is a range of insulin solutions and suspensions for injection and is indicated for diabetes patients when treatment with insulin is required. Human insulin is produced by recombinant DNA technology in Escherichia coli strains. Insuman is supplied in vials, cartridges, and pre-filled disposable pens (OptiSet and SoloSTAR). The Insuman range includes rapid-acting insulin solutions (Insuman Rapid and Insuman Infusat) that contain soluble insulin, an intermediate-acting insulin suspension (Insuman Basal) that contains isophane insulin, and combinations of fast-acting and intermediate-acting insulins in various proportions (Insuman Comb). Insuman is principally sold in Germany and in Emerging Markets. Lyxumia Lyxumia (lixisenatide) is a once-daily prandial GLP-1 receptor agonist and is indicated for the treatment of adults with type 2 diabetes to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. In 2013, the European Commission granted marketing authorization in Europe for Lyxumia. On completion of pricing and reimbursement discussions, the company initiated a phased launch of Lyxumia in most E.U. countries. Applications for regulatory approval have also been submitted in various other countries worldwide and are being reviewed. Lyxumia has been approved in approximately 60 countries and launched in approximately 35 countries worldwide. The countries with the largest sales are Japan, Spain, the U.K. and Belgium. Recent launches include Russia and Korea. Lyxumia has been withdrawn from the market in Germany. Lixisenatide was submitted to the FDA on July 27, 2015 after the results of ELIXA demonstrated cardiovascular safety in type 2 diabetes patients with high cardiovascular risk. A launch is anticipated in the third quarter of 2016. Other major launches expected in 2016 include France in the fourth quarter. Additional Phase IIIb studies are ongoing including research into the safety and efficacy of Lyxumia in the pediatric setting. Afrezza Afrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes. The product was launched in the U.S. at the beginning of February 2015. In January 2016, the company exercised its option to terminate the license and collaboration agreement with MannKind Corporation, the developer of Afrezza, and would transfer the rights for Afrezza back to MannKind on April 4, 2016. Integrated Care Solutions The company is committed to developing integrated care solutions to improve diabetes health outcomes for people with diabetes. The company and Verily entered into a collaboration to improve diabetes health outcomes. The company would work together on new digital technology and tools for diabetes. In the framework of their partnership, the company and AgaMatrix have co-developed MyStar Dose Coach, a dose helper for Insulin Glargine with an integrated blood glucose meter, which has obtained the CE mark. The company and AgaMatrix have already co-developed intelligent solutions in diabetes care, such as blood glucose monitoring solutions, such as BGStar, iBGStar and MyStar Extra. Cardiovascular Praluent Praluent is a human monoclonal antibody (mAb) that blocks the interaction of PSCK9 with LDL receptors, increasing the recycling of LDL receptors and reducing LDL-C levels. Praluent has been extensively studied through the ODYSSEY Phase III program with 16 global trials, including approximately 23,500 patients in approximately 40 countries to evaluate the efficacy and safety of Praluent across various high cardiovascular risk patients (due to but not limited to diabetes, family hypercholesterolemia or previous events), including patients with Heterozygous Familial Hypercholesterolemia (HeFH), patients with primary hypercholesterolemia uncontrolled on statins and/or other lipid-modifying therapies, post Acute Coronary Syndrome (ACS) patients and as a monotherapy for patients who are unable to tolerate effective dose of statins. The effect of Praluent on cardiovascular morbidity a
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