Celgene

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Celgene Corporation

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legal form Corporation
ISIN US1510201049
founding 1986
Seat Summit , United StatesUnited StatesUnited States 
management Mark J. Alles, CEO
Number of employees 7,500 (2017)
sales $ 15.3 billion (2018)
Branch Pharmaceutical manufacturer ( biotechnological )
Website www.celgene.com

Celgene is an American pharmaceutical company that specializes in the manufacture of drugs for cancer and immune system diseases. Celgene is headquartered in Summit , New Jersey . The company, which describes itself as a biopharmaceutical company , employs around 7,500 people and has sales of $ 15.3 billion (2018). Celgene works in the fields of hematology , oncology and inflammatory diseases . Celgene developed immunomodulators , known as IMiDs ( immunomodulatory drugs ), originally from thalidomide were derived molecule, aimed at combating the causes of disease, not the symptoms . The most important representative of the IMiDs is lenalidomide for the treatment of multiple myeloma .

In January 2019, Celgene accepted the acquisition by Bristol-Myers Squibb (BMS) for $ 74 billion. The shareholders of both companies have yet to agree. The completion is expected in the 3rd quarter of 2019.

history

Celgene was founded in 1980 as a business unit of Celanese . In 1986 it was spun off as part of the takeover of Celanese by Hoechst AG and floated on the stock exchange a year later. In 1992 the rights to thalidomide were in-licensed, for which Celgene received FDA approval in 1998 . Other companies have been acquired throughout history, including Signal Pharmaceuticals (2000), Anthrogenesis (2003), Pharmion (2008), Glouster Pharmaceuticals (2010), Abraxis (2010), Agios (2015), Quanticel (2015), Receptos (2015) ), Delinia (2017) and Juno Therapeutics Inc (2018). In 2001, Celgene received from Novartis, among other things, the license to market the isomerically pure version of methylphenidate ( Ritalin ).

In January 2019, Celgene accepted the acquisition by BMS for $ 74 billion. Closing is expected in Q3 2019, as shareholders of both companies have yet to approve. However, there is also speculation that BMS itself could still become the target of a takeover, as is currently taking place in the pharmaceutical sector.

Research & Development

Celgene invests an average of 25-30 percent of sales in research and development . It has established its own research and development platforms. Celgene conducts research in the fields of hematology ( lenalidomide , azacitidine , romidepsin and pomalidomide ), oncology ( Nab-Paclitaxel ) and immune / inflammatory diseases ( apremilast ). In addition, research is being carried out on cell therapeutics - based on stem cells from the placenta and umbilical cord blood. The most intensively studied active ingredients are primarily IMiDs. These are low molecular weight compounds ( small molecules ) that can be administered orally. They modulate the immune system and other important metabolic processes through various mechanisms of action.

The product pipeline also includes other low molecular weight compounds that inhibit the production of various inflammatory mediators, such as IL-2 , IL-12 , interferon-gamma , TNF-alpha , the leukokinins or nitride oxide synthase. Kinase inhibitors and ligase modulators are additional active ingredients from Celgene's research department.

Product pipeline

Not least because of the acquisitions of companies (see also the history section ), Celgene has numerous drug candidates in the so-called pipeline .

Products

The following Celgene products are approved in Europe:

  • Abraxane ® ( nab-Paclitaxel ) was approved by the European Commission in January 2008 for the treatment of metastatic breast cancer . The paclitaxel in Abraxane is incorporated into the human protein albumin in the form of nanoparticles . This means that it is available in a water-soluble formulation, i.e. no solubilizer is required. This has numerous advantages (no premedication against hypersensitivity reactions (HSR) required, higher dosages possible, linear pharmacokinetics, faster infusion time (30 min) and overall faster application, etc.). nab-Paclitaxel is being further developed in various indications, including: a. also in melanoma and pancreatic carcinoma .
  • Vidaza ® ( azacitidine ) is the first representative of a new class of substances, the so-called demethylating agents. The European Commission approved azacitidine as an "orphan drug" for the therapy of myelodysplastic syndromes (MDS) in December 2008. The indication includes the treatment of MDS patients with a higher risk of the categories "Int-2" and "High-Risk" according to the International Prognostic Scoring System (IPSS). Further indicated subgroups according to the WHO classification are chronic myelomonocytic leukemia (CMML) with 10 to 29 percent blasts in the bone marrow without myeloproliferative disorder and acute myeloid leukemia (AML) with 20 to 30 percent blasts in the bone marrow and simultaneous multiline dysplasia (RAEB -t according to FAB classification). Untreated patients in these risk groups only have a median survival time of about 5-14 months. The approval of Vidaza ® in the European Union is based on data from the AZA-001 study, the largest international randomized phase III study to date in high-risk MDS patients. The patent protection of azacitidine expires in 2019, which is why Celgene has also applied for approval for the generic drug ( Azacitidin Celgene ). In June 2019, the Committee for Medicinal Products for Human Use (CHMP) gave a positive vote. As a rule, the European Commission follows this recommendation and grants approval.
  • Thalidomide received approval from the American Medicines Agency (FDA) in May 2006 as an oral therapy in combination with dexamethasone for patients with newly diagnosed multiple myeloma under the trade name Thalomid . In the 1950s and 1960s, thalidomide, then marketed by the Grünenthal company under the trade name Contergan , caused serious damage to unborn life (see Contergan scandal ).
The Australian Drug Evaluation Committee (ADEC) approved thalidomide in 2008 for a combination therapy with melphalan and prednisone for patients with multiple myeloma who have not been previously treated or who are not eligible for high-dose chemotherapy. In addition, thalidomide was approved for prior induction therapy in combination with dexamethasone for high-dose chemotherapy with autologous stem cell transplantation in previously untreated myeloma patients. In 2003, the Australian regulatory agency approved thalidomide as a monotherapy for the treatment of multiple myeloma patients for whom standard therapies had failed. For safety reasons, Celgene developed an extensive program to ensure that the drug, known to be teratogenic, was not given to pregnant women. STEPS, the System for Thalidomide Education and Prescribing Safety, requires doctors and pharmacists to register before prescribing or administering thalidomide, thereby confirming that they have carried out comprehensive educational measures. Only within this closed program is it possible to receive and administer thalidomide from Celgene at all.
In April 2008 the European Commission approved thalidomide under the trade name Thalidomide PharmionTM 50 mg hard capsules for the first-line treatment of multiple myeloma. Thalidomide may therefore be used in combination with melphalan and prednisone in previously untreated myeloma patients who are 65 years of age or older or for whom high-dose chemotherapy is not an option. Thalomid®, Thalidomide PharmionTM and Thalidomide PharmionTM 50 mg hard capsules are the names of the same substance that, under all trade names, may only be sold and used within the framework of a strict safety program - especially with regard to pregnancy prevention. This safety program is part of the approvals by both the European and national approval authorities. The product is now called Thalidomide Celgene.
  • Otezla ® ( apremilast ) is an orally administered immunomodulator that influences various inflammatory processes ( psoriasis and psoriatic arthritis ) in the body. Apremilast was approved in the US in March 2014. European approval was granted on January 16, 2015.

Celgene also operates LifebankUSA , a blood bank that was the first to extract stem cells from umbilical cord blood. The stem cells are used to treat leukemia and related diseases.

Cooperations

Celgene cooperates with numerous companies in the development of new product candidates, e. B. with:

Individual evidence

  1. ↑ Senior Management on celgene.com (Management)
  2. ↑ Celgene 2017 Form 10-K Report , accessed February 24, 2018
  3. ↑ Celgene Reports Fourth Quarter and Full Year 2018 Operating and Financial Results , Celgene PM, January 31, 2019, accessed February 2, 2019
  4. ↑ a b CELGENE REPORTS FOURTH QUARTER AND FULL-YEAR 2017 OPERATING AND FINANCIAL RESULTS . Celgene. January 25, 2018. Retrieved February 2, 2018.
  5. ↑ a b IMiDs on celgene.com
  6. ^ A b Bristol-Myers Squibb to Acquire Celgene to Create a Premier Innovative Biopharma Company PM BMS, January 3, 2019, accessed January 3, 2019
  7. ↑ a b Creating an Innovative Biopharma Leader with Global Reach and Scale PM Celgene, January 3, 2019, accessed January 5, 2019
  8. ↑ a b Bristol-Myers Squibb and Celgene are Combining to Create a Global Biopharma Leader Separate WebSite for the Merger, accessed on January 5, 2019
  9. ↑ a b Yesterday, Bristol-Myers Squibb took over Celgene for 74 billion dollars - these are the next takeover candidates in the pharmaceutical industry , NZZ from January 4, 2019, accessed on January 5, 2019
  10. ↑ Celgene Completes Acquisition of Juno Therapeutics, Inc., Advancing Global Leadership in Cellular Immunotherapy , Celgene PM, March 6, 2018, accessed April 3, 2018
  11. ↑ History on celgene.com (History)
  12. ↑ a b Product Pipeline (PDF; 349 kB), on celgene.com (Investor Relations)
  13. ↑ Istodax ® (PDF; 221 kB), Highlights of Prescribing Information on the FDA website, accessed on December 12, 2012.
  14. ↑ Committee for Medicinal Products for Human Use (CHMP) WebSite EMA, accessed February 2, 2016
  15. ↑ Celgene to Acquire Receptos, Advancing Leadership in Immune-Inflammatory Diseases , Celgene PM, July 14, 2015, accessed June 9, 2017
  16. ↑ Celgene Announces Positive Results from Phase III SUNBEAM Trial of Oral Ozanimod in Patients with Relapsing Multiple Sclerosis , PM Celgene, February 17, 2017, accessed June 9, 2017
  17. ↑ Celgene Announces Positive Results from RADIANCE, the Second Pivotal Phase III Trial of Oral Ozanimod in Patients with Relapsing Multiple Sclerosis , PM Celgene, May 22, 2017, accessed June 9, 2017
  18. ↑ Orphan Designation (EU / 3/03/177) by the European Commission (English)
  19. ↑ Orphan Designation (EU / 3/07/494) by the European Commission (English)
  20. ^ Public assessment report (EPAR) of the European Medicines Agency (EMA) on: Revlimid .
  21. ↑ Public Assessment Report (EPAR) of the European Medicines Agency (EMA) on: Abraxane .
  22. ↑ Celgene: Technical Information Abraxane (PDF; 159 kB), as of April 2012, accessed on May 23, 2012.
  23. ↑ ABRAXANE ® Demonstrates Significant Improvement in Progression-Free Survival Compared to Standard Chemotherapy in Advanced Melanoma Patients ( Memento from January 18, 2013 in the web archive archive.today ). Press release on melanoma from Celgene International Sàrl (English).
  24. ↑ ABRAXANE ® Demonstrates Statistically Significant Improvement in Overall Survival for Patients with Advanced Pancreatic Cancer in Phase III Study ( Memento from January 18, 2013 in the web archive archive.today ). Press release on pancreatic carcinoma from Celgene International Sàrl.
  25. ↑ Public Assessment Report (EPAR) of the European Medicines Agency (EMA) on: Vidaza .
  26. ↑ Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2019 , PM EMA of June 28, 2019, accessed on July 12, 2019
  27. ↑ Public Assessment Report (EPAR) of the European Medicines Agency (EMA) for: Thalidomide Celgene (previously Thalidomide Pharmion) .
  28. ↑ US Food and Drug Administration Approves POMALYST® (pomalidomide) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma ( Memento of April 7, 2013 in the web archive archive.today ). Celgene press release dated February 8, 2013.
  29. ↑ Phase III Study (MM-003) of Pomalidomide Plus Low-Dose Dexamethasone Demonstrates Significant Progression-Free and Overall Survival Improvement for Patients with Relapsed or Refractory Multiple Myeloma ( Memento from January 18, 2013 in the web archive archive.today ). Celgene press release dated December 11, 2012.
  30. ^ New Drugs Online , UK Medicines Information, a service of the UK National Health Service (NHS), accessed August 15, 2013.
  31. ↑ Public Assessment Report (EPAR) of the European Medicines Agency (EMA) for: Imnovid (previously Pomalidomide Celgene) pomalidomide .
  32. ↑ Anti-Inflammatory Compounds on celgene.com
  33. ↑ OTEZLA® (apremilast) - First Oral Therapy Approved by the US Food and Drug Administration for the Treatment of Adults with Active Psoriatic Arthritis , PM Celgene, March 24, 2014, accessed April 4, 2018.
  34. ↑ Oral OTEZLA® (apremilast) Approved by the European Commission for the Treatment of both Patients with Psoriasis and Psoriatic Arthritis. Celgene, accessed March 3, 2015.
  35. ↑ Luspatercept Phase 2 Data Presented at the 14th International Symposium on Myelodysplastic Syndromes , PM Celgene, May 6, 2017, accessed on June 9, 2017
  36. ↑ Celgene and Acceleron Complete Target Enrollment in the MEDALIST and BELIEVE Phase 3 Studies of Luspatercept in Myelodysplastic Syndromes and Beta-Thalassemia , Celgene PM June 1, 2017, accessed June 9, 2017
  37. ↑ Sotatercept - Being Investigated to treat chronic anemia in myelofibrosis , WebSite Acceleron, accessed on June 9, 2017
  38. ↑ FDA Grants Approval of IDHIFA®, the First Oral Targeted Therapy for Adult Patients with Relapsed / Refractory Acute Myeloid Leukemia and an IDH2 Mutation , PM Celgene, August 1, 2017, accessed February 20, 2018
  39. ↑ Idhifa: Withdrawal of the marketing authorization application , EMA of January 31, 2020, accessed on January 31, 2020
  40. ↑ AstraZeneca enters strategic immuno-oncology collaboration with Celgene Corporation to develop PD-L1 inhibitor programs for patients with serious blood cancers , PM AstraZeneca, April 24, 2015, accessed June 15, 2017
  41. ↑ IMFINZI ™ (durvalumab) significantly reduces the risk of disease worsening or death in the Phase III PACIFIC trial for Stage III unresectable lung cancer , PM AstraZeneca of May 15, 2017, accessed on June 15, 2017
  42. ↑ Celgene in Collaboration with Astrazeneca Announce Initiation of Fusion Clinical Development Program in Immuno-Oncology , Celgene PM, December 7, 2015, accessed June 15, 2017
  43. ↑ bluebird bio and Celgene Corporation Announce Updated Clinical Results from Ongoing First-in-Human Multicenter Study of bb2121 Anti-BCMA CAR T Cell Therapy in Relapsed / Refractory Multiple Myeloma at ASCO Annual Meeting , PM Celgene, June 5, 2017, accessed June 9, 2017 June 2017
  44. ↑ bluebird bio and Celgene Corporation Enter into Agreement to Co-Develop and Co-Promote Anti-BCMA CAR T Cell Therapy bb2121 in the United States , PM Celgene, March 28, 2018, accessed April 3, 2018

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