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March 2009



Industry News and Innnovations

Sanofi-Aventis Launches Diabetes-Focused Channel on YouTube
Sanofi-Aventis announced the launch of a new YouTube diabetes channel, www.youtube.com/goinsulin, designed to challenge the barriers, myths, and misperceptions about insulin use and empower people living with type 2 diabetes to make better-informed decisions for managing their condition, according to a news release. The channel is part of the broader GoInsulin campaign, a multimedia resource for people living with type 2 diabetes to help dispel the myths about insulin so that they can consider adding insulin to their overall diabetes treatment plan to help control their blood sugar.

Despite the availability of convenient new tools like insulin pen delivery devices, delay in adding insulin to an overall diabetes treatment plan including diet, exercise, and other diabetes medications, may be one reason why some patients do not reach their blood glucose control goals. Many patients feel that starting insulin means that they have failed or that adding insulin may mean "the end of the road" for their diabetes, the news release stated. Others may feel that taking insulin will interfere with their daily routine or that the injections will be too painful. According to the company, GoInsulin was developed to help correct these myths about diabetes and insulin and to help educate patients so they can make the best decision about treatment for them.

The GoInsulin YouTube Channel features real-life inspiring video stories of people with type 2 diabetes who use insulin as part of their overall diabetes treatment plan, while also balancing information about the risks and benefits of insulin.

Please visit www.youtube.com/goinsulin and www.goinsulin.com for more information.

PrandiMet—Repaglinide, Metformin Fixed-Dose Combination, Now Available
Novo Nordisk and Sciele Pharma, Inc., announced the availability of PrandiMet (repaglinide and metformin HCl) tablets, the first and only fixed-dose combination of the short-acting secretagogue repaglinide (Prandin) and insulin sensitizer metformin for the treatment of type 2 diabetes in the United States.

According to a company news release, PrandiMet is a meglitinide and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are already treated with a meglitinide and metformin or who have inadequate glycemic control on a meglitinide alone or metformin alone. For more information, please visit www.prandimet.com.

Pfizer to Publicly Disclose Payments to US Health Care Professionals, Investigators
Pfizer Inc. announced its plans to make publicly available its compensation of US health care professionals for consulting, speaking engagements, and clinical trials, according to a company news release. The disclosure will include payments made to practicing US physicians and other health care providers, as well as principal investigators, major academic institutions and research sites for clinical research. This makes Pfizer the first biopharmaceutical company to commit to reporting payments for conducting phase 1 to 4 clinical trials in addition to disclosing payments for speaking and consulting. This disclosure demonstrates Pfizer's commitment to increased transparency and public candor, the release stated.

Pfizer is committing to share this information in order to provide greater clarity and understanding of the valuable scientific innovations and improved patient care that result from these collaborations with health care professionals.

"These collaborations are an essential part of medical progress," said Jeffrey B. Kindler, Chairman and Chief Executive Officer of Pfizer. "Simply put, without these collaborations, Pfizer would not be able to continue delivering the medical innovations that the global health community has come to expect."

MegaRed Omega-3 Krill Oil Now Available Nationwide
Consumers who prefer not to take several large fish oil softgels every day now have a smaller, more powerful alternative to fish oil supplements in MegaRed Omega-3 Krill Oil from Schiff, according to the company. MegaRed delivers essential omega-3 fatty acids combined with powerful antioxidants, and is three times better than fish oil for supporting heart health. One MegaRed softgel per day supports overall cardiovascular health, helps maintain healthy cholesterol levels and promotes joint health and flexibility. MegaRed is now available nationwide at retailers such as Costco, Walgreens, CVS, and Sam's Club.

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

Support for Families of Children With Type 1 Diabetes
Sanofi-Aventis announced the availability of the diabetes KidCare Kit, a multimedia resource that will provide children and their families with valuable tools and information to help guide them through the difficult but crucial first 30 days following a diagnosis of type 1 diabetes.

The KidCare Kit was developed in partnership with Children with Diabetes, a national diabetes advocacy group offering support and education for children with diabetes and their families, and is the product of more than a year of research and feedback collected from families of children with diabetes, physicians, certified diabetes educators and other healthcare professionals from across the country. The kit is now available free of charge at participating hospitals and doctor's offices nationwide to families with children that have just received a diagnosis of type 1 diabetes.

"When a child is diagnosed with type 1 diabetes it impacts the entire family and parents can often feel emotionally and physically overwhelmed in the first weeks and months following their child's diagnosis," said Jeff Hitchcock, founder and CEO of Children with Diabetes. "With the diabetes KidCare Kit, we hope to provide resources and tools to help these families get through the first 30 days after their child's diagnosis."

Fore more information, please visit www.KidCare4Diabetes.com or www.childrenwithdiabetes.com.

Phase 2a Trial for a Novel Type 2 Diabetes Treatment
Arete Therapeutics Inc. announced the initiation of a phase 2a clinical trial for AR9281, an orally-administered soluble epoxide hydrolase (s-EH) inhibitor being developed for the treatment of type 2 diabetes. S-EH is an enzyme involved in the metabolism of arachidonic acid, a key signaling molecule implicated in diabetes, hypertension, and inflammatory disorders.

The phase 2a multicenter, double-blind, placebo-controlled study will enroll 150 prediabetic patients with impaired glucose tolerance, mild obesity and mild to moderate hypertension. All patients enrolled in the study will be treatment-na•ve for type 2 diabetes medications. The trial will evaluate two schedules of AR9281 and placebo using a parallel design to determine the feasibility of twice-a-day dosing. Each patient will receive 28 days of treatment. Endpoints for the trial include safety, tolerability, reduction of blood pressure and various measures of glucose and lipid metabolism, with results expected in the first quarter of 2010.

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

Vivus Initiates Second Pivotal Phase 3 Trial of Avanafil for ED
Vivus, Inc. announced it has initiated a second pivotal phase 3 study of avanafil, its investigational new drug 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 news release, the study, REVIVE-Diabetes (TA-302), is a multicenter, randomized, double-blind, placebo-controlled trial and will evaluate the safety and efficacy of avanafil in the treatment of ED in men with type 1 or type 2 diabetes. The coprimary endpoints of the study will be improvement in erectile function as measured by changes in the sexual encounter profile questions 2 and 3, and improvement in erectile function as measured by the erectile function domain score of the International Index of Erectile Function. For more information about the trial, please visit www.clinicaltrials.gov.

Merck Initiates Phase 2 Niacin Receptor Agonist Clinical Trial
Arena Pharmaceuticals, Inc, announced the initiation of a phase 2 clinical trial of an orally administered niacin receptor agonist drug candidate being developed by Merck & Co., Inc., under its collaboration with Arena to treat atherosclerosis. Agonists of the niacin receptor have the potential to regulate plasma lipid profiles, including HDL. The phase 2 clinical trial is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, as well as potential efficacy, of the niacin receptor agonist in patients with dyslipidemia. For more information, please visit www.arenapharm.com/wt/page/home.html.