Clinigen Group acquires Ethyol (amifostine) global rights from AstraZeneca

Ethyol is a cytoprotective drug indicated as an adjuvant therapy to reduce the incidence of xerostomia (dry mouth) as a side-effect in patients undergoing post-operative radiation treatment for head and neck cancer. It also reduces the cumulative renal toxicity associated with the repeated administration of cisplatin in patients with advanced ovarian cancer.

In 1995, the US Food and Drug Administration (FDA) granted Ethyol a New Drug Application (‘NDA’) and in 2013, Ethyol revenue was approximately $4.9million.

This is the second product Clinigen has acquired from AstraZeneca (the first being the anti-viral Foscavir® in 2010), and the Group’s third oncology support product adding to Cardioxane® and Savene® bringing the Specialty Pharmaceuticals portfolio to five products in total.

Under the terms of the agreement, Clinigen will assume full responsibility for the distribution of the product with immediate effect. AstraZeneca, working closely with Clinigen, will continue to manufacture the product whilst the NDA and Investigational New Drug (‘IND’) authorizations are transferred and the technical transfer to a third party manufacturer is completed. The acquisition will be paid for in milestone related stage payments linked to the transfer of manufacturing. The financial terms of the agreement are not disclosed. Fox Rothschild advised on legal matters.

Peter George, Chief Executive Officer, Clinigen Group, said: "I am very pleased to be working with the AstraZeneca team again. In acquiring Ethyol, as well as bringing our total number of products to five, we now have a portfolio of three oncology support products, adding to Cardioxane® and Savene®. This acquisition is in line with our stated strategy of acquiring niche, hospital-only therapies which have the potential to save and improve the lives of critically ill patients. Ethyol was originally identified through our acquisition database of large pharma product candidates as a very good fit for Clinigen’s business model; whilst it was one of the original 12 targets and took some time to close, it is further evidence that the Clinigen model works."