Industry News and Innovations

FDA OK's NovoLog Labeling Update
Diabetes patients taking NovoLog (insulin aspart [rDNA origin] injection) can now use the insulin in their pump for up to 6 days following the US Food and Drug Administration (FDA) approval of a labeling change, Novo Nordisk announced. The previous label allowed for NovoLog to be stored in the pump reservoir for 2 days. This makes NovoLog the first and only rapid-acting insulin with this extended in-use time.

The updated NovoLog label also states that patients using NovoLog in their pumps should change the infusion set and the infusion set insertion site at least every three days. The previous label stated that NovoLog in the pump reservoir, infusion set and the infusion set insertion site be changed at least every 48 hours. The revised label keeps the same recommendation that NovoLog should be discarded after exposure to temperatures that exceed 37°C (98.6°F).

"The ability to go longer between changes of insulin in the pump allows people with diabetes to have more active and flexible lifestyles, which are integral to the success of long-term diabetes management," said Richard R. Rubin, PhD, Professor, Medicine and Pediatrics, The Johns Hopkins University School of Medicine.

For more information, visit www.novolog.com.

Mylan Receives FDA Approval of Generic Version of Thyroid Treatment Cytomel
Mylan Inc. announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the FDA for its abbreviated new drug application for liothyronine sodium tablets USP, 5 µg (base), 25 µg (base) and 50 µg (base).

Liothyronine sodium tablets are the generic version of King Pharmaceuticals' thyroid deficiency treatment Cytomel, which had total US sales of approximately $54 million for the 12 months ending March 31 for the same strengths, according to IMS Health. Mylan has begun to ship this product.

For more information, visit www.mylan.com.

Sirona Biochem Optimizes Key Test For Diabetes and Obesity Drug Development
Sirona Biochem Corp. announced that it will begin testing its novel new compounds to fight diabetes and obesity. The completion of the company's key sodium glucose transporter (SGLT) biological assessment test and testing will be done under contract with SignalChem.

According to a company news release, Sirona Biochem owns the worldwide rights to a library of potential new SGLT inhibitors developed to treat diabetes and obesity. SGLT inhibitors are a novel new drug class currently under development that block the reuptake of excess sugars from urine in the kidney which can then reduce high blood sugar to normal levels. Excess sugar in the blood is a primary medical challenge associated with treating diabetes and obesity.

Sirona has a research and development agreement with TFChem (Rouen, France), where a significant number of SGLT drug analogs are being prepared for first stage evaluation. Preliminary primary stage testing conducted earlier this year provided positive indications to support Sirona Biochem's project and provided key insights to optimize the new test that is now ready for use to evaluate the next library set of molecules.

For more information, visit www.sironabiochem.com.

New Blood Glucose Meter Connects to Gaming Systems
A new blood glucose monitor connects directly to Nintendo DST and Nintendo DST Lite gaming systems and was designed specifically for children with diabetes. According to the manufacturer, Bayer Diabetes Care UK, the Didget meter aims to encourage children to build good blood glucose testing habits by awarding points that children can use to unlock new game levels and customize their gaming experience.

"For many people with type 1 diabetes, particularly children, having to do finger prick testing and inject insulin several times a day is an unpleasant but vital part of good diabetes management," said Pav Kalsi, Care Advisor at Diabetes UK. "Diabetes is a serious condition and can lead to long-term complications such as heart disease, kidney failure and blindness if not effectively managed. "Any safe and effective innovation which could encourage children to develop good testing habits now and for the rest of their lives is welcomed."

For more information, visit www.bayerdidget.co.uk/About-Didget/Product-Information.

Reliv International's GlucAffect Proven Effective in Clinical Study
A study published in Phytotherapy Research found that GlucAffect, a nutritional supplement developed by Reliv International, Inc., significantly reduced blood glucose levels and helped control weight in study participants.

According to a company news release, the study included 50 overweight individuals who had prediabetic glucose levels prior to the study. Individuals taking GlucAffect, a powdered product mixed with water or other liquids, lowered their fasting blood glucose by an average of 30% and they lost an average of 16 lbs. People in the control group reported a marginal decline in blood glucose levels and no significant weight loss.

The study was conducted at Gabriele D'Annunzio University in Chieti-Pescara, Italy.

"The people in the GlucAffect group achieved statistically significant lower blood sugar levels as well as significant weight loss compared with both their own baseline starting point and to the results of the people in the placebo group," said Carl Hastings, PhD, Reliv's vice chairman and chief scientific officer. "GlucAffect enabled [individuals] to achieve healthy weight and blood sugar levels after 8 weeks," Dr. Hastings added.

The participants consumed GlucAffect or a placebo product four times a day for six days a week, participated in an exercise program and ate a healthy diet. They didn't follow the study regimen on the seventh day of the week.

Reliv will apply for a patent on GlucAffect. All Reliv products are developed, tested and manufactured at the company's headquarters in Chesterfield, Mo.

For more information, visit www.reliv.com.

89% of Endocrinologists Surveyed Identify Need for More GLP-1 Analogs
Decision Resources (Waltham MA), one of the world's leading research and advisory firms for pharmaceutical and health care issues, found that most surveyed clinicians identify a need for additional therapies from the glucagon-like peptide-1 (GLP-1) analogue and dipeptidyl peptidase-IV (DPP-4) inhibitor drug classes for the treatment of type 2 diabetes.

According to a company news release, the new Physician & Payer Forum report entitled "A Clinician and Payer Perspective on Changing Dynamics in the Diabetes Market: Is There Room for New GLP-1 Analogues or DPP-IV Inhibitors?" finds that 89% of surveyed endocrinologists and 77% of surveyed primary care physicians (PCPs) indicate there is a need for additional GLP-1 analogue therapies. The report also finds that 71 percent of endocrinologists and 74% of PCPs indicate there is a need for additional DPP-4 therapies.

For more information, visit www.dresources.com.

Contrave Obesity Research Phase 3 Program Meets Key Endpoints
Orexigen Therapeutics, Inc. announced that all three remaining Phase 3 trials evaluating bupropion SR/naltrexone SR (Contrave), its investigational drug for the treatment of obesity, met its coprimary endpoints. The results from the successfully completed COR (Contrave Obesity Research) program of more than 4,500 patients exceded the FDA categorical efficacy benchmark for clinically significant weight loss, the company said, supporting its plan to file a new drug application in the first half of 2010.

Key top-line data from the COR Phase 3 program include:

• 48.0% and 56.3% of patients on the bupropion SR/naltrexone SR combination in COR-I and COR-II lost at least 5% of their body weight after 56 weeks, approximately three times the placebo categorical response rates of 16.4% and 17.1%, respectively (intention-to-treat [ITT], P<.001).
• Treated in COR-I and COR-II on bupropion SR/naltrexone SR had mean weight loss of 6.1% and 6.4% after 56 weeks, compared with 1.3% and 1.2% on placebo, respectively (ITT, P<.001).
• In the COR-Diabetes, 44.5% of patients on bupropion SR/naltrexone SR lost ³5% of their body weight after 56 weeks, more than double the 18.9% of patients on placebo (P<.001). Contrave patients also showed a 0.6% reduction in A1C from baseline, compared with a 0.1% reduction in placebo. This difference of 0.5% is clinically and statistically significant (ITT, P<.001).
• Key secondary endpoints met across the entire COR Phase 3 program included significant improvements in cardiovascular and metabolic risk factors such as waist circumference, visceral fat, HDL cholesterol, and triglycerides.

For more information, www.orexigen.com.