Photocure ASA

Regulatory Filings • Sep 4, 2015

Photocure announces submission of application for Hexvix® marketing authorization in Australia

Photocure announces submission of application for Hexvix® marketing authorization in Australia

Oslo, Norway, 4 September,  2015: Photocure ASA (OSE: PHO), a specialty

pharmaceutical company focused on photodynamic technologies in dermatology and

cancer, announces that its partner and exclusive distributor, Juno

Pharmaceuticals, has filed a marketing authorization application (MAA) for the

registration of Hexvix in Australia. Hexvix is Photocure's flagship product used

to aid in the diagnosis and management of bladder cancer.

Under the guidance provided by the Therapeutics Goods Agency in Australia, the

average review time for applications is twelve months from the date of

submission. Photocure will receive a milestone payment of EUR250,000 upon approval

of Hexvix in Australia, estimated to occur in the second half of 2016.

Kjetil Hestdal, President & CEO of Photocure, said: "The partnership with Juno

Pharmaceuticals is progressing well and we are pleased that they have reached

this significant milestone with the filing of the MAA. We continue to expand

Hexvix into new territories to ensure patients and urologists have access to the

most optimal treatment for the diagnosis and management of bladder cancer."

During the review process, Juno Pharmaceuticals will begin to prepare for the

commercial launch of Hexvix in Australia. The market potential in the territory

is estimated to be similar to the potential in the Nordics, where Photocure

commercializes Hexvix with its own sales team.

For further information, please contact:

Photocure

President & CEO Kjetil Hestdal

Tel: + 47 913 19 535, Email: kh@photocure.no

CFO Erik Dahl

Tel: +47 50 55 000, Email: ed@photocure.no

About Photocure ASA

Photocure ASA, headquartered in Oslo, Norway, is a specialty pharmaceutical

company and world leader in photodynamic technology. Based on our unique

proprietary Photocure Technology(®) platform, Photocure develops and

commercializes highly selective and effective solutions in disease areas with

high unmet medical need, such as bladder cancer, HPV and precancerous cervical

lesions, colorectal cancer and skin conditions. Our aim is to provide solutions

that can improve health outcomes for patients worldwide. Photocure is listed on

the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at

www.photocure.com.

About Hexvix(®)/Cysview(®)

Hexvix(®)/Cysview(®) (hexaminolevulinate hydro-chloride) is an innovative

breakthrough technology in the diagnosis and management of non-muscle-invasive

bladder cancer. It is designed to selectively target malignant cells in the

bladder and induce fluorescence during a cystoscopic procedure using a blue-

light enabled cystoscope. Using Hexvix(®)/Cysview(®) as an adjunct to standard

white-light cystoscopy enables the urologist to better detect and remove

lesions, leading to a reduced risk of recurrence. Hexvix(®)/Cysview(®) is

approved in Europe and the USA.

About Juno Pharmaceuticals

Juno Pharmaceuticals is a privately held global health care company dedicated to

introducing a range of innovative pharmaceutical products. Juno Pharmaceuticals

was founded in 2012 by a group of experienced international pharmaceutical

executives and are a fast growing global specialty pharmaceutical company. Our

product portfolio and pipeline covers a broad spectrum of therapeutic areas and

formats including oral solid dosages, injectable, suspensions, ophthalmic

solutions, creams and patches. With a primary focus on the hospital market

channel, Juno has access to a range of presentations across multiple therapeutic

areas including biosimilar products. An extensive global network of

manufacturers allows us to source niche, lifesaving products for our customers.

Juno operates in the Australian, Canadian, Polish and United Kingdom markets.

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

trademarks of Photocure ASA.

This information is subject of the disclosure requirements acc. to §5-12 vphl

(Norwegian Securities Trading Act)

[HUG#1949254]