CAELYX? SUPPLY RESTORED IN NORWAY

Confirmed stock level allows return to normal commercial ordering processes
Norway, April 30th 2013 ? Janssen-Cilag AS (Janssen) has today announced that sufficient stock of CAELYX? (pegylated liposomal doxorubicin) – a drug approved in the EU for the treatment of a range of cancers1 ? has been reached to enable the return to normal commercial supply of this medicine across the European Economic Area (EEA) and Switzerland. This means that healthcare professionals (HCPs) in Norway can now order CAELYX? through standard local procedures. As a result of this, CAELYX? Managed Access (CMA), a temporary system to facilitate access during the period of limited supply, has now been closed.
The recent history of CAELYX? supply
CAELYX? is a drug approved [1] In March 2012, as a result of ongoing production problems at BenVenue Labs (BVL), the independent, contracted manufacturer for CAELYX?, the European Medicines Agency (EMA) announced an Article 20 procedure for CAELYX?.2 Based on this, CAELYX? in the EU was restricted for use only in patients who were currently already receiving treatment. However, in October 2012, an alternative manufacturing process for CAELYX? was approved by the Committee for Medical Products for Human Use (CHMP), part of the EMA, and the Article 20 restrictions were lifted. At that time, the CHMP recommended that healthcare professionals prioritise patients needing CAELYX? by supplying them in the following order: Firstly, existing patients to complete treatment courses that had already been initiated; secondly, to new patients for whom no alternative treatment was available; and, thirdly, to new patients for whom alternative treatment was available.
CAELYX? Managed Access (CMA)
In order to facilitate transparent and equitable access to CAELYX?, Janssen developed CMA; a web-based ordering and reservation system that enabled HCPs to guarantee a full course of treatment for their patients during a temporary period of limited stock. Following its activation in October 2012, CMA facilitated access to CAELYX? for more than 5,000 patients in 25 countries across the EEA and Switzerland.
Restoring a sustainable supply of CAELYX?
CAELYX? is a specific formulation requiring a highly complex and specialised manufacturing process. Since BVL announced its manufacturing issues, Janssen has had a dedicated project team on-site assisting them in resolving these. In order to re-establish supply of CAELYX? as quickly and safely as possible, Janssen developed a short-term production solution, which involved formulating product at BVL and then transferring it to another manufacturer to complete the process. Meanwhile, Janssen has also been putting into place a framework to support a longer-term, consistent supply of CALEYX?. New manufacturing partners have been identified and Janssen is in the process of finalising steps required to commence production at their sites.
References
[1] CAELYX SPC Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000089/WC500020180.pdf
2 European Medicines Agency (EMA) Press release: European Medicines Agency recommends transfer of manufacturing sites for Caelyx and Ceplene http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/03/news_detail_001470.jsp&mid=WC0b01ac058004d5c1
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