Oslo, Norway, September 27, 2011: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces today the execution of a new commercial strategy for Hexvix, its flagship product to aid in diagnosing bladder cancer. Photocure has entered into a strategic collaboration with Ipsen, a global specialty-driven biopharmaceutical company focused on four franchises, including uro-oncology, to commercialise Hexvix worldwide, excluding the US and Nordic region. Additionally, to capitalise on the untapped US market opportunity, Photocure plans to launch the product, approved as Cysview™ in the US, through its own commercial operations. The new strategy will maximise the potential of Hexvix on a global basis.
Hexvix has been the first significant advance for the improved detection of bladder cancer. It is designed to induce specific fluorescence in the malignant cells in the bladder during a cystoscopic procedure, making it easier for the urologist to detect bladder cancer. Hexvix, initially approved in Sweden in 2004, was approved across Europe by 2006 and as Cysview 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 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 transform the diagnosis of bladder cancer and may significantly improve patient outcomes.
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 commercialise Hexvix through its dedicated urology salesforce. Photocure retains the rights to the product in the Nordics and the US.
Photocure will receive an upfront payment of EUR 6.5 million related to the successful completion of transition milestones, as well as double digit royalties on all sales and milestones on specific sales achievements. In addition, Photocure will manufacture the product for Ipsen. In 2012 and 2013 Photocure will invest with Ipsen in marketing and sales programs to drive momentum and accelerate the sales growth of Hexvix. Detailed financial terms were not disclosed but are in line with standard industry agreements for a marketed product.
In the US, Photocure will commercialise Cysview through establishing its own operations. The target market in the US is concentrated and can be addressed with a niche salesforce. Photocure will leverage its knowledge and expertise in marketing and selling Hexvix in the Nordics where it has achieved greater than 30% market share, to maximise the potential of Cysview in the US market. Timing of launch is anticipated during the first quarter of 2012.
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, combined with establishing our own commercial operations in the US, will maximise the potential of Hexvix/Cysview 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 medical drug-device procedure 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 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 product, 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 commercialise 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/Cysview 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 urology will be better placed to enable Hexvix to reach its full market potential and benefit more patients.”
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%3,4. 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 risk 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 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 fourth quarter 2011.
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, 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 women1. Each year in Europe, approximately 36,500 men and 13,000 women die due 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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Important Risk and Safety Information about Cysview (hexaminolevulinate HCl)
INDICATIONS: Cysview is an optical imaging agent for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder in patients with known or suspected lesion(s) on the basis of a prior cystoscopy. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system for blue light cystoscopy as an adjunct to the white light setting. Limitations - Cysview is not a replacement for random biopsies or other procedures used in the detection of bladder cancer. It is not for repeat use; the potential risks associated with repetitive exposure have not been studied. CONTRAINDICATIONS: Cysview is contraindicated in patients with porphyria, gross hematuria, BCG immunotherapy or intravesical chemotherapy within 90 days prior, or with known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid. WARNINGS AND PRECAUTIONS: Anaphylaxis: Anaphylaxis, including anaphylactoid shock, has been reported following administration of Cysview. Failed Detection - Cysview may fail to detect some bladder tumors, including malignant lesions. False Fluorescence: Fluorescent areas detected during blue light cystoscopy may result from inflammation, cystoscopic trauma, scar tissue or bladder mucosal biopsy from a previous cystoscopic examination. Urine and/or blood within the bladder may interfere with the detection of tissue fluorescence. ADVERSE REACTIONS: Clinical Study Experience: The most common adverse reactions were bladder spasm, dysuria, hematuria, and bladder pain. Postmarketing Experience: Anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis and abnormal urinalysis have been reported. USE IN SPECIFIC POPULATIONS: Pregnancy: Cysview should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether hexaminolevulinate is excreted in human milk. Because many drugs are excreted in human milk, exercise caution when Cysview is administered to nursing mothers. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: No clinically important differences in safety or efficacy have been observed between older and younger patients.
Prior to Cysview administration, please read the Full Prescribing Information
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™. 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™ 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 www.photocure.com.
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.
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