Thema: Presse: Licenses TransMID Brain Cancer Product
Presse: Licenses TransMID Brain Cancer Product
Katja[a]
18.09.2002 13:31:50
K S Biomedix Holdings PLC (LS:KSB)
GUILDFORD, England, Sept. 17, 2002
Licenses TransMID Brain Cancer Product To Nycomed In European Collaboration
KS Biomedix Holdings announces that it has appointed Nycomed as the European Licensee for its TransMID(TM) product in a licensing agreement worth up to $60 million. TransMID(TM) is a novel biopharmaceutical product in development for the treatment of high grade glioma, a terminal brain cancer for which there is no known cure.
TransMID(TM) is based on the transferrin-mediated delivery of a modified diphtheria toxin, which is capable of selectively killing cancer cells. A completed Phase II study conducted in leading neuro-oncology centres in the USA showed highly promising clinical response rates and an improvement in survival times in patients with recurrent brain cancer. The FDA has granted TransMID(TM) Fast Track status and Orphan Drug Status for the treatment of malignant tumours of the central nervous system and the European Medicines Evaluation Agency´s Committee for Orphan Medicinal Products granted Orphan designation for the treatment of glioma in March 2002.
The Nycomed license covers TransMID(TM) in all its potential brain cancer indications and extends to the fifteen European Union countries, Switzerland, Norway, the CIS and a number of East European countries. The European market for brain cancer treatment is the second largest in the world after the USA. KSB estimates that there are around 20,000 new cases of primary brain cancer diagnosed in Europe every year. Of these patients, over 50% will have high-grade gliomas and a life expectancy of around six months. An additional 25,000 patients with brain cancers arising from tumours elsewhere in the body ("metastatic brain tumours") may also potentially benefit from TransMID(TM) therapy.
Under the terms of the agreement, KSB has licensed the rights to the initial indication in patients with recurrent glioma, together with the rights for additional brain cancer indications including those relating to newly diagnosed and metastatic brain cancer patients. If development of all indications succeed, KSB will receive an upfront payment together with staged development milestone payments, development funding and sales-related milestones, which could amount to up to $60 million, based on independent estimates of the market potential of all indications. KSB will also receive royalties on product sales and revenue from the sale to Nycomed of TransMID(TM) materials manufactured at KSB´s Edmonton (Alberta, Canada) facility.
Nycomed and KSB will co-fund the development of products for each indication and Nycomed will be responsible for product registration and marketing of TransMID(TM) in the licensed territory. The Nycomed Group has a well developed European sales organisation with particular strength in Germany and the Nordic region. TransMID(TM) is a key part of Nycomed´s strategy of in-licensing proprietary therapeutic products with significant potential value and extending the geographic reach of its sales and marketing operations. A pivotal Phase III trial for the lead indication, recurrent high grade glioma, is due to commence in North America and Europe in the last quarter of 2002.
This latest agreement is the second major territory licensed for TransMID(TM) by KSB since it acquired the technology in July 2001, the Group having agreed a $25 million licensing deal with Sosei for the Japanese market in May 2002.
Steven Powell, KSB Chief Executive Officer, commented: "Conclusion of this latest licensing agreement is a major milestone in the TransMID(TM) development programme. In appointing Nycomed we are working with a partner that has a large and experienced hospital sales force capable of ensuring the product achieves wide market reach across the European territory. Nycomed will also contribute significant regulatory and clinical expertise, which should drive patient recruitment into the European arm of the pivotal trial and secure quality and efficiency in the submission of registration documents in Europe.
"This latest agreement brings the total potential value of license deals now secured for TransMID(TM) to $85 million plus manufacturing and royalty returns. While we intend to retain the valuable North American rights to the TransMID(TM) product, negotiations for a number of smaller territories are ongoing and we hope to conclude further agreements in the near future."
Hakan Bjorklund, Nycomed Chief Executive Officer, said "Nycomed is pleased to work together with KSB in the further development of TransMID(TM), benefiting from KSB´s expertise in the cancer field. If the Phase III study with TransMID(TM) can confirm the positive Phase II results in recurrent brain cancer, we will be launching the product that represents a breakthrough in cancer therapy addressing a very significant unmet medical need.
The agreement with KSB fits well with Nycomed´s plans to in-license and launch specialised and sophisticated hospital pharmaceuticals across Europe. Earlier this year Nycomed entered a collaboration with The Medicines Company for the marketing of the direct thrombin inhibitor Angiomax(R) in Europe".
Notes
KS Biomedix Holdings Plc (Guildford, UK) is a biopharmaceutical company headquartered in the UK that is developing a broad late-stage pipeline of drugs for a range of cancer indications. In addition, it has a number of technology platforms based on its range of receptor-based targeting technologies one of which is KSB´s super high-affinity monoclonal antibodies (SMAs). The Company has six active clinical programmes, including TransMID-107R(TM) for the treatment of adult, recurrent, inoperable high-grade gliomas (brain tumours) and KSB303, an anti-CEA antibody for the diagnosis and treatment of cancer.
KS Biomedix was founded in 1993 and floated on the Alternative Investment Market of the London Stock Exchange in 1995. The Company joined the Official List of the London Stock Exchange in 1998.
Nycomed is a European healthcare marketing company. Nycomed sources, develops, manufactures and markets pharmaceuticals and consumer health products. Sales teams are specialised on hospital specialists, General Practitioners or pharmacy. Late stage clinical trials, local & European registration, as well as life cycle management and production, are all in-house capabilities. Nycomed has manufacturing facilities in Norway, Denmark, Austria, Belgium and Estonia. Revenue in 2001 amounted to Euro 509.4 million, with EBITDA (Earnings before taxation, depreciation and amortisation) of Euro 106.0 million. The total number of employees amounts to approximately 2,600, of whom more than half are within sales & marketing.
GUILDFORD, England, Sept. 17, 2002
Licenses TransMID Brain Cancer Product To Nycomed In European Collaboration
KS Biomedix Holdings announces that it has appointed Nycomed as the European Licensee for its TransMID(TM) product in a licensing agreement worth up to $60 million. TransMID(TM) is a novel biopharmaceutical product in development for the treatment of high grade glioma, a terminal brain cancer for which there is no known cure.
TransMID(TM) is based on the transferrin-mediated delivery of a modified diphtheria toxin, which is capable of selectively killing cancer cells. A completed Phase II study conducted in leading neuro-oncology centres in the USA showed highly promising clinical response rates and an improvement in survival times in patients with recurrent brain cancer. The FDA has granted TransMID(TM) Fast Track status and Orphan Drug Status for the treatment of malignant tumours of the central nervous system and the European Medicines Evaluation Agency´s Committee for Orphan Medicinal Products granted Orphan designation for the treatment of glioma in March 2002.
The Nycomed license covers TransMID(TM) in all its potential brain cancer indications and extends to the fifteen European Union countries, Switzerland, Norway, the CIS and a number of East European countries. The European market for brain cancer treatment is the second largest in the world after the USA. KSB estimates that there are around 20,000 new cases of primary brain cancer diagnosed in Europe every year. Of these patients, over 50% will have high-grade gliomas and a life expectancy of around six months. An additional 25,000 patients with brain cancers arising from tumours elsewhere in the body ("metastatic brain tumours") may also potentially benefit from TransMID(TM) therapy.
Under the terms of the agreement, KSB has licensed the rights to the initial indication in patients with recurrent glioma, together with the rights for additional brain cancer indications including those relating to newly diagnosed and metastatic brain cancer patients. If development of all indications succeed, KSB will receive an upfront payment together with staged development milestone payments, development funding and sales-related milestones, which could amount to up to $60 million, based on independent estimates of the market potential of all indications. KSB will also receive royalties on product sales and revenue from the sale to Nycomed of TransMID(TM) materials manufactured at KSB´s Edmonton (Alberta, Canada) facility.
Nycomed and KSB will co-fund the development of products for each indication and Nycomed will be responsible for product registration and marketing of TransMID(TM) in the licensed territory. The Nycomed Group has a well developed European sales organisation with particular strength in Germany and the Nordic region. TransMID(TM) is a key part of Nycomed´s strategy of in-licensing proprietary therapeutic products with significant potential value and extending the geographic reach of its sales and marketing operations. A pivotal Phase III trial for the lead indication, recurrent high grade glioma, is due to commence in North America and Europe in the last quarter of 2002.
This latest agreement is the second major territory licensed for TransMID(TM) by KSB since it acquired the technology in July 2001, the Group having agreed a $25 million licensing deal with Sosei for the Japanese market in May 2002.
Steven Powell, KSB Chief Executive Officer, commented: "Conclusion of this latest licensing agreement is a major milestone in the TransMID(TM) development programme. In appointing Nycomed we are working with a partner that has a large and experienced hospital sales force capable of ensuring the product achieves wide market reach across the European territory. Nycomed will also contribute significant regulatory and clinical expertise, which should drive patient recruitment into the European arm of the pivotal trial and secure quality and efficiency in the submission of registration documents in Europe.
"This latest agreement brings the total potential value of license deals now secured for TransMID(TM) to $85 million plus manufacturing and royalty returns. While we intend to retain the valuable North American rights to the TransMID(TM) product, negotiations for a number of smaller territories are ongoing and we hope to conclude further agreements in the near future."
Hakan Bjorklund, Nycomed Chief Executive Officer, said "Nycomed is pleased to work together with KSB in the further development of TransMID(TM), benefiting from KSB´s expertise in the cancer field. If the Phase III study with TransMID(TM) can confirm the positive Phase II results in recurrent brain cancer, we will be launching the product that represents a breakthrough in cancer therapy addressing a very significant unmet medical need.
The agreement with KSB fits well with Nycomed´s plans to in-license and launch specialised and sophisticated hospital pharmaceuticals across Europe. Earlier this year Nycomed entered a collaboration with The Medicines Company for the marketing of the direct thrombin inhibitor Angiomax(R) in Europe".
Notes
KS Biomedix Holdings Plc (Guildford, UK) is a biopharmaceutical company headquartered in the UK that is developing a broad late-stage pipeline of drugs for a range of cancer indications. In addition, it has a number of technology platforms based on its range of receptor-based targeting technologies one of which is KSB´s super high-affinity monoclonal antibodies (SMAs). The Company has six active clinical programmes, including TransMID-107R(TM) for the treatment of adult, recurrent, inoperable high-grade gliomas (brain tumours) and KSB303, an anti-CEA antibody for the diagnosis and treatment of cancer.
KS Biomedix was founded in 1993 and floated on the Alternative Investment Market of the London Stock Exchange in 1995. The Company joined the Official List of the London Stock Exchange in 1998.
Nycomed is a European healthcare marketing company. Nycomed sources, develops, manufactures and markets pharmaceuticals and consumer health products. Sales teams are specialised on hospital specialists, General Practitioners or pharmacy. Late stage clinical trials, local & European registration, as well as life cycle management and production, are all in-house capabilities. Nycomed has manufacturing facilities in Norway, Denmark, Austria, Belgium and Estonia. Revenue in 2001 amounted to Euro 509.4 million, with EBITDA (Earnings before taxation, depreciation and amortisation) of Euro 106.0 million. The total number of employees amounts to approximately 2,600, of whom more than half are within sales & marketing.
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