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MorphoSys

From Wikipedia, the free encyclopedia
German biopharmaceutical company
MorphoSys AG
Company typePublic
IndustryBiotechnology
Founded1992; 34 years ago (1992)
Headquarters,
Germany
Key people
Dr. Jean-Paul Kress (CEO)
Sung Lee (CFO)
Dr. Malte Peters (Chief Research & Development Officer)
Dr. Roland Wandeler (CCO)
Dr. Marc Cluzel (chairman ofSupervisory Board)
ProductsImmunotherapy
Revenue€327.7 million(2020)[1]
€27.4 million(2020)[1]
€97.9 million(2020)[1]
Total assets€1,659.5 million(end 2020)[1]
Total equity€621.3 million(end 2020)[1]
Number of employees
615(end 2020)[1]
ParentNovartis
Websitemorphosys.com

MorphoSys AG is a Germanbiopharmaceutical company founded in 1992. The company is headquartered nearMunich,Germany, and has a wholly owned subsidiary, MorphoSys US Inc.,[2] inBoston, Massachusetts, in the US. The company has variousantibody,protein andpeptide technologies that it uses to discover and develop both proprietary and partnered drug candidates. The company has more than 100 drugs in its wider pipeline that are being investigated as treatments for a variety of diseases.[1][3][4] While many of these are being developed in partnership with pharma and biotech companies, MorphoSys also has a proprietary pipeline with a focus oncancer andautoimmune diseases.

MorphoSys AG was listed on theFrankfurt Stock Exchange and on the USNasdaq stock exchange.Novartis agreed to acquire the company in February 2024.[5]

History

[edit]

The company was founded in 1992. In 1999, MorphoSys listed on the Frankfurt Stock Exchange under the ticker symbol "MOR".

In 2004, MorphoSys andNovartis entered into a strategic partnership for the research and development of biopharmaceuticals, which was expanded in 2007.[1] Additional discovery partnerships included:Bayer (1999),Roche (2000), Centocor (nowJanssen Biotech, 2000),Schering AG (2001) andPfizer (2003).

In 2008, the company’s first proprietary antibody,MOR103 (now otilimab), entered clinical development.[6] Following the publication of promising results inrheumatoid arthritis, MorphoSys signed a license agreement withGlaxoSmithKline for otilimab.[7] In 2019, GlaxoSmithKline initiated a phase 3 clinical development program with otilimab (now GSK3196165).[8]

In 2010, MorphoSys signed a license agreement with Xencor Inc. for MOR208 (nowtafasitamab).[9]

In July 2017, the first of MorphoSys’ platform drugs received USmarketing approval.Guselkumab (brand nameTremfya), which was developed and is being commercialized byJanssen Biotech, a subsidiary ofJohnson & Johnson, was first approved for the treatment of moderate-to-severeplaque psoriasis in the United States, the European Union and Canada.[10][11]

In April 2018, following a USinitial public offering in which the company raised $239 million,American depositary shares of MorphoSys began trading on theNasdaq stock exchange under the symbol "MOR."[12][13]

In 2018, the company established a wholly owned US subsidiary, MorphoSys US Inc.[2]

In December 2019, based on positiveclinical trial results, the company submitted aBiologics License Application (BLA) to the FDA for tafasitamab in combination withlenalidomide for the treatment of relapsed/refractorydiffuse large B-cell lymphoma.[14] The submission was accepted for filing in February 2020, and a decision on the filing is expected in August 2020.[15]

In January 2020, MorphoSys andIncyte Corporation signed a collaboration and license agreement for the global development and commercialization of tafasitamab.[16] On March 3, 2020, the agreement received antitrust clearance and thus became effective.[17]

In March 2020, MorphoSys announced that the FDA had accepted theBiologics License Application (BLA) for filing and granted priority review for tafasitamab, setting aPrescription Drug User Fee Act (PDUFA) goal date of August 30, 2020.[18]

On July 31, 2020, Monjuvi (tafasitamab-cxix) was approved by the U.S. FDA in combination with lenalidomide for the medical treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible forautologous stem cell transplant (ASCT).[19][20]

In June 2021, MorphoSys announced its acquisition of clinical stage biotechnology company Constellation Pharma for US$1.7 billion.[21]

In February 2024,Novartis agreed to acquire MorphoSys for €2.7 billion.[5] In June 2024, MorphoSys announced its intention to delist from the Frankfurt Stock Exchange and merge into Novartis. The merger was approved in August 2024.[5][22][23]

Pipeline

[edit]

As of December 2020, MorphoSys had 116 drug candidates which are developed by MorphoSys and other pharmaceutical companies, 28 of which were in clinical development. Two antibodies developed by MorphoSys have already been approved and are currently being marketed.[1][4]

Tafasitamab (MOR208) is a humanized monoclonal antibody directed againstCD19 in clinical development for the treatment ofB-cell malignancies.[3][24] Tafasitamab is being evaluated in several clinical trials, alone and in combination with other anti-cancer drugs.[1][4][24]

Felzartamab (MOR202) is a humanized monoclonal antibody directed againstCD38 for the treatment of anti-PLA2R-positivemembranous nephropathy, anautoimmune disease affecting the kidneys.[3] In 2017, MorphoSys entered into a regional licensing agreement with I-Mab Biopharma to develop and commercialize Felzartamab (called TJ202 by I-Mab) inGreater China.[25] Felzartamab is currently under investigation by I-Mab in three clinical trials.[26]

Otilimab (MOR103/GSK3196165) is a fully human monoclonal antibody directed againstGM-CSF.[3] The program is outlicensed toGlaxoSmithKline.[6][7] Otilimab is currently under investigation in a Phase 3 trial inrheumatoid arthritis that started in July 2019.[8]

On March 2, 2023, MorphoSys announced that the company would end its preclinical research programs and cease all related activities. It stated that challenges in the pharmaceutical market forced it to optimize its cost structure and to focus all resources on oncology products in the mid to late stage of development.[27]

Technology

[edit]

MorphoSys has discovered a number of antibody technologies that are used for drug development. Its main technology is HuCAL (Human Combinatorial Antibody Library), which is a collection of more than ten billion fully human antibodies in the form of aphage display bank and a system for their optimization.[28]

Another technology recently developed is the OkapY bispecific antibody technology, which is a proprietary “2+1” bispecific antibody format with the physicochemical properties to simplify the development and large-scale production of such molecules.[clarification needed][1][29]

References

[edit]
  1. ^abcdefghijk"Annual Report 2020". MorphoSys. Retrieved29 April 2021.
  2. ^ab"MorphoSys US, Inc". Archived fromthe original on June 15, 2021.
  3. ^abcd"MorphoSys' therapeutic pipeline". MorphoSys.
  4. ^abc"Form 20-F". U.S. Securities and Exchange Commission.
  5. ^abc"Novartis to acquire cancer-centric MorphoSys for $2.9 bln". Reuters. 2024-02-05.
  6. ^ab"otilimab (MOR103/GSK3196165)". MorphoSys. 2014-10-27. Retrieved2018-06-23.
  7. ^ab"MorphoSys Signs Global License Agreement with GlaxoSmithKline for Anti-Inflammatory Program MOR103". MorphoSys. 2013-06-03. Retrieved2020-04-29.
  8. ^ab"MorphoSys's Licensing Partner GSK Initiates Phase 3 Clinical Program With Otilimab (MOR103/GSK3196165) in Rheumatoid Arthritis". dgap.de. 2019-07-03. Retrieved2020-04-29.
  9. ^"MorphoSys and Xencor Sign License and Collaboration Agreement for Clinical Antibody Program". MorphoSys. 2010-06-27. Retrieved2020-04-29.
  10. ^"MorphoSys' licensee Janssen receives Japanese approval for Tremfya to treat moderate to severe forms of psoriasis & psoriatic arthritis".pharmabiz.com. Retrieved2018-06-05.
  11. ^Guselkumab BLA Approval Letter
  12. ^"Nasdaq Welcomes MorphoSys AG (Nasdaq: MOR) to The Nasdaq Stock Market". Nasdaq. 2018-04-19. Retrieved2020-04-29.
  13. ^"MorphoSys Announces Closing of Nasdaq IPO through an ADS Offering and Exercise of the Underwriters' Option to Purchase Additional ADSs, Leading to Total Gross Proceeds of USD 239 million". dgap.de. 2018-04-24. Retrieved2020-04-29.
  14. ^"MorphoSys Announces Submission of Biologics License Application for Tafasitamab in r/r DLBCL to the FDA". dgap.de. 2019-12-30. Retrieved2020-04-29.
  15. ^"MorphoSys Initiates Expanded Access Program for Tafasitamab in the U.S." dgap.de. 2020-01-13. Retrieved2020-04-29.
  16. ^"MorphoSys and Incyte Sign Global Collaboration and License Agreement, including U.S. Co-Commercialization and Ex-U.S. Commercialization Rights, for Tafasitamab". dgap.de. 2020-01-13. Retrieved2020-04-29.
  17. ^"MorphoSys and Incyte Announce Antitrust Clearance of Global Collaboration and License Agreement for Tafasitamab". dgap.de. 2020-03-03. Retrieved2020-04-29.
  18. ^"FDA Accepts MorphoSys' Biologics License Application (BLA) and Grants Priority Review for Tafasitamab and Lenalidomide for the Treatment of Relapsed/Refractory DLBCL". dgap.de. 2020-03-02. Retrieved2020-04-29.
  19. ^"FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)". dgap.de. 2020-08-01. Retrieved2021-04-30.
  20. ^"FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma". FDA.gov. 2020-08-03. Archived fromthe original on August 8, 2020. Retrieved2021-04-30.
  21. ^Nathan-Kazis, Josh (2021-06-02)."MorphoSys Buys Constellation Pharma in $1.7B Deal. Is Biotech M&A Back?".Barron's.
  22. ^"MorphoSys and Novartis Sign Delisting Agreement and Intend to Implement a Merger Squeeze-out of MorphoSys' Minority Shareholders – Company Announcement - FT.com".markets.ft.com. Retrieved2024-06-21.
  23. ^"Merger Squeeze-Out of MorphoSys Minority Shareholders Approved at 2024 Annual General Meeting".Morphosys de. Retrieved2024-08-28.
  24. ^ab"tafasitamab". MorphoSys.
  25. ^"MorphoSys Signs Regional License Agreement for Antibody MOR202 with I-Mab". dgap.de. 2017-11-30. Retrieved2020-04-29.
  26. ^"I-Mab Biopharma's therapeutic pipeline". I-Man Biopharma.
  27. ^"MorphoSys Stops Work and Operations on Pre-Clinical Research Programs". Retrieved2023-03-02.
  28. ^"HuCaL". MorphoSys.
  29. ^MorphoSys (January 13, 2021).Engineering the Medicines of Tomorrow(PDF) (Speech). J.P. Morgan Healthcare Conference. Archived fromthe original(PDF) on April 29, 2021. RetrievedApril 29, 2021.

External links

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