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Home  /   Forum   /   Pharming   /   Op naar 18 mei

Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

Laatste koers (eur) Verschil Volume
0,725   -0,015   (-1,96%) Dagrange 0,723 - 0,736 3.267.119   Gem. (3M) 4,8M

Op naar 18 mei

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1.162 Posts
Pagina: 1 2 3 4 5 6 ... 59 »» | Laatste | Omlaag ↓
  1. [verwijderd] 7 april 2016 08:33
    OUTLOOK 2016

    For the remainder of 2016, the Company expects:
    •Investment in the production of RUCONEST® in order to ensure continuity of supply to the growing markets in the US, Europe and the rest of the world.

    •Investment in the clinical trial program for RUCONEST® in prophylaxis of HAE and the development of a sub-cutaneous version of RUCONEST®.

    •We will also continue to invest carefully in the new pipeline programs in Pompe disease and Fabry’s disease, and other new development opportunities and assets as these occur. To this end, we will be expanding in a modest way at our R&D centre at Evry in France, and in our milk production sites in the Netherlands.

    •Increasing selected marketing activity where this can be profitable for Pharming, such as in our current territories of Austria, Germany and the Netherlands.

    •We will continue to support all our marketing partners in order to enable the maximization of the sales and distribution potential of RUCONEST® for patients in all territories, as we continue to believe that RUCONEST® represents the fastest, most effective, most reliable and safest therapy option available to HAE patients.

    No financial guidance for 2016 is provided.

    Although the requirement to produce quarterly reports has been discontinued under the new EU Transparency Directive and the Amended Transparency Directive Implementation Act, Pharming intends to continue to provide quarterly operating and financial reports on a voluntary basis

    GOING CONCERN
    Pharming’s 2015 financial statements have been drawn up on the basis of a going concern assumption.

    The 2015 year-end cash balance of €31.8 million is expected to fund the Company for more than one year from the date of the report. The receipts from commercial supply of product to our partners in the USA,
    Europe, the Middle East, Latin America, South Korea and Israel and proceeds from direct sales in Austria, Germany and the Netherlands will further support our financial reserves.

    Pharming has a history of operating losses and anticipates that it will continue to incur losses until such quantities of RUCONEST® are being sold (directly or by our partners) that the proceeds to Pharming from such sales become sufficient to meet our operating costs.

    Presently, no assurance can be given both on the timing and size of future profits and whether profitability can be achieved on this basis. We remain confident that the development of RUCONEST® will enable this situation to occur, however.

    In addition, in the event that the Company needs to raise capital by issuing additional shares,shareholders’ equity interests may be diluted as to voting power, and their interests as to value will depend on the price at which such issues are made.

    SUMMARY OF GOALS FOR 2016
    • Achievement of (internal) market share/sales targets for RUCONEST®, in the US by Valeant Pharmaceuticals.

    • Achievement of (internal) market share/sales targets for RUCONEST® in Europe and otherterritories by our partners SOBI, HyupJin, Cytobioteck and MegaPharm and by direct commercialisation in Austria, Germany and the Netherlands.

    • Completion of the Phase II randomised clinical trial of RUCONEST® for the prophylaxis of HAE and continued development on the basis of positive results if these are achieved.

    • Prioritisation of new development projects and release in due course of the new products’ clinical strategy and development plans.

    • Development of the Company’s visibility amongst institutional investors and other market participants (both buy- and sell-side analysts and financial press and trade press journalists).
  2. [verwijderd] 7 april 2016 15:51
    -TREATMENT OF HAE ATTACKS IN ADOLESCENTS WITH HAE APPROVED-

    -IGE TESTING REQUIREMENTS REMOVED-

    Leiden, The Netherlands, 07 April 2016: Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT: PHARM) today announced that the European Commission adopted the CHMP recommendation to include the treatment of HAE attacks in adolescents with HAE and to remove the requirements for rabbit IgE testing that formed part of the EU label for RUCONEST®. The CHMP also noted that the importance of favourable effects of RUCONEST® is further supported by the continued availability of supply of RUCONEST® (produced by recombinant technology) in comparison to supply from blood donor plasma that may vary and not being a blood derived product thereby removing the potential risk of exposure to blood borne pathogens.
    This will mean that, effective now, adolescents also have access to (non- blood derived) recombinant C1- inhibitor therapy for the treatment of their angioedema attacks. In addition, the requirement to test HAE patients for pre-existing antibodies against rabbit dander, prior to treatment with RUCONEST and following each tenth treatment with RUCONEST, has been removed from the label. The requirement for IgE testing was a specific EU request based on a single adverse drug reaction in a study subject. The need for testing was not required in the US as more safety data were available at the time of the Biologics License Application (BLA) and subsequent FDA-approved label in 2014. The EU patient information leaflet will be updated to reflect these changes over the coming months. Prof. Bruno Giannetti, MD, PhD, Pharming’s COO commented: “This EU label change now also gives adolescents in the EU the long awaited access to treat their HAE attacks with a non- blood derived C1- inhibitor and in addition, the adoption by the European commission of the CHMP recommendation again confirms the well-established safety profile of RUCONEST® , based on a database of a dozen controlled clinical trials as well as now some 13,000 post-marketing doses of RUCONEST® provided to HAE patients. We are pleased that the burden on patients and doctors to perform testing prior to and after treatments with RUCONEST® has been removed and that emergency treatments of HAE attacks in previously untreated HAE patients, that were until now dependent on plasma derived C1INH therapies can now be made with RUCONEST®, with, as per the CHMP opinion, the added benefit of eliminating risks of exposure to known blood borne pathogens, such as Hepatitis A, B, C, E, HIV, and CJD, as well as continuously (re)-emerging other pathogens. Please see Prescribing Information for RUCONEST as applicable for various jurisdictions.
  13. [verwijderd] 7 april 2016 18:06
    Valeant, -voorlopig nog de belangrijkste distributeur van Ruconest- is hard op weg de zaken op orde te brengen. Wat hieraan relavant is voor Pharming, is een hernieuwde focus op de marketing en sales van Ruconest. Over de linie is Valeant sales personeel voor andere medicijnen aan het afstoten, maar dedicated sales voor Ruconest aan het recruiten.

    De Europese markt wordt een stuk eenvoudiger te bewerken en sales te genereren door Pharming zelf en distributiepartners na de EMA melding vandaag.
  15. [verwijderd] 8 april 2016 07:42
    quote:

    PrinsVaillant schreef op 7 april 2016 16:49:

    Zo langzamerhand gaan waarschijnlijk de commissies inzien dat er beter een recombinant medicijn gegeven kan worden ipv risicovollere plasmaprodukten.das mooi heel mooi nieuws voor pharming.
    Ruconest kan best wel eens de opstap worden voor een brede vraag naar andere medicijnen uit konijnenmelk :)
  16. forum rang 7 roon 8 april 2016 07:57
    Het kan vandaag gewoon doorgaan met de koersstijging want misschien zien mensen weer iets in een overname als je dit leest;

    De farmaceutische industrie zat donderdag in de lift, vanwege speculatie over de vraag wat de Amerikaanse farmaceut Pfizer gaat doen nu het zijn plan om het Ierse Allergan over te nemen voor 150 miljard dollar heeft laten varen.

    Soms kan het meezitten.
  18. [verwijderd] 13 april 2016 08:53
    Ondanks alle perikelen bij Valeant gaat daar de business op de werkvloer gewoon door, en zullen deze, als de emmer ellende normale kwartaalrapportage niet in de weg staat, op 4 mei gepresenteerd worden

    www.nasdaq.com/earnings/report/vrx

    Wellicht dat daarin informatie opduikt die relevant is voor Pharming, en dan kan deze datum dus belangrijk zijn voor ons aandeel. Hoe het ook zij, 18 mei komt er sneller dan de notering van een euro, en na de 18e kunnen wij een nieuw draadje starten: op naar de 2 euro!

    groeten van de rozebrillenbrigade
1.162 Posts
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