Monday, May 22, 2017 - 06:45

Clinigen Group plc (AIM: CLIN, ‘Clinigen’ or the ‘Group’), the global pharmaceutical and services company, announces that its Specialty Pharma (SP) division has achieved a positive CHMP opinion in Europe to modify the current product information for Cardioxane.

It is expected that the European Commission (EC) will accept the CHMP opinion and will issue its approval later this year. This is a significant step forward in the assessment of the regulatory application which should ultimately allow physicians to consider use in paediatric patients where high dose anthracycline therapy is planned. 

Since Clinigen acquired Cardioxane in March 2013, the Group has actively engaged with paediatric oncologists and cardiologists in the European Union (EU) and United States (US) to understand new data which supported a change to the product information. This work has been driven by a common desire for physicians in the EU to be allowed to use Cardioxane in children who previously did not have that option due to the paediatric contraindication introduced during the Article 31 referral (2011).

Once final EC approval is obtained, physicians will be able to consider using Cardioxane to protect the hearts of paediatric cancer patients when they plan to administer a cumulative dose of more than 300mg/m2 of doxorubicin or the equivalent cumulative dose of another anthracycline.

The safety profile of the product was also reassessed in the adult population. The regulatory authorities have agreed that the new data demonstrates a more favorable safety profile for Cardioxane, which will also be reflected in the updated product information.

This represents a major regulatory achievement for the Group and is a key milestone in the revitalisation of the Cardioxane brand by Clinigen SP.  Clinigen will implement appropriate safety measures to ensure the continued safe use of the product and to expand the clinical understanding in the paediatric population.

Ivo Timmermans, Chief Medical Officer of Clinigen said:

“Paediatric oncologists and cardiologists have been limited in their options to effectively manage cardiotoxicity associated with anthracycline chemotherapy when used to treat certain childhood cancers. I am proud of the fact we have been able to work with EU and US experts and the regulatory agencies to reach this positive CHMP opinion, which should result in changes to the Cardioxane product information.”

Shaun Chilton, Group Chief Executive Officer of Clinigen said:

“The CHMP positive opinion on Cardioxane follows a significant international effort between Clinigen, paediatric oncologists and cardiologists. This clearly demonstrates our capabilities in revitalising our products so that they can benefit more patients. It is a significant milestone in our history to be part of a change that could offer Cardioxane as an additional option for children being treated for certain types of cancer.”

- Ends-


Clinigen Group plc
Shaun Chilton, Group Chief Executive Officer
Martin Abell, Group Chief Financial Officer
Ivo Timmermans, Chief Medical Officer
Tel: +44 (0) 1283 495 010

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About Cardioxane® (dexrazoxane)

Cardioxane is a cardioprotective agent used to prevent chronic cumulative cardiotoxicity caused by doxorubicin or epirubicin in advanced and/or metastatic adult breast cancer patients who have received a prior cumulative dose of 300mg/m2 of doxorubicin or 540mg/m2 of epirubicin when further chemotherapy treatment is required. Cardioxane is administered by intravenous infusion. It is believed to work by binding to metal ions, thus decreasing the formation of intracellular superoxide radicals and preventing cardiotoxicity. Cardioxane was initially licensed in 1992. Subsequently, Novartis acquired the product as part of the 2006 acquisition of Chiron. The product is currently licensed for sale in 22 markets around the world, including 10 in Latin America.

Within the EU, Cardioxane underwent a revision to its label in 2011 as a result of an Article 31 referral, restricting its licensed indication and introducing a paediatric contraindication.

About Clinigen Group

Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing access to medicines. Its mission is to deliver the right medicine to the right patient at the right time.

The Group consists of five synergistic businesses focused in three areas of global medicine supply; clinical trial, unlicensed and licensed medicines.

Clinigen Clinical Trial Services is the global market leader in the management and supply of commercial medicines for clinical trials.

The Group is also the trusted global leader in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet need, through three of its divisions: Idis Managed Access runs early access programmes for innovative new medicines. Idis Global Access and Link Healthcare work directly with healthcare professionals to enable compliant access to unlicensed medicines on a global basis and niche essential licensed and generic medicines across Australasia, Africa and Asia (AAA region).

Clinigen Specialty Pharmaceuticals acquires global rights, revitalises and markets its own portfolio of niche hospital commercial products.

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