Date: 2012-04-11
Type of information: Milestone
Compound: Hexvix® (hexaminolevulinate hydrochloride for intravesical solution)
Company: Ipsen (France) Photocure (Norway)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
commercialisation
Action mechanism: Hexvix®/Cysview® 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.
Disease: bladder cancer
Details: * On September 27, 2011, Ipsen and Photocure have entered into a strategic collaboration with Ipsen to commercialise Hexvix®, its flagship product for the diagnosis and resection of bladder cancer, worldwide except in the USA and the Nordic region. Hexvix® has been the first significant advance for the improved detection of bladder cancer. The drug has been designed to induce specific fluorescence in the malignant cells in the bladder during a cystoscopic procedure, by improving the detection and resection of non invasive bladder cancer. Hexvix®, initially approved in Sweden in 2004, was approved across Europe by 2006 and in the US in 2010. Since 2006, the product has been commercialized in Europe by GE Healthcare. Hexvix® was initially approved in the EU based on strong clinical data showing improved detection and resection of bladder cancer. More recently, new clinical data has shown that improved detection using Hexvix® makes local surgery more complete and leads to significant reduction in the recurrence of bladder cancer2. Based on this, Hexvix® has the potential to change the diagnosis of bladder cancer and significantly improve patient outcomes. The French authorities have qualified the “actual benefit” (“service medical rendu”) of Hexvix® as “substantial” and have assessed that “fluorescence cystoscopy with Hexvix 85mg, used as adjunct to white light cystoscopy, provides an Important Improvement in Actual Benefit (IAB II) in the diagnostic management strategy of superficial bladder tumor”. With € 14 million estimated sales base in 2011, Ipsen will be responsible for marketing and selling Hexvix® worldwide, excluding the US and Nordic region.
Financial terms: Ipsen will pay Photocure and GE Healthcare an upfront payment of €19 million as well as manufacturing milestones to Photocure of € 5 million. Ipsen will also pay royalties on net sales and milestones on specific sales achievements. In addition, Photocure will manufacture the product for Ipsen and, in 2012 and 2013 will invest with Ipsen in marketing and sales programs up to € 3 million to drive momentum and accelerate the sales growth of Hexvix®. Detailed financial terms are not disclosed but are in line with standard industry agreements for a marketed product.
Latest news: * On April 11, 2012, Photocure has announced the achievement of the first allotment of the third and final manufacturing transition milestone from Ipsen. This triggers a payment of €750,000. As part of this collaboration, Photocure received € 1.5 million upon signing and will receive a total of € 5 million in manufacturing transition milestone payments. Photocure will receive the remaining € 750,000 upon achievement of the second stage of the manufacturing transition milestone, estimated to be completed by second quarter 2012. Photocure has received € 3.5 million on completion of the first two transition milestones bringing the total manufacturing milestones achieved to date to €4.25 million. * On March 5, 2012, Photocure ASA has announced the achievement of the second manufacturing transition milestone from Ipsen. This triggers a payment of € 1.5 million. Photocure has successfully completed the second manufacturing transition milestone which triggered a € 1.5 million payment. This follows the € 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 € 3.5 million.
