Genmab — Februar 2021
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Looks interesting...
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Several drugs developed by Genmab A/S are already on the market, but the company is planning to participate in its first commercial launch in 2021. Genmab is preparing for the US launch of the antibody-drug conjugate tisotumab vedotin for metastatic cervical cancer in the second half of the year in partnership with Seagen Inc. , if it is approved by the US Food and Drug Administration as expected.
The companies plan to file tisotumab vedotin for accelerated approval for metastatic cervical canc
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cancer based on positive Phase II data. (Also see "Genmab And Seattle Genetics Progress Cervical Cancer ADC" - Scrip, 30 Jun, 2020.)
It is a transitional year for Genmab as it begins to build out a commercial footprint for the first time. The Danish biotech has developed several drugs that have reached the market, but those drugs have been launched by the company's partners. They include Johnson & Johnson's Darzalex (daratumumab), Novartis AGs' Kesimpta (ofatumumab) and Horizon Therapeutics plc
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Tepezza (teprotumumab) – and Genmab receives sales royalties on all of them.
"This is probably one of our most exciting years ever for the company," CEO Jan van de Winkel said in a recent interview. "To become an end-to-end integrated biotech, a powerhouse, directly delivering new molecules to patients with the Genmab name on the vial is a big thrill for us."
The company is taking a cautious, stepwise approach to building out a commercial organization, focusing on the US and Japan. The team wi
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50/50 Deals At Least
The company's commercial evolution will impact its partnering strategy going forward as Genmab looks to hold onto more commercial rights for its products and eventually launch drugs independently. For example, a rich $750m upfront deal the company signed last year with AbbVie Inc. to develop and commercialize three next-generation bispecific antibody candidates included co-commercialization rights in the US and Japan and an option to co-promote in other regions for two of th -
the products. (Also see "Genmab Lands Experienced Partner AbbVie In Broad Bispecific Antibody Collaboration" - Scrip, 10 Jun, 2020.)
"At a minimum, we will ask for 50% co-ownership," van de Winkel said, pointing to the AbbVie partnership as an example of the kinds of deals Genmab hopes to mirror in the future. "That is one of the nice things about the AbbVie relationship, they were perfectly on board to do 50/50 with us.
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Wealthier biotechs are gaining new leverage when it comes to deal-making, van de Winkel added. "The dynamics between smaller biotech companies and bigger players is changing right now because some of the biotech companies, like Genmab, are very well capitalized."
Genmab also plans to retain full ownership of some molecules, at least in the regions where it builds up a commercial presence.
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"It's difficult to say right now which molecule it will be [that] we will hang onto 100%," he said. If it is a drug targeted to a smaller cancer indication that can be marketed optimally with a specialized sales force, then that would be an appropriate candidate to launch independently, but for a drug with broad reach like Darzalex, the exec explained Genmab will still look to partner, particularly because of the broad scope of the clinical development program.
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The most advanced candidate in the deal with AbbVie is epcoritamab (CD3xCD20), which moved into Phase III testing in diffuse large B-cell lymphoma (DLBCL) early this year. (Also see "Genmab/AbbVie’s Epcoritamab Advances As Deal Bears Fruit" - Scrip, 14 Jan, 2021.) The deal also includes two other bispecific antibody candidates developed using Genmab's DuoHexaBody and DuoBody development platforms, which Genmab expects will continue to deliver drug candidates into the pipeline.
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Bispecific antibodies are getting a lot of attention, although toxicity concerns remain. Genmab is developing a PD-L1x4-1BB bispecific antibody in early clinical testing in solid tumors in collaboration with BioNTech SE a collaboration dating back to 2015 that gives Genmab 50/50 commercial rights.
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J&J recently submitted a biologic licensing application for a Genmab-developed bispecific antibody with the FDA. Amivantamab targets tumors with activating and resistant EGFR mutations and MET mutations. It is pending approval for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations, whose tumors do not typically respond to standard of care. (Also see "Keeping Track: J&J Amivantamab, Infectious Disease Agents From Iterum, VBI And Atox Submitted; Another Furoscix CRL" -
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Pink Sheet, 11 Dec, 2020.) Amivantamab was developed using Genmab's DuoBody platform and licensed to Janssen.
J&J has a full range of bispecific antibodies in development with Genmab, including teclistamab (BCMAxDC3) in early clinical development for relapsed refractory multiple myeloma and four more candidates in earlier trials.
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Thank you so much StockBull - looks like Jan is vigilant in balancing risk/investment going forwards
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Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer https://ir.genmab.com/news-releases/news-release-details/genmab-and-seagen-submit-tisotumab-vedotin-biologics-license
So he confirms they are hoping for Tisotumab to be approved this year already, quite ambitious , we should see the filing any day now then i would think
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