Industry News and Innnovations

MannKind Announces Pivotal Efficacy, Safety Endpoints Met in Pivotal Trials
MannKind Corporation announced that it has met the primary endpoints of its final two pivotal Phase 3 studies of Afresa, the company's ultra rapid-acting, inhaled insulin product. The company expects to disclose more details of the top-line data from these studies in patients with type 1 and type 2 diabetes, according to a news release.

"We are very pleased to announce the positive outcome of these, the last of our three pivotal Phase 3 studies, said Peter Richardson, MRCP, MannKind's Chief Scientific Officer. "We look forward to presenting more complete data, including analyses of secondary endpoints, as soon as they are available. Afresa promises to be an important additional option for the treatment of patients with diabetes. Our next step is to finalize a new drug application for Afresa, which we expect to submit to the [US] Food and Drug Administration [FDA] in early 2009," Dr. Richardson said.

Study 030 compared the pulmonary safety of meal-time inhalation of Afresa versus usual care in more than 2,000 patients with type 1 and type 2 diabetes. The study met its primary endpoint: after 2 years of treatment, no adverse effects were observed on patients' lungs in the treated group.

Study 102 compared the efficacy of meal-time Afresa in combination with a long-acting basal insulin versus twice daily injections of premixed insulin (a mixture of a rapid-acting insulin analog and intermediate-acting insulin). Study 102 met its primary endpoint, showing comparable improvements in A1C levels over 52 weeks between the two treatment groups.

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

Amylin, Lilly Update FDA Review of Exenatide Injection Monotherapy Submission
Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced that the FDA is continuing with its review of the regulatory application for use of exenatide (Byetta injection) as monotherapy in patients with type 2 diabetes who are not achieving acceptable blood sugar control. It is likely that this review will extend into 2009, according to a news release.

"Our discussions with the FDA continue to progress and we remain confident in the strength of our regulatory submission," said Orville G. Kolterman, Senior Vice President of Research and Development at Amylin. "Importantly, we have not received any request for additional studies. We look forward to working closely with the agency as needed throughout the review process."

The regulatory application for use of exenatide as monotherapy was submitted in the first quarter of 2008. The FDA is also reviewing several other exenatide prescribing information updates submitted by the companies, including revision of safety language and conversion of physician labeling to the new standard format.

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

New Study Application to Vaccinate Against Type 1 Diabetes with Diamyd
Lund University (Lund, Sweden) has filed an application with the Swedish Medical Products Agency to carry out a study of the diabetes vaccine Diamyd for the prevention of type 1 diabetes in Swedish children, according to a company news release. This is the second prevention study with the diabetes vaccine Diamyd for which approval has been sought in a short period.

Several independent research groups plan prevention studies using the diabetes vaccine Diamyd with the aim of vaccinating children at risk of developing type 1 diabetes, before disease onset. The company has previously announced that a Nordic prevention study is being planned. The current announcement concerns a Swedish prevention study that is being planned under the leadership of Helena Elding Larsson, MD, pediatrician and researcher at Lund University.

"We are on the threshold of an eventful period, in which Diamyd Medical's diabetes vaccine is evermore sought after for various studies," said Elisabeth Lindner, President and CEO of Diamyd. "There is an optimistic aura about Diamyd. We end this year with two world news within the last 10 days; the planned start of two independent prevention studies. We have also reached all of our goals for 2008."

For more information, please visit www.diamyd.com

Sensei for Weight Loss Launches Device to Promote Nutrition on a Budget
Sensei Inc. (Boca Raton, FL), a pioneer in mobile and Web-based wellness solutions, introduced the next-generation platform of its award-winning approach to health and weight management, Sensei for Weight Loss. The release includes new features such as a budget-friendly version of its popular meal planner, as well as a "Favorites" tab. The program is also now available in the App store for iPhone and iTouch users, according to a news release.

Proving that eating healthful foods on a budget is not an oxymoron, Sensei dieticians and nutritionists added these options to provide the planning and advice necessary to eat well and save money. The new budget-friendly version automatically creates weekly menus customized to suit individual preferences and optimized to reduce food bills. The Favorites tab enables users to flag their favorite ingredients or meals, as well as weekly sale items at their local grocer, and have them incorporated into their weekly meal plans.

Current subscribers to Sensei, a program that transforms a consumer's mobile phone and desktop into their own "personal digital coach," will notice a newly enhanced Web site that is richer in functionality and easier to navigate. The new program will be priced at $15/month for Web-only access, and $20/month for mobile and Web access, which is comparatively cheaper than most weight-loss programs currently on the market.

"Consumers are under the impression that in order to achieve a healthier lifestyle, specifically to eat more healthful and nutritious meals, they have to spend more money. Sensei for Weight Loss proves that this simply is not the case," said Robert Schwarzberg, MD, a cardiologist and Sensei Chief Executive Officer.

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

Arena Initiates Trial of Type 2 Diabetes Drug With Ortho-McNeil-Janssen
Arena Pharmaceuticals, Inc. announced that Ortho-McNeil-Janssen Pharmaceuticals, Inc. initiated under their partnership a first-in-human phase 1 clinical trial of APD597, a novel oral drug candidate discovered by Arena that targets the glucose-dependent insulinotropic receptor (GDIR) for the treatment of type 2 diabetes. The GDIR was also discovered by Arena and has the potential to stimulate insulin release in response to increases in blood glucose, according to a news release.

Ortho-McNeil's phase 1 program will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of APD597 in single and multiple ascending dose studies in healthy volunteers. Ortho-McNeil's planned clinical studies will also include the evaluation of patients with type 2 diabetes.

The GDIR is an orphan G protein-coupled receptor, discovered by Arena, according to a company news release. It is expressed in beta-cells. The GDIR signals through a similar intracellular pathway as the GLP-1 receptor, with common downstream effects, but unlike the GLP-1 receptor, the GDIR has proven amenable to small-molecule drug discovery. Stimulation of the GDIR is intended to more efficiently promote insulin release by beta-cells in response to elevated blood glucose levels. In addition, the GDIR is expressed in cells other than pancreatic beta-cells, such as endocrine cells in the gastrointestinal tract, and in preclinical studies the GDIR stimulates the release of GLP and GIP, two incretins that play an important role in insulin regulation and glucose homeostasis. GDIR stimulation has also been found to increase the levels and activity of intracellular factors thought to be involved in the preservation of beta-cells, and GDIR signaling may therefore also serve to maintain beta-cell mass in type 2 diabetes.