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    Ähnlich Biolitec - Photodynamische Therapie -Vertrieb durch GE (Seite 7)

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    ISIN: NO0010000045 · WKN: 931150 · Symbol: PHS
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      schrieb am 24.05.17 11:10:11
      Beitrag Nr. 73 ()
      Antwort auf Beitrag Nr.: 54.693.485 von R-BgO am 06.04.17 23:33:45RESULTS FOR THE FIRST QUARTER OF 2017

      Oslo, Norway, 23 May 2017:

      Photocure ASA (OSE: PHO) today reported a Hexvix/Cysview revenue growth of 9% to NOK 36.5 million in the first quarter of 2017 (Q1 2016: NOK 33.5), with an EBITDA of NOK 4.9 million for the Hexvix/Cysview commercial franchise.

      The company reported a growth of 32% for the important US market, were the company recently unveiled the new growth strategy towards 2020.

      “Hexvix/Cysview delivered strong growth in major markets, outside the Nordic regions, during the first quarter. In particular, we saw good momentum in the US, driven by strong demand for Cysview. As planned, we are increasing our investments in sales and marketing in the US in order to drive further awareness for Cysview and growth in the region,” says Kjetil Hestdal, president and CEO.

      Photocure reported total group revenues of NOK 36.5 million in the first quarter of 2017 (34.9), with a recurring EBITDA of NOK -4.2 million (-3.7). Net profit was NOK -6.9 million (-0.7), while the cash position ended at NOK 155.5 million. The in-market unit sales increased 10%, driven by a volume growth of 28% in the US, representing a US revenue growth of 32%. The EBITDA for the Hexvix/Cysview commercial franchise ended at NOK 4.9 million in the first quarter of 2017.

      Photocure has built considerable experience in the urology sector through its Hexvix/Cysview franchise and sees significant long-term value creation potential in this market segment. The company has over the last years experienced a strong and growing penetration of Hexvix in key European markets and aims to capitalize on the inclusion in the AUA guidelines, as well as the increased patient awareness, to significantly increase penetration in the US market.

      Photocure plans to double its salesforce and increase sales and marketing expenses towards the end of 2017. The goal of these efforts is to quadruple the revenues from the US operations by 2020. The company is fully funded for this market strategy.

      “We believe strongly in the US market and are ramping up as planned throughout 2017 and 2018. After the end of the quarter, we were very pleased to report positive data from our Phase 3 study in the surveillance setting. This is an attractive market for Photocure and is an important component of our long term growth plans in the US. We are preparing to file the data from the Phase 3 study with the FDA later this year to support a potential expansion in this setting,” says Hestdal.

      The results from the Phase 3 study with Blue Light Flexible Cystoscopy (BLFC™) with Hexvix®/Cysview® were presented at the AUA annual meeting in May and showed that Cysview provided a highly significant (p<0.0001) improvement in detecting additional patients (21.5%) with bladder cancer in the surveillance setting.

      “In addition, Photocure will continue to work on reimbursement in the US and will utilize an ongoing stream of publications documenting the medical benefits of Blue Light Cystoscopy with Hexvix/Cysview to demonstrate its clinical benefits,” Hestdal concludes.
      Avatar
      schrieb am 06.04.17 23:33:45
      Beitrag Nr. 72 ()
      PHOTOCURE PROVIDES STRATEGIC UPDATE

      • Following non-conclusive partnering discussions, the company will assess further strategic alternatives for Cevira and Visonac
      • Company still to focus on urology franchise, with continued commitment to driving growth in United States


      Oslo, Norway, 5 April 2017:

      Photocure ASA (Photocure, OSE: PHO), today announces that the company will assess further strategic alternatives for its non-urology assets, Cevira and Visonac, in parallel with ongoing partner search. The company will focus on its urology franchise and its continued commitment to driving growth, particularly in the United States (U.S.).

      The decision to initiate a broad review of possible strategic alternatives for Cevira and Visonac follows a non-conclusive comprehensive partnering process. Photocure has experienced substantial interest, with several possible partners having recognised the unmet medical need in the target therapeutic areas and engaged in thorough discussions and due diligence for both Cevira and Visonac. However, at this stage remaining development risk is expressed as a concern for establishing an optimal partnership for Cevira, while the current combination of drug and device is an expressed commercial concern for Visonac. Based on the input received in the partnering process, Photocure has decided to broaden its review of strategic alternatives for Cevira and Visonac.

      Kjetil Hestdal, President & CEO, Photocure ASA, said, ”With the increasing focus on our urology franchise, we believe now is the time to re-assess our pipeline. While we have engaged in a comprehensive process of partnering for Visonac and Cevira, we have been disappointed with the progress and recent feedback. That said, while we are continuing with some discussions, we will now also assess strategic alternatives, including a sale, spin-outs or other strategic opportunities for these non-urology assets in the future“.

      Photocure announced 15 February 2017, that the company sees a significant long-term value creation potential for its Hexvix/Cysview urology franchise. The company aims to capitalize on the inclusion in the AUA guidelines as well as the increased patient awareness to significantly increase penetration in the U.S. market. The company has an ambition to quadruple the U.S. revenues to USD 15 million by 2020.

      Kjetil Hestdal, continued, “We see real opportunity in our urology franchise and we are committed to make further investments in our U.S. sales and marketing infrastructure in the coming years to drive growth. We have built considerable expertise in this specialist field, and believe this as an area where we have a potential to generate significant value, for all our stakeholders”.
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      schrieb am 15.02.17 11:03:16
      Beitrag Nr. 71 ()
      RESULTS FOR FOURTH QUARTER AND FULL YEAR 2016

      Oslo, Norway, 15 February 2017:

      Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in cancer and dermatology, reported a revenue growth of 10 % to NOK 38.1 million in the fourth quarter of 2016 (Q4 2015: NOK 34.5), with an EBITDA of NOK 10.7 million for the Hexvix/Cysview commercial franchise. Full year 2016 revenues ended at NOK 143.6 million (134.7). Photocure targets revenues from the US operations to quadruple to a range of USD 15 million by 2020.

      “2016 was a positive year for Photocure as we continued to build momentum in the US with Cysview. A significant milestone was reached by the inclusion and recommendations of Cysview in National treatment guidelines in the US. In addition, several papers including strong new clinical evidence supporting the use of Hexvix/Cysview were published during 2016.

      These events, together with the increase in installed base of Blue Light enabled Cystoscopes in the US and a higher level of patient awareness, provide us with confidence that our planned increase in investment in the US commercial urology franchise will create value for our shareholders in the future. Lastly, we are also looking forward to receiving results from our expanded use Phase 3 study in the US with the Karl Storz flexible scope in the surveillance setting in the middle of the year.” said Kjetil Hestdal, President and CEO.

      Photocure reported total revenues of NOK 38.1 million in the fourth quarter of 2016 (34.5), with an EBITDA of NOK -0.3 million (-8.7). Net profit was NOK 17.9 million (-9.4), while the cash position ended at NOK 169.2 million. Hexvix/Cysview revenues grew 13% for the full year but declined 5% in the fourth quarter mainly due to inventory reductions at distributors, as well as a negative impact from foreign exchange rates. In-market unit sales increased with 3% in the quarter.

      “Photocure has built considerable experience in the urology sector through its Hexvix/Cysview franchise and sees significant long-term value creation potential in this market segment. The company has over the last years experienced a strong and growing penetration of Hexvix in key European markets and aims to capitalize on the inclusion in the AUA guidelines as well as the increased patient awareness to significantly increase penetration in the US market. Photocure does however believe that in order to increase market shares in the US to European levels, an investment in the US salesforce is required,” said Hestdal.

      The company will therefore double its salesforce and increase sales and marketing expenses accordingly towards the end of 2017. The company believes these efforts will result in revenues from the US operations to quadruple to a range of USD 15 million by 2020.

      “As a result of the increased activity level, the added operating expenses will contribute to an EBITDA decline for the group in 2017 and 2018. Photocure is fully funded for this market strategy. Photocure has also completed enrollment in its Phase 3 study of Hexvix/Cysview in the surveillance patient segment and expect to report clinical results in mid-2017. The company will then submit an sNDA to the US FDA, with a possible approval in 2018 for use of Blue Light Flexible Cystoscopy with Cysview in this setting,“ Hestdal concludes.

      Photocure is continuing its discussions and due diligence processes with potential partners to establish strategic partnerships for its non-urology products, Visonac and Cevira.
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      schrieb am 24.08.16 12:23:07
      Beitrag Nr. 70 ()
      HEXVIX® MARKETING AUTHORIZATION APPROVAL IN AUSTRALIA

      Oslo, Norway, August 24, 2016:

      Photocure ASA (OSE: PHO), announces that its partner and exclusive distributor, Juno Pharmaceuticals Pty Ltd, have received marketing authorization approval (MAA) for Hexvix in Australia. The market potential in the territory is estimated to be similar to the potential in the Nordics, where Photocure commercializes Hexvix with its own sales team. Hexvix is Photocure's flagship product used to aid in the diagnosis and management of bladder cancer. Under the terms of the agreement, with the MAA approval in Australia, Photocure will receive EUR 250,000 in milestone payments.
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      schrieb am 17.05.16 13:35:46
      Beitrag Nr. 69 ()
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      schrieb am 20.11.15 10:06:32
      Beitrag Nr. 68 ()
      BIOSYENT PHARMA ANNOUNCES THE CANADIAN LAUNCH OF CYSVIEW® (HEXAMINOLEVULINATE HYDROCHLORIDE)
      FOR IMMEDIATE RELEASE NOVEMBER 17, 2015


      TORONTO, ONTARIO (November 17, 2015) BioSyent Inc. (“BioSyent”, TSX Venture: RX) today announced that its subsidiary BioSyent Pharma Inc. has commenced the Canadian launch of CYSVIEW®, a new photosensitizer for the detection and management of papillary Non-Muscle Invasive Bladder Cancer (NMIBC).

      Bladder cancer like many cancers is a life threatening disease. In Canada, it is the 4th most common cancer in men and the 12th most common cancer in women. Each year over 8,000 patients are diagnosed with bladder cancer and over 70% of these patients have Non-Muscle Invasive Bladder Cancer.

      CYSVIEW® is used with blue light cystoscopy to detect papillary Non-Muscle Invasive Bladder Cancer in patients with known or suspected bladder cancer. It selectively targets tumour cells in the bladder and causes them to emit a red fluorescence against a dark blue background of healthy tissue under blue light cystoscopy. This makes the tumours easier to see and remove. Studies show that 24.9% of patients had tumours that were detected by CYSVIEW® with blue light cystoscopy which were not detected by the current standard of care.

      This improved detection of bladder cancer tumours gives doctors a better ability to remove the tumour. This results in lower rates of cancer recurrence and increased time to the next recurrence.
      CYSVIEW® has been approved by Health Canada and is also approved across Europe (branded as Hexvix®) and the U.S. (branded as CYSVIEW®). It is recommended by the European Association of Urology (EAU), the U.S. treatment guidelines on NMIBC, and a number of expert panels because of the benefit it brings to treating cancer. “BioSyent is proud to bring this innovative technology to Canada to help doctors better detect and manage bladder cancer” said René Goehrum, President and CEO of BioSyent. “This marks a further step in executing against our mission to source and market innovative pharmaceutical products that improve the lives of Canadian patients and support the healthcare providers that treat them.”

      CYSVIEW® has been studied extensively with 5 multi-centre Phase III studies in the U.S., Europe and Canada and has over 100 additional studies published in peer reviewed journals globally.
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      schrieb am 05.09.15 08:00:29
      Beitrag Nr. 67 ()
      PHOTOCURE ANNOUNCES SUBMISSION OF APPLICATION FOR HEXVIX® MARKETING AUTHORIZATION IN AUSTRALIA
      Oslo, Norway, 4 September, 2015: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces that its partner and exclusive distributor, Juno Pharmaceuticals, has filed a marketing authorization application (MAA) for the registration of Hexvix in Australia. Hexvix is Photocure's flagship product used to aid in the diagnosis and management of bladder cancer.
      Under the guidance provided by the Therapeutics Goods Agency in Australia, the average review time for applications is twelve months from the date of submission. Photocure will receive a milestone payment of €250,000 upon approval of Hexvix in Australia, estimated to occur in the second half of 2016.

      Kjetil Hestdal, President & CEO of Photocure, said: "The partnership with Juno Pharmaceuticals is progressing well and we are pleased that they have reached this significant milestone with the filing of the MAA. We continue to expand Hexvix into new territories to ensure patients and urologists have access to the most optimal treatment for the diagnosis and management of bladder cancer.”

      During the review process, Juno Pharmaceuticals will begin to prepare for the commercial launch of Hexvix in Australia. The market potential in the territory is estimated to be similar to the potential in the Nordics, where Photocure commercializes Hexvix with its own sales team.
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      schrieb am 19.08.15 17:33:30
      Beitrag Nr. 66 ()
      PHOTOCURE ANNOUNCES BIOSYENT AS EXCLUSIVE PARTNER FOR CYSVIEW® IN CANADA
      Oslo, Norway, 19 August, 2015:

      Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies, announces today the appointment of BioSyent Pharma Inc. as their exclusive distributor for the commercialization of Cysview in Canada. Cysview®/Hexvix® is Photocure’s flagship product to aid in the diagnosis and management of bladder cancer.
      Under the terms of the agreement, Photocure will receive up to USD 1,000,000 in milestone payments for the rights to Cysview in the territory, which includes USD 650,000 upon signing of the agreement.

      BioSyent Pharma will fund all costs related to the launch and commercialization of Cysview, which was approved by Health Canada in January 2015. The market potential in the territory is estimated to be similar to the potential in the Nordics, where Photocure commercializes Hexvix with its own sales team.
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      schrieb am 10.08.15 11:26:54
      Beitrag Nr. 65 ()
      PHOTOCURE ANNOUNCES AGREEMENT WITH US FDA FOR CEVIRA PHASE 3 REGISTRATION PROGRAM

      Oslo, Norway, 10 August, 2015:

      Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces today the approval of the Special Protocol Agreement (SPA) from the US FDA on the design of the Phase 3 clinical registration program for Cevira, which is in development for the treatment of high grade pre-cancerous lesions of the cervix. The SPA defines the size, design and analysis of clinical trials that will form the primary basis of approval.

      In response to Photocure’s request for a special protocol assessment (SPA), the US FDA has agreed that the design and planned analysis of the pivotal Phase 3 protocols address the objectives in support of a regulatory submission. Ensuring regulatory alignment before initiating the Phase 3 registration trials reduces the risk of the development program and is an important milestone in the continued development of Cevira.

      Kjetil Hestdal, President & CEO of Photocure, said: “Gaining alignment with the FDA on the Cevira registration program through the SPA process is a significant milestone in the continued development of this breakthrough technology. Cevira will offer a convenient and effective alternative to surgery in the large number of affected women globally, while preserving fertility and avoiding the potential for future neonatal morbidity and mortality which results from surgery.”

      With alignment with FDA on Phase 3 clinical studies now obtained, Photocure plans to finalize necessary documentation for the Cevira device to ensure readiness for the Phase 3 trial. The Phase 3 registration program will consist of two identical double blind, randomized trials, each with approximately 200 patients, comparing Cevira to placebo in women with biopsy proven high-grade cervical lesions. The primary endpoint will be clearance of the high-grade lesion, as determined by an independent panel of pathologists, at six months.
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      schrieb am 22.05.15 11:05:35
      Beitrag Nr. 64 ()
      PHOTOCURE ANNOUNCES EXCLUSIVE PARTNER FOR HEXVIX® IN AUSTRALIA AND NEW ZEALAND
      Oslo, Norway, 22 May, 2015

      Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces today the appointment of Juno Pharmaceuticals as their exclusive distributor for the registration and commercialization of Hexvix in Australia and New Zealand. Hexvix is Photocure's flagship product to aid in the diagnosis and management of bladder cancer.

      Under the terms of the agreement, Photocure will receive €500,000 in milestone payments for the rights to Hexvix in the territory, of which Photocure has received €250,000.

      Juno, who will fund all costs to secure regulatory approval, will begin the filing process immediately. During the review process, Juno Pharmaceuticals will initiate the preparations for the launch of Hexvix in Australia and New Zealand. The market potential in the territory is estimated to be similar to the potential in the Nordics, where Photocure commercializes Hexvix with its own sales team.

      Kjetil Hestdal, President & CEO of Photocure, said: "We are happy to report that Hexvix commercialization is progressing well and we continue to expand into new territories to ensure patients and Urologists have access to the most optimal treatment for the diagnosis and management of bladder cancer. We are pleased to have secured Juno Pharmaceuticals as our new distribution partner in Australia and New Zealand with their strong and experienced team”.
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