Oslo, Norway, 18 June 2012: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces today the achievement of the final manufacturing transition milestone from Ipsen, its strategic partner for commercializing Hexvix worldwide, excluding the US and Nordic region. This triggers a payment of EUR 750 thousand. Hexvix is Photocure’s flagship product to aid in diagnosing bladder cancer.
As part of the strategic collaboration with Ipsen for the commercialization of Hexvix, Photocure received EUR 1.5 million upon signing and with completion of this last remaining payment, Photocure have received a total of EUR 5 million in manufacturing transition milestone payments.
This last milestone is related to the approval of the transfer of Hexvix manufacturing to Patheon in Milan, Italy. The transition to Patheon provides for overall efficiencies in the Photocure supply chain.
Under the terms of the partnership, Ipsen is responsible for marketing and selling Hexvix worldwide, excluding the US and Nordic region where Photocure is reponsible. Ipsen has a strong and well established uro-oncology franchise and is commercializing Hexvix through its dedicated urology sales force. Photocure will receive double digit royalties on all sales, milestones on specific sales achievements and will manufacture the product for Ipsen.
Kjetil Hestdal, President & CEO of Photocure, said: “We are happy to report that the Hexvix commercialization is progressing well and we continue to deliver on our commitments to our strategic partner, Ipsen. We are pleased to have secured approval for the manufacturing transfer to Patheon, which allows us to realize efficiencies within our overall supply chain.”
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. An updated blue light cystoscope from Karl Storz for use in combination with Cysview/Hexvix was approved in USA in May 2012.
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.
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