ProStrakanís Sancuso Approved in Europe

Released: Thursday 26th April 2012

ProStrakan’s Sancuso Approved in Europe

ProStrakan Group plc, the international specialty pharmaceutical company which is a subsidiary of Kyowa Hakko Kirin Co. Ltd. (KHK), today announces that it has received notice from the European Commission that the Commission has granted a Marketing Authorisation for ProStrakan‟s Sancuso transdermal patch in Europe. This follows the recommendation for approval of the European Medicines Agency‟s Committee for Medicinal Products for Human Use (CHMP) received in February 2012.

Sancuso is indicated for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of three to five consecutive days, where oral anti-emetic administration is complicated by factors making swallowing difficult.

Sancuso is a patch that is placed on the skin of the arm and which contains granisetron – a drug that prevents nausea and vomiting. The Sancuso patch can be left on for up to a week; and prevents nausea and vomiting following chemotherapy (given over the course of three to five days). Patients who have inflammation and ulcers in their mouth (mucositis) or who have a very dry mouth as a side effect of chemotherapy or radiotherapy, or who have difficulty in swallowing after head and neck surgery, would be suitable for Sancuso instead of taking tablets each day.

Key Points The Marketing Authorisation Application for Sancuso was filed through the EU centralised procedure and its approval results in a centralised marketing authorisation which is valid in all 27 EU Member States plus Norway, Iceland and Liechtenstein Sancuso is the world‟s first licensed transdermal 5HT3 receptor antagonist product and is already marketed by ProStrakan in the US As a patch, Sancuso offers cancer sufferers in the EU who are at risk of severe nausea and vomiting, and for whom oral anti-emetic administration is complicated by factors making swallowing difficult, a new treatment choice that is both non-invasive and non-oral The Sancuso patch is simple to apply and can be put on by the patient, a carer or by a healthcare practitioner. Sancuso was developed in-house by ProStrakan – from inception to US launch in five years Sancuso will be marketed by ProStrakan‟s own sales forces in UK, France, Germany, Spain, Italy and other EU countries. The company will also make Sancuso available for out-licensing in EU countries in which it does not have a sales presence. Sancuso is already approved in the US (where it is sold by ProStrakan‟s sales force) as well as in certain Asian countries.

Tom Stratford PhD, Chief Executive of ProStrakan, said: “We are particularly proud of Sancuso as it is the world‟s first licensed transdermal 5HT3 receptor antagonist product and is one that was developed entirely in-house at ProStrakan. Chemotherapy-induced nausea and vomiting is a distressing and debilitating condition for some cancer patients and we are pleased that Sancuso will now become available to clinicians and patients in Europe as well as the US. This product fits well with both ProStrakan‟s and KHK‟s oncology focus and will become a valuable part of our European portfolio of products.” Ends

Callum Spreng,

Corporate Communications

Tel: +44 (0)1896 664000 Mobile: +44 (0)7803 970103

Notes to Editors:

For more information visit the EMA website: (“New medicines” section; 16 February 2012).

Sancuso Overview Sancuso is a transdermal patch that delivers granisetron, an established 5HT3 receptor antagonist, steadily into the bloodstream. Sancuso has been shown to be non-inferior to oral granisetron in preventing the side effects of nausea and vomiting in patients undergoing chemotherapy (for three to five days). Sancuso has the advantage of offering this protection through a single transdermal patch application, eradicating the need for repeated daily injections, or having to swallow multiple pills on a repeated daily basis, which is often not possible in cancer patients due to oral mucositis. A clinical trial compared the efficacy and safety of Sancuso with that of 2 mg oral granisetron given once daily in the prevention of nausea and vomiting. A total of 641 patients were included in the trial who were receiving chemotherapy for between 3 and 5 days, consecutively. All patients were receiving moderately or highly emetogenic chemotherapy. The study was a standard non-inferiority design i.e. to show that Sancuso was „no worse than‟ oral granisetron. The study was double masked, so that neither the patient nor the doctor knew if they were receiving active or dummy patch or tablet. Patients from Europe, the US and certain Asian countries were included. Sancuso was applied 24 to 48 hours before the first dose of chemotherapy, and kept in place for 7 days. Granisetron tablets were given before each dose of chemotherapy. The patients‟ degree of nausea and vomiting was assessed from the first administration of chemotherapy until 24 hours after the start of the last day‟s administration of the moderately or highly emetogenic chemotherapy regimen. The study outcome was positive showing that Sancuso is non-inferior to oral granisetron. Complete control (CC) was experienced by 60% of patients in the Sancuso arm and 65% of patients receiving oral granisetron in the per protocol set (difference -5%; 95% confidence interval –12.91% to +3.13%; n=284 transdermal patch, n=298 oral). [CC was defined as no vomiting and/or retching, no more than mild nausea and no rescue medicine from the first administration until 24 hours after the start of the last day‟s administration of multi-day chemotherapy.]
Due to the gradual increase in plasma levels of granisetron following application of the transdermal patch, initial plasma levels at the start of chemotherapy may be lower than 2 mg oral granisetron and a slower onset of efficacy may therefore be observed.

Consequently, Sancuso is indicated for use in patients where oral anti-emetic administration is complicated by factors making swallowing difficult. Safety of Sancuso The most commonly reported adverse reaction in clinical studies was constipation, occurring in approximately 9% of patients. The majority of adverse reactions were mild or moderate in severity. Special Precautions for Using Sancuso Application site reactions In clinical trials with Sancuso, application site reactions were reported which were generally mild in intensity and did not lead to discontinuation of use. If severe reactions, or a generalised skin reaction occur (e.g. allergic rash, including erythematous, macular, papular rash or pruritus), the transdermal patch must be removed. Gastrointestinal disorders As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following its administration. Cardiac disorders 5-HT3 receptor antagonists, such as granisetron, may be associated with arrhythmias or ECG abnormalities. This potentially may have clinical significance in patients with pre-existing arrhythmias or cardiac conduction disorders or patients who are being treated with antiarrhythmics or beta-blockers. No clinically relevant effects have been observed in clinical studies with Sancuso. Exposure to sunlight Granisetron may be affected by direct natural or artificial sunlight. Patients must be advised to cover the transdermal patch application site, e.g. with clothing, if there is a risk of exposure to sunlight throughout the period of wear and for 10 days following its removal. Showering or washing Showering or washing normally can be continued while wearing Sancuso. Activities such as swimming, strenuous exercise or using a sauna should be avoided. External heat External heat (for example hot water bottles or heat pads) should be avoided on the area of the transdermal patch. Special populations No dose adjustments are necessary for the elderly or patients with renal or hepatic impairment. Although no evidence of an increased incidence of adverse reactions have been observed in patients with renal or hepatic impairment receiving granisetron orally and intravenously, based on granisetron pharmacokinetics, a degree of caution must be exercised in this population. About ProStrakan: 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 is a subsidiary of Kyowa Hakko Kirin Co. Ltd., the Japan-based global specialty pharmaceutical company.

ProStrakan's head office is located in Galashiels in Scotland. The company‟s development capabilities are centered in Galashiels and Bridgewater, New Jersey, USA. Sales and marketing of ProStrakan's portfolio of products are handled by commercial subsidiaries in the UK, US, France, Germany, Spain, Italy and other EU countries.

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