Photocure ASA: Phase 3 study investigating Blue Light Flexible Cystoscopy with Cysview® in surveillance setting meets primary endpoint

 | Source: Photocure ASA Photocure ASA

Oslo, Norway, May 12th, 2017: Photocure ASA (Photocure, PHO:OSE), today announced that a Phase 3 trial investigating Blue Light Flexible Cystoscopy (BLFC(TM)) with Cysview®/Hexvix® in the surveillance setting met the study primary end point. Results from the study showed a highly statistically significant improvement (p <0.0001) in the detection of patients with recurrence of bladder cancer using BLFC with Cysview compared to white light (WL) alone in patients with non-muscle invasive bladder cancer (NMIBC) undergoing surveillance cystoscopy. Detailed data from the study will be presented during a late-breaking plenary abstract session on May 14th at the American Urological Association, 2017 meeting.

"We are very pleased with the strong results of this Phase 3 study and we appreciate the work from investigators and patients who participated in the study. There are approximately 1.4 million surveillance cystoscopies performed in the US annually. These results represent an important milestone for the potential improvement in the management of patients. Later this year we intend to submit the data to the US Food and Drug Administration (FDA) to seek a label expansion for the indication of BLFC with Cysview in the surveillance setting." said Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA."

The Phase 3 study was a prospective, open, comparative, within-patient controlled study, including 304 patients enrolled at 17 academic institutions in the US.

About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the fourth most common cancer found in men in the US1, 2, 3. In 2016, it is estimated that 76,960 new cases of bladder cancer will occur along with 16,390 deaths due to bladder cancer. Risk factors for bladder cancer include advancing age, cigarette smoking, occupational exposure to dyes, tar, rubber and solvent, chronic bladder irritation and infections, and prior diagnosis of bladder cancer. Bladder cancer is one of the most expensive cancers to manage, accounting for approximately $3.7 billion in direct costs each year4, 5.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall6. NMIBC is still in the inner layer of cells. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat7.

About Hexvix®/Cysview®
Hexvix® is a drug that is taken up selectively by cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix® improves the detection of tumors and leads to more complete resection, less residual tumors and better management decisions (US)/ reduced risk of recurrence and progression (Nordic).

Hexvix® is the tradename in Europe, Cysview® in the US and Canada. Hexvix® is marketed and sold by Photocure in the Nordic countries and in the US with the trade name Cysview®. Photocure has a strategic partnership with Ipsen for the commercialization of Hexvix® in Europe, excluding the Nordic region. Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.

About Photocure ASA
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company focusing on urology. Based on its unique proprietary Photocure Technology® platform, Photocure is committed to developing and commercializing highly selective and minimally invasive solutions to improve health outcomes for patients worldwide. The company is listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at www.photocure.com.

For more information, please contact:
Kjetil Hestdal
President and CEO, Photocure ASA
Tel: + 47 91319535
Email: kh@photocure.no

Erik Dahl
Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no

Emily Dell
Media contact
MCS Healthcare public relations
Tel: +1 732 589-0757
Email: emilyd@mcspr.com

1 SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute. Bethesda, MD. http://seer.cancer.gov/statfacts/html/urinb.html. Accessed April 2016.
2 Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.
3 Hall M, Chang S, Dalbagni G et al. Guideline for the Management of Nonmuscle Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007 Update. J Urol. 2007;178 (6):2314-2330.
4 Avritscher EB et al., Clinical model of lifetime cost of treating bladder cancer and associated complications. Urology. 2006; 68:549-553.
5 Botteman et al. Clinical model of lifetime costs of treating bladder cancer: a comprehensive review of the published literature. Pharmacoeconomics. 2003; 21:315-1330.
6 Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.
7 Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.