MorphoSys

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MorphoSys AG
Novartis
Websitemorphosys.com

MorphoSys AG is a German

autoimmune diseases
.

MorphoSys AG was listed on the Frankfurt Stock Exchange and on the US Nasdaq stock exchange. Novartis agreed to acquire the company in February 2024.[4]

History

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

In 2004, MorphoSys and

Janssen Biotech, 2000), Schering AG (2001) and Pfizer
(2003).

In 2008, the company’s first proprietary antibody

GlaxoSmithKline for otilimab.[6] In 2019, GlaxoSmithKline initiated a phase 3 clinical development program with otilimab (now GSK3196165).[7]

In 2010, MorphoSys signed a license agreement with Xencor Inc. for MOR208 (now tafasitamab).[8]

In July 2017, the first of MorphoSys’ platform drugs received US

plaque psoriasis in the United States, the European Union and Canada.[9][10]

In April 2018, following a US

American depositary shares of MorphoSys began trading on the Nasdaq stock exchange, also under the symbol "MOR."[11][12]

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

In December 2019, based on positive

Biologics License Application (BLA) to the FDA for tafasitamab in combination with lenalidomide for the treatment of relapsed/refractory diffuse large B-cell lymphoma.[13] The submission was accepted for filing in February 2020, and a decision on the filing is expected in August 2020.[14]

In January 2020, MorphoSys and Incyte Corporation signed a collaboration and license agreement for the global development and commercialization of tafasitamab.[15] On March 3, 2020, the agreement received antitrust clearance and thus became effective.[16]

In March 2020, MorphoSys announced that the FDA had accepted the

Biologics License Application (BLA) for filing and granted priority review for tafasitamab, setting a Prescription Drug User Fee Act (PDUFA) goal date of August 30, 2020.[17]

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 for

autologous stem cell transplant (ASCT).[18][19]

In June 2021, Morphosys announced its acquisition of clinical stage biotechnology company Constellation Pharma for US$1.7 billion.[20]

In February 2024, Novartis agreed to acquire Morphosys for €2.7 billion.[4] 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.[4][21][22]

Pipeline

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 are already approved and marketed. [1][3]

Tafasitamab (MOR208) is a humanized monoclonal antibody directed against

B-cell malignancies.[2][23] Tafasitamab is being evaluated in several clinical trials, alone and in combination with other anti-cancer drugs.[1][3][23]

Felzartamab (MOR202)is a humanized monoclonal antibody directed against

membranous nephropathy, an autoimmune disease affecting the kidneys.[2] In 2017, MorphoSys entered into a regional licensing agreement with I-Mab Biopharma to develop and commercialize Felzartamab (called TJ202 by I-Mab) in Greater China.[24] Felzartamab (MOR202/TJ202) is currently under investigation by I-Mab in three clinical trials.[25]

Otilimab (MOR103/GSK3196165) is a fully human monoclonal antibody directed against

GlaxoSmithKline.[5][6] Otilimab is currently under investigation in a Phase 3 trial in rheumatoid arthritis that started in July 2019.[7]

On March 2, 2023, MorphoSys announced that the company would end its preclinical research programs and cease all related activities. According to the press release, this step is justified by challenges in the pharmaceutical market, which are forcing the company to optimize its cost structure and to focus all resources more on oncology products in the mid to late stage of development.[26]

Technology

MorphoSys has discovered a number of antibody technologies that are use for drug development.

MorphoSys’ main technology is HuCAL (Human Combinatorial Antibody Library), which is a collection of more than ten billion fully human antibodies in the form of a phage display bank and a system for their optimization.[27]

Another technology recently developed is the OkapY bispecific antibody technology. MorphoSys’ OkapY technology is a new proprietary “2+1” bispecific antibody format with the hysicochemical properties to simplify the development and large-scale production of such molecules.[1][28]

References

  1. ^ a b c d e f g h i j k "Annual Report 2020". MorphoSys. Retrieved 29 April 2021.
  2. ^ a b c d "MorphoSys' therapeutic pipeline". MorphoSys.
  3. ^ a b c "Form 20-F". U.S. Securities and Exchange Commission.
  4. ^ a b c "Novartis to acquire cancer-centric MorphoSys for $2.9 bln". Reuters. 2024-02-05.
  5. ^ a b "otilimab (MOR103/GSK3196165)". MorphoSys. 2014-10-27. Retrieved 2018-06-23.
  6. ^ a b "MorphoSys Signs Global License Agreement with GlaxoSmithKline for Anti-Inflammatory Program MOR103". MorphoSys. 2013-06-03. Retrieved 2020-04-29.
  7. ^ a b "MorphoSys's Licensing Partner GSK Initiates Phase 3 Clinical Program With Otilimab (MOR103/GSK3196165) in Rheumatoid Arthritis". dgap.de. 2019-07-03. Retrieved 2020-04-29.
  8. ^ "MorphoSys and Xencor Sign License and Collaboration Agreement for Clinical Antibody Program". MorphoSys. 2010-06-27. Retrieved 2020-04-29.
  9. ^ "MorphoSys' licensee Janssen receives Japanese approval for Tremfya to treat moderate to severe forms of psoriasis & psoriatic arthritis". pharmabiz.com. Retrieved 2018-06-05.
  10. ^ Guselkumab BLA Approval Letter
  11. ^ "Nasdaq Welcomes MorphoSys AG (Nasdaq: MOR) to The Nasdaq Stock Market". Nasdaq. 2018-04-19. Retrieved 2020-04-29.
  12. ^ "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. Retrieved 2020-04-29.
  13. ^ "MorphoSys Announces Submission of Biologics License Application for Tafasitamab in r/r DLBCL to the FDA". dgap.de. 2019-12-30. Retrieved 2020-04-29.
  14. ^ "MorphoSys Initiates Expanded Access Program for Tafasitamab in the U.S." dgap.de. 2020-01-13. Retrieved 2020-04-29.
  15. ^ "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. Retrieved 2020-04-29.
  16. ^ "MorphoSys and Incyte Announce Antitrust Clearance of Global Collaboration and License Agreement for Tafasitamab". dgap.de. 2020-03-03. Retrieved 2020-04-29.
  17. ^ "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. Retrieved 2020-04-29.
  18. ^ "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. Retrieved 2021-04-30.
  19. ^ "FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma". FDA.gov. 2020-08-03. Retrieved 2021-04-30.
  20. ^ Nathan-Kazis, Josh (2021-06-02). "MorphoSys Buys Constellation Pharma in $1.7B Deal. Is Biotech M&A Back?". Barron's.
  21. ^ "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. Retrieved 2024-06-21.
  22. ^ "Merger Squeeze-Out of MorphoSys Minority Shareholders Approved at 2024 Annual General Meeting". Morphosys de. Retrieved 2024-08-28.
  23. ^ a b "tafasitamab". MorphoSys.
  24. ^ "MorphoSys Signs Regional License Agreement for Antibody MOR202 with I-Mab". dgap.de. 2017-11-30. Retrieved 2020-04-29.
  25. ^ "I-Mab Biopharma's therapeutic pipeline". I-Man Biopharma.
  26. ^ "MorphoSys Stops Work and Operations on Pre-Clinical Research Programs". Retrieved 2023-03-02.
  27. ^ "HuCaL". MorphoSys.
  28. ^ MorphoSys (January 13, 2021). Engineering theMedicinesofTomorrow (PDF) (Speech). J.P. Morgan HealthcareConference. Retrieved April 29, 2021.
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