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 disease1. 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

  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 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. 

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