Photocure announces regulatory approval of Hexvix in Chile
Oslo, Norway, August 16, 2021: Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that the Marketing Authorization for Hexvix® in Chile has been granted. Photocure’s partner and exclusive distributor, Genotests SpA, received the official regulatory approval by the Instituto de Salud Pública de Chile on August 12th.
Now that the product is approved, Genotests will prepare for the commercialization.
In August 2020, Photocure entered into an agreement with Genotests, a privately held company specializing in the marketing of genetic tests for cancer and targeting cancer specialists, to exclusively market and distribute Hexvix in Chile. Under the terms of the agreement, Genotests will fund all costs to secure regulatory approval and commercialize Hexvix in Chile. Photocure will manufacture the product and support Genotests with regulatory activities, training, and promotional materials.
"The fast track designation by the Chilean regulatory authority and the expedited approval shows the significance of bringing this important solution to bladder cancer patients in the region,” said Dan Schneider, President and CEO of Photocure. “With Genotests’ dedication and strong execution on this initiative, we expect that Hexvix will become accessible to patients in Chile in the fourth quarter of this year. This partnership represents Photocure’s first step into the South American continent, and supports our strategy of expanding the availability of Hexvix into new territories to ensure that patients and urologists have access to the benefits of using blue light cystoscopy (BLC®). The procedure with Hexvix, or Cysview, is recommended in guidelines for the management of bladder cancer around the world.”
“It is a privilege to bring this fantastic product to Chile” said Oscar Varas, founder and owner of Genotests. “There are approximately 1,500 new bladder cancer cases annually in our country, an estimated 5,000 TURBT* procedures and nearly 11,000 surveillance cystoscopies. We look forward to building on our established network and to collaborate with providers of capital equipment to launch blue light cystoscopy with Hexvix into the Chilean urology community as soon as possible.”
*TURBT: trans-urethral resection of bladder tumors
Note to editors:
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About Bladder Cancer
Bladder cancer ranks as the seventh most common cancer worldwide with 1 720 000 prevalent cases (5-year prevalence rate)1a, 573 000 new cases and more than 200 000 deaths annually in 2020.1b
Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with an average of 61% in year one and 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3
Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.
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 wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC 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 treat.4
1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: https://gco.iarc.fr/today, accessed [April 2021].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295–300
4 Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html
About Hexvix®/Cysview® (hexaminolevulinate HCl)
Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLC®). BLC with Hexvix/Cysview improves the detection of tumors and leads to more complete resection, fewer residual tumors and better management decisions.
Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe, and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Canada, Chile, Australia and New Zealand. Please refer to https://photocure.com/partnering-with-photocure/our-partners/ for further information on our commercial partners.
About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at www.photocure.com, www.hexvix.com, www.cysview.com