Regulatory News:
Ipsen (Paris:IPN) (Euronext: IPN, ADR: IPSEY) announces today a partnership with Photocure (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in cancer and dermatology. Photocure has 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 United States of America (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 cancer1. 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. Ipsen has a strong and well established uro-oncology franchise and will initially commercialize Hexvix® in Europe through its dedicated salesforce.
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.
Kjetil Hestdal, President & CEO of Photocure, said: "We are delighted to announce a new and focused commercial platform for our Hexvix® brand. Our strategy is to build Photocure into a profitable specialty pharmaceutical company by maximising the potential of our products. This is a major step forward in executing our strategy. Ipsen is an excellent partner with its strategic focus on uro-oncology and a dedicated salesforce. We believe this agreement and establishing own commercial operations in the US will maximise the potential of Hexvix® and provide long term value for our shareholders."
Marc de Garidel, Ipsen´s Chairman and CEO, said: "The new strategy we announced on 9 June is based on an increased focus on our key franchises. We are therefore proud to announce the in-licensing of an innovative drug indicated in the management of bladder cancer to complement our offer in uro-oncology. Hexvix® will develop commercial synergies with Decapeptyl®, our GnRh analog indicated for the treatment of advanced prostate cancer and with tasquinimod currently in phase III development by our partner Active Biotech for asymptomatic or mildly symptomatic, chemotherapy-naive men with metastatic, castration-resistant prostate cancer (mCRPC). Hexvix® is a unique product which considerably improves the detection and resection of bladder cancers and ameliorates our offer in uro-oncology for the benefit of patients, prescribers and all stakeholders".
GE Healthcare has held the licence to market, sell and distribute Hexvix® since 2006. GE Healthcare continues to have the highest confidence in the drug, but since urology is not a core business area for the company, Photocure has renegotiated the global licensing agreement enabling it to license the marketing rights for Hexvix® to Ipsen and to commercialize the product directly in the US.
Stephen Lightfoot, COO, Medical Diagnostics, GE Healthcare said: "We have had a successful collaboration with Photocure and are proud to have launched Hexvix® and to have worked with the product over the last six years. Urology is not a core business area for GE Healthcare and we believe a company that is dedicated to uro-oncology would be better placed to enable Hexvix® to reach its full market potential and benefit more patients."
About Hexvix®
Hexvix® is the first approved drug for improved detection and resection 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. Clinical data showed a 30%3 increase in detection of the malignant cells in the bladder as compared to the white light system, bringing the total detection rate to 96%4. 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 risks of progression4. 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 November 2010, clinical results from a follow up of recurrence in patients with Non Muscle Invasive Bladder Cancer were published5. 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.
In Europe, the bladder cancer is the seventh most common type of cancer in men and the fourteenth in women6. Each year in Europe, approximately 36,500 men and 13,000 women die due bladder cancer (Ferlay et al., 2001). The bladder cancer is notoriously difficult to detect. The most common, initial sign is red-colored urine, which calls for urine cytology and cystoscopy.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.1 billion in 2010. Ipsen´s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by four franchises: neurology / Dysport®, endocrinology / Somatuline®, uro-oncology / Decapeptyl® and hemophilia. Moreover, the Group has an active policy of partnerships. R&D is focused on innovative and differentiated technological patient-driven platforms, peptides and toxins. In 2010, R&D expenditure totaled more than €220 million, above 20% of Group sales. The Group has total worldwide staff of close to 4,500 employees. Ipsen´s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the "Service de Règlement Différé" ("SRD"). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
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. Allumera®, Photocure® and Hexvix® are registered trademarks of Photocure ASA. For more information about Photocure, visit our website at www.photocure.com.
Ipsen´s Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are based on the Group´s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group´s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today.
Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from Generics that might translate into loose of market shares. Furthermore, the Research and Development process involves several stages each of which involve the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favourable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group´s activities and financial results. The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group´s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.
1 Jichlinski P et al. J Urol 2003; 170: 226-9
2 Stenzl. J Urol, 2010; 184: 1907-1914
3 Jichlinski P et al. J Urol 2003; 170: 226-9
4 Jocham D et al. J Urol 2005; 174: 862-6
5 Stenzl A et al. J Urol 2010; 184: 1907-1914
6 European Network of cancer surgeries; N°3 - September 2003
