Oslo, Norway, 20 October, 2010: Photocure (OSE: PHO), a Norwegian specialty pharmaceutical company focused in dermatology and cancer, announced today it has signed a strategic global agreement with Salix Pharmaceuticals Inc. (NASDAQ:SLXP), the US specialty pharmaceutical company focused on gastrointestinal diseases, for the development and commercialisation of Lumacan. Lumacan is a photodynamic colorectal diagnostic intended to significantly improve the detection of precancerous and cancerous lesions in the colon through fluorescence diagnosis.
Under the agreement, Salix will obtain an exclusive worldwide license to Lumacan excluding the Nordic region. Photocure will receive a signing fee of US$4 million and is entitled to receive additional milestone payments totalling up to US$126.5 million, if certain conditions are satisfied. The milestones relate to development, regulatory events and sales achievement. In addition to the milestones, Salix will pay Photocure tiered double digit royalties on net sales and pay a percentage of all Salix sublicense revenue worldwide outside of the US. Salix will control and cover development, registration and commercialisation costs for Lumacan worldwide, with Photocure covering certain costs of formulation development up to US$3 million.
Photocure has retained the rights to market and sell Lumacan in the Nordic countries. In addition to the development of Lumacan for colorectal cancer, Salix has the exclusive right to explore and develop products for additional indications involving the diagnosis of gastrointestinal dysplasia and cancer. Payments for products in respect of any such additional indications will be negotiated if and when new product development is initiated.
Colon cancer is traditionally diagnosed through colonoscopies (visual examination) with white light. It is increasingly being recognized that standard white-light colonoscopy has limitations in the detection of colon cancer. Earlier studies undertaken by Photocure have demonstrated an increased detection rate of nearly 40% when Lumacan-colonoscopy diagnostic was used. Lumacan is currently in Phase I/II trials.
Photocure and Salix believe earlier detection and diagnosis of precancerous and cancerous lesions in the colon could ultimately lead to better targeted therapeutic care and increased colorectal cancer survival rates in patients. Lumacan is being developed for use in conjunction with standard white light colonoscopy diagnosis. Annually, approximately 14 million colonoscopies are performed in US. Lumacan will target high risk screening patients and diagnostic patients in follow-up of colon cancer. Collectively, these subgroups are estimated to be approximately 20% of total colonoscopies undertaken.
Chief Executive Officer of Photocure, Kjetil Hestdal, said "We are delighted to have signed this agreement with Salix Pharmaceuticals. The value of the deal in this early clinical phase reflects the great potential of Lumacan. Given its successful expertise and experience in developing and marketing treatments for gastrointestinal diseases, Salix is an excellent partner to take Lumacan to the market. We believe this agreement represents the best way to accelerate the development of Lumacan and create long term value for our shareholders. We look forward to working closely with Salix on the future development of Lumacan."
Chief Executive Officer of Salix Pharmaceuticals, Carolyn Logan, stated "We believe Lumacan is truly an innovative and groundbreaking diagnostic which should complement our portfolio of gastrointestinal offerings. Lumacan's efficacy results thus far have been promising and show great potential if approved for marketing by the FDA. Lumacan will be our first gastrointestinal diagnostic product and we hope to save lives through earlier and more successful colon cancer detection."
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For further information, please contact
President & CEO Kjetil Hestdal
Phone: + 47 913 19 535
CFO Christian Fekete
Phone: + 47 916 42 938
Mary Clark, Justine Lamond and Hollie Vile
Ph: +44 (0)20 7307 5337
About Lumacan and colon cancer
Colon cancer is traditionally diagnosed through colonoscopies (visual examination) with white light. It is increasingly being recognized that standard white-light colonoscopy has considerable limitations in the optimal detection of colon cancer. Lumacan is being developed to increase the detection rate for polyps and colon cancer through fluorescence diagnosis. Earlier studies undertaken by Photocure have shown a significant increased detection rate when Lumacan-colonoscopy diagnostic was used. It is currently in Phase I/II trials. The market for colonoscopies is growing as a result of extensive patient screening programs in Europe and USA. In the US, it is estimated approximately 14 million colonoscopies are undertaken annually for diagnosis of colon cancer.
Photocure is a Norwegian speciality pharmaceutical company listed on the Oslo Stock Exchange (OSE: PHO). The company develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications.
Photocure's commercial activities includes own marketing and sales in selected markets as well as out-licensing to leading pharmaceutical companies on a regional or global basis prior to Phase III.
Photocure has one proprietary pharmaceutical product on the market: Hexvix®, for the diagnosis of bladder cancer. Hexvix® is approved in Europe and in the US. In addition, the company has developed a proprietary light source, which is used in combination with the Visonac™ cream. Through worldwide studies, Photocure is continuously testing its products for new indications, and the aim is to develop a pipeline of follow-on products based on the Photocure Technology™ platform.
Photocure® and Hexvix® are registered trademarks of Photocure ASA.
For more information about Photocure, visit our website at www.photocure.com
Salix Pharmaceuticals, Inc., headquartered in Raleigh, North Carolina, USA develops and markets prescription pharmaceutical products for the prevention and treatment of gastrointestinal diseases. Salix's strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the Company's gastroenterology specialty sales and marketing team.
Salix also markets Xifaxan® (rifaximin tablets 200mg and 550mg ), MOVIPREP® (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), OSMOPREP® (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets,), VISICOL® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO(TM) (mesalamine) extended-release capsules 0.375 g., METOZOLV® ODT (metoclopramide HCl), PEPCID® (famotidine) for Oral Suspension, Oral Suspension DIURIL® (Chlorothiazide), AZASAN® Azathioprine Tablets, USP, 75/100 mg, ANUSOL-HC® 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT® Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. Budesonide foam, crofelemer and rifaximin for additional indications are under development.
For full prescribing information, including BOXED WARNINGS for VISICOL, OSMOPREP and METOZOLV, on Salix products, please visit www.salix.com or contact the Company at 919 862-1000.
Salix trades on the NASDAQ Global Select Market under the ticker symbol "SLXP."
For more information please visit the web site www.salix.com . Information on the web site is not incorporated in Salix' SEC filings.
Please Note: The materials provided herein contain forward-looking statements regarding future events. Such statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: reliance on collaborators; the unpredictable nature of the duration and results of regulatory review of new drug applications; market acceptance for approved product; generic and other competition; the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties. The reader is referred to the documents that Photocure files with the Norwegian Securities Authority and Salix files with the U.S. Securities and Exchange Commission.
This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)