Photocure submits application for marketing approval for Hexvix® in
USA to the FDA>
Photocure submits application for marketing approval for Hexvix® in USA to the FDA
(Thomson Reuters ONE) - Oslo, Norway, 30 June 2009Photocure announces today that a New Drug Application (NDA) has beensubmitted to the US Health Authorities (FDA) to obtain approval forHexvix for use in the detection of papillary bladder cancer usingfluorescence cystoscopy.The NDA includes clinical data from 1838 patients, comprising tworecently completed clinical studies, one Phase III pivotal study in789 patients from EU/US and a Phase III study performed in Denmark in233 patients. The NDA includes analyses in patients with papillarybladder cancer from earlier Phase III studies. The pivotal Phase IIIstudy shows a significantly improved detection (p=0.001) ofnon-invasive papillary bladder cancer in fluorescence cystoscopy withHexvix compared to standard cystoscopy followed by a significantreduction in recurrence at 9 months (p= 0.026). The results from thepivotal Phase III study are supported by the Danish Phase III studywhich showed similar reduction in recurrence. All studies in thedocumentation demonstrate that fluorescence cystoscopy using Hexvixsignificantly improves detection of papillary bladder cancer comparedto standard white light cystoscopy.Photocure, in collaboration with GE Healthcare, has had severalmeetings with the FDA, leading up to this submission and the resultsof the pivotal Phase III study have been presented to the FDA.All Hexvix clinical studies have been conducted using endoscopyequipment from Karl Storz, which enables cystoscopy using bothstandard white light and the blue light necessary for fluorescencecystoscopy.The Principal Investigator of the pivotal Phase III study, ProfessorH. Barton Grossman at MD Anderson Cancer Center comments:" There is asignificant need to improve the detection of bladder cancer in the USpopulation and to reduce the recurrence of this disease. Based on therecently published clinical data from this study Hexvix will be animportant tool in improving detection and treatment of bladder cancerin the US market."Kjetil Hestdal, President and CEO of Photocure comments: "The NDAsubmission is a very important step for Photocure. With theseexcellent clinical data included in the NDA, Photocure is lookingforward to receiving FDAs view on the NDA."About PhotocurePhotocure ASA is a Norwegian pharmaceutical company listed on theOslo Stock Exchange (OSE: PHO). The company develops and sellspharmaceuticals and medical devices for the photodynamic treatmentand diagnosis of cancer.Photocure has two proprietary pharmaceutical products on the market:Metvix®, for the treatment of sun-damaged skin and certain types ofskin cancer, and Hexvix®, for the diagnosis of bladder cancer. Inaddition, the company has developed a proprietary light source, theAktilite® lamp, which is used in combination with the Metvix cream.Through worldwide studies, Photocure is continuously testing itsproducts for new indications, and the aim is to develop a pipeline offollow-on products and technologies. For more information aboutPhotocure, visit our website at www.photocure.comPhotocure®, Metvix®, Hexvix® and Aktilite® are registered trademarksof Photocure ASA.Bladder cancer is the fourth most commonly diagnosed malignancy inmen and tenth among women. The recurrence rate for patients withnon-invasive bladder cancer is 50-70%. Bladder cancer is one of themost expensive cancers to treat because of its combination of longsurvival and intensive and costly routine monitoring and treatmentdue to the recurrent nature of the disease.For further information, contact:President and CEO Kjetil HestdalE-mail: kh(at)photocure.noMobile: +47 913 19 535Office: +47 22 06 22 10CFO Christian FeketeE-mail: cf(at)photocure.noMobile: +47 916 42 938Office: +47 22 06 22 10www.photocure.comThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
" alt="Delivery of Seajacks Leviathan - on time and on budget>
">
" alt="Correction - Final Results>
">
Datum: 30.06.2009 - 08:51 Uhr
Sprache: Deutsch
News-ID 1002348
Anzahl Zeichen: 0
contact information:
Contact person:
Town:
London
Phone:
Kategorie:
Business News
Anmerkungen:
Diese Pressemitteilung wurde bisher 310 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Photocure submits application for marketing approval for Hexvix® in
USA to the FDA>
"
steht unter der journalistisch-redaktionellen Verantwortung von
Photocure ASA (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
