SancusoTreatment for Nausea/Vomiting -- Chemotherapy Induced
Update: Sancuso Now FDA Approved - September 12, 2008
Update on Sancuso Review Status
ProStrakan Presents Update on Sancuso US Regulatory Review Status
GALASHIELS, Scotland, 2 June, 2008 -- ProStrakan Group plc announces today that, as a result of continuing discussions with the US Food & Drug Administration (FDA), it believes that there are now no outstanding technical questions from the FDA's review of Sancuso other than those which will be dealt with in labeling negotiations. Sancuso is ProStrakan's novel, patent-protected transdermal patch for the prevention of chemotherapy-induced nausea and vomiting (CINV).
The Company is also issuing an updated timeline for completion of the remaining review process. ProStrakan submitted a New Drug Application (NDA) for Sancuso to the FDA in June 2007. The FDA originally assigned an Action Date of 2 May 2008 but, due to internal resource constraints at the FDA, this date was amended to 10 June 2008. Following discussions with the FDA, it is the Company's understanding that there are currently no outstanding questions and that the FDA has commenced review of the proposed Sancuso labeling. It is clear, however, that the remaining processes and procedural steps cannot be completed by 10 June. The current estimate is that these will complete in the week of 7 July.
In view of the advanced stage of the review at the FDA and continued progress, ProStrakan is maintaining its plans for the timing of the US launch of Sancuso in H2 2008, subject to successful completion of the US review process, and is committing to manufacturing and packaging schedules in support of this date.
Commenting on today's announcement, Dr Wilson Totten, ProStrakan's Chief Executive, said:
"The FDA review of Sancuso is clearly now at a very advanced stage. We are increasingly confident of gaining US approval for Sancuso in the next few weeks. We are now working with our manufacturers and suppliers to commit to manufacture of launch materials and maintain focus on our planned launch date, which remains scheduled for the second half of this year."
ProStrakan Group plc is a rapidly growing specialty pharmaceutical company engaged in the development and commercialisation of prescription medicines for the treatment of unmet therapeutic needs in major markets.
ProStrakan's head office and development facilities are situated in Galashiels in Scotland. EU-wide sales and marketing of ProStrakan's portfolio of products are handled by commercial subsidiaries in the UK, US, France, Germany, Spain and other EU countries.
Nausea and vomiting is a significant problem afflicting many patients who undergo chemotherapy, either immediately following the chemotherapy or for up to five days after. Sancuso delivers the anti-emetic, granisetron, steadily into the patient's bloodstream for five days without the need for injections or swallowing pills. Transdermal delivery is especially beneficial to patients receiving chemotherapy who cannot swallow medicines due to nausea or mucositis. Granisetron is a 5-HT3 receptor antagonist with well-established efficacy against CINV.
Posted: June 2008
- FDA Approves Sancuso, the First and Only Patch for Preventing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy - September 15, 2008