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:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: firstname.lastname@example.org
CFO Erik Dahl
Tel: +47 50 55 000, Email: email@example.com
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.
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.