Scottish firm targets South Korea for cancer patch
its novel transdermal patch for chemotherapy-induced nausea, the
firm's first patch product with ambitions to steal a sizeable chunk
of a €2bn market.
The company has signed an exclusive distribution agreement with South Korean firm LG Life Sciences, who will take care of commercialising the patch product in what ProStrakan consider the 'core' South Korean market.
The Scottish firm has developed a transdermal delivery system for the anti-emetic granisetron, the active ingredient in Roche's Kytril, formulated in a patch that can last four to five days.
This a major benefit to the majority of chemotherapy patients who experience nausea and vomiting as a result of their treatment, as it offers a non-invasive, convenient treatment method that doesn't involve injections or having to swallow tablets.
ProStrakan's transdermal product, Sancuso, delivers the drug steadily to the patient's bloodstream through a patch worn on the skin, and has been formulated with an adhesive that will withstand daily stresses such as washing, so that the patch will remain in place for days at a time.
Granisetron is a well-known 5-HT3 receptor agonist, and a widely-used treatment for chemotherapy-induced nausea and vomiting.
According to ProStrakan, sales of 5-HT3 agonist products in the US and five largest European countries totalled over €2bn for the year ending August 2006, with the company hoping to siphon off a portion of these riches towards its own coffers when Sancuso hits the market in a couple of years.
"We believe this could be a $100m product," Callum Spreng of ProStrakan told in-PharmaTechnologist.com.
Under the terms of the agreement with LG, ProStrakan will receive upfront and milestone payments up to $6m, subject to certain approval and sales targets.
ProStrakan will supply Sancuso exclusively to its South Korean partner, and will receive royalty payments on sales generated in the region by LG.
ProStrakan reported successful results from pivotal Phase III trials of the granisetron patch in December last year, and submitted a new drug application in the US in June, closely followed by a marketing authorisation application for the EU in July.
The patch product is expected to be launched during the first half of 2009, subject to approval by the relevant authorities.
Once approval has been granted in the US (anticipated in 2008), LG Life Sciences will pursue approval in the South Korean market.
ProStrakan already has its own sales force in place to serve the European market, and is planning to establish another sales team in the US following US approval of Sancuso, but is keen to generate value from areas in which it does not intend to build its own commercial presence, said Spreng.
Granisetron is the active ingredient in Roche's drug Kytril, which has suffered a significant down turn in sales thanks to increased competition.
Despite figures having plummeted 17 per cent compared to last year, Kytril (available as an oral solution, tablets or for injection) still managed to generate CHF205m (€125m) over the first half of this year.