Clinigen Group Further Strengthens Oncology Support Portfolio with Acquisition of Ethyol® (amifostine), from AstraZeneca

  Clinigen Group Further Strengthens Oncology Support Portfolio with
  Acquisition of Ethyol® (amifostine), from AstraZeneca

     Clinigen Specialty Pharmaceuticals division expands to five products

Business Wire

BURTON-ON-TRENT, England -- August 20, 2014

Clinigen Group plc (‘Clinigen’ or the ‘Group’) (LSE: CLIN) (AIM: CLIN) the
specialty global pharmaceutical company today announces the acquisition of the
global rights to the oncology support therapy, Ethyol^® (amifostine) from

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

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Notes to Editors

About Ethyol^® (amifostine)

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.

About Clinigen Group

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

About AstraZeneca

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:


Clinigen Group plc
Tel: +44 (0) 1283 495010
Peter George, Group Chief Executive Officer
Robin Sibson, Group Chief Financial Officer
Shaun Chilton, Group Chief Operating Officer
Numis Securities Limited
Tel: +44 (0) 20 7260 1000
Michael Meade/Freddie Barnfield (Nominated Adviser)
James Black/Tom Ballard (Corporate Broking)
Peel Hunt LLP - Joint Broker
Tel: +44 (0) 20 7418 8900
James Steel / Jock Maxwell Macdonald
Instinctif Partners (media relations)
Tel: +44 (0) 20 7457 2020
Melanie Toyne-Sewell/ Jen Lewis
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