Novozymes' Half-Life Extension Technology Reaches Landmark Milestone as GlaxoSmithKline's Albiglutide is Granted FDA Marketing Approval

6 May 2014
Kerry Parker
CEO

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Novozymes' VELTIS® technology enables optimized dosing regimens for type 2 diabetes medicine

The US Food and Drug Administration (FDA) has granted marketing approval to GlaxoSmithKline's new type 2 diabetes drug, branded Tanzeum in the US and Eperzan in Europe, which uses Novozymes' Veltis technology to achieve an extended half-life that means patients are only required to inject their medication once a week. The FDA approval follows GlaxoSmithKline's announcement in March that albiglutide received marketing authorization in Europe.

"This is yet another important market approval for a drug based on Novozymes' Veltis technology", says Dermot Pearson, Marketing Director, Novozymes Biopharma. “The versatile capabilities of our solution are being continually demonstrated by our customers. Not only has Novozymes developed a platform that helps medicines achieve optimum therapeutic effect, but that also improves the day-to-day management of conditions by extending drug half-life and, therefore, reducing the frequency at which patients need to inject."

Veltis is a half-life extension platform based on engineered albumins that enables manufacturers to define and optimize the therapeutic window of their drug candidate to control dose frequency, dose quantity and improve drug tolerability. The platform also offers Novozymes' partners, such as the recently announced collaboration with Janssen, the ability to provide once-weekly, once two-weekly or once-monthly peptide or protein dosing, and, as a result, offers the potential for enhanced patient compliance and improved therapeutic impact.
The market approvals for albiglutide do not impact Novozymes’ financial outlook for 2014.

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Medicinal ChemistryMedicinal chemistry is a broad discipline encompassing the design, identification, synthesis and development of chemicals in drug discovery. It includes a number of techniques covering structural biology, synthetic chemistry and molecular biology. Technologies used in medicinal chemistry include ADME, lab-on-a-chip, high content screening and assay assembly.Discovery SoftwareComputational techniques used in both the chemistry and biology aspects of drug discovery, for data acquisition, processing and storage. Software is used for analysis of pathways, target identification, genomics, proteomics, modelling, lead identification, compound analysis and drug modelling among many others. Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. Lead OptimizationLead optimization is a phase in the drug discovery process. A lead is a compound that has demonstrated desired biological effects on a target. Optimization involves making chemical modifications to the structure in order to generate analogues of the original compound, which have higher potency and safety profiles.Drug DosageDosage is the size or frequency of the administration of a drug. Determination of the dosage of a drug is critical in pharmaceutical development to ensure the optimum balance between efficacy and toxicity.
Novozymes' Half-Life Extension Technology Reaches Landmark Milestone as GlaxoSmithKline's Albiglutide is Granted FDA Marketing Approval