24 okt: Admiral Capital A/S - Salg af ejendomme
25 okt: Delårsrapport for de første 9 måneder af 2017
24-10-2017 19:42:05

Genmab Announces Additional Information Concerning Net Sales of DARZALEX® (daratumumab) for Third Quarter of 2017

Relateret indhold
21 sep - 
Aktier/åbning: Danske Bank skraber bunden i positivt el..
21 sep - 
Aktier/tendens: Danske Bank trækker overskrifter i vent..
20 sep - 
Torsdagens aktier: Comeback til Danske Bank i generelt ..
Relateret debat
21 sep - 
Cassiopeia er også på vej. Catch 22 :)
21 sep - 
Så falder den, men kommer tilbage da de har andet i pip..
21 sep - 
Ja, om det lykkedes og hvis ikke, hvad så?

Company Announcement

  • Johnson & Johnson confirms additional information provided on third quarter 2017 net sales

  • Rest of World third quarter sales reported as USD 87 million

  • The reported number included a one-time adjustment related to accruals of approximately USD 20 million for retroactive reimbursement matters

  • Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc.

Copenhagen, Denmark; October 24, 2017 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Johnson & Johnson has given additional information relating to rest of world sales of DARZALEX (daratumumab) in the third quarter of 2017. As previously reported, net sales were USD 87 million in the rest of the world. This figure was negatively impacted by a one-time adjustment of approximately USD 20 million related to accruals for retroactive reimbursement matters in Germany and France. Genmab receives royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

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; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a 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 in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy and 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.  In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market.  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 cells.  Daratumumab 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.  A comprehensive clinical development program, including multiple Phase III studies, is ongoing with daratumumab in relapsed and frontline multiple myeloma settings, 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, 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 DARZALEX Prescribing information, June 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761036s004lbl.pdf  Last accessed June 2017

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. 35

CVR no. 2102 3884

LEI Code 529900MTJPDPE4MHJ122

Genmab A/S

Kalvebod Brygge 43

1560 Copenhagen V

Denmark

Opret kommentar

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
18 sep
GEN
Janssen præsenterer også kliniske data for deres bispecifikke antistof cMET/EGFR den 25 september og..
10
20 sep
GEN
Være lige opmærksom på vedlagte - CEO er jo supersælger som jo samtidig har noget at have hans posit..
6
16 sep
GEN
Eliot - har stor respekt for dig, - iøvrigt mener jeg at alle nævnte deltager i større eller mindre ..
5
19 sep
GEN
Har aktien:   GENMAB A/S: GENMAB TO HOST CAPITAL MARKETS DAY 14:59Media Release * Review of Genmabs ..
3
20 sep
GEN
nogen der smider badebukserne
2
18 sep
GEN
@MarkusK Jeg tror, at @johnwestergaard mente, at du ikke skulle debattere med @birketvedhotmailcom. ..
2
18 sep
GEN
Indlysende aktiekurserne svinger uden shorts, - har altid gjort det,  men shortede ses ofte i forbin..
2
16 sep
GEN
  Se denne link og lyt omhyggeligt. Iøvrigt - se de mange indslag om samme emne, nemlig svindelen de..
2
21 sep
GEN
Nu ved jeg godt direktøren er typen der kan sælge sand i sahara, men han skriver, at MAIA vil være b..
1
20 sep
GEN
Genmab bør snart suse mod 1450 kr...  
1

Danske: Moody's ser risiko for sænkning af kreditvurderingen - NY

21-09-2018 15:14:23
Moody's Investors Service er gået i gang med at kigge kreditvurderingen af Danske Bank efter i sømmene og forudser, at der er risiko for en nedjustering. Det oplyser ratinginstituttet fredag, hvor udsigten for Danske Banks kreditvurdering er sænket til "negativ" fra "stabil".Ændringen kommer, efter at banken har offentliggjort rapporten om hvidvask i sin estiske filial tidligere på ugen, skriver M..

Mærsk/Sydbank: Fundamentaler peger ikke mod gode fragtrater

21-09-2018 11:08:55
Efter en periode med overvejende positiv udvikling i fragtraterne er rateindekset Shanghai Containerized Fright Index, SCFI, nu faldet tre uger i træk. Den negative udvikling stopper dog ikke nødvendigvis her, vurderer senioranalytiker Morten Imsgard fra Sydbank, der dækker A.P. Møller-Mærsk. - Nu har vi set tre uger i træk, så det er lidt en trend, men ellers er der stor udsving i de her ugentlig..

Aktier/tendens: Danske Bank trækker overskrifter i ventet grønt marked

21-09-2018 08:04:56
Danske Bank kan fredag komme under investorernes kritiske lup, efter at flere danske aviser endnu engang har banken og undersøgelsen af dens rolle i hvidvasksagen som forsidestof.Børsen kan berette, at selskabet Deminor, der er ekspert i gruppesøgsmål, vil forsøge at samle opbakning blandt aktionærerne til en ny granskning af hvidvasksagen. I Jyllands-Posten Erhverv mener flere eksperter, at det e..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Hold på hat og briller: Wall Street kan blive ramt af udsving fredag
2
Vestas-kunde dropper vindmølleprojekt på 600 megawatt
3
NKT/Jyske: Milliardprojekt nærmer sig - kursmålet løftes - NY
4
Vestas/Sydbank: Venter stærk kvartalsafslutning på ordrefronten
5
Aktier/tendens: Danske Bank trækker overskrifter i ventet grønt marked

Relaterede aktiekurser

Genmab A/S 1.050,00 0,1% Stigning i aktiekurs

Køb- og salgsanbefalinger

  • Trend
  • Pengemaskinen

Copyright Berlingske Media 2018  Handelsbetingelser  |  Cookiedeklaration  |  Cookie- og Privatlivspolitik  |  Ophavsret og vilkår
Aktieinformation leveres af Morningstar.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
22. september 2018 01:15:46
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20180919.1 - EUROWEB1 - 2018-09-22 01:15:46 - 2018-09-22 01:15:46 - 1 - Website: OKAY