Oslo, Norway, 17. December 2009: The FDAs Oncologic Drugs Advisory Committee (ODAC) met in Washington, D.C., today to discuss Photocure’s new drug application (NDA) for Hexvix. ODAC recommended Hexvix as an adjunct to white light cystoscopy in the detection of non-muscle invasive papillary cancer of the bladder.
The Committee consisted of 17 permanent and temporary voting members including the Chair. Members and the Chair are selected by the FDA from among authorities knowledgeable in the fields of oncology, biostatistics, and other related professions. The Committee also included 1 non-voting member and FDA representatives who are experts in applicable professions.
The meeting followed a standard protocol which included presentations by Photocure and the FDA, in addition to an Open Public Hearing and ended with a Committee discussion and finally the vote on the question from FDA. The discussions were related to: the robustness of Photocure’s phase 3 study, the benefit/risk of Hexvix as presented in the NDA, the role of Hexvix in clinical practice, and the potential need for additional clinical studies.
Photocure presented its pivotal phase 3 study which is a robust, adequate and well-controlled trial that demonstrates a statistically significant improvement after Hexvix cystoscopy in detection of non-muscle invasive papillary bladder lesions compared to standard white light cystoscopy. The robustness of the study is supported by the consistency across subpopulations and with supportive data from additional studies in the NDA. The benefit of Hexvix is also supported by the fact that increased detection of non-invasive bladder tumors with Hexvix leads to a reduced rate of recurrence of the tumors.
The Committee discussed the questions from FDA and agreed that Hexvix as an adjunct to white light cystoscopy is a well-documented diagnostic procedure and has a favorable benefit/risk profile in the detection of non-muscular invasive bladder cancer. The Committee voted 9-8 in favor of Hexvix on FDAs question.
Kjetil Hestdal, President and CEO of Photocure comments “We are pleased that the Committee had a balanced and supportive discussion of the benefits and risks related to Hexvix and the medical need for Hexvix in clinical practice. Hexvix has already been used by over 57, 000 patients in Europe since approval there in 2005. We look forward to FDA completing the review of the Hexvix NDA, which we anticipate to be within the PDUFA date of December 30, 2009.”
About Bladder Cancer
Globally, bladder cancer is ranked 4th and 8th in men and women respectively as the most common form of cancer causing mortality. It is expected that the incidence of bladder cancer will continue to increase concurrent with an increase in industrialization, lifestyle factors and an aging population.
Risk factors for bladder cancer include age, tobacco use, occupation (carcinogens in the workplace), infections, drinking arsenic-contaminated water, Caucasian race, male gender, family history, treatment with chemotherapy or radiation therapy, low fluid consumption and personal history of the disease.
Over 500,000 people in the United States are survivors of this cancer. It is the fourth most frequent cancer diagnosed in men in the US, and the ninth most frequent cancer diagnosed in women. Bladder cancer is 4 times more likely to be found in men than women. Many of the survivors need frequent follow up and treatment, some as often as 2-4 times per year.
Common symptoms of bladder cancer include blood in the urine (making the urine slightly rusty to deep red), pain during urination, and frequent urination, or feeling the need to urinate without results.
American Cancer Society, Key Statistics for Bladder Cancer, www.cancer.org
National Cancer Institute, Surveillance Epidemiology and End Results, http://seer.cancer.gov
National Cancer Institute, Cancer Topics, Bladder Cancer, http://www.cancer.gov
Photocure is a Norwegian pharmaceutical company listed on the Oslo Stock Exchange (OSE: PHO). The company develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications.
Photocures commercial activities includes own marketing and sales in selected markets as well as out-licensing to leading pharmaceutical companies 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 in EU and under priority review by FDA in the US. In addition, the company has developed a proprietary light source, which is used in combination 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 on the Photocure Technology(TM) platform.
For more information about Photocure, visit our website at www.photocure.com.
Photocure®, the Photocure logo and Hexvix® are registered trademarks of Photocure ASA.
For further information, contact:
Attn. Kjetil Hestdal (President and CEO) or Christian Fekete (CFO)
NO-0377 Oslo, Norway
E-mail: firstname.lastname@example.org or email@example.com
Telephone: +47 22 06 22 10
Kjetil Hestdal mobile +47 913 19 535 – Christian Fekete mobile +47 916 42 938