Voraxaze (TM) Update
- Category: Proteins and Peptides
- Published on Wednesday, 23 May 2007 04:00
- Hits: 2609
LONDON, UK and Brentwood, TN, USA | May 22, 2007 | Protherics PLC (“Protherics” or the“Company”), the international biopharmaceutical company focused on critical care andcancer, today provided an update on its Voraxaze™ marketing applications in the US andEU. Voraxaze™ is an adjunctive therapy for patients with impaired renal function who areexperiencing, or at risk of, toxicity from methotrexate (“MTX”), a widely used anti-canceragent.
Following recent successful discussions with the Food and Drug Administration (“FDA”),Protherics has agreed to provide additional manufacturing and stability data requirements tosupport a Biologicals License Application (“BLA”) for Voraxaze™ in the US. The FDA hasalso agreed to Protherics resubmitting its application as a rolling submission, starting in early2008
Discussions were also held regarding the interaction of Voraxaze™ with leucovorin, thestandard supportive therapy given with high dose MTX therapy. The FDA has askedProtherics to undertake a 12 patient study to support a label claim regarding the dosing ofleucovorin following administration of Voraxaze™.
Voraxaze™ was previously granted a Fast Track Designation by the FDA for the rapid andsustained reduction in toxic MTX levels in patients with impaired renal function. The rollingBLA submission will enable the FDA to review sections of the application whilst Prothericscollects the additional manufacturing and clinical data. The Company is seeking a PriorityReview, which would reduce the time for the BLA review to six months from 10 fromsubmission of the final part of the application. If granted, Voraxaze™ could be approved inthe US towards the end of 2009. Protherics believes that approximately 500 cancer patientsper annum are candidates for treatment with Voraxaze™ in the US under the labellingassumed under the Fast Track Designation.
The FDA has indicated that it will allow Protherics to supply Voraxaze™ in the US under aTreatment Protocol, prior to marketing authorisation being granted, and to charge for itssupply to allow the recovery of some of the costs associated with the development andsupply of Voraxaze™. Protherics is planning to commence the supply of Voraxaze™ in theUS by the end of May, once the FDA has agreed to the documentation to be provided tophysicians, using AAI Pharma as its distributor. Voraxaze™ was previously made availablefor compassionate use in the US by the National Cancer Institute (NCI).
In Europe, Protherics submitted a Marketing Authorisation Application ("MAA") forVoraxaze™ to the European Medicines Evaluation Agency ("EMEA") in June 2005. Aspreviously announced, the EMEA’s Day 180 Assessment Report identified the needfor further information on manufacturing in addition to data to assess the potential ofVoraxaze™ to interact with leucovorin. In-line with this feedback, Protherics has nowwithdrawn its MAA in the EU as the additional data cannot be generated in the timeframeavailable under the centralised procedure.
The manufacturing and stability data being generated to support the BLA in the US shouldalso be able to support an MAA in the EU. The Company will consider resubmitting an MAAapplication if the 12 patient study requested by the FDA is acceptable to the EMEA toaddress the clinical relevance of the leucovorin interaction.
Protherics will continue to supply Voraxaze™ on a named patient basis in Europe forintervention use in patients at risk of severe or life-threatening methotrexate toxicity due todelayed elimination of MTX following high dose MTX therapy.
The Company has initiated several pilot studies to investigate the potential role ofVoraxaze™ as a routine adjunct to high dose MTX therapy, on a repeated planned usebasis. If these studies are successful, Protherics will discuss the data with the regulatoryagencies in the US and EU to determine the development programme required for approvalin repeated planned use, a much larger market opportunity.
Andrew Heath, Chief Executive of Protherics, said:“Following positive and helpful discussions with the FDA about Voraxaze, we now have anagreed work plan to facilitate the potential approval of this important and potentially lifesavingproduct in 2009. We also hope to progress our discussions with the regulators in theEU, where we will continue to make Voraxaze available on a named patient basis for patientsexperiencing delayed MTX elimination following high dose methotrexate therapy.”
SOURCE: Protherics PLC