Oslo, Norway, 5 March 2012: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces today the achievement of the second manufacturing transition milestone from Ipsen, its new strategic partner for commercializing Hexvix worldwide, excluding the US and Nordic region. This triggers a payment of EUR 1.5 million. Hexvix is Photocure's flagship product to aid in diagnosing bladder cancer.
On 27 September 2011 Photocure and Ipsen announced a new strategic collaboration for the commercialization of Hexvix. In accordance with the agreement with Ipsen, Photocure received EUR 1.5 million upon signing and will receive a total of EUR 5 million in manufacturing transition milestone payments.
Photocure has successfully completed the second manufacturing transition milestone which triggered a EUR 1.5 million payment. This follows the EUR 2.0 million received on completion of the first transition milestone announced on 11 October 2011. The total manufacturing milestones Photocure has achieved to date is EUR 3.5 million.
Photocure will receive the remaining EUR 1.5 million upon achievement of the final manufacturing transition milestone. Additionally, Photocure will receive double digit royalties on all sales, milestones on specific sales achievements and will manufacture the product for Ipsen.
In the new partnership, Ipsen will be responsible for marketing and selling Hexvix worldwide, excluding the US and Nordic region. Ipsen has a strong and well established uro-oncology franchise and will commercialize Hexvix through its dedicated urology salesforce.
Kjetil Hestdal, President & CEO of Photocure, said: "We are happy to report that the Hexvix transition is progressing according to plan. Ipsen is a strong strategic partner for Photocure and we remain committed to delivering on our obligations to Ipsen to secure an optimal growth trajectory for Hexvix."
Hexvix/Cysview (hexaminolevulinate hydrochloride for intravesical solution), is the first approved drug-device procedure for improved detection of bladder cancer. It is designed to induce fluorescence in the malignant cells in the bladder during a cystoscopic procedure, making it easier for the urologist to detect non muscle invasive bladder cancer, as an adjunct to white light cystoscopy. Clinical data show an up to 30% increase in detection of the malignant cells in the bladder as compared to the white light system, bringing the total detection rate to 96%. Hexvix also showed a 32% increase in detection of carcinomas in situ, where tumor cells have not yet penetrated in deep tissues, but carry high risk of progression. It is the first product in a new diagnostic class known as photodynamic diagnostic (PDD) agents.
The product is used in combination with a blue light cystoscopy system. Blue light cystoscopes are broadly available across Europe, where there are an estimated 800 systems currently placed. In the US there are currently only a few systems available. Karl Storz has submitted a supplement to the approved PMA to the FDA for an improved blue light system. This system is similar to the model sold in Europe. Karl Storz estimates that FDA will respond to this application in the near future.
In November 2010, clinical results from a follow up of recurrence in patients with Non Muscle Invasive Bladder Cancer were published. Results, based on both EU and US clinical data, showed a long term benefit of the use of Hexvix compared to patients who received white light cystoscopy alone. The number of patients who have experienced recurrence of their bladder cancer is significantly lower, and the time it takes before the recurrence occurs is longer when they had Hexvix-guided fluorescence cystoscopy, although this has not yet been approved by the relevant regulatory authorities.
Bladder cancer is the fourth most common type of cancer in men and the eighth most common in women in the US. More than 70,000 people in the US were diagnosed with cancer of the bladder in 2009, with an estimated 14,000 people dying from the disease, according to the National Cancer Institute. In Europe, bladder cancer is the seventh most common type of cancer in men and the fourteenth in women. Each year in Europe, approximately 36,500 men and 13,000 women die due to bladder cancer (Ferlay et al., 2001). It is notoriously difficult to detect. The most common initial sign is red-colored urine, which calls for urine cytology and cystoscopy.
For further information, please contact:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: email@example.com
Mary Clark, Amber Bielecka, Hollie Vile
Tel: +44 207920 2361, Email: firstname.lastname@example.org
About Photocure ASA
Photocure ASA is a worldwide leader in photodynamic technology. Listed on the Oslo Stock Exchange (OSE: PHO), Photocure is focused on photodynamic technologies in dermatology and cancer. The company strives to solve unmet needs by developing new and innovative solutions based on its patented Photocure Technology(TM). Photocure markets and sells its own products in selected markets and has developed strong partnerships with leading pharmaceutical companies on a regional and global basis. Photocure's bladder cancer diagnostic product, Hexvix is approved in Europe and the US. In addition, the company markets Allumera®, a photodynamic cosmetic in the US. Setting new standards for diagnosis and treatment of several different conditions, Photocure Technology(TM) is continuously being tested for new products and applications in cancer and dermatology.
Visonac®, Allumera®, Photocure® and Hexvix®/Cysview® are registered trademarks of Photocure ASA. For more information about Photocure, visit www.photocure.com.
This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)