Photocure ASA

Regulatory Filings • Aug 24, 2016

Photocure: Hexvix® marketing authorization approval in Australia

Photocure: Hexvix® marketing authorization approval in Australia

Oslo, Norway, August 24, 2016: Photocure ASA (OSE: PHO), announces that its

partner and exclusive distributor, Juno Pharmaceuticals Pty Ltd, have received

marketing authorization approval (MAA) for 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. Hexvix

is Photocure's flagship product used to aid in the diagnosis and management of

bladder cancer. Under the terms of the agreement, with the MAA approval in

Australia, Photocure will receive EUR 250,000 in milestone payments.

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

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

reached this significant milestone with the approval 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."

George Katsanos, CEO of Juno Pharmaceutical, said: "We are excited to launch

Hexvix in Australia to help improve the accuracy of diagnosis, treatment and

management of bladder cancer. Several major centers in Australia have already

used Hexvix under a Special Access Scheme, and the feedback has been excellent.

The availability of Hexvix in Australia will allow for more appropriate and

individualized diagnosis and post-operative treatment, and the benefits will

flow to patients, doctors and the health care system as a whole."

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.

About Bladder Cancer

Bladder cancer is the fifth most common cancer in men with more than 330 000 new

cases annually and more than 130 000 die of the disease(1). It has a high

recurrence rate with an average of 61% in one year and 78% over five years,

making the lifetime costs of managing bladder cancer one of the highest amongst

all cancers. It is a costly, potentially progressive disease for which, patients

have to undergo multiple cystoscopies because of the high risk of recurrence.

A recent paper on the economic burden of bladder cancer across the European

Union estimates that bladder cancer cost the EU 4.9 billion Euro in 20122. 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 is still in the inner layer of cells. These

cancers are the most common (75%) of all bladder cancer 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 treat.

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(®) is the tradename in Europe, Cysview(®) in U.S. 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

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

Photocure Technology® platform, Photocure develops and commercializes highly

selective and effective solutions within disease areas with high unmet medical

need, such as bladder cancer, HPV and precancerous cervical lesions, and skin

conditions. Our aim is to provide solutions, which 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.

For further information, please contact:

Photocure

President & CEO Kjetil Hestdal

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

CFO Erik Dahl

Tel: +47 450 55 000, Email: ed@photocure.no

1. Globocan. Incidence/mortality by population. Available at:

ttp://globocan.iarc.fr/Pages/bar_pop_sel.aspx (accessed March 2015)

2. Leal et al, Eur Urol 2016; 69: 438-447

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

(Norwegian Securities Trading Act)