judges have sorted through hundreds of nominations for the 2008 Diabetes Educator of the Year Contest and are happy to announce the five finalists: Linda C. Aman, RN, BS, MSN, NP-C; Suzanne Swann Laws, MS, RD, LD, CNS, FADA, BC-ADM, CDE; Janet W. Brown Crockrel, LPN, RN, CDE; Laurie Terrio, RN, BS, CDE; and Joyce Malaskovitz, PhD, RN, CDE. The discount provider of diabetic supplies to everyone including the insured, uninsured, and anyone paying out of pocket, created the Diabetes Educator of the Year Contest to recognize the unsung heroes who are committed to helping those living with diabetes, according to a news release.

"We have been overwhelmed by the positive response from the community to our second annual Diabetes Educator of the Year Contest," said Chris Maguire, Vice President and Co-Founder of American Diabetes Wholesale. "All of us at American Diabetes Wholesale are grateful for the support we have received and are looking forward to continuing to find innovative ways to service and improve the lives of people living with diabetes and their families."

The winner of the contest will receive a 3 day/2 night stay at the Boca Raton Resort and Club in Boca Raton, Florida, roundtrip airfare for themselves and a guest as well as ground transfers between the airport and the hotel. The winner will also be honored at a special ceremony, taking place on Friday, May 1st, 2009 at the Boca Raton Resort and Club, coordinated by American Diabetes Wholesale and diabetes advocate partners. The winner will be announced at the ceremony. Voting for the contest began January 14, 2009 and ends March 20, 2009. For more information please visit www.americandiabeteswholesale.com/Contest.

Galapagos Enters Strategic Alliance in Diabetes and Obesity With Merck
Galapagos NV (Mechelen, Belgium) announced that it has entered into a multiyear global strategic alliance with Merck & Co., Inc. to develop potential new therapies in obesity and diabetes.

Galapagos will be responsible for the discovery and preclinical development of new small-molecule candidate drugs based on novel Galapagos targets, according to the company. Merck will have the exclusive option to license each candidate for clinical development and commercialization on a worldwide basis. The alliance will make use of Galapagos' proprietary SilenceSelect target discovery platform for identification of novel targets in obesity and diabetes. After validation, targets will be selected by a joint steering committee and entered into screening and chemistry by Galapagos. Merck has the option to acquire an exclusive license to each candidate drug and upon exercise of such an option, Merck will be responsible for the development and commercialization of the candidate drug. For more information, please visit www.glpg.com.