Photocure ASA

Regulatory Filings • Aug 13, 2020

Photocure appoints Genotests as exclusive partner for Hexvix[ ]in Chile

Photocure appoints Genotests as exclusive partner for Hexvix[ ]in Chile

Oslo, Norway, 13 August 2020: Photocure ASA (OSE: PHO), today announced the

appointment of Genotests SpA as the exclusive distributor for the

commercialization of Hexvix[®] in Chile.

"We are proud to take our first step into the South American continent and make

Hexvix accessible to Chilean bladder cancer patients. Chile is a stable, well

regulated market with a strong economy, and Genotests is well positioned to

leverage their network of urologists and uro-oncologists both in the private and

public hospitals", says Dan Schneider, President and CEO of Photocure.

Photocure has appointed Genotests, a privately held company founded in 2014

specializing in genetic tests for cancer targeting cancer specialists, as the

exclusive distributor of Hexvix in Chile. Under the terms of the agreement,

Genotests will fund all costs to secure regulatory approval and the launch and

commercialization of Hexvix in Chile. Photocure will manufacture the product and

support Genotests with the regulatory file, training and promotional materials.

There are approximately 1500 new bladder cancer cases annually in Chile, an

estimated 5000 TURBT* procedures and nearly 3000 surveillance cystoscopies.

"I am delighted to get the opportunity to bring Hexvix to Chile. It is a

fantastic product that the urology community has been waiting for, especially

after the successful demo done in collaboration with Karl Storz at the Chilean

Urology Conference. After following Photocure and Hexvix/Cysview for years I

know it is a complex sell, and we are well prepared with an established

relationship with the leading cystoscopy equipment supplier. We'll initiate the

regulatory submission process immediately and look very much forward to work

with the Photocure team", says Oscar Varas, founder and owner of Genotests.

*TURBT: trans-urethral resection of bladder tumors

About Bladder Cancer

Bladder cancer ranks as the sixth most common cancer worldwide with 1 650 000

prevalent cases (5 year prevalence rate), 550 000 new cases and almost 200 000

deaths annually in 2018.[1]

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. Incidence/mortality by

population. Available at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx

[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 is selectively taken up by tumor cells in

the bladder making them glow bright pink during Blue Light Cystoscopy (BLC[TM]).

BLCT 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 the Nordic region and has strategic partnerships for

the commercialization of Hexvix[®]/Cysview[®] in Europe, Canada, Australia and

New Zealand. Please refer to https://bit.ly/2wzqSQQ for further information on

our commercial partners.

About Photocure

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

About Genotests SpA:

Genotests is a medical company in-licensing and commercializing innovative

cancer diagnostics test and treatments for health care providers and their

patients in the Latin America & Caribbean countries, with special emphasis in

the field of uro-oncology.

For more information, please contact:

Dan Schneider

President and CEO

Photocure ASA

Tel: + 1-609 759-6515

Email: ds@photocure.com

Erik Dahl

CFO

Photocure ASA

Tel: +4745055000

Email: ed@photocure.com

Media and IR enquiries:

Geir Bjørlo

Corporate Communications (Norway)

Tel: +47 91540000

Email: geir.bjorlo@corpcom.no