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
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
-
Globocan. Incidence/mortality by population.
Available at: ttp://globocan.iarc.fr/Pages/bar_pop_sel.aspx
(accessed March 2015)
-
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)
