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 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
In 1995, the US Food and Drug Administration (FDA) granted Ethyol a New
Drug Application (NDA) and in 2013, Ethyol revenue was approximately
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 Geore, 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
- Ends -
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
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 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
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