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Feedback2014 BUSINESS PERFORMANCE GOALS UPDATE
Oslo, Norway, 22th December 2014: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, provides an update on business performance for 2014. The company is on track to deliver on its objectives of successfully increasing sales of Hexvix/Cysview and improving financial performance of the commercial franchise. This, together with the payment from Salix, is expected to result in cash reserves at the end of the year that are higher than previous guidance of NOK 145-155 million. For the pipeline progress has been made with the FDA designated end of phase 2 meeting for Cevira. However, a strategic partnership for Visonac is no longer expected to occur by the end of 2014
Hexvix®/Cysview®
In line with the company’s guidance for 2014, Photocure expects global Hexvix/Cysview in-market unit sales for 2014 to grow at or above 10 per cent as compared to the previous year (based on end user sales November 2014). The solid performance is driven by continued growth in the Nordic region, strong results from the strategic partnership with Ipsen, as well as increasing sales for Cysview in the US.
Driven by solid customer demand, price increases supported by strong health economic data, favourable currency fluctuations and cost containment; the financial performance of the Hexvix/Cysview franchise has strengthened significantly. The franchise attained profitability for the first-time during Q3 2014 and is expected to remain so through the end of the year.
In order to achieve a long-term sustainable reimbursement solution for Cysview in the US, Photocure has continued to work closely with leading urology associations, patient groups, other key stakeholders and members of Congress in support of the proposed Congressional Bill, introduced in June 2014, which will secure US senior cancer patients access to state of the art treatments, including Cysview. The bill was not acted upon by the Congress before the year-end recess. Photocure will continue its work to obtain reimbursement of Cysview in the US, and expects that support of the bill will continue when Congress reconvenes in 2015.
Visonac®
Visonac has successfully completed a phase 2b clinical trial and is phase 3 ready. Photocure’s strategy is to establish a development and commercialization partnership for Visonac prior to initiation of the phase 3 clinical program.
Photocure has engaged in discussions with potential partners, where the priority is to secure an agreement demonstrating the full value of Visonac. Photocure´s initial expectation was to have a partnership in place before year-end 2014. Obtaining alignment with a strategic partner on the value of the asset will require additional time and therefore the discussions will need to continue into 2015.
Cevira®
A key objective in 2014 was to secure the regulatory pathway on a late stage clinical development plan for Cevira prior to initiation of the phase 3 clinical development.
As communicated earlier this year, discussions with Health Authorities in key European markets have been completed and support has been achieved to continue with the proposed phase 3 program, targeting women with high grade precancerous lesions of the cervix (HSIL (CIN2)) as the first indication.
Additionally, Photocure completed the re-analysis of the clinical data, in accordance with the new diagnostic consensus classification system and guidance provided by US FDA, which demonstrated that Cevira provides improved treatment efficacy compared to placebo among patients with HSIL.
After submission of the new results to FDA, Photocure discussed the results at the FDA designated end of Phase 2 meeting held in early December. Photocure is awaiting final minutes from FDA early 2015.
Photocure is in discussions with companies that are leaders in women’s healthcare to secure a strategic partnership to assist with the late stage development and commercialization of Cevira.
Cash position
Based on the improved financial performance of the Hexvix/Cysview commercial franchise as well as the $ 5 million payment received from Salix, Photocure has increased its guidance on the expected cash reserves at the end of 2014 from in excess of NOK 105 million to a range of NOK 145-155 million. Based on the performance as of November 30, 2014 the company expects to end the year at or above the higher part of this range.
The objectives for 2015 will be announced in the next financial report on 12 February 2015.
Umsatz machen sie unverändert nur mit Hexvix; aber allein damit sind sie nicht mehr weit vom break-even entfernt.
Dazu kommt die Pipeline.
Dazu kommt die Pipeline.
nicht gut:
REGULATORY UPDATE ON CEVIRA
Oslo, Norway, December 27, 2013: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces an update on Cevira, which is in development for the treatment of oncogenic human papilloma virus (HPV) infection and pre-cancerous cervical abnormalities.
Photocure submitted its application for Fast Track Designation for Cevira to the US FDA in October 2013. Fast Track designation allows for improved access to FDA for feedback and alignment as the clinical development program is conducted. Photocure’s application was based on the significant medical benefit demonstrated by Cevira on treatment of patients with CIN2 in the recently completed phase 2b study. It followed positive previous discussions with the FDA’s Office of Oncology and Hematology Products on the need for new treatments for CIN2.
FDA has informed Photocure that the application for Fast Track Designation for Cevira cannot be granted at this time. The FDA’s decision is based on the recently published consensus recommendation for diagnosis of pre-cancerous lesions of the cervix. In this new diagnostic classification system, severity of disease is divided as either low grade or high grade, in place of previous categorization by grade of lesion severity (CIN 1, CIN 2 and CIN 3).
Photocure will evaluate the existing clinical data in accordance with the new consensus classification system for continued discussion and alignment with the FDA. In addition, Photocure will continue the discussion with FDA on classification of severity as recent clinical management guidelines recommend distinct treatment options for women with CIN2 and CIN3, particularly for the large group of women of child bearing potential. This is to avoid overtreatment of women with CIN 2 due to potential morbidities caused by invasive treatments offered to treat higher grade lesions.
Kjetil Hestdal, President and CEO of Photocure, said: “This decision is surprising and disappointing, particularly following the ongoing discussions with the FDA. The recent results for Cevira in the treatment of HPV associated diseases of the cervix showed a statistically significant and sustained lesion response and high HPV clearance in CIN2 patients. This was further supported by high clearance of HPV subtypes 16 and 18, which carry high oncogenic risk in the overall population. We believe that Cevira has great potential in treating these patients and we will continue our discussions with the FDA on the optimum development route for this product.”
- See more at: http://www.photocure.com/Pressmedia/News/Regulatory-Update-o…
REGULATORY UPDATE ON CEVIRA
Oslo, Norway, December 27, 2013: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces an update on Cevira, which is in development for the treatment of oncogenic human papilloma virus (HPV) infection and pre-cancerous cervical abnormalities.
Photocure submitted its application for Fast Track Designation for Cevira to the US FDA in October 2013. Fast Track designation allows for improved access to FDA for feedback and alignment as the clinical development program is conducted. Photocure’s application was based on the significant medical benefit demonstrated by Cevira on treatment of patients with CIN2 in the recently completed phase 2b study. It followed positive previous discussions with the FDA’s Office of Oncology and Hematology Products on the need for new treatments for CIN2.
FDA has informed Photocure that the application for Fast Track Designation for Cevira cannot be granted at this time. The FDA’s decision is based on the recently published consensus recommendation for diagnosis of pre-cancerous lesions of the cervix. In this new diagnostic classification system, severity of disease is divided as either low grade or high grade, in place of previous categorization by grade of lesion severity (CIN 1, CIN 2 and CIN 3).
Photocure will evaluate the existing clinical data in accordance with the new consensus classification system for continued discussion and alignment with the FDA. In addition, Photocure will continue the discussion with FDA on classification of severity as recent clinical management guidelines recommend distinct treatment options for women with CIN2 and CIN3, particularly for the large group of women of child bearing potential. This is to avoid overtreatment of women with CIN 2 due to potential morbidities caused by invasive treatments offered to treat higher grade lesions.
Kjetil Hestdal, President and CEO of Photocure, said: “This decision is surprising and disappointing, particularly following the ongoing discussions with the FDA. The recent results for Cevira in the treatment of HPV associated diseases of the cervix showed a statistically significant and sustained lesion response and high HPV clearance in CIN2 patients. This was further supported by high clearance of HPV subtypes 16 and 18, which carry high oncogenic risk in the overall population. We believe that Cevira has great potential in treating these patients and we will continue our discussions with the FDA on the optimum development route for this product.”
- See more at: http://www.photocure.com/Pressmedia/News/Regulatory-Update-o…
PHOTOCURE ANNOUNCES PAYMENT RECEIVED FOR LUMACAN® DEVELOPMENT
Oslo, Norway, January 2, 2012: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces today that it has received a payment of US$4.5M from Salix Pharmaceuticals, Inc. (NASDAQ:SLXP) regarding development of Lumacan® to date and the commitment to continue the development.
Lumacan is a photodynamic colorectal diagnostic intended to significantly improve the detection of precancerous and cancerous lesions in the colon through fluorescence diagnosis. Photocure signed a strategic global agreement with Salix for the development and commercialization of Lumacan in October 2010. The collaboration with Salix is progressing well.
Salix is currently developing an optimal oral formulation of Lumacan to be used in clinical studies. During the third quarter of 2012 Salix initiated an exploratory study designed to evaluate fluorescence kinetics of Lumacan following enema administration. The oral prototypes are planned to be introduced into clinical trial in 2013.
Kjetil Hestdal, President and CEO of Photocure, said: “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 look forward to continuing the collaboration with Salix on the future development of Lumacan.”
Oslo, Norway, January 2, 2012: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces today that it has received a payment of US$4.5M from Salix Pharmaceuticals, Inc. (NASDAQ:SLXP) regarding development of Lumacan® to date and the commitment to continue the development.
Lumacan is a photodynamic colorectal diagnostic intended to significantly improve the detection of precancerous and cancerous lesions in the colon through fluorescence diagnosis. Photocure signed a strategic global agreement with Salix for the development and commercialization of Lumacan in October 2010. The collaboration with Salix is progressing well.
Salix is currently developing an optimal oral formulation of Lumacan to be used in clinical studies. During the third quarter of 2012 Salix initiated an exploratory study designed to evaluate fluorescence kinetics of Lumacan following enema administration. The oral prototypes are planned to be introduced into clinical trial in 2013.
Kjetil Hestdal, President and CEO of Photocure, said: “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 look forward to continuing the collaboration with Salix on the future development of Lumacan.”
PHOTOCURE ANNOUNCES POSITIVE RESULTS OF CEVIRA® STUDY
RESULTS DEMONSTRATE SIGNIFICANT EFFICACY IN TREATMENT OF LESIONS AND ONCOGENIC HUMAN PAPILLOMA VIRUS IN PATIENTS WITH PRECANCEROUS LESIONS OF THE CERVIX
Oslo, Norway, December 5, 2012: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces the initial three month results of the phase 2b study of Cevira in patients with human papilloma virus (HPV) related disease of the cervix. Cevira, a novel and easy to use integrated drug-delivery device, demonstrated statistically significant efficacy in eradication of oncogenic HPV infections and precancerous lesions in CIN2 patients.
The phase 2b trial is a multicenter, randomized, double-blind placebo controlled trial in patients with histologically confirmed low to moderate grade cervical intraepithelial neoplasia (CIN1/2). The study enrolled 262 patients at 23 office or hospital based gynecology practices in the US and Europe. Patients were randomized to three different doses of hexylaminolevulinate to evaluate the optimal dose as compared to placebo. The treatment regimen consisted of up to two treatments, each three months apart. Efficacy, measured by histology, cytology and HPV DNA as well as safety, was assessed three months after the last treatment. Results after the six-nine month assessment will be presented in the first half 2013.
The optimal dose of Cevira, 5%, demonstrated a statistically significant lesion response compared to placebo in patients with precancerous CIN2 lesions, 95% vs 57% respectively, (p<0.01). This was further supported by significant clearance of HPV types 16 and 18, which carry high oncogenic risk, in the CIN2 cohort of 83% vs 0%,(p<0.02). In the overall CIN1 and CIN2 study population, Cevira, at the optimal dose, showed a higher response (73% vs 60%, p=0.2) and clearance of high oncogenic risk in HPV types 16 and 18 (54% vs 11%, p=0.07) as compared to placebo.
Cevira was well tolerated and easy to use by both the gynecologists and patients. No treatment related serious adverse events were reported in the study. No patients withdrew from the study due to treatment related events. In addition, patients experienced only expected benign and self-limiting events.
Principal investigator, Professor Peter Hillemans, Head of Department of Gynecology and Obstetric at Medical Institute of University of Hannover, Germany: “These data are encouraging as they demonstrate that Cevira is a novel, easy to use and safe tissue preserving treatment that has the potential to be the first non surgical alternative for the treatment of patients with precancerous lesions of the cervix. There is a high medical need for non-invasive treatments in patients with high risk oncogenic HPV infections and precancerous lesions of the cervix in whom the current treatment options are limited to tedious watchful waiting and surgical procedures with a high degree of associated morbidity.”
Kjetil Hestdal, President and CEO of Photocure, said: “These positive results with our new integrated drug-device represent a significant milestone as the results confirm our previous positive clinical experience with Cevira. These initial results support the ongoing partnership discussions for the further development and commercialization of Cevira as a promising new treatment option for the large number of women globally who suffer from HPV infections and related precancerous lesions of the cervix. We are looking forward to having the final results including long term follow up in the first half next year.”
RESULTS DEMONSTRATE SIGNIFICANT EFFICACY IN TREATMENT OF LESIONS AND ONCOGENIC HUMAN PAPILLOMA VIRUS IN PATIENTS WITH PRECANCEROUS LESIONS OF THE CERVIX
Oslo, Norway, December 5, 2012: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces the initial three month results of the phase 2b study of Cevira in patients with human papilloma virus (HPV) related disease of the cervix. Cevira, a novel and easy to use integrated drug-delivery device, demonstrated statistically significant efficacy in eradication of oncogenic HPV infections and precancerous lesions in CIN2 patients.
The phase 2b trial is a multicenter, randomized, double-blind placebo controlled trial in patients with histologically confirmed low to moderate grade cervical intraepithelial neoplasia (CIN1/2). The study enrolled 262 patients at 23 office or hospital based gynecology practices in the US and Europe. Patients were randomized to three different doses of hexylaminolevulinate to evaluate the optimal dose as compared to placebo. The treatment regimen consisted of up to two treatments, each three months apart. Efficacy, measured by histology, cytology and HPV DNA as well as safety, was assessed three months after the last treatment. Results after the six-nine month assessment will be presented in the first half 2013.
The optimal dose of Cevira, 5%, demonstrated a statistically significant lesion response compared to placebo in patients with precancerous CIN2 lesions, 95% vs 57% respectively, (p<0.01). This was further supported by significant clearance of HPV types 16 and 18, which carry high oncogenic risk, in the CIN2 cohort of 83% vs 0%,(p<0.02). In the overall CIN1 and CIN2 study population, Cevira, at the optimal dose, showed a higher response (73% vs 60%, p=0.2) and clearance of high oncogenic risk in HPV types 16 and 18 (54% vs 11%, p=0.07) as compared to placebo.
Cevira was well tolerated and easy to use by both the gynecologists and patients. No treatment related serious adverse events were reported in the study. No patients withdrew from the study due to treatment related events. In addition, patients experienced only expected benign and self-limiting events.
Principal investigator, Professor Peter Hillemans, Head of Department of Gynecology and Obstetric at Medical Institute of University of Hannover, Germany: “These data are encouraging as they demonstrate that Cevira is a novel, easy to use and safe tissue preserving treatment that has the potential to be the first non surgical alternative for the treatment of patients with precancerous lesions of the cervix. There is a high medical need for non-invasive treatments in patients with high risk oncogenic HPV infections and precancerous lesions of the cervix in whom the current treatment options are limited to tedious watchful waiting and surgical procedures with a high degree of associated morbidity.”
Kjetil Hestdal, President and CEO of Photocure, said: “These positive results with our new integrated drug-device represent a significant milestone as the results confirm our previous positive clinical experience with Cevira. These initial results support the ongoing partnership discussions for the further development and commercialization of Cevira as a promising new treatment option for the large number of women globally who suffer from HPV infections and related precancerous lesions of the cervix. We are looking forward to having the final results including long term follow up in the first half next year.”
Trading Spotlight
Oslo, Norway, 5 March 2012: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces today the achievement of the second manufacturing transition milestone from Ipsen, its new strategic partner for commercializing Hexvix worldwide, excluding the US and Nordic region. This triggers a payment of EUR 1.5 million. Hexvix is Photocure's flagship product to aid in diagnosing bladder cancer.
On 27 September 2011 Photocure and Ipsen announced a new strategic collaboration for the commercialization of Hexvix. In accordance with the agreement with Ipsen, Photocure received EUR 1.5 million upon signing and will receive a total of EUR 5 million in manufacturing transition milestone payments.
Photocure has successfully completed the second manufacturing transition milestone which triggered a EUR 1.5 million payment. This follows the EUR 2.0 million received on completion of the first transition milestone announced on 11 October 2011. The total manufacturing milestones Photocure has achieved to date is EUR 3.5 million.
Photocure will receive the remaining EUR 1.5 million upon achievement of the final manufacturing transition milestone. Additionally, Photocure will receive double digit royalties on all sales, milestones on specific sales achievements and will manufacture the product for Ipsen.
In the new partnership, 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 commercialize Hexvix through its dedicated urology salesforce.
Kjetil Hestdal, President & CEO of Photocure, said: "We are happy to report that the Hexvix transition is progressing according to plan. Ipsen is a strong strategic partner for Photocure and we remain committed to delivering on our obligations to Ipsen to secure an optimal growth trajectory for Hexvix."
On 27 September 2011 Photocure and Ipsen announced a new strategic collaboration for the commercialization of Hexvix. In accordance with the agreement with Ipsen, Photocure received EUR 1.5 million upon signing and will receive a total of EUR 5 million in manufacturing transition milestone payments.
Photocure has successfully completed the second manufacturing transition milestone which triggered a EUR 1.5 million payment. This follows the EUR 2.0 million received on completion of the first transition milestone announced on 11 October 2011. The total manufacturing milestones Photocure has achieved to date is EUR 3.5 million.
Photocure will receive the remaining EUR 1.5 million upon achievement of the final manufacturing transition milestone. Additionally, Photocure will receive double digit royalties on all sales, milestones on specific sales achievements and will manufacture the product for Ipsen.
In the new partnership, 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 commercialize Hexvix through its dedicated urology salesforce.
Kjetil Hestdal, President & CEO of Photocure, said: "We are happy to report that the Hexvix transition is progressing according to plan. Ipsen is a strong strategic partner for Photocure and we remain committed to delivering on our obligations to Ipsen to secure an optimal growth trajectory for Hexvix."
Oslo, Norway, October 11, 2011: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces today the achievement of the first transition milestone from Ipsen, its new strategic partner for commercialising Hexvix worldwide, excluding the US and Nordic region.
On September 27, Photocure and Ipsen announced a new strategic collaboration for the commercialization of Hexvix. In accordance with the agreement with Ipsen, Photocure will receive a total of EUR 5 million in transition payments. Photocure has successfully completed the first transition milestone which triggered a EUR 2.0 million payment. This milestone is in addition to the EUR 1.5 million that was received upon signing of the l agreement.
Photocure will receive an additional EUR 3 million upon achievements of remaining transition milestones, estimated to be completed by first quarter 2012. Additionally Photocure will receive double digit royalties on all sales, milestones on specific sales achievements and will manufacture the product for Ipsen.
In the new partnership, 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 commercialize Hexvix through its dedicated urology salesforce.
On September 27, Photocure and Ipsen announced a new strategic collaboration for the commercialization of Hexvix. In accordance with the agreement with Ipsen, Photocure will receive a total of EUR 5 million in transition payments. Photocure has successfully completed the first transition milestone which triggered a EUR 2.0 million payment. This milestone is in addition to the EUR 1.5 million that was received upon signing of the l agreement.
Photocure will receive an additional EUR 3 million upon achievements of remaining transition milestones, estimated to be completed by first quarter 2012. Additionally Photocure will receive double digit royalties on all sales, milestones on specific sales achievements and will manufacture the product for Ipsen.
In the new partnership, 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 commercialize Hexvix through its dedicated urology salesforce.
PHOTOCURE ANNOUNCES NEW COMMERCIAL STRATEGY FOR HEXVIX®, THE INNOVATIVE PRODUCT FOR IMPROVED DETECTION OF BLADDER CANCER
• Strategic collaboration with Ipsen for marketing rights in Europe and the rest of the world except Nordics and the US
• Photocure to commercialise the product directly in the US market
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.
• Strategic collaboration with Ipsen for marketing rights in Europe and the rest of the world except Nordics and the US
• Photocure to commercialise the product directly in the US market
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.
Antwort auf Beitrag Nr.: 41.576.255 von R-BgO am 30.05.11 15:14:38Wo ist denn das Teil in Deutschland handelbar?
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Allumera is First Photodynamic Cosmetic
Oslo, Norway, 27 May – Photocure ASA (OSE:PHO), a Norwegian specialty pharmaceutical company specializing in dermatology and cancer, is pleased to announce the first commercial sale of Allumera® by its US specialty dermatology organization.
Allumera is a topical cream representing the first in a new class of photodynamic cosmetics which has been clinically proven to improve the overall appearance of skin, visibly reduce the outward signs of aging and reduce the appearance of pores. Treatment with Allumera is non invasive and has minimal down time as compared to more aggressive cosmetic procedures.
In the US, Allumera will compete in the growing market of cosmetic dermatology procedures, currently valued at an estimated $4B. Allumera will be sold to aesthetic dermatology practices across the US at a price per unit of $120, which establishes it as an attractive addition to the cosmetic armamentarium available to dermatologists today.
“Today marks a significant milestone for Photocure on its journey to establish our US dermatology footprint,” said Kjetil Hestdal, President and CEO of Photocure.
Plans are on track for the full commercial launch in June. The US management team is in place, led by Terry Conrad, and the hiring and training of ten sales representatives is underway. Photocure will focus its initial efforts to approximately 1,500 dermatologists who perform the highest volumes of cosmetic procedures. More than fifteen studies are in various stages and already generating scientific data that will drive the adoption of Allumera.
Hestdal adds “By launching Allumera in the US, Photocure has completed a key step in its strategic plan to transform the company from an R&D organization into a specialty pharmaceutical company.”
Oslo, Norway, 27 May – Photocure ASA (OSE:PHO), a Norwegian specialty pharmaceutical company specializing in dermatology and cancer, is pleased to announce the first commercial sale of Allumera® by its US specialty dermatology organization.
Allumera is a topical cream representing the first in a new class of photodynamic cosmetics which has been clinically proven to improve the overall appearance of skin, visibly reduce the outward signs of aging and reduce the appearance of pores. Treatment with Allumera is non invasive and has minimal down time as compared to more aggressive cosmetic procedures.
In the US, Allumera will compete in the growing market of cosmetic dermatology procedures, currently valued at an estimated $4B. Allumera will be sold to aesthetic dermatology practices across the US at a price per unit of $120, which establishes it as an attractive addition to the cosmetic armamentarium available to dermatologists today.
“Today marks a significant milestone for Photocure on its journey to establish our US dermatology footprint,” said Kjetil Hestdal, President and CEO of Photocure.
Plans are on track for the full commercial launch in June. The US management team is in place, led by Terry Conrad, and the hiring and training of ten sales representatives is underway. Photocure will focus its initial efforts to approximately 1,500 dermatologists who perform the highest volumes of cosmetic procedures. More than fifteen studies are in various stages and already generating scientific data that will drive the adoption of Allumera.
Hestdal adds “By launching Allumera in the US, Photocure has completed a key step in its strategic plan to transform the company from an R&D organization into a specialty pharmaceutical company.”
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