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Clinigen Receives EC Approval for Updates to Cardioxane Product Information

04:00 EDT 8 Aug 2017 | Instinctif Partners

Clinigen Group plc (AIM: CLIN, ‘Clinigen’ or the ‘Group’), the global pharmaceutical and services company, announces that its Commercial Medicines operation received a European Commission (EC) approval to update the current product information for Cardioxane.

Cardioxane is an oncology support drug that prevents chronic cumulative cardiotoxicity caused by high dose anthracycline chemotherapy. In 1992, it was licensed for international markets but its label was revised in Europe as a result of an Article 31 referral in 2011. This restricted its indication and introduced a paediatric contraindication.

The EC approval follows a positive opinion issued by the EMA Committee for Medicinal Products for Human Use (CHMP) in May 2017, which was highlighted in the Group’s trading update on 18 July, 2017.

Approval will enable physicians to consider the use of Cardioxane in paediatric patients where high dose anthracycline therapy is planned. The product information will also be updated to reflect a more favourable safety profile for Cardioxane in adult populations at the same time.

Since Clinigen acquired Cardioxane three and a half years ago, a multi-disciplinary team at Clinigen has actively engaged with an extensive group of international paediatric oncologists and cardiologists. The aim was to achieve updates to the product information, especially concerning the paediatric population, to align with new data.

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 and will submit amendments to the labelling in countries where Cardioxane licences are held.

Merav Edan, Head of Regulatory Specialty Pharmaceuticals of Clinigen said:

“EC approval is the final step to ensuring that the paediatric oncologists can effectively manage cardiotoxicity associated with anthracycline chemotherapy by using Cardioxane when needed. Not only that, the additional changes to the Cardioxane product information will extend its use in the adult population.”

Shaun Chilton, Group Chief Executive Officer of Clinigen said:
“Final approval to enable Clinigen to implement the label change is a milestone achievement. This decision has been the work of many years, driven by a dedicated Clinigen team with the growing support of healthcare professionals. The impact for Cardioxane usage will not be immediate but this is a major regulatory achievement for us and demonstrates our ability to revitalise products so that they can benefit more patients over the long term.”

Issued for and on behalf of Clinigen Group plc by Instinctif Partners.

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 through three areas of global medicine supply; clinical trial, unlicensed and licensed medicines.

For more information, please visit www.clinigengroup.com

Clinigen Group plc Shaun Chilton, Group Chief Executive Officer Martin Abell, Group Chief Financial Officer Numis Securities Limited Michael Meade / Freddie Barnfield (Nominated Adviser) James Black / Tom Ballard (Corporate Broking) RBC Capital Markets – Joint Broker Marcus Jackson / Elliot Thomas / Jack WoodTI Instinctif Partners (media relations) Melanie Toyne-Sewell / Alex Shaw / Deborah Bell Tel: +44 (0) 1283 495 010 Tel: +44 (0) 20 7260 1000 Tel: +44 (0) 20 7653 4000 Email: clinigen@instinctif.com Tel: +44 (0) 20 7457 2020 NEXT ARTICLE

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