31 March 2014

London, 31 March 2014, 07:00 AM GMT. SpePharm AG, an affiliate of Norgine B.V. announced today that it has agreed to sell SAVENE® (dexrazoxane) to Clinigen Group plc (‘Clinigen’ or the ‘Group’) (LSE: CLIN) (AIM: CLIN) a specialty global pharmaceutical company. The financial terms of the acquisition are not being disclosed.


SAVENE® is indicated for the treatment of extravasation in anthracycline chemotherapy in adults. Extravasation occurs when anticancer drugs, normally injected into a vein, leak or are accidentally injected into tissue surrounding the vein where they can cause serious damage. SAVENE® is the only authorised treatment of its kind available. Its use within the first six hours of extravasation occurring is crucial and enables affected patients to continue their anticancer treatment.


SAVENE® has Orphan Drug status and protection until late 2016 with a worldwide method of use patent until 2020. In 2013 the full year sales were approximately €3.8 million.


Under the terms of the agreement, Clinigen will assume full responsibility for SAVENE®’s manufacturing, registration, distribution, and commercialisation in all markets excluding North America, South America, Israel, South Africa. In Japan, Clinigen will provide SAVENE®  through an existing supply and license agreement with Kissei Pharmaceutical Co. Ltd, the marketing authorisation holder.


Peter Stein, CEO at Norgine said: “Following a comprehensive strategic review, we believe this transaction represents an excellent outcome to maximise access to SAVENE® for those patients who need it. Together with our partners in SpePharm AG, we will look to deploy the proceeds to acquire further speciality pharmaceutical products for sale through Norgine’s European infrastructure.”


– Ends –


Notes to Editors


About SAVENE® (dexrazoxane)

SAVENE® is a powder and diluent that are made up into a solution for infusion. It contains the active substance dexrazoxane. SAVENE® is used to treat extravasation of anthracyclines in adults.

SAVENE® has two major mechanisms of action:

  • Chelation of iron

  • Inhibition of DNA topoisomerase II. 

Dexrazoxane binds to iron and prevents the formation of free radicals, which are considered to play a major role in the development of extravasation-induced tissue necrosis. In addition, dexrazoxane binds to DNA topoisomerase II at a different step in the catalytic cycle than anthracyclines and locks the enzyme in a form that is no longer affected by the anthracyclines.


About SpePharm AG

SpePharm AG is a joint venture between Norgine B.V. and the former shareholders of SpePharm Holding B.V. which was formed  in 2012 to commercialise SpePharm’s Specialty Pharmaceutical products through Norgine’s European infrastructure.


About Norgine

Norgine is a leading independent European specialty pharmaceutical company that has been established for over 100 years and has a presence in all major European markets. In 2013, Norgine’s total revenue was €274 million and the company employs over 1,000 people.


Norgine’s focus is the development and marketing of pharmaceutical products that address significant unmet clinical needs in therapeutic areas such as gastroenterology, hepatology, critical and supportive care. Norgine owns a manufacturing and development site in Hengoed, UK and a manufacturing site in Dreux, France.  For more information, please visit www.norgine.com.


NORGINE and the sail logo are trademarks of the Norgine group of companies.


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 is focused on acquiring its own intellectual property in licensed, niche, hospital-only critical care medicines, 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.


Contact details:



Corporate and Business Development:  Paul Pay, Tel: +44 (0) 1895 826600

Media: Isabelle Jouin, Tel: +44 (0) 1895 453 643


Clinigen Group plc

Tel: +44 (0) 1283 495 010

Peter George, Group Chief Executive Officer


Robin Sibson, group Chief Financial Officer


Shaun Chilton, Group Chief Operating Officer