Hexvix® has been granted priority review by the FDA
(Thomson Reuters ONE) - Oslo, Norway, 31 August 2009Photocure announces today that the US Food and Drug Administration(FDA) has designated priority review for the Hexvix New DrugApplication (NDA).The NDA was submitted to the FDA 30 June 2009 to obtain approval forHexvix for use in the detection of papillary bladder cancer usingfluorescence cystoscopy.The standard target review time of an NDA is 10 months from thesubmission. A priority review has a target review time of 6 months.FDA assigns priority review to products which the FDA considers toprovide a significant improvement over current standard of care.Photocure's Licence Agreement with GE Healthcare includes a milestoneof EUR 10 million at an approval of Hexvix in combination with bluelight cystoscopy (NDA and PMA).Hexvix has been approved for use in diagnosis of bladder cancer inEurope since 2005, and its usefulness is acknowledged by the factthat fluorescence cystoscopy, for which Hexvix is the only approveddrug on the global market, is recommended in the European Associationof Urology's guidelines. The cystoscopic procedure is used forbladder mapping, guiding of biopsies in suspect areas of the bladderand trans urethral resection of the bladder (TURB), i.e. removal ofcancerous bladder tissue.Kjetil Hestdal, President and CEO of Photocure comments: " This wasvery good news, and we are happy that FDA acknowledge that Hexvix canhave a major medical benefit for bladder cancer patients. Inaddition, a shorter review time enables an earlier introduction ofHexvix on the US market by Photocure's licence partner, GEHealthcare."Photocure ASA is a Norwegian pharmaceutical company founded in 1993and listed on Oslo Stock Exchange. The company develops and sellspharmaceuticals and medical devices based on proprietary photodynamictechnologies, targeting key dermatology and oncology markets.Photocure has two products with sales and marketing approvals:Metvix®, which is a product developed for the treatment of skincancer (basal cell carcinoma) and pre-cancerous skin lesions (actinickeratosis), and Hexvix®, which is developed for the detection ofbladder cancer. Both products are based on the same photodynamictechnology, combining the drug known as a photosensitiser with alight source that activates the photosensitiser. Photocure aims todevelop a pipeline of follow-on products and technologies.Photocure®, Metvix®, Hexvix® and Aktilite® are registered trademarksof Photocure ASA.For further information, contact:Photocure ASAAttn. Kjetil Hestdal (President and CEO) or Christian Fekete (CFO)Hoffsveien 48NO-0377 Oslo, Norwaywww.photocure.comE-mail: kh(at)photocure.no or cf(at)photocure.noTelephone: +47 22 06 22 10Kjetil Hestdal mobile +47 913 19 535 - Christian Fekete mobile +47916 42 938This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 31.08.2009 - 08:34 Uhr
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