Photocure ASA: Photocure Announces Transfer of Marketing Authorisation for Cysview in the USA
PHOTOCURE ANNOUNCES TRANSFER OF MARKETING AUTHORISATION FOR CYSVIEW IN THE USA
Oslo, Norway, December 30, 2011:
Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces, consistent with the new commercial strategy for the Hexvix franchise announced in September, the transfer of the New Drug Application (NDA) for Cysview in the USA from GE Healthcare has been initiated and will be complete by December 31, 2011.
The transfer of the NDA completes the transition of all rights and responsibilities for Cysview to Photocure, who are well advanced in preparations to have the commercial organization in place to be able to fully support the brand during 1Q2012.
Photocure has also initiated its commercial collaboration with Karl Storz in the USA. This collaboration will support the strategy to broaden the use of Cysview in USA through expansion of blue light cystoscope placements. Karl Storz USA has received additional questions from the FDA related to their application for approval of new upgraded version of the blue light cystoscope. They are in close communication with FDA and expect to have resolution in near future.
Kjetil Hestdal, MD, PhD, President and CEO of Photocure said: "We are pleased that the transfer of the NDA for Cysview in the USA is going according to plan, which is one of the cornerstones to our new commercial strategy for the Hexvix franchise. Our initial focus for Cysview will be to establish our commercial Cysview organization and support our current customers. We are confident that Karl Storz in USA will receive the approval of the upgraded scopes shortly which will allow for further expansion of the installed base and greater Cysview adoption."
For further information, please contact:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: firstname.lastname@example.org
Mary Clark, Amber Bielecka, Hollie Vile
Tel: +44 207920 2361, Email: email@example.com
Cysview/Hexvix (hexaminolevulinate hydrochloride) is the first approved drug-device procedure for improved detection of bladder cancer. It is designed to induce fluorescence in the malignant cells in the bladder during a cystoscopic procedure, making it easier for the urologist to detect non muscle invasive bladder cancer, as an adjunct to white light cystoscopy. It is the first product in a new diagnostic class known as photodynamic diagnostic (PDD) agents.
The product is used in combination with a blue light cystoscopy system. Blue light cystoscopes are broadly available across Europe, where there are an estimated 800 systems currently placed. In the US there are currently only a few systems available. Karl Storz has submitted a supplement to the approved PMA to the FDA for an improved blue light system. This system is similar to the model sold in Europe.
Bladder cancer is the fourth most common type of cancer in men and the eighth most common in women in the US. More than 70,000 people in the US were diagnosed with cancer of the bladder in 2009, with an estimated 14,000 people dying from the disease, according to the National Cancer Institute. In Europe, bladder cancer is the seventh most common type of cancer in men and the fourteenth in women. Each year in Europe, approximately 36,500 men and 13,000 women die due bladder cancer (Ferlay et al., 2001). It is notoriously difficult to detect. The most common, initial sign is red-colored urine, which calls for urine cytology and cystoscopy.
About Photocure ASA
Photocure ASA is a worldwide leader in photodynamic technology. Listed on the Oslo Stock Exchange (OSE: PHO), Photocure is focused on photodynamic technologies in dermatology and cancer. The company strives to solve unmet needs by developing new and innovative solutions based on its patented Photocure Technology(TM). Photocure markets and sells its own products in selected markets and has developed strong partnerships with leading pharmaceutical companies on a regional and global basis. Photocure's bladder cancer diagnostic product, Cysview/Hexvix is approved in Europe and the US. In addition, the company markets Allumera®, a photodynamic cosmetic in the US. Setting new standards for diagnosis and treatment of several different conditions, Photocure Technology(TM) is continuously being tested for new products and applications in cancer and dermatology.
Allumera®, Photocure® and Cysview(TM)/Hexvix® are registered trademarks of Photocure ASA. For more information about Photocure, visit www.photocure.com.
Important Risk and Safety Information about Cysview (hexaminolevulinate HCl)
INDICATIONS: Cysview is an optical imaging agent for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder in patients with known or suspected lesion(s) on the basis of a prior cystoscopy. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system for blue light cystoscopy as an adjunct to the white light setting. Limitations - Cysview is not a replacement for random biopsies or other procedures used in the detection of bladder cancer. It is not for repeat use; the potential risks associated with repetitive exposure have not been studied. CONTRAINDICATIONS: Cysview is contraindicated in patients with porphyria, gross hematuria, BCG immunotherapy or intravesical chemotherapy within 90 days prior, or with known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid. WARNINGS AND PRECAUTIONS: Anaphylaxis: Anaphylaxis, including anaphylactoid shock, has been reported following administration of Cysview. Failed Detection - Cysview may fail to detect some bladder tumors, including malignant lesions. False Fluorescence: Fluorescent areas detected during blue light cystoscopy may result from inflammation, cystoscopic trauma, scar tissue or bladder mucosal biopsy from a previous cystoscopic examination. Urine and/or blood within the bladder may interfere with the detection of tissue fluorescence. ADVERSE REACTIONS: Clinical Study Experience: The most common adverse reactions were bladder spasm, dysuria, hematuria, and bladder pain. Postmarketing Experience: Anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis and abnormal urinalysis have been reported. USE IN SPECIFIC POPULATIONS: Pregnancy: Cysview should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether hexaminolevulinate is excreted in human milk. Because many drugs are excreted in human milk, exercise caution when Cysview is administered to nursing mothers. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: No clinically important differences in safety or efficacy have been observed between older and younger patients.
Prior to Cysview administration, please read the Full Prescribing Information