MorphoSys

MorphoSys AG is a biopharmaceutical company founded in 1992. The company is headquartered near Munich, Germany and has a wholly owned subsidiary, MorphoSys US Inc., in Boston MA in the US, where it is building a commercial organization. The company has various antibody, protein and peptide technologies that it uses to discover and develop both proprietary and partnered drug candidates. The company claims to have more than 100 drugs in its wider pipeline that are being investigated for a variety of diseases.[2][3] While many of these are being developed in partnership with pharma and biotech companies, MorphoSys also has a proprietary pipeline with a focus on cancer.

MorphoSys AG
Public Company
Traded as
ISINDE0006632003 
IndustryBiotechnology
Founded1992 (1992)
Headquarters
Planegg, Germany
Key people
Dr. Jean-Paul Kress, Chief Executive Officer
Jens Holstein, Chief Financial Officer
Dr. Malte Peters, Chief Research & Development Officer
Dr. Roland Wandeler, Chief Commercial Officer
Dr. Marc Cluzel, Chairman of Supervisory Board
ProductsImmunotherapy
Revenue€71.8 million (2019)[1]
€-107.9 million (2019)[1]
€-103.0 million (2019)[1]
Total assets€496.4 million (end 2019)[1]
Total equity€394.7 million (end 2019)[1]
Number of employees
426 (end 2019)[1]
Websitewww.morphosys.com

MorphoSys AG is listed on the Frankfurt Stock Exchange and on the US Nasdaq stock exchange.

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 Novartis entered into a strategic partnership for the research and development of biopharmaceuticals, which was expanded in 2007.[1] Additional discovery partnerships included: with Bayer (1999), Roche (2000), Centocor (now Janssen Biotech, 2000), Schering AG (2001) and Pfizer (2003).

In 2008, the company’s first proprietary antibody MOR103 (now otilimab) entered clinical development.[4] Following the publication of promising results in rheumatoid arthritis, MorphoSys signed a license agreement with GlaxoSmithKline for MOR103.[5] In 2019, GlaxoSmithKline initiated a phase 3 clinical development program with MOR103 (now GSK3196165).[6]

In 2010, MorphoSys signed a license agreement with Xencor Inc. for MOR208 (now tafasitamab).[7]

In July 2017, the first of MorphoSys’ platform drugs received US marketing approval. Guselkumab (brand name Tremfya), which was developed and is being commercialized by Janssen Biotech a subsidiary of Johnson & Johnson, was first approved for the treatment of moderate-to-severe plaque psoriasis in the United States, the European Union and Canada.[8][9]

In April 2018, following a US initial public offering in which the company raised $239 million, American Depositary Shares of MorphoSys began trading on the Nasdaq stock exchange, also under the symbol "MOR."[10][11]

In 2018, the company established a wholly owned US subsidiary, MorphoSys US Inc., to prepare for the planned commercialization of tafasitamab, subject to FDA approval.

In December 2019, based on positive clinical trial results, the company submitted a Biologics License Application (BLA) to the FDA for tafasitamab in combination with lenalidomide for the treatment of relapsed/refractory diffuse large B-cell lymphoma.[12] The submission was accepted for filing in February 2020, and a decision on the filing is expected in August 2020.[13]

In January 2020, MorphoSys and Incyte Corporation signed a collaboration and license agreement for the global development and commercialization of tafasitamab.[14] On March 3, 2020, the agreement received antitrust clearance and thus became effective.[15]

Pipeline

As of December 2019, MorphoSys had 116 drug candidates (twelve proprietary and 104 partnered programs), 28 of which were in clinical development.[1][3]

Tafasitamab (MOR208) is a humanized monoclonal antibody directed against CD19 in clinical development for the treatment of B-cell malignancies.[2][16] Tafasitamab is being or has been evaluated in several clinical trials, alone and in combination with other anti-cancer drugs.[1][3][16]

In March 2020, MorphoSys announced that the FDA had accepted the Biologics License Application (BLA) for filing and granted priority review, setting a Prescription Drug User Fee Act (PDUFA) goal date of August 30, 2020.[17]

MOR202 is a humanized monoclonal antibody directed against CD38 for the treatment of anti-PLA2R-positive 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 MOR202 (called TJ202 by I-Mab) in Greater China.[18] MOR202/TJ202 is currently under investigation by I-Mab in three clinical trials.[19]

Otilimab (MOR103/GSK3196165) is a fully human monoclonal antibody directed against GM-CSF.[2] The program is outlicensed to GlaxoSmithKline.[4][5] Otilimab is currently under investigation in a Phase 3 trial in rheumatoid arthritis that started in July 2019.[6]

Technology

MorphoSys has developed a number of antibody technologies that it uses for its proprietary programs as well as partnered programs.

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.[20]

gollark: The interesting maths is the stuff computers can't really do.
gollark: What is this from, anyway? I can tell it's something with image processing.
gollark: It looks mostly fine, but it's hard to tell sideways.
gollark: It wants something in terms of p and q, so just simplify it a bit.
gollark: Although I don't know why you can't long-divide it, p and q are just constants for the purposes of that.

References
  1. "Annual Report 2019" (PDF). MorphoSys. Retrieved 29 April 2020.
  2. "MorphoSys' therapeutic pipeline". MorphoSys.
  3. "Form 20-F". U.S. Securities and Exchange Commission.
  4. "otilimab (MOR103/GSK3196165)". MorphoSys. 2014-10-27. Retrieved 2018-06-23.
  5. "MorphoSys Signs Global License Agreement with GlaxoSmithKline for Anti-Inflammatory Program MOR103". MorphoSys. 2013-06-03. Retrieved 2020-04-29.
  6. "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.
  7. "MorphoSys and Xencor Sign License and Collaboration Agreement for Clinical Antibody Program". MorphoSys. 2010-06-27. Retrieved 2020-04-29.
  8. "MorphoSys' licensee Janssen receives Japanese approval for Tremfya to treat moderate to severe forms of psoriasis & psoriatic arthritis". pharmabiz.com. Retrieved 2018-06-05.
  9. Guselkumab BLA Approval Letter
  10. "Nasdaq Welcomes MorphoSys AG (Nasdaq: MOR) to The Nasdaq Stock Market". Nasdaq. 2018-04-19. Retrieved 2020-04-29.
  11. "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.
  12. "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.
  13. "MorphoSys Initiates Expanded Access Program for Tafasitamab in the U.S." dgap.de. 2020-01-13. Retrieved 2020-04-29.
  14. "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.
  15. "MorphoSys and Incyte Announce Antitrust Clearance of Global Collaboration and License Agreement for Tafasitamab". dgap.de. 2020-03-03. Retrieved 2020-04-29.
  16. "tafasitamab". MorphoSys.
  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. "MorphoSys Signs Regional License Agreement for Antibody MOR202 with I-Mab". dgap.de. 2017-11-30. Retrieved 2020-04-29.
  19. "I-Mab Biopharma's therapeutic pipeline". I-Man Biopharma.
  20. "HuCaL". MorphoSys.
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