FDA Grants GSK and Genmab's Arzerra® (Ofatumumab) Breakthrou
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FDA Grants GSK and Genmab's Arzerra
(Ofatumumab) Breakthrough Therapy Designation for Previously Untreated Chronic Lymphocytic LeukemiaCompany Announcement
Ofatumumab receives Breakthrough Therapy designation in CLL
Potential for expedited development
Copenhagen, Denmark; September 13, 2013 - Genmab A/S (OMX: GEN) and GlaxoSmithKline plc (GSK) announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Arzerra (ofatumumab) in combination with chlorambucil for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior treatment and are inappropriate for fludarabine-based therapy. Ofatumumab is not approved or licensed anywhere in the world for use in this treatment setting. Breakthrough Therapy designation is the newest of the FDA's programs aimed at accelerating the development and review times of drugs for serious or life-threatening conditions.
CLL is the most common form of leukemia in adults. Based on estimates by the American Cancer Society, CLL will account for more than 15,680 new cases and more than 4,580 deaths in the United States of America alone in 2013. At present, no curative chemotherapy is available.
The Breakthrough Therapy designation was based on the results from an international, multicenter, randomized Phase III clinical trial in more than 400 patients with previously untreated CLL. Headline results from this trial were announced in May 2013 and the full study results have been submitted for presentation at the 2013 American Society of Hematology Annual Meeting in December.
"We are exceedingly proud to receive the Breakthrough Therapy designation, the second this year for GSK. This FDA program is intended to expedite not just the development but also the review of drugs for serious or life threatening conditions," said Dr. Kathy Rouan, Vice President and Head of Biopharmaceutical Development, GlaxoSmithKline. "We are actively working on our submission and look forward to the enhanced regulatory interaction allowed for Breakthrough Therapies."
"Both of Genmab's lead products, ofatumumab and daratumumab, have now been granted Breakthrough Therapy designations from the FDA. This designation for ofatumumab reflects Genmab's mission to create differentiated products aimed at improving the lives of patients suffering from debilitating diseases and for whom existing treatments are inadequate," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About Breakthrough Therapy designation
The Breakthrough Therapy designation was enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA) and is intended to expedite development and review of drugs to treat serious or life-threatening medical conditions when preliminary clinical evidence demonstrates that the drug may have substantial improvement on at least one clinically significant endpoint over available therapies. Breakthrough Therapy designation includes all the features of the Fast Track designation, as well as more intensive guidance from the FDA on a drug's clinical development program.
About ofatumumab
Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops[i]. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GSK. For Full US Prescribing Information for the approved indication, please visit: us.gsk.com/html/medicines/index.html and visit health.gsk.com for the EU SPC for the approved indication.
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company's first marketed antibody, ofatumumab (Arzerra, was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab's validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com. -
Super fed nyhed her op til weekenden.....glæder mig allerede til det bliver mandag
Tror lige jeg kigger en ekstra gang på reolen efter en god vin. Det må fejres det her Lige det ekstra skub aktien har brug for, så mon ikke kurs 200 snart ligger bag os?
God weekend til alle jer lykkelige Genmab-ejere
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Meget afgørende nyhed på mange måder for Genmab. Udover at de er virkeligt tæt på CLL i mange indikationer, så har det også en stor betydning for investor sentiment i aktien.
Vi ved allerede idag at Rituxian tjener rigtigt mange penge i CLL, Genmab har den mindste flig af det markedet, som resulterer i 120-150 millioner i royalty for en indikation hvor patienterne har været igennem mange behandlinger før.
Jo længere fremme i behandlingskøen man kan komme med Arzerra jo flere penge er der at tjene. Så det her får en betydning for hvor hurtigt Genmab vil komme til at tjene penge.
En anden faktor er hvad det har betydet for investorsentiment, både hos de private og de professionelle at GA101 fik Breakthrough designation. For den langsigtede investor er det måske lidt ligegyldigt, men for en mellem til kort investor har det betydning.
Genmab har tradet i range 150-190 i et halvt år fordi hestene ikke kunne slippes løs for alvor uden en ny stærk nyhed. I mellemtiden virkede det som om at Roche med GA101 helt havde overhalet arzerra på den kliniske udvikling og nogle analytikere begyndte at tvivle på om Arzerra kunne nå at spille en rolle i CLL, mest bemærkelsesværdigt nok Dr. Genmab, Peter Aabo.
Det blev bekræftet at de blev tildelt Break Through tidligere på året.
Igen der er enormt mange penge i at komme på markedet hurtigere, vi taler mange milliarder.
Nu får Genmab så også BTD i Arzerra og det betyder både noget for den umiddelbare værdisætning og investor sentiment.
Til slut må vi også lige læne os tilbage tage en cigar, og så konstaterer sammen med Jan Van de Vinkel at Genmab nu har sine 2 førende stoffer, som de ypperste indenfor megablockbuster katagorien kræft, med break through designationen.
Et flot vidnesbyrd om at Genmab er et af verdens absolutte førende biotekselskaber.
Tillykke.
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Ja vi kan nok have en lancering i første halvdel af næste år, svært at sige om det kan nåes til Q1, men det er inden for mulighedernes grænse. Vi har fået data på det de søger på næste gang, så der er ingen anden overraskelse der ligger der end hvornår de så ansøger.
Det er egentligt meget overraskende at de får det, når man tænker på hvor tæt det i virkningsprofil egentligt ligger op ad Rituxian. Så hvorfor er det lige Breakthrough? Men hvorom alting er så burde det fremskynde alle instanser, ansøgning og godkendelse. Hvorvidt det nu betyder at FDA hjælper den med ansøgningen ved jeg ikke. Det giver mening man hjælper med protokollen, men med ansøgningen? Det virker da som inhabilitet der står i kø for at ske. Med lidt snild og held kan vi få den nye indikations salgstal midt næste år. Og det bliver altså rigtigt stort.
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Der ligger mig bekendt ikke en BTD sbla til godkendelse hos FDA. Mon ikke vi er "in for a big surprise" på hvor lang tid FDAs behandling af ansøgningen tager?
Det her er noget vildt, men nu tror jeg en action date omkring ASH.
Der må vel være en eller anden logisk baggrund til at Ofa har fået BTD på dette meget sene tidspunkt - både generelt, men specifikt overfor GA101...
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Betegnelsen Breakthrough Therapy blev indført som en del af 2012 FDA Safety and Innovation Act (FDASIA) og har til formål at fremskynde den kliniske udvikling og processen for regulatorisk evaluering af lægemidler til behandling af
alvorlige eller livstruende sygdomme, når foreløbig klinisk evidens viser, at lægemidlet kan give en væsentlig forbedring på mindst ét klinisk signifikant endpoint i forhold til de tilgængelige behandlinger. Breakthrough Therapy-betegnelsen omfatter alle de procedurer, som Fast Track-status indebærer, og derudover en mere intensiv vejledning fra FDA omkring lægemidlets -
Det er alt for gode dage for os aktionærer. Den afgørende sentiment changer var BTD i Arzerra. Men vi skal have flere news til at underbygge flere kursstigninger.
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Det fortsætter.
Helt afgørende vending for mig at se med gennembruddet af 220.
http://onlinelibrary.wiley.com/doi/10.1002/emmm.201201929/full
De kan potentielt have gang i et antistofformat, der er mere effektivt end hidtil anvendte.Solsen
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The paper explained
PROBLEM:Despite clinical successes the efficacy of anti-cancer therapeutic mAbs needs further improvement. Currently, all antibodies are of the IgG isotype that engage Fcgamma receptors (FcγRs) to mediate activation of immune effector cells. In vitro results show that IgA anti-tumour antibodies are also able to mediate effective tumour cell killing. IgA antibodies engage Fcalpha receptor (FcαRI) that is expressed by different effector cells than FcγRs. However, the anti-tumour activity of IgA antibodies has not been tested in vivo.
RESULTS:
In this work, we report in vivo anti-cancer activity of IgA antibodies targeting epidermal growth factor receptor (EGFR) in both immunodeficient and immunocomptenent tumour models in mice. Since mice do not have FcαRI, we used mice transgenic for human FcαRI. We have found potent anti-tumour activity of IgA EGFR antibodies that greatly depended on the presence of human FcαRI transgene. We identified macrophages as the predominant effector cells mediating in vivo anti-tumour activity of IgA antibodies.
IMPACT:
These results demonstrate the anti-tumour activity of IgA antibodies in vivo and support the development of immunotherapeutic strategies against cancer based on targeting FcαRI.
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Genmabs antistoffer har isotypen IgG1, abgenix havde IgG2. Ingen har tidligere anvendt IgA isotypen og Winkel et al skriver, at dette format er potentielt mere effektiv i cancerbehandling.
Ganske interessant, hvis de også her kan vise vejen til en bedre behandling !
Solsen
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