Ontvang nu dagelijks onze kooptips!
word abonnee
sluiten ✕
Terug naar discussie overzicht
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 basisGOING 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).
-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.
Ruconest wordt het topprodukt !
Wachten is op de knalpijp KBC Die moet nu naar kopen gaan bijstellen.
KBC komaan jongens bijstellen en dan kopen
KBC heeft al bijgesteld van Kopen doel € 0,70 naar Houden € 0,30 Wat een klunsen:-)
en weer een heleboel mensen de boot in.
het zinkende schip wel te verstaan
spijtoptanten hebbebn vandaar geen leuke dag
Blijven toch kopers... morgen 27 cent?
we hebben onze zakcentjes voor vandaag al weer verdiend, wat jij mazzel? straks ff sightseeying op kosten van de mooie pha dag.tis nog vroeg ...
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.
een goede beloning voor de vele jaren onderzoek, tegenslagen voor Galapagos- Esperite en Pharming zit nu aan te komen.. hup hup.. Valeant is druk doendezaken op orde te stellen en Gillead maakt zich klaar om Galapagos in te lijven. Esperite doen het nu ook beter.. dus kom op....
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 :)
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.
In mei leggen alle vogels een Ei. In mei worden de Pharming konijnen Blij. In mei breekt het aandeel Pharming Vrij.
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 wordenwww.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
papaji: stockholmsyndroom?
Aantal posts per pagina:
20
50
100
Direct naar Forum
-- Selecteer een forum --
Koffiekamer
Belastingzaken
Beleggingsfondsen
Beursspel
BioPharma
Daytraders
Garantieproducten
Opties
Technische Analyse
Technische Analyse Software
Vastgoed
Warrants
10 van Tak
4Energy Invest
Aalberts
AB InBev
Abionyx Pharma
Ablynx
ABN AMRO
ABO-Group
Acacia Pharma
Accell Group
Accentis
Accsys Technologies
ACCSYS TECHNOLOGIES PLC
Ackermans & van Haaren
ADMA Biologics
Adomos
AdUX
Adyen
Aedifica
Aegon
AFC Ajax
Affimed NV
ageas
Agfa-Gevaert
Ahold
Air France - KLM
Airspray
Akka Technologies
AkzoNobel
Alfen
Allfunds Group
Allfunds Group
Almunda Professionals (vh Novisource)
Alpha Pro Tech
Alphabet Inc.
Altice
Alumexx ((Voorheen Phelix (voorheen Inverko))
AM
Amarin Corporation
Amerikaanse aandelen
AMG
AMS
Amsterdam Commodities
AMT Holding
Anavex Life Sciences Corp
Antonov
Aperam
Apollo Alternative Assets
Apple
Arcadis
Arcelor Mittal
Archos
Arcona Property Fund
arGEN-X
Aroundtown SA
Arrowhead Research
Ascencio
ASIT biotech
ASMI
ASML
ASR Nederland
ATAI Life Sciences
Atenor Group
Athlon Group
Atrium European Real Estate
Auplata
Avantium
Axsome Therapeutics
Azelis Group
Azerion
B&S Group
Baan
Ballast Nedam
BALTA GROUP N.V.
BAM Groep
Banco de Sabadell
Banimmo A
Barco
Barrick Gold
BASF SE
Basic-Fit
Basilix
Batenburg Beheer
BE Semiconductor
Beaulieulaan
Befimmo
Bekaert
Belgische aandelen
Beluga
Beter Bed
Bever
Binck
Biocartis
Biophytis
Biosynex
Biotalys
Bitcoin en andere cryptocurrencies
bluebird bio
Blydenstijn-Willink
BMW
BNP Paribas S.A.
Boeing Company
Bols (Lucas Bols N.V.)
Bone Therapeutics
Borr Drilling
Boskalis
BP PLC
bpost
Brand Funding
Brederode
Brill
Bristol-Myers Squibb
Brunel
C/Tac
Campine
Canadese aandelen
Care Property Invest
Carmila
Carrefour
Cate, ten
CECONOMY
Celyad
CFD's
CFE
CGG
Chinese aandelen
Cibox Interactive
Citygroup
Claranova
CM.com
Co.Br.Ha.
Coca-Cola European Partners
Cofinimmo
Cognosec
Colruyt
Commerzbank
Compagnie des Alpes
Compagnie du Bois Sauvage
Connect Group
Continental AG
Corbion
Core Labs
Corporate Express
Corus
Crescent (voorheen Option)
Crown van Gelder
Crucell
CTP
Curetis
CV-meter
CVC Capital Partners
Cyber Security 1 AB
Cybergun
D'Ieteren
D.E Master Blenders 1753
Deceuninck
Delta Lloyd
DEME
Deutsche Cannabis
DEUTSCHE POST AG
Dexia
DGB Group
DIA
Diegem Kennedy
Distri-Land Certificate
DNC
Dockwise
DPA Flex Group
Draka Holding
DSC2
DSM
Duitse aandelen
Dutch Star Companies ONE
Duurzaam Beleggen
DVRG
Ease2pay
Ebusco
Eckert-Ziegler
Econocom Group
Econosto
Edelmetalen
Ekopak
Elastic N.V.
Elia
Endemol
Energie
Energiekontor
Engie
Envipco
Erasmus Beursspel
Eriks
Esperite (voorheen Cryo Save)
EUR/USD
Eurobio
Eurocastle
Eurocommercial Properties
Euronav
Euronext
Euronext
Euronext.liffe Optiecompetitie
Europcar Mobility Group
Europlasma
EVC
EVS Broadcast Equipment
Exact
Exmar
Exor
Facebook
Fagron
Fastned
Fingerprint Cards AB
First Solar Inc
FlatexDeGiro
Floridienne
Flow Traders
Fluxys Belgium D
FNG (voorheen DICO International)
Fondsmanager Gezocht
ForFarmers
Fountain
Frans Maas
Franse aandelen
FuelCell Energy
Fugro
Futures
FX, Forex, foreign exchange market, valutamarkt
Galapagos
Gamma
Gaussin
GBL
Gemalto
General Electric
Genfit
Genmab
GeoJunxion
Getronics
Gilead Sciences
Gimv
Global Graphics
Goud
GrandVision
Great Panther Mining
Greenyard
Grolsch
Grondstoffen
Grontmij
Guru
Hagemeyer
HAL
Hamon Groep
Hedge funds: Haaien of helden?
Heijmans
Heineken
Hello Fresh
HES Beheer
Hitt
Holland Colours
Homburg Invest
Home Invest Belgium
Hoop Effektenbank, v.d.
Hunter Douglas
Hydratec Industries (v/h Nyloplast)
HyGear (NPEX effectenbeurs)
HYLORIS
Hypotheken
IBA
ICT Automatisering
Iep Invest (voorheen Punch International)
Ierse aandelen
IEX Group
IEX.nl Sparen
IMCD
Immo Moury
Immobel
Imtech
ING Groep
Innoconcepts
InPost
Insmed Incorporated (INSM)
IntegraGen
Intel
Intertrust
Intervest Offices & Warehouses
Intrasense
InVivo Therapeutics Holdings Corp (NVIV)
Isotis
JDE PEET'S
Jensen-Group
Jetix Europe
Johnson & Johnson
Just Eat Takeaway
Kardan
Kas Bank
KBC Ancora
KBC Groep
Kendrion
Keyware Technologies
Kiadis Pharma
Kinepolis Group
KKO International
Klépierre
KPN
KPNQwest
KUKA AG
La Jolla Pharmaceutical
Lavide Holding (voorheen Qurius)
LBC
LBI International
Leasinvest
Logica
Lotus Bakeries
Macintosh Retail Group
Majorel
Marel
Mastrad
Materialise NV
McGregor
MDxHealth
Mediq
Melexis
Merus Labs International
Merus NV
Microsoft
Miko
Mithra Pharmaceuticals
Montea
Moolen, van der
Mopoli
Morefield Group
Mota-Engil Africa
MotorK
Moury Construct
MTY Holdings (voorheen Alanheri)
Nationale Bank van België
Nationale Nederlanden
NBZ
Nedap
Nedfield
Nedschroef
Nedsense Enterpr
Nel ASA
Neoen SA
Neopost
Neovacs
NEPI Rockcastle
Netflix
New Sources Energy
Neways Electronics
NewTree
NexTech AR Solutions
NIBC
Nieuwe Steen Investments
Nintendo
Nokia
Nokia OYJ
Nokia Oyj
Novacyt
NOVO-NORDISK AS
NPEX
NR21
Numico
Nutreco
Nvidia
NWE Nederlandse AM Hypotheek Bank
NX Filtration
NXP Semiconductors NV
Nyrstar
Nyxoah
Océ
OCI
Octoplus
Oil States International
Onconova Therapeutics
Ontex
Onward Medical
Onxeo SA
OpenTV
OpGen
Opinies - Tilburg Trading Club
Opportunty Investment Management
Orange Belgium
Oranjewoud
Ordina Beheer
Oud ForFarmers
Oxurion (vh ThromboGenics)
P&O Nedlloyd
PAVmed
Payton Planar Magnetics
Perpetuals, Steepeners
Pershing Square Holdings Ltd
Personalized Nursing Services
Pfizer
Pharco
Pharming
Pharnext
Philips
Picanol
Pieris Pharmaceuticals
Plug Power
Politiek
Porceleyne Fles
Portugese aandelen
PostNL
Priority Telecom
Prologis Euro Prop
ProQR Therapeutics
PROSIEBENSAT.1 MEDIA SE
Prosus
Proximus
Qrf
Qualcomm
Quest For Growth
Rabobank Certificaat
Randstad
Range Beleggen
Recticel
Reed Elsevier
Reesink
Refresco Gerber
Reibel
Relief therapeutics
Renewi
Rente en valuta
Resilux
Retail Estates
RoodMicrotec
Roularta Media
Royal Bank Of Scotland
Royal Dutch Shell
RTL Group
RTL Group
S&P 500
Samas Groep
Sapec
SBM Offshore
Scandinavische (Noorse, Zweedse, Deense, Finse) aandelen
Schuitema
Seagull
Sequana Medical
Shurgard
Siemens Gamesa
Sif Holding
Signify
Simac
Sioen Industries
Sipef
Sligro Food Group
SMA Solar technology
Smartphoto Group
Smit Internationale
Snowworld
SNS Fundcoach Beleggingsfondsen Competitie
SNS Reaal
SNS Small & Midcap Competitie
Sofina
Softimat
Solocal Group
Solvac
Solvay
Sopheon
Spadel
Sparen voor later
Spectra7 Microsystems
Spotify
Spyker N.V.
Stellantis
Stellantis
Stern
Stork
Sucraf A en B
Sunrun
Super de Boer
SVK (Scheerders van Kerchove)
Syensqo
Systeem Trading
Taiwan Semiconductor Manufacturing Company (TSMC)
Technicolor
Tele Atlas
Telegraaf Media
Telenet Groep Holding
Tencent Holdings Ltd
Tesla Motors Inc.
Tessenderlo Group
Tetragon Financial Group
Teva Pharmaceutical Industries
Texaf
Theon International
TherapeuticsMD
Thunderbird Resorts
TIE
Tigenix
Tikkurila
TINC
TITAN CEMENT INTERNATIONAL
TKH Group
TMC
TNT Express
TomTom
Transocean
Trigano
Tubize
Turbo's
Twilio
UCB
Umicore
Unibail-Rodamco
Unifiedpost
Unilever
Unilever
uniQure
Unit 4 Agresso
Univar
Universal Music Group
USG People
Vallourec
Value8
Value8 Cum Pref
Van de Velde
Van Lanschot
Vastned
Vastned Retail Belgium
Vedior
VendexKBB
VEON
Vermogensbeheer
Versatel
VESTAS WIND SYSTEMS
VGP
Via Net.Works
Viohalco
Vivendi
Vivoryon Therapeutics
VNU
VolkerWessels
Volkswagen
Volta Finance
Vonovia
Vopak
Warehouses
Wave Life Sciences Ltd
Wavin
WDP
Wegener
Weibo Corp
Wereldhave
Wereldhave Belgium
Wessanen
What's Cooking
Wolters Kluwer
X-FAB
Xebec
Xeikon
Xior
Yatra Capital Limited
Zalando
Zenitel
Zénobe Gramme
Ziggo
Zilver - Silver World Spot (USD)