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Photocure ASA

Regulatory Filings Feb 14, 2020

3714_rns_2020-02-14_14c92ecd-922d-4dcf-a99e-1de66aed0603.html

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Photocure announces new US patent for Hexvix

Photocure announces new US patent for Hexvix

Oslo, Norway February 14, 2020, Photocure ASA (OSE: PHO) is pleased to announce

that the United States Patent and Trademark Office (USPTO) has granted US Patent

No. 10,556,010 covering the use of Blue Light Cystoscopy (BLC[®]) with Hexvix as

neoadjuvant* therapy in the treatment of bladder cancer in patients who are

scheduled for a cystectomy.

Early stage study results have shown an antitumor effect and induced systemic

immune effects of hexaminolevulinate (HAL) and blue light in an orthotopic model

of rat bladder cancer. Photocure has the intention to further investigate Hexvix

for its therapeutic effect and the patent is a result of Photocure's continued

focus on securing intellectual property rights for its research results and

pipeline activities.

The patent was issued on 11 February 2020 and will expire in December 2036.

* Neoadjuvant therapy: treatment (such as chemotherapy) administered before

primary cancer treatment (such as surgery) to enhance the outcome of primary

treatment

For more information, please contact:

Dan Schneider

President and CEO

Photocure ASA

Tel: + 1-609 759-6515

Email: [email protected]

Erik Dahl

CFO

Photocure ASA

Tel: +4745055000

Email: [email protected]

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]

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 US and Canada, Hexvix[®] is the tradename in

all other markets. Photocure is commercializing Cysview[®] / Hexvix[®] directly

in the US 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.

All trademarks mentioned in this release are protected by law and are registered

trademarks of Photocure ASA

This press release may contain product details and information which are not

valid, or a product is not accessible, in your country. Please be aware that

Photocure does not take any responsibility for accessing such information which

may not comply with any legal process, regulation, registration or usage in the

country of your origin.

About Photocure ASA

Photocure: The Bladder Cancer Company delivers transformative solutions to

improve the lives of bladder cancer patients. Our unique technology, which makes

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 or www.cysview.com

References

[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

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