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{{Cleanup|date=May 2024|reason=A mess of an article whose lede is a disaster.}}{{Short description|Danish healthcare company}} |
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{{Infobox company |
{{Infobox company |
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| name = Genmab A/S |
| name = Genmab A/S |
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| logo = Genmab.svg |
| logo = Genmab.svg |
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| logo_size = 250px |
| logo_size = 250px |
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| type = [[Public company| |
| type = [[Public company|Public]] |
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| traded_as = {{OMX|CSE11143|GMAB}}<br>{{NASDAQ|GMAB}} ([[American Depositary Receipt|ADR]])<br>[[OMX Copenhagen 25]] component<ref>{{cite web | url=https://www.nasdaqomxnordic.com/indeksit/index_info?Instrument=DK0060775369 | title=OMX Copenhagen 25 index info}}</ref> |
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| traded_as = {{OMX|CSE11143|GMAB}} |
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| foundation = {{start date and age|1999}} |
| foundation = {{start date and age|1999}} |
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| founder = Florian Schönharting<ref name="Biotekstjerne spottede de gode forretninger">{{cite web |title=Biotekstjerne spottede de gode forretninger |url=https://www.berlingske.dk/virksomheder/biotekstjerne-spottede-de-gode-forretninger |website=Berlingske | |
| founder = Florian Schönharting<ref name="Biotekstjerne spottede de gode forretninger">{{cite web |title=Biotekstjerne spottede de gode forretninger |url=https://www.berlingske.dk/virksomheder/biotekstjerne-spottede-de-gode-forretninger |website=Berlingske |date=20 October 2018 |access-date=14 November 2020}}</ref><ref name="Marketscreener">{{cite web |title=Marketscreener |url=https://www.marketscreener.com/business-leaders/Florian-Schonharting-06FYJR-E/biography/ |website=Marketscrenner |publisher=Marketscreener |access-date=14 November 2020}}</ref><ref name="Forward Pharma Board Members">{{cite web |title=Forward Pharma Board Members |url=http://ir.forward-pharma.com/board-member/florian-schonharting-msc-econ |website=Forward Pharma |access-date=14 November 2020}}</ref> and Lisa Drakeman<ref name="Life Science Leader 2019" /> |
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| location = [[Copenhagen]], |
| location = [[Copenhagen]], Denmark |
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| num_locations = 4 ( |
| num_locations = 4 (2023)<ref name="AR2023"/> |
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| key_people = {{unbulleted list |
| key_people = {{unbulleted list |
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|Jan Van de Winkel ([[President (corporate title)| |
|Jan Van de Winkel ([[President (corporate title)|president]] and [[Chief executive officer|CEO]], from 2010) |
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|Deirdre P. Connelly ([[Chairperson|Board chair]])<ref name=" |
|Deirdre P. Connelly ([[Chairperson|Board chair]])<ref name="AR2023"/> |
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}} |
}} |
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| industry = [[Biotechnology]] |
| industry = [[Biotechnology]] |
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| products = [[ |
| products = [[Daratumumab|DARZALEX]]/<br/>[[Daratumumab/hyaluronidase|DARZALEX FASPRO]]<br/> [[Epcoritamab|EPKINLY/TEPKINLY]]<br/> [[Ofatumumab|Kesimpta]]<br/> [[Amivantamab|RYBREVANT]]<br/> [[Talquetamab|TALVEY]]<br/> [[Teclistamab|TECVAYLI]]<br/> [[Teprotumumab|TEPEZZA]]<br/> [[Tisotumab_vedotin|Tivdak]] |
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| revenue = [[Danish krone|DKK]] |
| revenue = [[Danish krone|DKK]] 16.474 billion (2023)<ref name="AR2023"/><!--Genmab Group Revenue line item--> |
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| operating_income = DKK |
| operating_income = DKK 5.321 billion (2023)<ref name="AR2023"/><!--Genmab Group Operating result line item--> |
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| net_income = DKK |
| net_income = DKK 4.352 billion (2023)<ref name="AR2023"/><!--Genmab Group Net Result line item--> |
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| num_employees = |
| num_employees = 2,204 (2023)<ref name="AR2023"/><!--FTE at end of year--> |
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| footnotes = |
| footnotes = |
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| homepage = {{url|https://www.genmab.com|Genmab.com}} |
| homepage = {{url|https://www.genmab.com|Genmab.com}} |
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}} |
}} |
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'''Genmab A/S''' is a [[Denmark|Danish]] [[biotechnology company]], founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund.<ref>{{Cite report|url=https://www.sec.gov/Archives/edgar/data/874255/0000950130-99-001225.txt|title=Form 8-K Current Report|date=March 5, 1999|publisher=US Securities and Exchange Commission|access-date=6 January 2020|at=Contacts|type=[[Form 8-K]]}}</ref> The company is based in [[Copenhagen]], Denmark |
'''Genmab A/S''' is a [[Denmark|Danish]] [[biotechnology company]], founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund.<ref>{{Cite report|url=https://www.sec.gov/Archives/edgar/data/874255/0000950130-99-001225.txt|title=Form 8-K Current Report|date=March 5, 1999|publisher=US Securities and Exchange Commission|access-date=6 January 2020|at=Contacts|type=[[Form 8-K]]}}</ref> The company is based in [[Copenhagen]], Denmark – internationally, it operates through the subsidiaries '''Genmab B.V.''' in [[Utrecht (city)|Utrecht]], [[Netherlands|The Netherlands]], '''Genmab U.S., Inc.''' in [[Princeton, New Jersey|Princeton]], [[United States|USA]], and '''Genmab K.K.''' in [[Tokyo]], [[Japan]]. Genmab is a dual-listed company with shares traded on both the [[Copenhagen Stock Exchange]] in Denmark<ref>{{cite web|url=http://www.nasdaqomxnordic.com/aktier/microsite?Instrument=CSE11143|title=GMAB, Genmab, (DK0010272202)| publisher=Nasdaq Nordic Ltd|type=Dynamic webpage|access-date=9 March 2022|quote=Market: Nasdaq Copenhagen}}</ref> and the [[NASDAQ]] [[NASDAQ#Market tiers|Global Select Market]] in the US.<ref>{{cite web|url=https://www.nasdaq.com/market-activity/stocks/gmab|title=Genmab A/S ADS (GMAB)|publisher=Nasdaq Inc|type=Dynamic webpage|access-date=9 March 2022|quote=Market: Nasdaq}}</ref> |
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The company has 5 approved antibodies used in 5 marketed products, covering cancer indications and autoimmune diseases:<ref name="AR2021"/> |
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Proprietary, marketed with [[Seagen]]: |
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* Tivdak [[Tisotumab_vedotin| (tisotumab vedotin-tftv)]] for the treatment of previously treated recurrent or metastatic [[cervical cancer]] |
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Marketed by partners: |
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* Darzalex ([[Intravenous infusion|IV]]) ([[daratumumab]]) / Darzalex Faspro ([[Subcutaneous injection|SC]]) ([[Daratumumab/hyaluronidase|daratumumab and hyaluronidase-fihj]]) for the treatment of all stages of [[multiple myeloma]] as combination therapy or monotherapy, and for the treatment of newly diagnosed [[AL amyloidosis|amyloid light-chain (AL) amyloidosis]] |
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* Rybrevant ([[Amivantamab|amivantamab-vmjw]]) for the treatment of [[non-small-cell lung cancer]] (EGFR exon 20 insertion mutations) |
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* Kesimpta ([[ofatumumab]]) for the treatment of [[relapsing remitting multiple sclerosis]] |
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* Tepezza ([[Teprotumumab|teprotumumab-trbw]]) for the treatment of [[Graves' ophthalmopathy|thyroid eye disease]] |
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Furthermore both Genmab and its partners have a whole range of antibody programs, building on Genmab technologies, in clinical and pre-clinical development. Genmab have several late stage clinical programs for tisotumab vedotin ([[cervical cancer]], [[ovarian cancer]] and [[Neoplasm|solid tumors]]) and epcoritamab ([[diffuse large B-cell lymphoma]] and B-cell [[non-Hodgkin lymphoma]]). The partners have, among others, clinical programs for daratumumab (non-MM [[blood cancer]]s), amivantamab ([[Stomach cancer|gastric cancer]] and [[esophageal cancer]]), and teprotumumab ([[Systemic scleroderma|diffuse cutaneous systemic sclerosis]]).<br/><br/> |
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==Technology== |
==Technology== |
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== History == |
== History == |
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Genmab was founded as a European spin-off of American Biotech company [[Medarex]] in February 1999. Danish investment firm BankInvest, under [[Florian Schönharting]], provided the seed investment for the company to start up in Copenhagen. Like Medarex, Genmab began work producing monoclonal antibodies for life-threatening or debilitating diseases. Rising quickly in the Biotech world, Genmab attracted many investors, especially venture capital firms. The company went public in October 2000, earning DKK 1.56 billion, and had a second public offering in January 2006 yielding DKK 800 million. |
Genmab was founded as a European spin-off of American Biotech company [[Medarex]] in February 1999. Danish investment firm BankInvest, under [[Florian Schönharting]], provided the seed investment for the company to start up in Copenhagen. Like Medarex, Genmab began work producing monoclonal antibodies for life-threatening or debilitating diseases. Rising quickly in the Biotech world, Genmab attracted many investors, especially venture capital firms. The company went public in October 2000, earning DKK 1.56 billion, and had a second public offering in January 2006, yielding DKK 800 million. |
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The company's initial R&D location was a nine-story building in [[Utrecht Science Park]], in the Netherlands; this was replaced with an "R&D Center" also in [[Utrecht]], in June 2018.<ref name="Life Science Leader 2019" /> By mid-2019, this new facility was at capacity, and plans were set afoot to build an adjacent, connected facility.<ref name="Life Science Leader 2019" /> |
The company's initial R&D location was a nine-story building in [[Utrecht Science Park]], in the Netherlands; this was replaced with an "R&D Center" also in [[Utrecht]], in June 2018.<ref name="Life Science Leader 2019" /> By mid-2019, this new facility was at capacity, and plans were set afoot to build an adjacent, connected facility.<ref name="Life Science Leader 2019" /> |
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By 2001, Medarex and Genmab had come back together in a drug development partnership, which highlighted the manufacturing deficit and clinical development expertise of Genmab relative to Medarex.<ref>{{Cite news|url=https://www.newspapers.com/clip/41822740/business_notes/|title=Business Notes|last=Staff|date=June 28, 2001|work=Courier News|access-date=6 January 2020|publisher=Gannett|issue=23|department=Central Jersey Briefcase|location=Bridgewater, New Jersey|volume=119|page=A11|via=Newspapers.com}}</ref> |
By 2001, Medarex and Genmab had come back together in a drug development partnership, which highlighted the manufacturing deficit and clinical development expertise of Genmab relative to Medarex.<ref>{{Cite news|url=https://www.newspapers.com/clip/41822740/business_notes/|title=Business Notes|last=Staff|date=June 28, 2001|work=Courier News|access-date=6 January 2020|publisher=Gannett|issue=23|department=Central Jersey Briefcase|location=Bridgewater, New Jersey|volume=119|page=A11|via=Newspapers.com}}</ref> |
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In 2005 the [[Biotechnology Industry Organization]] (BIO) and the [[Long Island Life Sciences Initiative]] honored Genmab with a [[James D. Watson Helix Award]].<ref>{{Cite press release|url=http://www.bio.org/news/pressreleases/newsitem.asp?id= |
In 2005, the [[Biotechnology Industry Organization]] (BIO) and the [[Long Island Life Sciences Initiative]] honored Genmab with a [[James D. Watson Helix Award]].<ref>{{Cite press release|url=http://www.bio.org/news/pressreleases/newsitem.asp?id=2005_02|title=James D. Watson Helix Awards Honor Biotech's Top Performers|last=Debbie|first=Strickland|date=February 24, 2005|url-status=dead|archive-url=https://web.archive.org/web/20101213141912/http://bio.org/news/pressreleases/newsitem.asp?id=2005_0224_01|archive-date=December 13, 2010|access-date=17 January 2011|publisher=Biotechnology Industry Organization}}</ref> |
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2008 saw the company purchasing a 22,000-litre, 36-acre antibody manufacturing plant in [[Brooklyn Park, Minnesota]] from [[PDL BioPharma]], with plans to retain all 170 employees thereat.<ref name="Life Science Leader 2019" /><ref>{{Cite news|url=https://www.newspapers.com/clip/41823183/pdl_biopharma_to_sell_antibody_plant/|title=PDL Biopharma to sell antibody plant|date=February 22, 2008|work=Star Tribune|access-date=6 January 2020|publisher=The Star Tribune Company|agency=Dow Jones News Service|issue=324|location=Minneapolis, Minnesota|volume=XXVI|page=D2|via=Newspapers.com}}</ref> However, the company ran into financial trouble originating from several quarters, and a decision to sell the facility was reached in late 2009, after Genmab had started producing development scale batches from the facility.<ref name="Life Science Leader 2019" /> In 2008, the world was experiencing a financial crisis as a whole, and GlaxoSmithKline decided to exit oncology, which impacted co-development of ofatumumab, an oncology-directed product.<ref name="Life Science Leader 2019" /> In tandem with the sale of the plant, the company reorganized and planned to dismiss about 300 employees.<ref name="Life Science Leader 2019" /> Selling the facility, though, proved very difficult, due in large part to the global financial crisis; by 2012, Genmab had decided to simply [[write-off]] the entire facility from the company's balance sheets.<ref name="Life Science Leader 2019" /> A sale of the facility to [[Baxter International|Baxter]] came in February 2013.<ref name="Life Science Leader 2019" /> |
2008 saw the company purchasing a 22,000-litre, 36-acre antibody manufacturing plant in [[Brooklyn Park, Minnesota]] from [[PDL BioPharma]], with plans to retain all 170 employees thereat.<ref name="Life Science Leader 2019" /><ref>{{Cite news|url=https://www.newspapers.com/clip/41823183/pdl_biopharma_to_sell_antibody_plant/|title=PDL Biopharma to sell antibody plant|date=February 22, 2008|work=Star Tribune|access-date=6 January 2020|publisher=The Star Tribune Company|agency=Dow Jones News Service|issue=324|location=Minneapolis, Minnesota|volume=XXVI|page=D2|via=Newspapers.com}}</ref> However, the company ran into financial trouble originating from several quarters, and a decision to sell the facility was reached in late 2009, after Genmab had started producing development scale batches from the facility.<ref name="Life Science Leader 2019" /> In 2008, the world was experiencing a financial crisis as a whole, and GlaxoSmithKline decided to exit oncology, which impacted co-development of ofatumumab, an oncology-directed product.<ref name="Life Science Leader 2019" /> In tandem with the sale of the plant, the company reorganized and planned to dismiss about 300 employees.<ref name="Life Science Leader 2019" /> Selling the facility, though, proved very difficult, due in large part to the global financial crisis; by 2012, Genmab had decided to simply [[write-off]] the entire facility from the company's balance sheets.<ref name="Life Science Leader 2019" /> A sale of the facility to [[Baxter International|Baxter]] came in February 2013.<ref name="Life Science Leader 2019" /> |
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Lisa N. Drakeman, Ph.D. had been a vice president at Medarex and wife of [[Donald L. Drakeman|Donald Drakeman]], Medarex's CEO and President at the time. Drakeman was one of Genmab's co-founders and was appointed [[chief executive officer]] (CEO) of the company upon incorporation in 1999, also joining the board of directors.<ref name="Life Science Leader 2019" /> {{As of|2002||df=}}, Drakeman remained in the CEO role,<ref name="Nutley Sun 2002">{{Cite news|url=https://www.newspapers.com/clip/41820722/roche_expands_commitment_to_innovated/|title=Roche expands commitment to innovative advanced medicines|last=Staff|date=June 27, 2002|work=The Nutley Sun|access-date=6 January 2020|publisher=North Jersey Media Group|location=Nutley, New Jersey|page=10|via=Newspapers.com}}</ref> but by 2010 she had announced her retirement.<ref name="Life Science Leader 2019" /> |
Lisa N. Drakeman, Ph.D. had been a vice president at Medarex and wife of [[Donald L. Drakeman|Donald Drakeman]], Medarex's CEO and President at the time. Drakeman was one of Genmab's co-founders and was appointed [[chief executive officer]] (CEO) of the company upon incorporation in 1999, also joining the board of directors.<ref name="Life Science Leader 2019" /> {{As of|2002||df=}}, Drakeman remained in the CEO role,<ref name="Nutley Sun 2002">{{Cite news|url=https://www.newspapers.com/clip/41820722/roche_expands_commitment_to_innovated/|title=Roche expands commitment to innovative advanced medicines|last=Staff|date=June 27, 2002|work=The Nutley Sun|access-date=6 January 2020|publisher=North Jersey Media Group|location=Nutley, New Jersey|page=10|via=Newspapers.com}}</ref> but by 2010 she had announced her retirement.<ref name="Life Science Leader 2019" /> |
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In 2010 Jan Van de Winkel, a co-founder of the firm, was appointed as [[President (corporate title)|President]] and CEO of Genmab.<ref name="Life Science Leader 2019">{{Cite magazine|last=Wright|first=Rob|date=December 30, 2019|title=The 5-Step Strategy That Saved Genmab From A Dire Outlook|url=https://www.lifescienceleader.com/doc/the-step-strategy-that-saved-genmab-from-a-dire-outlook-0001?vm_tId=2182764&user=c04f77ce-db7d-4d91-a0bb-3e5ddd7ea5ca&vm_alias=The%205-Step%20Strategy%20That%20Saved%20Genmab%20From%20A%20Dire%20Outlook&mkt_tok=eyJpIjoiTmpneE5ETmlabUUwT0RnMSIsInQiOiJ2V1ZEZGR0ZzFOQVNlWlZZYWRyamJCbjNGYWhzS2R4WjNvc1VQUFE1RFhkQlV6V3I3OERyQmRmWGJGb2UzaHdVeFdaZmF4WHJlVFg2TnduVkNseDdVclRNOFpaTFZYMVNveWI0N1BINHA4YitobUFyQnBocFZEMDBrZ3JRSkVwSCJ9|magazine=Life Science Leader|publisher=VertMarkets|access-date=6 January 2020}}</ref> Since the company started in 1999, he had been Genmab's [[chief scientific officer]] (CSO); he had concurrently served as head of research, then president of R&D.<ref name="Life Science Leader 2019" /> {{As of|2019||df=}}, Van de Winkel remained CEO of the firm.<ref name="Life Science Leader 2019" /> Van de Winkel is a scientist, having produced more than 300 publications during his career.<ref name="Life Science Leader 2019" /> |
In 2010, Jan Van de Winkel, a co-founder of the firm, was appointed as [[President (corporate title)|President]] and CEO of Genmab.<ref name="Life Science Leader 2019">{{Cite magazine|last=Wright|first=Rob|date=December 30, 2019|title=The 5-Step Strategy That Saved Genmab From A Dire Outlook|url=https://www.lifescienceleader.com/doc/the-step-strategy-that-saved-genmab-from-a-dire-outlook-0001?vm_tId=2182764&user=c04f77ce-db7d-4d91-a0bb-3e5ddd7ea5ca&vm_alias=The%205-Step%20Strategy%20That%20Saved%20Genmab%20From%20A%20Dire%20Outlook&mkt_tok=eyJpIjoiTmpneE5ETmlabUUwT0RnMSIsInQiOiJ2V1ZEZGR0ZzFOQVNlWlZZYWRyamJCbjNGYWhzS2R4WjNvc1VQUFE1RFhkQlV6V3I3OERyQmRmWGJGb2UzaHdVeFdaZmF4WHJlVFg2TnduVkNseDdVclRNOFpaTFZYMVNveWI0N1BINHA4YitobUFyQnBocFZEMDBrZ3JRSkVwSCJ9|magazine=Life Science Leader|publisher=VertMarkets|access-date=6 January 2020}}</ref> Since the company started in 1999, he had been Genmab's [[chief scientific officer]] (CSO); he had concurrently served as head of research, then president of R&D.<ref name="Life Science Leader 2019" /> {{As of|2019||df=}}, Van de Winkel remained CEO of the firm.<ref name="Life Science Leader 2019" /> Van de Winkel is a scientist, having produced more than 300 publications during his career.<ref name="Life Science Leader 2019" /> |
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=== Partnerships === |
=== Partnerships === |
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'''Amgen:''' In May 1999, Genmab entered a sub-license agreement with Amgen where it would gain rights to the IL15 antibodies. In October 2001, this was replaced by a direct license agreement where Amgen retained exclusive commercialization options for the products through phase II. Amgen has also expanded its agreement to a new antibody program targeting additional disease targets. Amgen has discontinued development of the IL15 antibody, AMG 714, in psoriasis and rheumatoid arthritis based on disappointing results from recent clinical studies. Amgen is exploring options to maximize the value of this asset, but as this time, no further internal development of a lead indication is planned. |
'''Amgen:''' In May 1999, Genmab entered a sub-license agreement with Amgen where it would gain rights to the IL15 antibodies. In October 2001, this was replaced by a direct license agreement where Amgen retained exclusive commercialization options for the products through phase II. Amgen has also expanded its agreement to a new antibody program targeting additional disease targets. Amgen has discontinued development of the IL15 antibody, AMG 714, in psoriasis and rheumatoid arthritis based on disappointing results from recent clinical studies. Amgen is exploring options to maximize the value of this asset, but as this time, no further internal development of a lead indication is planned. |
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'''GlaxoSmithKline:''' In December 2006, Genmab entered a deal with [[GlaxoSmithKline]] to co-develop and commercialize [[ofatumumab]],<ref name=":0">{{Cite news|url=https://www.newspapers.com/clip/41821831/glaxo_buys_stake_in_genmab/|title=Glaxo buys stake in Genmab|date=December 20, 2006|work=The Boston Globe|access-date=6 January 2020|agency=Associated Press|issue=173|volume=270|page=D5|via=Newspapers.com}}</ref> a drug that could be used for treatment in [[CD20#Clinical significance|CD20 positive]] [[B-cell chronic lymphocytic leukemia]], [[Follicular non-Hodgkin's lymphoma|follicular non-Hodgkin’s lymphoma]], [[rheumatoid arthritis]] and other indications. The agreement gave Genmab a license fee of DKK 582 million ({{US$|102 million}}) and GSK bought 4,471,202 shares of Genmab for DKK 2,033 million ({{US$|359 million}}). |
'''GlaxoSmithKline:''' In December 2006, Genmab entered a deal with [[GlaxoSmithKline]] to co-develop and commercialize [[ofatumumab]],<ref name=":0">{{Cite news|url=https://www.newspapers.com/clip/41821831/glaxo_buys_stake_in_genmab/|title=Glaxo buys stake in Genmab|date=December 20, 2006|work=The Boston Globe|access-date=6 January 2020|agency=Associated Press|issue=173|volume=270|page=D5|via=Newspapers.com}}</ref> a drug that could be used for treatment in [[CD20#Clinical significance|CD20 positive]] [[B-cell chronic lymphocytic leukemia]], [[Follicular non-Hodgkin's lymphoma|follicular non-Hodgkin’s lymphoma]], [[rheumatoid arthritis]] and other indications. The agreement gave Genmab a license fee of DKK 582 million ({{US$|102 million}}) and GSK bought 4,471,202 shares of Genmab for DKK 2,033 million ({{US$|359 million}}). The potential value of this agreement could be DKK 12.0 billion ({{US$|2.1 billion}}) if all milestones are reached and commercial success is reached in the fields of cancer, autoimmune, and inflammatory disease.<ref name=":0" /> The intention of GlaxoSmithKline to exit oncology, disagreement around milestones reached, and financial difficulties of Genmab, led to re-negotiation of the partnership in mid-2010, resulting in an immediate {{US$|135 million}} payment by GlaxoSmithKline and future financial and licensing concessions on the part of Genmab.<ref name="Life Science Leader 2019" /> |
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In addition, Genmab has collaborations with Roche (RG1507, a monoclonal antibody directed against [[IGF-1R]], collaboration was terminated in 2009)<ref>{{cite web|url=http://www.fiercebiotech.com/biotech/genmab-shares-slide-after-roche-dumps-collaboration|title=Genmab shares slide after Roche dumps collaboration|author=Carroll|first=John|date=7 December 2009|website=FierceBiotech|publisher=Questex|access-date=6 January 2020}}</ref> |
In addition, Genmab has collaborations with Roche (RG1507, a monoclonal antibody directed against [[IGF-1R]], collaboration was terminated in 2009)<ref>{{cite web|url=http://www.fiercebiotech.com/biotech/genmab-shares-slide-after-roche-dumps-collaboration|title=Genmab shares slide after Roche dumps collaboration|author=Carroll|first=John|date=7 December 2009|website=FierceBiotech|publisher=Questex|access-date=6 January 2020}}</ref> |
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In April 2024, the company announced it would acquire ProfoundBio for $1.8 billion.<ref>{{cite web | url=https://www.biospace.com/article/biospace-mergers-and-acquisitions-tracker/?s=79 | title=Novartis, Ono Latest to Announce Billion-Dollar M&A Deals }}</ref> |
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== Products and pipeline == |
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Status, as of 16 February 2022.<ref name="AR2021"/> |
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== Products == |
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=== Genmab's Proprietary Pipeline === |
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The company has 8 approved [[Antibody|antibodies]] ([[Monoclonal_antibody|monoclonal]] and [[Bispecific_monoclonal_antibody|bispecific]]) used in 8 marketed products, covering [[cancer]] indications and [[Autoimmune_disease|autoimmune diseases]].<ref name="AR2023" /> |
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Proprietary, marketed with partners: |
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* Epkinly/Tepkinly ([[epcoritamab]]) for the treatment of [[Relapse|Relapsed]]/[[Resistant_cancer|refractory]] [[diffuse large B-cell lymphoma]] (DLBCL) ([[AbbVie]]) |
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* Tivdak [[Tisotumab_vedotin|(tisotumab vedotin)]] for the treatment of previously treated [[Recurrent_cancer|recurrent]] or [[Metastasis|metastatic]] [[cervical cancer]] ([[Seagen]]) |
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Marketed by partners: |
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* Darzalex ([[Intravenous infusion|IV]]) ([[daratumumab]]) / Darzalex Faspro ([[Subcutaneous injection|SC]]) ([[Daratumumab/hyaluronidase|daratumumab and hyaluronidase]]) for the treatment of all stages of [[multiple myeloma]] as combination therapy or monotherapy, and for the treatment of newly diagnosed [[AL amyloidosis|amyloid light-chain (AL) amyloidosis]] ([[Janssen Pharmaceuticals|Janssen]]) |
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* Kesimpta ([[ofatumumab]]) for the treatment of [[relapsing remitting multiple sclerosis]] ([[Novartis]]) |
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* Rybrevant ([[amivantamab]]) for the treatment of [[non-small-cell lung cancer]] (EGFR exon 20 insertion mutations) (Janssen) |
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* Talvey ([[talquetamab]]) for the treatment of [[Multiple_myeloma#Relapse|relapsed/refractory MM]] (Janssen) |
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* Tecvayli ([[teclistamab]]) for the treatment of [[Multiple_myeloma#Relapse|relapsed/refractory MM]] (Janssen) |
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* Tepezza ([[teprotumumab]]) for the treatment of [[Graves' ophthalmopathy|thyroid eye disease]] ([[Horizon Therapeutics|Horizon]]) |
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Furthermore both Genmab and its partners have a whole range of antibody programs, building on Genmab technologies, in [[Clinical_trial|clinical]] and [[Phases_of_clinical_research#Summary|pre-clinical]] development in both cancer and autoimmune diseases.<br />Genmab have several late stage clinical programs for tisotumab vedotin ([[cervical cancer]], [[ovarian cancer]] and [[Neoplasm|solid tumors]]) and epcoritamab (B-cell [[non-Hodgkin lymphoma]] and Relapsed/refractory [[Follicular lymphoma]]).<br />The partners have, among others, clinical programs for daratumumab (non-MM [[blood cancer]]s), amivantamab ([[Stomach cancer|gastric cancer]] and [[esophageal cancer]]), [[Mim8]] ([[Factor VIII (medication)|Factor VIII]] mimetic bi-specific antibody) ([[Haemophilia A]]), [[inclacumab]] ([[Vaso-occlusive crisis|VOC]] in [[Sickle cell disease]]) and teprotumumab ([[Systemic scleroderma|diffuse cutaneous systemic sclerosis]]).{{Citation needed|date=March 2023}} |
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== Pipeline == |
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=== Proprietary Products === |
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==== Approved Medicines/Products ==== |
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{| class="wikitable" |
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|- |
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! Approved Product !! Target !! Developed by !! Disease indications !! Approval Year |
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|- |
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| EPKINLY/TEPKINLY ([[epcoritamab]]) || [[CD3 (immunology)|CD3]], [[CD20]] || 50:50 Genmab/[[AbbVie]] || [[Relapse|Relapsed]]/[[Resistant_cancer|refractory]] [[diffuse large B-cell lymphoma]] (DLBCL) || 2023<ref>{{Cite press release|url=https://www.globenewswire.com/news-release/2023/05/19/2672708/0/en/EPKINLY-epcoritamab-bysp-Approved-by-U-S-Food-and-Drug-Administration-as-the-First-and-Only-Bispecific-Antibody-to-Treat-Adults-with-Relapsed-or-Refractory-R-R-Diffuse-Large-B-cell.html/|title=EPKINLY™ (epcoritamab-bysp) Approved by U.S. Food and Drug Administration as the First and Only Bispecific Antibody to Treat Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)|publication-date=19 May 2023|publisher=globenewswire|access-date=20 May 2023}}</ref> |
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|- |
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| Tivdak [[Tisotumab_vedotin|(tisotumab vedotin)]] || [[Tissue factor|TF]] || 50:50 Genmab/[[Seagen]] || [[Recurrent_cancer|Recurrent]] or [[Metastasis|metastatic]] [[Cervical cancer]] || 2021 |
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|} |
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==== Pipeline, Including Further Development for Approved Medicines ==== |
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{| class="wikitable" |
{| class="wikitable" |
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| Line 82: | Line 101: | ||
! Product !! Target !! Developed by !! Disease indications !! Most Advanced Development Phase |
! Product !! Target !! Developed by !! Disease indications !! Most Advanced Development Phase |
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|- |
|- |
||
| |
| Epcoritamab || CD3, CD20 || 50:50 Genmab/AbbVie || Relapsed/refractory DLBCL || III |
||
|- |
|- |
||
| |
| " || " || " || Relapsed/refractory [[Follicular lymphoma]] (FL) || III |
||
|- |
|- |
||
| " || " || " || |
| " || " || " || First line DLBCL || III |
||
|- |
|- |
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| " || " || " || [[B-cell]] [[non-Hodgkin lymphoma]] (B-NHL) || II |
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| [[Epcoritamab]] <br/>(DuoBody-CD3, CD20) || [[CD3 (immunology)|CD3]], [[CD20]] || 50:50 Genmab/[[AbbVie]] || Relapsed/refractory [[diffuse large B-cell lymphoma]] (DLBCL) || III<ref>{{Cite web|url=https://clinicaltrials.gov/ct2/show/NCT04628494/|title=A Phase 3 Trial of Epcoritamab in R/R DLBCL|publication-date=10 November 2021|publisher=National Library of Medicine|access-date=7 January 2022}}</ref><br/>Est. prim. completion 2023-06 |
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|- |
|- |
||
| " || " || " || |
| " || " || " || Relapsed/refractory [[chronic lymphocytic leukemia]] (CLL) & [[Richter's transformation|Richter's syndrome]] || I/II |
||
|- |
|- |
||
| " || " || " || |
| " || " || " || Indolent NHL, pediatric patients || I |
||
|- |
|- |
||
| Tisotumab vedotin || TF || 50:50 Genmab/Seagen || Cervical cancer || III |
|||
| " || " || " || Relapsed/refractory [[chronic lymphocytic leukemia]] (CLL) || I |
|||
|- |
|- |
||
| |
| " || " || " || [[Neoplasm|Solid tumors]] || II |
||
|- |
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| Acasunlimab<br/>(GEN1046/BNT311) || [[PD-L1]], [[4-1bb|4-1BB]] || 50:50 Genmab/[[BioNTech]] || [[Non-small-cell lung cancer]] (NSCLC) || II |
|||
|- |
|||
| " || " || " || Advanced [[endometrial cancer]] || II |
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|- |
|- |
||
| " || " || " || Solid tumors || I/II |
| " || " || " || Solid tumors || I/II |
||
|- |
|- |
||
| |
| Tecaginlimab<br/>(GEN1042/BNT312) || [[CD40]], 4-1BB || " || Solid tumors || II |
||
|- |
|||
| HexaBody-CD38<br/>(GEN3014) || [[CD38]] || Genmab (under an exclusive worldwide license/option agreement with Janssen) || Hematologic malignancies || II |
|||
|- |
|||
| DuoBody-CD3xB7H4<br/>(GEN1047) || CD3, [[VTCN1|B7H4]] || Genmab || Solid tumors || II |
|||
|- |
|- |
||
| |
| HexaBody-CD27<br/>(GEN1053/BNT313) || [[CD27]] || 50:50 Genmab/[[BioNTech]] || Solid tumors || I |
||
|- |
|- |
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| GEN1056<br/>(BNT322) || Undisclosed || " || Solid tumors || I |
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| HexaBody-CD38<br/>(GEN3014) || [[CD38]] || Genmab (under an exclusive worldwide license/option agreement with Janssen) || Hematologic malignancies || I |
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|- |
|- |
||
| DuoBody-CD3xCD20<br/>GEN3017 || CD3, CD20 || Genmab || Relapsed/refractory [[Hodgkin lymphoma]] (HL) & NHL || I |
|||
| DuoBody-CD3xB7H4<br/>(GEN1047) || CD3, [[VTCN1|B7H4]] || Genmab || Solid tumors || I<ref>{{Cite web|url=https://clinicaltrials.gov/ct2/show/NCT05180474/|title=Research Trial to Study Safety of GEN1047 (DuoBody®-CD3xB7H4) in Participants With Malignant Solid Tumors|publication-date=6 January 2022|publisher=National Library of Medicine|access-date=7 January 2022}}</ref> |
|||
|} |
|} |
||
=== Programs Incorporating Genmab’s |
=== Programs Incorporating Genmab’s Innovation and Technology === |
||
==== Approved Medicines ==== |
==== Approved Medicines/Products ==== |
||
{| class="wikitable" |
{| class="wikitable" |
||
|- |
|- |
||
! Product !! Target !! Developed & Marketed |
! Approved Product !! Target !! Discovered and/or Developed & Marketed By !! Disease indications !! Approval Year !! Royalties |
||
|- |
|- |
||
| |
|DARZALEX (iv) ([[daratumumab]]) and DARZALEX FASPRO (subcu.) ([[Daratumumab/hyaluronidase|daratumumab and hyaluronidase]]) || [[CD38]] || [[Janssen Pharmaceuticals|Janssen]] || [[Multiple myeloma]] (MM) || 2015 (iv), 2020 (sc) || 0-$3bn tiered: 14.92% (avg.), >$3bn fixed: 20% |
||
|- |
|- |
||
| |
| DARZALEX FASPRO || CD38 || Janssen || [[AL Amyloidosis]] || 2021 || As for MM |
||
|- |
|- |
||
| Kesimpta ([[ofatumumab]]) || CD20 || [[Novartis]] || [[Multiple_sclerosis#Types_and_variants|Relapsing remitting multiple sclerosis]] (RRMS) || 2020 || 10% |
|||
| Daratumumab || " || " || Non-MM [[blood cancer]]s || II || " |
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|- |
|- |
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| TEPEZZA ([[teprotumumab]]) || [[IGF-1R]] || [[Amgen]] <br/> (under sublicense from [[Hoffmann-La Roche|Roche]]) || [[Graves' ophthalmopathy|Thyroid eye disease]] (TED) || 2020 || 6% (Jan Van de Winkel<ref name="event.webcasts.com">{{Cite web|url=https://event.webcasts.com/viewer/event.jsp?ei=1566172&tp_key=9e580f9efc/|title=Morgan Stanley 20th Annual Global Healthcare Conference|publication-date=13 September 2022|publisher=event.webcasts.com|access-date=14 September 2022}}</ref>) |
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| Kesimpta ([[ofatumumab]]) || CD20 || [[Novartis]] || [[Relapsing remitting multiple sclerosis]] (RMS) || Approved (2020) || 10% |
|||
|- |
|- |
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| RYBREVANT ([[amivantamab]]) || [[Epidermal growth factor receptor|EGFR]], [[C-Met|cMet]] || Janssen || NSCLC || 2021 || 8-10% |
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| Arzerra (ofatumumab)<br/>(Ofatumumab is no longer in development for CLL)|| " || Novartis (originally [[GlaxoSmithKline]]) || [[Chronic lymphocytic leukemia]] (CLL) || Approved (2009) || - (2019: In EU and several other territories marketing discontinued for commercial reasons; 2020: In US transitioned to free oncology access program) |
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|- |
|- |
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| TECVAYLI ([[teclistamab]]) || [[B-cell maturation antigen|BCMA]], CD3 || Janssen || [[Multiple_myeloma#Relapse|Relapsed/refractory MM]] (RRMM) || 2022 || ~5-6% |
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| Tepezza ([[teprotumumab]]) || [[IGF-1R]] || [[Horizon Therapeutics|Horizon]] (under sublicense from [[Hoffmann-La Roche|Roche]]) || [[Graves' ophthalmopathy|Thyroid eye disease]] (TED) || Approved (2020) || ~5-6% (GMAB: "mid single-digit") |
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|- |
|- |
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| TALVEY ([[talquetamab]]) || [[GPRC5D]], CD3 || Janssen || RRMM || 2023 || ~5-6% |
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| Teprotumumab || " || " || [[Systemic scleroderma|Diffuse cutaneous systemic sclerosis]] (dcSSc) || I || - |
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|- |
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| [[Rybrevant]] ([[amivantamab]]) || [[Epidermal growth factor receptor|EGFR]], [[C-Met|cMet]] || Janssen || (NSCLC) || Approved (2021) || ~10-12% (GMAB: "low double-digit") |
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|- |
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| Amivantamab || " || " || Advanced or Metastatic [[Stomach cancer|Gastric cancer]] or [[Esophageal cancer]] || II<ref>{{Cite web|url=https://clinicaltrials.gov/ct2/show/NCT04945733/|title=A Study of Amivantamab in Participants With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer (v7)|publication-date=4 November 2021|publisher=National Library of Medicine|access-date=12 November 2021}}</ref> || - |
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|} |
|} |
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==== Pipeline, Partner-owned products incorporating Genmab’s innovation, ≥Phase 2 Development ==== |
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==== Clinical Stage Programs ==== |
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{| class="wikitable" |
{| class="wikitable" |
||
|- |
|- |
||
! Product |
! Product !! Target !! Discovered and/or Developed & Marketed By !! Disease indications !! Most Advanced Development Phase !! Royalties |
||
|- |
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| [[Teclistamab]] (JNJ-64007957) || [[B-cell maturation antigen|BCMA]], CD3 || DuoBody || Janssen || Relapsed or refractory MM || III<ref>{{Cite web|url=https://clinicaltrials.gov/ct2/show/NCT05083169/|title=A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3) (v2)|publication-date=4 November 2021|publisher=National Library of Medicine|access-date=5 November 2021}}</ref><br/>Est. prim. completion 2024-07<br/>BLA to FDA submitted 2021-12<ref>{{Cite web|url=https://www.prnewswire.com/news-releases/janssen-submits-biologics-license-application-to-us-fda-seeking-approval-of-teclistamab-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma-301451472.html/|title=Janssen Submits Biologics License Application to U.S. FDA Seeking Approval of Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma|publication-date=29 December 2021|publisher=PR Newswire|access-date=29 December 2021}}</ref> || ~5-6% |
|||
|- |
|- |
||
| Amivantamab || EGFR, cMet || Janssen || Advanced or Metastatic [[Stomach cancer|Gastric]] or [[Esophageal cancer]] || II || 8-10% |
|||
| [[Mim8]] ([[Factor VIII (medication)|Factor VIII]] mimetic bi-specific antibody) || [[Factor IX|FIXa]], [[Factor X|FX]] || DuoBody || [[Novo Nordisk]] || [[Haemophilia A]] || III<ref>{{Cite web|url=https://clinicaltrials.gov/ct2/show/NCT05053139/|title=A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors|publication-date=4 January 2022|publisher=National Library of Medicine|access-date=7 January 2022}}</ref><br/>Est. prim. completion 2023-09 || - |
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|- |
|- |
||
| Amivantamab || " || " || [[Hepatocellular carcinoma]] || II || " |
|||
| [[Inclacumab]] || [[selectin P]] || UltiMAb || Global Blood Therapeutics (under sublicense from Roche) || [[Vaso-occlusive crisis|VOC]] in [[Sickle cell disease]] || III<ref>{{Cite web|url=https://clinicaltrials.gov/ct2/show/NCT04935879/|title=A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises|publication-date=5 November 2021|publisher=National Library of Medicine|access-date=7 January 2022}}</ref><br/>Est. prim. completion 2023-07 || - |
|||
|- |
|- |
||
| |
| Amivantamab || " || " || Advanced or metastatic [[colorectal cancer]] || I/II || " |
||
|- |
|- |
||
| [[Inclacumab]] || [[selectin P]] || [[Pfizer]] || [[Vaso-occlusive crisis|VOC]] in [[Sickle cell disease]] || III<br/>Est. prim. completion 2023-12 || 5-6% (Jan Van de Winkel: "mid single-digit"<ref name="event.webcasts.com"/>) |
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| [[Camidanlumab tesirine]] || [[IL2RA|CD25]] || UltiMAb || [[ADC Therapeutics]] || Relapsed or refractory [[Hodgkin lymphoma]] (HL) || II<br/>BLA discussions meeting with FDA planned<ref>{{Cite web|url=https://www.businesswire.com/news/home/20220610005073/en/ADC-Therapeutics-Announces-Results-from-Pivotal-Phase-2-Clinical-Trial-of-Camidanlumab-Tesirine-Cami-in-Relapsed-or-Refractory-Hodgkin-Lymphoma/|title=ADC Therapeutics Announces Results from Pivotal Phase 2 Clinical Trial of Camidanlumab Tesirine (Cami) in Relapsed or Refractory Hodgkin Lymphoma|publication-date=10 June 2022|publisher=Business Wire|access-date=10 June 2022}}</ref> || 5-9% tiered (GMAB: "mid-to-high single-digit tiered") |
|||
|- |
|- |
||
| [[Mim8]]<br/>([[Factor VIII (medication)|Factor VIII]] mimetic bispecific antibody) || [[Factor IX|FIXa]], [[Factor X|FX]] || [[Novo Nordisk]] || [[Haemophilia A]] || III<br/>Est. prim. completion 2024-05 || 5-6% (Jan Van de Winkel: "mid single-digit"<ref name="event.webcasts.com"/>) |
|||
| Camidanlumab tesirine || " || " || " || Solid tumors || I || " |
|||
|- |
|- |
||
| [[Camidanlumab tesirine]]<br/>(ADCT-301) || [[IL2RA|CD25]] || [[ADC Therapeutics]]|| Relapsed/refractory HL || II<br/>2022-11: FDA has advised ADCT that an ongoing ph3 study - preferably with full enrollment - is needed to support a BLA submission. ADCT therefore plans to conduct a ph3 study for which full enrollment is estimated to take 2 years.<ref>{{Cite web|url=https://www.cancernetwork.com/view/confirmatory-phase-3-trial-needed-prior-to-camidanlumab-tesirine-bla-submission-for-accelerated-approval-path-fda-says/|title=Confirmatory Phase 3 Trial Needed Prior to Camidanlumab Tesirine BLA Submission for Accelerated Approval Path, FDA Says|publication-date=11 November 2022|publisher=www.cancernetwork.com|access-date=11 December 2022}}</ref> || 5-9% tiered (GMAB: "mid-to-high single-digit tiered") |
|||
| PRV-015<br/>(AMG 714) || [[Interleukin 15|IL-15]] || UltiMAb || Provention Bio || Gluten-free diet non-responsive [[Coeliac disease|Celiac disease]] || II || - |
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|- |
|- |
||
| [[Ordesekimab]] || [[Interleukin 15|IL-15]] || [[Sanofi]] || Gluten-free diet non-responsive [[Coeliac disease|Celiac disease]] || II || - |
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| Lu AF82422 || [[Alpha-synuclein|alpha-Synuclein]] || UltiMAb || [[Lundbeck]] || [[Multiple system atrophy]] (MSA) || II<ref>{{Cite web|url=https://news.cision.com/h--lundbeck-a-s/r/lundbeck-launches-a-phase-ii-study-for-potential-new-treatment-of-multiple-system-atrophy,c3442560/|title=Lundbeck launches a phase II study for potential new treatment of multiple system atrophy|publisher=news.cision.com|publication-date=8 November 2021|access-date=8 November 2021}}</ref> || - |
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|- |
|- |
||
| |
| Lu AF82422 || [[Alpha-synuclein|Alpha-Synuclein]] || [[Lundbeck]] || [[Multiple system atrophy]] (MSA) || II || - |
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|} |
|} |
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<ref name="AR2023" /> |
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== References == |
== References == |
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{{Reflist|33em|refs= |
{{Reflist|33em|refs= |
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<ref name=" |
<ref name="AR2023">{{cite web |url=https://ml-eu.globenewswire.com/Resource/Download/e5ff6f57-ef04-4008-aa23-352e70c71477 |publication-date=14 February 2024 |title=Rooted in Science, Inspired by Patients - 2023 Annual Report |access-date=11 March 2024 |publisher=GlobeNewswire}}</ref>}} |
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Latest revision as of 04:10, 19 June 2024
 | This article may require cleanup to meet Wikipedia's quality standards. The specific problem is: A mess of an article whose lede is a disaster. (May 2024) |
 | |
| Company type | Public |
|---|---|
| Nasdaq Copenhagen: GMAB Nasdaq: GMAB (ADR) OMX Copenhagen 25 component[1] | |
| Industrie | Biotechnology |
| Gegründet | 1999 |
| Gründer | Florian Schönharting[2][3][4] and Lisa Drakeman[5] |
| Hauptsitz | Copenhagen, Denmark |
Number of locations | 4 (2023)[6] |
Key people |
|
| Produkte | DARZALEX/ DARZALEX FASPRO EPKINLY/TEPKINLY Kesimpta RYBREVANT TALVEY TECVAYLI TEPEZZA Tivdak |
| Revenue | DKK 16.474 billion (2023)[6] |
| DKK 5.321 billion (2023)[6] | |
| DKK 4.352 billion (2023)[6] | |
Number of employees | 2,204 (2023)[6] |
| Website | Genmab.com |
Genmab A/S is a Danish biotechnology company, founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund.[7] The company is based in Copenhagen, Denmark – internationally, it operates through the subsidiaries Genmab B.V. in Utrecht, The Netherlands, Genmab U.S., Inc. in Princeton, USA, and Genmab K.K. in Tokyo, Japan. Genmab is a dual-listed company with shares traded on both the Copenhagen Stock Exchange in Denmark[8] and the NASDAQ Global Select Market in the US.[9]
Technologie
[edit]Genmab's technology is licensed from Medarex to create fully human high affinity antibodies using transgenic mice. These antibodies are less likely to elicit an allergic reaction and other side effects compared with other types of man-made antibodies containing other animal proteins because the IgG antibodies produced have human proteins. This technology is called the HuMab-Mouse technology. One benefit of using this type of technology is that there is no need for humanization or complicated genetic engineering to make this antibody fit for humans which cuts down on expenses and time spent developing it. It can be generated within months and can be selected to bind to specific antigens such as tumor cells and other infectious agents.
Genmab also has developed its own technology called UniBody, which is used to make smaller antibodies in contrast to the traditional full sized monoclonal antibody. Its smaller size allows for better distribution over larger target areas like tumors. The UniBody can only bind to one site and doesn’t elicit a harmful immune response by binding to two sites and over-activating cell growth. It does not kill target cells but rather silences or inhibits them. Thus it can be used to treat certain cancers, inflammations, allergies and asthmas, where killing the cell isn’t the objective.[10]
The technology modifies the human IgG4 antibody. Normally the IgG4 is considered inert and doesn’t elicit an immune response. However, they are also unstable and fall apart easily, which makes them unsuitable for therapeutic use. Genmab changes the shape of the IgG4 antibody by eliminating the hinge, the part of the antibody that creates the “Y” shape. This halves the antibody, creating a smaller version now known as their UniBody. This smaller version can only bind to one site and does not stimulate cancer cells to grow.[11]
History
[edit]Genmab was founded as a European spin-off of American Biotech company Medarex in February 1999. Danish investment firm BankInvest, under Florian Schönharting, provided the seed investment for the company to start up in Copenhagen. Like Medarex, Genmab began work producing monoclonal antibodies for life-threatening or debilitating diseases. Rising quickly in the Biotech world, Genmab attracted many investors, especially venture capital firms. The company went public in October 2000, earning DKK 1.56 billion, and had a second public offering in January 2006, yielding DKK 800 million.
The company's initial R&D location was a nine-story building in Utrecht Science Park, in the Netherlands; this was replaced with an "R&D Center" also in Utrecht, in June 2018.[5] By mid-2019, this new facility was at capacity, and plans were set afoot to build an adjacent, connected facility.[5]
By 2001, Medarex and Genmab had come back together in a drug development partnership, which highlighted the manufacturing deficit and clinical development expertise of Genmab relative to Medarex.[12]
In 2005, the Biotechnology Industry Organization (BIO) and the Long Island Life Sciences Initiative honored Genmab with a James D. Watson Helix Award.[13]
2008 saw the company purchasing a 22,000-litre, 36-acre antibody manufacturing plant in Brooklyn Park, Minnesota from PDL BioPharma, with plans to retain all 170 employees thereat.[5][14] However, the company ran into financial trouble originating from several quarters, and a decision to sell the facility was reached in late 2009, after Genmab had started producing development scale batches from the facility.[5] In 2008, the world was experiencing a financial crisis as a whole, and GlaxoSmithKline decided to exit oncology, which impacted co-development of ofatumumab, an oncology-directed product.[5] In tandem with the sale of the plant, the company reorganized and planned to dismiss about 300 employees.[5] Selling the facility, though, proved very difficult, due in large part to the global financial crisis; by 2012, Genmab had decided to simply write-off the entire facility from the company's balance sheets.[5] A sale of the facility to Baxter came in February 2013.[5]
Following the failed strategy of in-housing manufacturing, Genmab chose to thereafter completely outsource both manufacturing and the conduct of clinical trials.[5]
The Company's first product, Arzerra (ofatumumab) reached the US market in 2009 for refractory chronic lymphocytic leukemia.[15][failed verification]
Executive history
[edit]Lisa N. Drakeman, Ph.D. had been a vice president at Medarex and wife of Donald Drakeman, Medarex's CEO and President at the time. Drakeman was one of Genmab's co-founders and was appointed chief executive officer (CEO) of the company upon incorporation in 1999, also joining the board of directors.[5] As of 2002[update], Drakeman remained in the CEO role,[16] but by 2010 she had announced her retirement.[5]
In 2010, Jan Van de Winkel, a co-founder of the firm, was appointed as President and CEO of Genmab.[5] Since the company started in 1999, he had been Genmab's chief scientific officer (CSO); he had concurrently served as head of research, then president of R&D.[5] As of 2019[update], Van de Winkel remained CEO of the firm.[5] Van de Winkel is a scientist, having produced more than 300 publications during his career.[5]
Partnerships
[edit]Amgen: In May 1999, Genmab entered a sub-license agreement with Amgen where it would gain rights to the IL15 antibodies. In October 2001, this was replaced by a direct license agreement where Amgen retained exclusive commercialization options for the products through phase II. Amgen has also expanded its agreement to a new antibody program targeting additional disease targets. Amgen has discontinued development of the IL15 antibody, AMG 714, in psoriasis and rheumatoid arthritis based on disappointing results from recent clinical studies. Amgen is exploring options to maximize the value of this asset, but as this time, no further internal development of a lead indication is planned.
GlaxoSmithKline: In December 2006, Genmab entered a deal with GlaxoSmithKline to co-develop and commercialize ofatumumab,[17] a drug that could be used for treatment in CD20 positive B-cell chronic lymphocytic leukemia, follicular non-Hodgkin’s lymphoma, rheumatoid arthritis and other indications. The agreement gave Genmab a license fee of DKK 582 million (US$102 million) and GSK bought 4,471,202 shares of Genmab for DKK 2,033 million (US$359 million). The potential value of this agreement could be DKK 12.0 billion (US$2.1 billion) if all milestones are reached and commercial success is reached in the fields of cancer, autoimmune, and inflammatory disease.[17] The intention of GlaxoSmithKline to exit oncology, disagreement around milestones reached, and financial difficulties of Genmab, led to re-negotiation of the partnership in mid-2010, resulting in an immediate US$135 million payment by GlaxoSmithKline and future financial and licensing concessions on the part of Genmab.[5]
In addition, Genmab has collaborations with Roche (RG1507, a monoclonal antibody directed against IGF-1R, collaboration was terminated in 2009)[18]
In April 2024, the company announced it would acquire ProfoundBio for $1.8 billion.[19]
Produkte
[edit]The company has 8 approved antibodies (monoclonal and bispecific) used in 8 marketed products, covering cancer indications and autoimmune diseases.[6]
Proprietary, marketed with partners:
- Epkinly/Tepkinly (epcoritamab) for the treatment of Relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (AbbVie)
- Tivdak (tisotumab vedotin) for the treatment of previously treated recurrent or metastatic cervical cancer (Seagen)
Marketed by partners:
- Darzalex (IV) (daratumumab) / Darzalex Faspro (SC) (daratumumab and hyaluronidase) for the treatment of all stages of multiple myeloma as combination therapy or monotherapy, and for the treatment of newly diagnosed amyloid light-chain (AL) amyloidosis (Janssen)
- Kesimpta (ofatumumab) for the treatment of relapsing remitting multiple sclerosis (Novartis)
- Rybrevant (amivantamab) for the treatment of non-small-cell lung cancer (EGFR exon 20 insertion mutations) (Janssen)
- Talvey (talquetamab) for the treatment of relapsed/refractory MM (Janssen)
- Tecvayli (teclistamab) for the treatment of relapsed/refractory MM (Janssen)
- Tepezza (teprotumumab) for the treatment of thyroid eye disease (Horizon)
Furthermore both Genmab and its partners have a whole range of antibody programs, building on Genmab technologies, in clinical and pre-clinical development in both cancer and autoimmune diseases.
Genmab have several late stage clinical programs for tisotumab vedotin (cervical cancer, ovarian cancer and solid tumors) and epcoritamab (B-cell non-Hodgkin lymphoma and Relapsed/refractory Follicular lymphoma).
The partners have, among others, clinical programs for daratumumab (non-MM blood cancers), amivantamab (gastric cancer and esophageal cancer), Mim8 (Factor VIII mimetic bi-specific antibody) (Haemophilia A), inclacumab (VOC in Sickle cell disease) and teprotumumab (diffuse cutaneous systemic sclerosis).[citation needed]
Pipeline
[edit]Proprietary Products
[edit]Approved Medicines/Products
[edit]| Approved Product | Target | Developed by | Disease indications | Approval Year |
|---|---|---|---|---|
| EPKINLY/TEPKINLY (epcoritamab) | CD3, CD20 | 50:50 Genmab/AbbVie | Relapsed/refractory diffuse large B-cell lymphoma (DLBCL) | 2023[20] |
| Tivdak (tisotumab vedotin) | TF | 50:50 Genmab/Seagen | Recurrent or metastatic Cervical cancer | 2021 |
Pipeline, Including Further Development for Approved Medicines
[edit]| Produkt | Target | Developed by | Disease indications | Most Advanced Development Phase |
|---|---|---|---|---|
| Epcoritamab | CD3, CD20 | 50:50 Genmab/AbbVie | Relapsed/refractory DLBCL | III |
| " | " | " | Relapsed/refractory Follicular lymphoma (FL) | III |
| " | " | " | First line DLBCL | III |
| " | " | " | B-cell non-Hodgkin lymphoma (B-NHL) | II |
| " | " | " | Relapsed/refractory chronic lymphocytic leukemia (CLL) & Richter's syndrome | I/II |
| " | " | " | Indolent NHL, pediatric patients | I |
| Tisotumab vedotin | TF | 50:50 Genmab/Seagen | Cervical cancer | III |
| " | " | " | Solid tumors | II |
| Acasunlimab (GEN1046/BNT311) |
PD-L1, 4-1BB | 50:50 Genmab/BioNTech | Non-small-cell lung cancer (NSCLC) | II |
| " | " | " | Advanced endometrial cancer | II |
| " | " | " | Solid tumors | I/II |
| Tecaginlimab (GEN1042/BNT312) |
CD40, 4-1BB | " | Solid tumors | II |
| HexaBody-CD38 (GEN3014) |
CD38 | Genmab (under an exclusive worldwide license/option agreement with Janssen) | Hematologic malignancies | II |
| DuoBody-CD3xB7H4 (GEN1047) |
CD3, B7H4 | Genmab | Solid tumors | II |
| HexaBody-CD27 (GEN1053/BNT313) |
CD27 | 50:50 Genmab/BioNTech | Solid tumors | I |
| GEN1056 (BNT322) |
Undisclosed | " | Solid tumors | I |
| DuoBody-CD3xCD20 GEN3017 |
CD3, CD20 | Genmab | Relapsed/refractory Hodgkin lymphoma (HL) & NHL | I |
Programs Incorporating Genmab’s Innovation and Technology
[edit]Approved Medicines/Products
[edit]| Approved Product | Target | Discovered and/or Developed & Marketed By | Disease indications | Approval Year | Royalties |
|---|---|---|---|---|---|
| DARZALEX (iv) (daratumumab) and DARZALEX FASPRO (subcu.) (daratumumab and hyaluronidase) | CD38 | Janssen | Multiple myeloma (MM) | 2015 (iv), 2020 (sc) | 0-$3bn tiered: 14.92% (avg.), >$3bn fixed: 20% |
| DARZALEX FASPRO | CD38 | Janssen | AL Amyloidosis | 2021 | As for MM |
| Kesimpta (ofatumumab) | CD20 | Novartis | Relapsing remitting multiple sclerosis (RRMS) | 2020 | 10% |
| TEPEZZA (teprotumumab) | IGF-1R | Amgen (under sublicense from Roche) |
Thyroid eye disease (TED) | 2020 | 6% (Jan Van de Winkel[21]) |
| RYBREVANT (amivantamab) | EGFR, cMet | Janssen | NSCLC | 2021 | 8-10% |
| TECVAYLI (teclistamab) | BCMA, CD3 | Janssen | Relapsed/refractory MM (RRMM) | 2022 | ~5-6% |
| TALVEY (talquetamab) | GPRC5D, CD3 | Janssen | RRMM | 2023 | ~5-6% |
Pipeline, Partner-owned products incorporating Genmab’s innovation, ≥Phase 2 Development
[edit]| Produkt | Target | Discovered and/or Developed & Marketed By | Disease indications | Most Advanced Development Phase | Royalties |
|---|---|---|---|---|---|
| Amivantamab | EGFR, cMet | Janssen | Advanced or Metastatic Gastric or Esophageal cancer | II | 8-10% |
| Amivantamab | " | " | Hepatocellular carcinoma | II | " |
| Amivantamab | " | " | Advanced or metastatic colorectal cancer | I/II | " |
| Inclacumab | selectin P | Pfizer | VOC in Sickle cell disease | III Est. prim. completion 2023-12 |
5-6% (Jan Van de Winkel: "mid single-digit"[21]) |
| Mim8 (Factor VIII mimetic bispecific antibody) |
FIXa, FX | Novo Nordisk | Haemophilia A | III Est. prim. completion 2024-05 |
5-6% (Jan Van de Winkel: "mid single-digit"[21]) |
| Camidanlumab tesirine (ADCT-301) |
CD25 | ADC Therapeutics | Relapsed/refractory HL | II 2022-11: FDA has advised ADCT that an ongoing ph3 study - preferably with full enrollment - is needed to support a BLA submission. ADCT therefore plans to conduct a ph3 study for which full enrollment is estimated to take 2 years.[22] |
5-9% tiered (GMAB: "mid-to-high single-digit tiered") |
| Ordesekimab | IL-15 | Sanofi | Gluten-free diet non-responsive Celiac disease | II | - |
| Lu AF82422 | Alpha-Synuclein | Lundbeck | Multiple system atrophy (MSA) | II | - |
References
[edit]- ^ "OMX Copenhagen 25 index info".
- ^ "Biotekstjerne spottede de gode forretninger". Berlingske. 20 October 2018. Retrieved 14 November 2020.
- ^ "Marketscreener". Marketscrenner. Marketscreener. Retrieved 14 November 2020.
- ^ "Forward Pharma Board Members". Forward Pharma. Retrieved 14 November 2020.
- ^ a b c d e f g h i j k l m n o p q Wright, Rob (December 30, 2019). "The 5-Step Strategy That Saved Genmab From A Dire Outlook". Life Science Leader. VertMarkets. Retrieved 6 January 2020.
- ^ a b c d e f g h "Rooted in Science, Inspired by Patients - 2023 Annual Report". GlobeNewswire. 14 February 2024. Retrieved 11 March 2024.
- ^ Form 8-K Current Report (Form 8-K). US Securities and Exchange Commission. March 5, 1999. Contacts. Retrieved 6 January 2020.
- ^ "GMAB, Genmab, (DK0010272202)" (Dynamic webpage). Nasdaq Nordic Ltd. Retrieved 9 March 2022.
Market: Nasdaq Copenhagen
- ^ "Genmab A/S ADS (GMAB)" (Dynamic webpage). Nasdaq Inc. Retrieved 9 March 2022.
Market: Nasdaq
- ^ "About Genmab". Genmab. Archived from the original on November 3, 2010. Retrieved 3 November 2010.[self-published source]
- ^ "Next Generation Technology". Science and Research. Genmab. Archived from the original on October 8, 2010. Retrieved 3 November 2010.[self-published source]
- ^ Staff (June 28, 2001). "Business Notes". Central Jersey Briefcase. Courier News. Vol. 119, no. 23. Bridgewater, New Jersey: Gannett. p. A11. Retrieved 6 January 2020 – via Newspapers.com.
- ^ Debbie, Strickland (February 24, 2005). "James D. Watson Helix Awards Honor Biotech's Top Performers" (Press release). Biotechnology Industry Organization. Archived from the original on December 13, 2010. Retrieved 17 January 2011.
- ^ "PDL Biopharma to sell antibody plant". Star Tribune. Vol. XXVI, no. 324. Minneapolis, Minnesota: The Star Tribune Company. Dow Jones News Service. February 22, 2008. p. D2. Retrieved 6 January 2020 – via Newspapers.com.
- ^ "2009 Annual Report". Genmed. Archived from the original on December 1, 2010. Retrieved 3 November 2010.[self-published source]
- ^ Staff (June 27, 2002). "Roche expands commitment to innovative advanced medicines". The Nutley Sun. Nutley, New Jersey: North Jersey Media Group. p. 10. Retrieved 6 January 2020 – via Newspapers.com.
- ^ a b "Glaxo buys stake in Genmab". The Boston Globe. Vol. 270, no. 173. Associated Press. December 20, 2006. p. D5. Retrieved 6 January 2020 – via Newspapers.com.
- ^ Carroll, John (7 December 2009). "Genmab shares slide after Roche dumps collaboration". FierceBiotech. Questex. Retrieved 6 January 2020.
- ^ "Novartis, Ono Latest to Announce Billion-Dollar M&A Deals".
- ^ "EPKINLY™ (epcoritamab-bysp) Approved by U.S. Food and Drug Administration as the First and Only Bispecific Antibody to Treat Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)" (Press release). globenewswire. 19 May 2023. Retrieved 20 May 2023.
- ^ a b c "Morgan Stanley 20th Annual Global Healthcare Conference". event.webcasts.com. 13 September 2022. Retrieved 14 September 2022.
- ^ "Confirmatory Phase 3 Trial Needed Prior to Camidanlumab Tesirine BLA Submission for Accelerated Approval Path, FDA Says". www.cancernetwork.com. 11 November 2022. Retrieved 11 December 2022.
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