24 jan: Transaktioner i henhold til aktietilbagekøbsprogram
24 jan: Påbegyndelse af aktietilbagekøbsprogram
24-01-2017 12:52:17

Genmab Announces 2016 Net Sales Figures for DARZALEX® (Daratumumab)

Relateret indhold
29 mar - 
Genmab dropper nu også nyheder på dansk
29 mar - 
Aktier/åbning: Mærsk trækker eliteindeks ned mens Carls..
29 mar - 
Aktier/tendens: Vestas kan komme i fokus i lysegrønt ma..
Relateret debat
08:28 - 
solsen:   "Man starter ikke et forsøg op, h..
07:52 - 
Janssens:   http://medwatch.dk/secure/Medicinal___..
07:47 - 
Nyt forsøg under opstart, taget fra proinvestor...

Company Announcement

  • Net sales of DARZALEX in 2016 totaled USD 572 million

  • Genmab will receive royalties on worldwide sales from Janssen Biotech, Inc.

Copenhagen, Denmark; January 24, 2017 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 572 million in 2016.  Net sales were USD 471 million in the U.S. and net sales in the rest of the world were USD 101 million.  Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

DARZALEX was approved in the U.S. in November 2015 and in Europe in May 2016.  Net sales of DARZALEX in the U.S. in 2015 were USD 20 million, resulting in royalty income of DKK 16 million to Genmab.

About DARZALEX® (daratumumab)

DARZALEX® (daratumumab) injection for intravenous infusion is indicated in the United States in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe for use as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.  For more information, visit www.DARZALEX.com.  

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cellsDaratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. Five Phase III clinical studies with daratumumab in relapsed and frontline multiple myeloma settings are currently ongoing, and additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma, non-Hodgkin’s lymphoma, NKT-cell lymphoma, amyloidosis, myelodysplastic syndromes and solid tumors.  Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.  

About Genmab

Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.  Founded in 1999, the company has two approved antibodies, DARZALEX® (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications.  Daratumumab is in clinical development for additional multiple myeloma indications, other blood cancers, and solid tumors.  A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis.  Genmab also has a broad clinical and pre-clinical product pipeline.  Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, and the HexaBody® platform which creates effector function enhanced antibodies.  The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies.  For more information visit www.genmab.com.

 

Contact:         

Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications

T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com

This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in relation to actual results, unless required by law.

Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody® and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Biotech, Inc.

1 FDA 2015. Daratumumab Prescribing information. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761036Orig1s000lbledt.pdf. Last accessed December 2016.

2 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.

3 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.

4 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.

5 Jansen, JH  et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking. Blood. 2012;120(21):abstract 2974.

Company Announcement no. 02

CVR no. 2102 3884

LEI Code 529900MTJPDPE4MHJ122

Genmab A/S

Bredgade 34E

1260 Copenhagen K

Denmark

Opret kommentar

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
24 mar
GEN
http://finans.dk/erhverv/ECE9448096/amerikansk-storinvestor-genmab-er-et-attraktivt-opkoeb-for-de-st..
4
26 mar
GEN
Solide kursstigninger er ikke at kimse af :-) Genmab har haft overskud i flere år og bruger deres o..
3
24 mar
GEN
du mener helt seriøst at Genmab har et efterslæb til C20........
3
07:52
GEN
Janssens:   http://medwatch.dk/secure/Medicinal___Biotek/article9465660.ece   Sklerose - Roche først..
2
07:47
GEN
Nyt forsøg under opstart, taget fra proinvestor.   https://clinicaltrials.gov/ct2/show/NCT03095118?t..
2
29 mar
GEN
Den tekniske konsolidering ser ud til at være overstået. Bunden er dobbelt testet i området 1390 og ..
2
26 mar
GEN
enig. Os fint at de benytter overskuddet til at fremskynde pipeline. 
2
26 mar
GEN
Jeg er godt tilfreds. Små 3000% de sidste fem år. Så pyt med et par kroner i udbytte.  
2
24 mar
GEN
Rising wedge identificeret som indikere kurs mod modstanden i 1488 inden for den naeste uges tid.
2
08:28
GEN
solsen:   "Man starter ikke et forsøg op, hvis der ikke er faglig begrundelse for at midlet har virk..
1

Vestas får tre ordrer i Kina - NY

29-03-2017 14:36:33
Vestas har fået tre vindmølleordrer til Kina, som alle er annonceret onsdag eftermiddag.Det danske vindmølleselskab skal levere møller til et projekt på 48 megawatt (MW) i Shandong-provinsen, til et 55 MW-projekt et uspecificeret sted i landet og til et andet 48 MW-projekt i Hebei-provinsen.Det fortæller Vestas i tre separate meddelelser.Det første projekt består af 22 V110-møller, der har en nomi..

Aktier/åbning: Mærsk trækker eliteindeks ned mens Carlsberg stiger

29-03-2017 09:36:06
Aktierne i A.P. Møller-Mærsk ligger omkring 150 kr. nede fra åbningen af aktiemarkedet onsdag - og det er lig det udbytte, der fragår aktierne. B-aktien falder med 1,1 pct. til 11.300 kr., mens A-aktien er 1,4 pct. nede i 10.880 kr.Samlet havde eliteindekset hikke fra morgenstunden - men efter 20 minutters handel har minusset bidt sig fast, og eliteindekset falder med 0,4 pct. til indeks 1069,4. D..

Aktier/tendens: Vestas kan komme i fokus i lysegrønt marked

29-03-2017 08:44:42
En større amerikansk satsning på olie og kul kan sætte Vestas i fokus fra morgenstunden, i et marked der ser ud til at åbne i plus.Præsident Donald Trump underskrev tirsdag et dekret om at tilbagerulle centrale dele af sin forgængers, Barack Obamas, klimalovgivning. Og Trump vil blandt andet fjerne et af Obamas tiltag, Clean Power Plan, fordi det ifølge dem er en hindring for olieboring og kulmine..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Vestas får tre ordrer i Kina - NY
2
Aktier/middag: Fransk storbank pifter efter Carlsberg - Pandora bakker
3
Genmab dropper nu også nyheder på dansk
4
Novo genindsender registreringsansøgning for Fiasp i USA - NY
5
TK Development kom endelig i plus og varsler ny fremgang

Relaterede aktiekurser

Genmab A/S 1.427,00 0,0% Aktiekurs uændret
Genmab AS DKK1 200,00 0,0% Aktiekurs uændret

Køb- og salgsanbefalinger

  • Trend
  • Pengemaskinen

Copyright Euroinvestor A/S 2017  Disclaimer Privatlivspolitik
Aktieinformation leveres af Interactive Data.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
30. marts 2017 08:45:45
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20170324.2 - EUROWEB1 - 2017-03-30 08:45:45 - 2017-03-30 08:45:45 - 1 - Website: OKAY

Når du besøger Euroinvestor.dk accepterer du, at der anvendes cookies, som vi og vores samarbejdspartnere benytter til funktionalitet, statistik og markedsføring. Læs mere om cookies på Euroinvestor.dk her

x