Oslo, Norway October 1, 2009: Photocure ASA has entered into agreements with Galderma S.A., under which Galderma has purchased global rights, assets, and liabilities related to Metvix and Metvixia, as well as the exclusive right to develop new dermatology products based on Photocure's patented substance, MAL. Photocure intends to invest the proceeds from this transaction into the further development and commercialization of its pipeline of products based on the use of photodynamic therapy.
The agreements are amending the current licence agreement and, among other terms, expand the territory to include the Nordic countries, transfer of all assets related to Metvix®/Aktilite® (Asset Purchase Agreement), expand the field to all dermatology uses (Paid-up License Agreement) and includes a licence to produce MAL. The agreements were concluded and the transaction executed effective as of September 30, 2009, as of when Galderma will retain all rights to Metvix®/Aktilite® worldwide. The transfer of rights, assets and liabilities to Galderma includes Photocure's Nordic marketing and sales organisation for Metvix® and Aktilite®.
In consideration, Photocure will receive a purchase price of EUR 44 million and additional future payments of EUR 7 million. The timing of the payment of EUR 7 million for rights related to future MAL-based dermatology products will depend on future regulatory approvals in the EU and the US, although payments are guaranteed for EUR 3 million by December 2012 and for EUR 4 million by December 2016, respectively.
The total compensation to Photocure is approximately NOK 450 million. Photocure had previously received milestone and royalty payments of approximately NOK 200 million and a gross profit from product sales of approximately NOK 50 million related to Metvix®/Aktilite®. In comparison, Photocure has over the years made investments of approximately NOK 325 million relating to Metvix®/Aktilite®. The net book value of the rights, assets and liabilities being transferred was NOK 17 million at June 30, 2009.
Metvix was the first PDT product developed and commercialised by Photocure, and it generated a strong return on the company's investment. Photocure will continue to further develop its Visonac(TM) product for the treatment of acne. Acne is a large and growing disease area with estimated 1.7 billion USD of sales. Combined with other possible product opportunities, Visonac(TM) is expected to provide Photocure with a strong platform in this market. Photocure remains committed to the PDT technology, and will focus on development, in-licensing and commercialisation of other PDT products.
Photocure and Galderma have agreed that in territories where Photocure choose to use a license or distribution partner for Visonac(TM), Galderma has, as part of the agreement, the first right of refusal for Visonac(TM) on certain conditions. The right is valid after Photocure has completed the first phase 3 study.
Photocure also remains committed to the further development of its cancer portfolio, including commercially available Hexvix® for detection of bladder cancer, and the pipeline products CeviraTM for treatment of cervical cancer and LumacanTM for detection of colon cancer. As opposed to the strategy for dermatology products, the company's ambition is to get licensing agreements for the two latter products before proceeding beyond phase 2 studies.
No agreements for the benefit of Photocure's board of directors, executive management or leading employees in the Metvix®/Aktilite® business have been or are planned entered into in connection with the transaction.
The divested products, consisting of the Metvix® cream and the Aktilite® light source, was first approved in EU in 2001 and internationally launched by Galderma in 2003. Metvix® is a topical cream that is applied on the skin for 3 hours. Then the deseased area is exposed to uniform red light of 633 nm wavelength from Aktilite® for approximately 10 minutes which destroys cancerous cells.
Metvix®/Aktilite® is now approved for treatment of BCC (basal cell carcinoma, non-malignant skin cancer) and AK (actinic keratosis, pre-cancerous skin lesions) in over 30 countries, including the EU, Australia, New Zealand and Brazil. Metvix®/Aktilite® were recently also recognized for treatment of Bowen's disease in 22 European countries. In the US, Metvix®/Aktilite® were approved for AK in 2008.
The transfer of rights, assets and liabilities to Galderma includes Photocure's Nordic marketing and sales organisation for Metvix® and Aktilite®, which comprises 10 employees in Norway, Denmark, Sweden and Finland. The employees have been informed that the responsibility for their employment contracts will be transferred to Galderma. Sales outside of the Nordic region were already out-licensed to Galderma.
Following the divestment of Metvix/Aktilite, Photocure will focus its dermatology activities on the development and commercialisation of Visonac(TM) and in-licensing of other products to establish a strong commercial platform with PDT based technology.
As described above, Photocure will deploy the proceeds from the divestment into the development and commercialisation of new products and markets. The company had a net cash position of NOK 151 million at 30 June, 2009, and will after the transaction have funding for both the current development program and to evaluate new opportunities.
Please see the attached appendix for information from Photocure on the financial and strategic implications of the transaction.
For further information, contact:
President and CEO Kjetil Hestdal
Mobile: +47 913 19 535
Office: +47 22 06 22 10
CFO Christian Fekete
Mobile: +47 916 42 938
Office: +47 22 06 22 10
Photocure is a Norwegian 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 EU and under priority review by FDA in the US. In addition, the company has developed a proprietary light source, which is used in combination with the Visonac(TM) 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(TM) platform.
For more information about Photocure, visit our website at www.photocure.com.