Du är här

2015-09-04

Photocure ASA: 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 €250,000 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)

---------------------------------------

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Photocure ASA via Globenewswire

HUG#1949254

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.