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Home  /  Forum  /  Pharming  /  HAEi Global Access Program for RUCONEST® Now Live

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Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

  • 0,900 24 apr 2024 15:40
  • -0,008 (-0,88%) Dagrange 0,899 - 0,917
  • 3.276.309 Gem. (3M) 6,9M

HAEi Global Access Program for RUCONEST® Now Live

16 Posts
| Omlaag ↓
  1. [verwijderd] 21 juli 2015 07:12
    Unique patient organization-driven program is enabling people with HAE who cannot access effective treatments to receive medication for the first time Leiden, Netherlands and Burton-on-Trent, UK – 21 July 2015 – Pharming Group N.V. (“Pharming or the Company”), Euronext: PHARM) and Clinigen Group plc (‘Clinigen’ or the ‘Group’, AIM: CLIN) today announce that their global collaboration to provide access to Pharming’s RUCONEST® (conestat alfa) is now live. The unique access program was initiated by HAEi, the International Patient Organization for C1- Inhibitor Deficiencies. RUCONEST is a recombinant human C1- inhibitor, approved by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for the treatment of acute attacks of hereditary angioedema (HAE). The “HAEi GAP” program enables patients in all countries where RUCONEST is not commercially available to gain access to the drug through an ethical and regulatory compliant “Named Patient Program” mechanism. Physicians wishing to request RUCONEST through the HAEi GAP program should contact the Clinigen customer services team at customer.services@clinigengroup.com / +44 1283 494340. “HAEi is committed to securing access to HAE medications for patients across the globe,” said Anthony J. Castaldo, President of HAEi. “We are extremely proud to have established HAEi GAP with our current partners and to be able to announce that, from today, physicians are able to request RUCONEST to meet the needs of their patients.” Sijmen de Vries, CEO, Pharming said: “As the first pharmaceutical company to partner with HAEi and provide access to RUCONEST through HAEi GAP, we are leading the charge to improve the lives of those HAE patients that otherwise would continue suffering from this debilitating and unpredictable disease.” Simon Estcourt, Managing Director, Managed Access, Clinigen Group said: “We are very pleased to work with Pharming to help HAEi realize their mission to ensure that sufferers of hereditary angioedema worldwide can access this effective and potentially life-saving treatment. The ground-breaking program provides RUCONEST to patients in an ethical and compliant way, removing the need and the risk for patients to resort to other less reliable or even illegal sources of the drug.” – Ends
  3. dreas 21 juli 2015 08:19
    Samenwerking met Clinigen.
    De samenwerking tussen Pharming Group en Clinigen Group om het geneesmiddel Ruconest beschikbaar te maken voor patiënten in landen waar Ruconest vooralsnog niet commercieel beschikbaar is, is van start gegaan. Dit maakte Pharming dinsdag voorbeurs bekend.

    "Dit gaat zeker tot extra omzet leiden", aldus CEO Sijmen de Vries van Pharming tegenover ABM Financial News. Een indicatie van de omvang van de additionele omzet kon De Vries evenwel nog niet geven, daarvoor is het nog te vroeg, aldus de topman.

    Het toegangsprogramma is geïnitieerd door HAEi, een Internationale Patiënten Organisatie voor C1-remmer tekortkomingen. Ruconest is een middel tegen onder meer acute aanvallen van angio-oedeem.???De samenwerking tussen Pharming en Clinigen werd medio mei reeds aangekondigd.

  4. forum rang 4 bammie 21 juli 2015 08:27
    quote:

    Grunniger schreef op 21 juli 2015 07:17:

    Klinkt goed, maar voor dit kwartaal dus nog geen verkopen vanuit dit initiatief. Q3 kan dus wel heel anders worden hierdoor. Misschien dat de beurs hier wel een impuls door krijgt. Of was dit de stijging van afgelopen dagen.
    Stijging uitbreiding M. Kingdon.;)
  5. Berdientje 21 juli 2015 08:33
    . About Global Access Programs Global Access Programs provide biopharmaceutical companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests, in a fully compliant manner, where no alternative treatment options are available. About HAEi HAEI – International Patient Organization for C1 inhibitor Deficiencies - is a global organization dedicated to raising awareness of C1 inhibitor deficiencies around the world. It is a non-profit international network of national HAE patient Associations. HAEI is established to promote co-operation, co-ordination and information sharing between HAE Specialists and National HAE Patient Associations in order to help facilitate the availability of effective diagnosis and management of C1 inhibitor deficiencies throughout the world. Our purpose is to join the efforts and experience of the global HAE community to achieve optimal standards of care and treatment for all those patients affected by C1 inhibitor deficiencies. For more information, please visit: www.haei.org About Pharming Group NV Pharming Group NV is developing innovative products for the treatment of unmet medical needs. RUCONEST® (conestat alfa) is a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with HAE in the USA, Israel all 28 EU countries plus Norway, Iceland, and Liechtenstein. RUCONEST is commercialised by Pharming in Austria, Germany and The Netherlands. RUCONEST is distributed by Swedish Orphan Biovitrum AB (publ) ?(SS: SOBI) in the other EU countries, and in Azerbaijan, Belarus, Georgia, Iceland, Kazakhstan, Liechtenstein, Norway, Russia, Serbia, and Ukraine. RUCONEST is partnered with Salix Pharmaceuticals, Ltd. (“Salix”) in North America. Salix is part of Valeant Pharmaceuticals International, Inc. (NYSE: VRX/TSX: VRX) RUCONEST is also being investigated in a randomised Phase II clinical trial for prophylaxis of HAE, in a Phase II clinical trial for the treatment of HAE in young children (2-13 years of age) and evaluated for various additional follow-on indications. Pharming has a unique GMP compliant, validated platform for the production of recombinant human proteins that has proven capable of producing industrial volumes of high quality recombinant human protein in a more economical way compared to current cell-based technologies. Leads for Enzyme Replacement Therapy (ERT) in Pompe, Fabry’s and Gaucher’s diseases are under early evaluation. The platform is partnered with Shanghai Institute of Pharmaceutical Industry (SIPI), a Sinopharm Company, for joint global development of new products. Pre-clinical development and manufacturing will take place at SIPI and are funded by SIPI. Pharming and SIPI initially plan to utilise this platform for the development of recombinant human Factor VIII for the treatment of Haemophilia A. For more information, please visit www.pharming.com About Clinigen Group Clinigen Group is a global pharmaceutical and services company with a unique business model dedicated to delivering the right drug to the right patient at the right time. The Group consists of four complementary businesses that provide medicines to patients with unmet need through clinical trials, licensed and unlicensed supply; Clinigen Specialty Pharmaceuticals (SP), Clinigen Clinical Trial Services (CTS), Idis Managed Access (MA) and Idis Global Access (GA). We are global leaders in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and doctors for patients with a high unmet need. Our Managed Access business provides early access to unlicensed investigational medicines on behalf of pharmaceutical companies. For more information, please visit www.clinigengroup.com Contact Details
    Clinigen Group Tel: +44 (0) 1283 495 010
    Peter George, Group Chief Executive Officer
    Shaun Chilton, Group Chief Operating Officer
    Instinctif Partners (Clinigen media relations) Tel: +44 (0) 20 7457 2020
    Melanie Toyne-Sewell/Jen Lewis/Emma Barlow Email: clinigen@instinctif.com
    Pharming Group Tel: +31 71 5247400
    Sijmen de Vries, Chief Executive Officer
    FTI Consulting (Pharming media relations) Tel: +44 (0) 20 3727 1136
    Julia Phillips/Victoria Foster Mitchell
  6. [verwijderd] 21 juli 2015 08:45
    Hoe zit het met jullie geheugen? ;)

    Lausanne, Switzerland – 16 May 2015 – Thousands of patients suffering from a rare and potentially fatal genetic disease will have access to medicines for the first time, with the launch of the HAEi Global Access Program (HAEi GAP), a “first-of-its-kind” medication access program.

    www.iex.nl/forum/Topic/1324999/Pharmi...

    ps en ga me nou niet vertellen dat het nieuws is dat dat programma nu "live" is...
  8. patrick 22 21 juli 2015 08:48
    HAEi Global Access Program for RUCONEST® Now Live

    Print Friendly

    Unique patient organization-driven program is enabling people with HAE who cannot access effective treatments to receive medication for the first time

    Leiden, Netherlands and Burton-on-Trent, UK – 21 July 2015 – Pharming Group N.V. (“Pharming or the Company”), Euronext: PHARM) and Clinigen Group plc (‘Clinigen’ or the ‘Group’, AIM: CLIN) today announce that their global collaboration to provide access to Pharming’s RUCONEST® (conestat alfa) is now live. The unique access program was initiated by HAEi, the International Patient Organization for C1- Inhibitor Deficiencies.

    RUCONEST is a recombinant human C1- inhibitor, approved by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for the treatment of acute attacks of hereditary angioedema (HAE). The “HAEi GAP” program enables patients in all countries where RUCONEST is not commercially available to gain access to the drug through an ethical and regulatory compliant “Named Patient Program” mechanism.

    Physicians wishing to request RUCONEST through the HAEi GAP program should contact the Clinigen customer services team at customer.services@clinigengroup.com / +44 1283 494340.

    “HAEi is committed to securing access to HAE medications for patients across the globe,” said Anthony J. Castaldo, President of HAEi. “We are extremely proud to have established HAEi GAP with our current partners and to be able to announce that, from today, physicians are able to request RUCONEST to meet the needs of their patients.”

    Sijmen de Vries, CEO, Pharming said: “As the first pharmaceutical company to partner with HAEi and provide access to RUCONEST through HAEi GAP, we are leading the charge to improve the lives of those HAE patients that otherwise would continue suffering from this debilitating and unpredictable disease.”

    Simon Estcourt, Managing Director, Managed Access, Clinigen Group said: “We are very pleased to work with Pharming to help HAEi realize their mission to ensure that sufferers of hereditary angioedema worldwide can access this effective and potentially life-saving treatment. The ground-breaking program provides RUCONEST to patients in an ethical and compliant way, removing the need and the risk for patients to resort to other less reliable or even illegal sources of the drug.”

    – Ends –
  13. alias25 21 juli 2015 11:01
    Is oud nieuws.
    Program voor landen waar Ruconest niet te krijgen is --> dus geen terugbetaling.
    Enkel physicians Kunnen via dit program Ruconest aanvragen --> geen patiënten, indien hij interesse heeft moet deze zijn behandelende dokter overtuigen.
    Ik ben niet overtuigd van de meerwaarde voor duizenden patiënten, zullen er maar enkelen zijn.
    Succes.
16 Posts
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