Algeta and IFE Agree to Collaborate for the Manufacture and Supply of Alpharadin for Future Commercial use and Clinical Trials
News Jan 18, 2010
Alpharadin is a first-in-class, highly targeted alpha-pharmaceutical under clinical evaluation to improve survival in patients with bone metastases from advanced prostate cancer. Its localised action helps preserve the surrounding healthy tissue thereby limiting side-effects. Bone metastases represent a major unmet medical need, occurring in up to 90% of certain late-stage cancers, e.g. prostate, breast and lung.
The decision constitutes the first part of Algeta’s manufacturing strategy to produce and supply Alpharadin to meet expected needs of Algeta’s ongoing ALSYMPCA phase III study and planned clinical trials in other cancer indications. In addition it is planned that this expanded capacity will supply the expected commercial demand around the world following its approval and worldwide launch in collaboration with Bayer Schering Pharma AG. Under the terms of this agreement Algeta has responsibility for the manufacturing and supply of Alpharadin for commercial use.
Andrew Kay, Algeta’s President and CEO said: “IFE has been an excellent manufacturer and supply partner of Alpharadin for all our clinical trials to date. We are very pleased to be able to extend this agreement to secure the future clinical and commercial supply of Alpharadin. This product has the potential to be one of the world’s leading oncology products”
Eva Dugstad, Executive Vice President at the IFE, added, “”We are very pleased that Algeta has chosen IFE as a producer of its new alpha-pharmaceutical, Alpharadin. The Isotope Laboratories at IFE are a national center of expertise for radiopharmaceuticals. The cooperation with Algeta has been inspiring to IFE. We are excited to participate in creating new business which at the same time gives hope to cancer patients with bone metastases. As a result of this collaboration, we expect to expand the activities at the IFE Isotope Laboratories with 10 - 20 new employees that will benefit the whole of the Norwegian cluster within nuclear medicine.”
A form of the hallucinogenic party drug ketamine has cleared one of the final hurdles toward clinical use as an antidepressant. During a meeting at the US Food and Drug Administration (FDA) in Silver Spring, Maryland, an independent advisory panel voted 14-2 in favor of recommending a compound known as esketamine for use in treating depression.READ MORE