FDA has posted an Advisory Committee meeting with Photocure to
discuss Hexvix® NDA
(Thomson Reuters ONE) - Hexvix new drug application (NDA) will be discussed in OncologicDrugs Advisory Committee meeting scheduled for 17th December 2009.Photocure submitted the NDA on 30 June 2009 and achieved a priorityreview scheduled to be completed by 30 December 2009. The NDAincludes data from from 1 pivotal and 4 supportive phase 3 studies.The Pivotal phase 3 study in 814 included patients showed asignificantly improved detection (p=0.001) of non-invasive papillarycancer using Hexvix cystoscopy compared to standard white lightcystoscopy in patients with non-invasive papillary bladder cancer.The improved detection was followed by a significant reduction (p=0.026) in recurrence at 9 months. All supportive Phase 3 studiesconfirmed the improved detection using Hexvix. The reduction inrecurrence was similar in a Danish Phase 3 supportive study.According to US Law all New Chemical Entities (NCE), such ashexaminolevulinate in Hexvix, should be subject to an AdvisoryCommittee meeting prior to approval by the FDA.The FDA has 32 advisory committees, of which one is the OncologicDrugs Advisory Committee that will review Hexvix. Advisory committeesprovide FDA with independent opinions and recommendations fromoutside experts on applications to market new drugs, and on FDApolicies, FDA generally follows an advisory committee'srecommendation, but is not bound to do so.Kjetil Hestdal says:" We are happy to see that the review isprogressing in accordance with the time lines provided by FDA and weare well prepared to present Hexvix to the advisory committee".About PhotocurePhotocure is a Norwegian pharmaceutical company listed on the OsloStock Exchange (OSE: PHO). The company develops and sellspharmaceuticals and medical devices for the photodynamic treatmentand diagnosis of cancer and selected dermatology indications.Photocure's commercial activities includes own marketing and sales inselected markets as well as out-licensing to leading pharmaceuticalcompanies on a regional or global basis prior to phase III.Photocure has one proprietary pharmaceutical product on the market:Hexvix®, for the diagnosis of bladder cancer. Hexvix is approved inEU and under priority review by FDA in the US. In addition, thecompany has developed a proprietary light source, which is used incombination with the Visonac(TM) cream. Through worldwide studies,Photocure is continuously testing its products for new indications,and the aim is to develop a pipeline of follow-on products based onthe Photocure Technology(TM) platform.For more information about Photocure, visit our website atwww.photocure.com.Photocure®, the Photocure logo and Hexvix® are registeredtrademarks of 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: 20.11.2009 - 07:56 Uhr
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