Clinigen : Acquires Oncology Support Therapy Ethyol® from AstraZeneca

Clinigen Specialty Pharmaceuticals division expands to five products

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."
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Ethyol is the trihydrate form of amifostine and is supplied as a sterile lyophilized powder requiring reconstitution for intravenous infusion. Each single-use 10 mL vial contains 500 mg of amifostine.
Ethyol is used therapeutically to reduce the incidence of neutropenia-related fever and infection induced by DNA-binding chemotherapeutic agents including alkylating agents (e.g. cyclophosphamide) and platinum-containing agents (e.g. cisplatin). It is also used to decrease the cumulative nephrotoxicity associated with platinum-containing agents. Ethyol is also indicated to reduce the incidence of xerostomia in patients undergoing radiotherapy for head and neck cancer.

The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group, dedicated to delivering 'the right drug, to the right patient at the right time', has three operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP). Clinigen SP focuses on acquiring and in licensing specialist, hospital only medicines worldwide, increasing the value of these
medicines by developing new formulations and indications, then registering and marketing them in defined global markets.
For more information, please visit www.clinigengroup.com.

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

Peter George, Group Chief Executive Officer Robin Sibson, Group Chief Financial Officer Shaun Chilton, Group Chief Operating Officer

Michael Meade/Freddie Barnfield (Nominated Adviser) James Black/Tom Ballard (Corporate Broking)

James Steel l Jock Maxwell Macdonald

Melanie Toyne-Sewell/ Jen Lewis

Tel: +44 (O) 20 7457 2020

Email: clinigen@instinctif.com

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