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Janssen Pharmaceuticals

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Johnson & Johnson Innovative Medicine
Company typeSubsidiary
IndustryPharmaceutical
Founded1953; 71 years ago (1953)
FounderPaul Janssen
HeadquartersTurnhoutseweg 30,
Beerse
,
Belgium
Area served
Worldwide
Key people
Jennifer Taubert
Number of employees
45.000
ParentJohnson & Johnson
Websitewww.janssen.com

Johnson & Johnson Innovative Medicine (formerly Janssen Pharmaceuticals) is a pharmaceutical company headquartered in Beerse, Belgium, and wholly-owned by Johnson & Johnson. It was founded in 1953 by Paul Janssen.

In 1961, Janssen Pharmaceuticals was purchased by New Jersey-based American corporation Johnson & Johnson, and became part of Johnson & Johnson Pharmaceutical Research and Development (J&J PRD), now renamed to Janssen Research and Development (JRD), which conducts research and development activities related to a wide range of human medical disorders, including mental illness, neurological disorders, anesthesia and analgesia, gastrointestinal disorders, fungal infection, HIV/AIDS, allergies and cancer. Janssen and Ortho-McNeil Pharmaceutical have been placed in the Ortho-McNeil-Janssen group within Johnson & Johnson Company.

Subsidiaries

History

Janssen (Leiden, 2021)

The early roots of what would become Janssen Pharmaceuticals date back to 1933. In 1933, Constant Janssen, the father of Paul Janssen, acquired the right to distribute the pharmaceutical products of Richter, a Hungarian pharmaceutical company, for Belgium, the Netherlands and Belgian Congo. On 23 October 1934, he founded the N.V. Produkten Richter in Turnhout. In 1937, Constant Janssen acquired an old factory building in the Statiestraat 78 in Turnhout for his growing company, which he expanded during World War II into a four-story building. Still a student, Paul Janssen assisted in the development of paracetamol (USP: acetaminophen, often referred to generically under the trademark Tylenol) under the name Perdolan, which would later become well-known. After the war, the name for the company products was changed to Eupharma, although the company name Richter would remain until 1956.[3]

Paul Janssen founded his own research laboratory in 1953 on the third floor of the building in the Statiestraat, still within the Richter-Eupharma company of his father. In 1955, he and his team developed their first drug, Neomeritine (ambucetamide), an antispasmodic found to be particularly effective for the relief of menstrual pain. On 5 April 1956, the name of the company was changed to NV Laboratoria Pharmaceutica C. Janssen (named after Constant Janssen). On 27 April 1957, the company opened a new research facility in Beerse, but the move to Beerse would not be completed until 1971–1972. On 2 May 1958, the research department in Beerse became a separate legal entity, the N.V. Research Laboratorium C. Janssen.

On 25 October 1961, the company was acquired by the American corporation Johnson & Johnson. The negotiations with Johnson & Johnson were led by Frans Van den Bergh, head of the board of directors. On 10 February 1964, the name was changed to Janssen Pharmaceutica N.V. and the seat of the company in Turnhout was also transferred to Beerse. The company was led by Paul Janssen, Bob Stouthuysen and Frans Van Den Bergh. When, in 1971-1972 the pharmaceutical production also moved to Beerse, the move from Turnhout was completed. Between 1990 and 2004, Janssen expanded worldwide, and the company grew in size to about 28,000 employees worldwide.

From the beginning, Janssen emphasized as its core activity research for the development of new drugs. The research department which was established in Beerse in 1957, developed into a large research campus. In 1987, the Janssen Research Foundation (JRF) was founded which performs research into new drugs at Beerse and in other laboratories around the globe. Janssen became the Flemish company with the largest budget for research and development. Beside the headquarters in Beerse with its research departments, pharmaceutical production and the administrative departments, Janssen Pharmaceutica in Belgium still has offices in Berchem (Janssen-Cilag), a chemical factory in Geel, and Janssen Biotech in Olen.

The Chemical Production plant in Geel makes the active ingredients for the company's medicines. In 1975, the first plant of a new chemical factory Plant I was established in Geel, Plant II was opened in 1977, Plant III' in 1984, and Plant IV in 1995. In 1999 the remaining chemical production in Beerse was transferred to Geel. About 80% of its active components are manufactured here. The site in Geel also manufactures about two-thirds of the worldwide chemical production of the pharmaceutical sector of Johnson & Johnson. In 1995, the Center for Molecular Design (CMD) was founded by Paul Janssen and Paul Lewi.

In 1999, clinical research and non-clinical development become a global organization within Johnson & Johnson. In 2001, part of the research activities was transferred to the United States with the reorganization of research activities in the Johnson & Johnson Pharmaceutical Research Development (JJPRD) organization. The research activities of the Janssen Research Foundation (JRF) and the R.W. Johnson Pharmaceutical Research Institute (PRI) (United States) were merged into the new global research organization. A new building for pharmaceutical development was completed in Beerse in 2001. In 2002, a new logistics and informatics centre was opened at a new site, Beerse 2. In 2003 two new research buildings were constructed, the Discovery Research Center (DRC), and the Drug Safety Evaluation Center (DSEC). On 27 October 2004, the Paul Janssen Research Center, for discovery research, was inaugurated.

In 2011, Johnson & Johnson subsidiary Centocor became Janssen Biotech, part of Janssen Pharmaceuticals.[1]

Also in 2011, Johnson & Johnson acquired Crucell, and assigned it to Janssen. The acquisition of Crucell provided Janssen with a disease prevention arm. By 2014, Crucell was renamed as Janssen Vaccines.[4][2]

In March 2015, Janssen licensed tipifarnib (a farnesyl transferase inhibitor) to Kura Oncology who will assume sole responsibility for developing and commercialising the anti-cancer drug.[5] Later in the same month the company announced that Galapagos Pharma had regained the rights to the anti-inflammatory drug candidate GLPG1690 as well as two other compounds including GLPG1205 (a first-in-class inhibitor of GPR84).[6]

In May 2016, the company launched a collaboration MacroGenics and their preclinical cancer treatment, MGD015. The deal could net MacroGenics more than $740 million.[7]

In September 2017 it was announced that Janssen teamed up with the Biomedical Advanced Research and Development Authority (BARDA), a unit of the U.S. Department of Health and Human Services, to create pandemic flu vaccines. BARDA is giving Janssen $43 million in the first year and $273 million over five years for the contract. One of the projects in the contract is the development of a universal flu vaccine. The intent of the vaccine would be to protect people against all or most flu strains.[8]

On 5 March 2019, the Food and Drug Administration approved Janssen's Spravato (esketamine nasal spray) for treatment-resistant major depressive disorder. This marked the first approval of a new type of antidepressant in decades.[9]

In 2021, Janssen was named as a defendant in a trial against several opioid manufacturers filed by New York Attorney General Letitia Jame.[10] The company was later removed from the case after Johnson & Johnson agreed to a pay a $230 million settlement to New York State.[11]

Janssen Biotech

The subsidiary Janssen Biotech, Inc. was founded in Philadelphia in 1979 as Centocor Biotech, Inc., with an initial goal of developing new diagnostic assays using monoclonal antibody technology.

Centocor Biotech

In 1982, Centocor transitioned into a publicly traded company.[12] In the early 1980s, the company moved to Malvern, Pennsylvania.[12] In 1984, Centocor opened an overseas plant in Leiden, the Netherlands.[13]

In 1997, eighteen years after its foundation, Centocor achieved its first year of operating profitability.[14][15] In 1998, Centocor sold its diagnostic division to Fujirebio, Inc.[16]

In 1999, Centocor became a wholly owned subsidiary of Johnson & Johnson.[17]

In 2004, Centocor purchased a new manufacturing plant in St. Louis, Missouri, and is currently opening a new manufacturing facility in County Cork, Ireland. The Dutch plant has been expanded substantially with a $250 million investment in additional production facilities, which were opened in 2006.[citation needed]

In 2007, Centocor broke new ground in advertising by releasing Innerstate, believed to be the first theatrically released documentary film both created and entirely funded by a drug company, to promote Remicade (Infliximab).[18]

Centocor Ortho Biotech

In 2008, Centocor, Inc. and Ortho Biotech Inc. merged to form Centocor Ortho Biotech Inc.

In June 2010, Centocor Ortho Biotech acquired RespiVert, a privately held drug discovery company focused on developing small-molecule, inhaled therapies for the treatment of pulmonary diseases.[19]

As Janssen Biotech

In June 2011, Centocor Ortho Biotech changed its name to Janssen Biotech, Inc. as part of a global effort to unite the Janssen Pharmaceutical Companies around the world under a common identity.[20]

In December 2014, the company announced it would co-develop MacroGenics cancer drug candidate (MGD011) which targets both CD19 and CD3 proteins in treating B-cell malignant tumours. This could net MacroGenics up to $700 million.[21]

In January 2015, the company announced it would utilise Ionis Pharmaceuticals' (formerly Isis Pharmaceuticals) Rna-targeting technology to discover and develop antisense drugs targeting autoimmune disorders of the gastrointestinal tract.[22]

In December 2019, XBiotech Inc. announced it would sell its novel antibody treatment (bermekimab) that neutralizes interleukin-1 alpha (IL-1⍺) to Janssen Biotech, Inc.[23][24]

COVID-19 vaccine development

Main article: Janssen COVID-19 vaccine

On 27 March 2020, the U.S. Biomedical Advanced Research and Development Authority (BARDA) allocated $456 million for J&J (Janssen) to develop a vaccine against the novel coronavirus.[25][26]

In China

Xi'an-Janssen

Janssen Pharmaceuticals was the first Western pharmaceutical company to set up a pharmaceutical factory in the People's Republic of China.[27]

In 1976, Paul Janssen met Ma Haide (born George Shafik Hatem), a Lebanese-American doctor who had started working in China in 1933. After three days of meetings, the two agreed to bring a modernized pharmaceutical business to China. When Deng Xiaoping opened China to the West in 1978, Janssen sent Paul Appermont and Joos Horsten to set up the project.[27]

In 1983, Janssen signed a cooperation contract to modernize production in an old chemical factory in the city of Hanzhong, in Shaanxi province. This factory would soon produce the active compound of some Janssen products, such as mebendazole. In 1985, now operating as Xian-Janssen Pharmaceuticals, a new large factory was opened in the city of Xi'an, also in Shaanxi province.[27]

Drugs developed

Risperdal tablets
R-code Name Brand name Synthesized Marketed
R5 ambucetamide Neomeritine 1953 1955
R79 isopropamide iodide Priamide-Janssen 1954 1955
R253 diisopromine Bilagol 1955 1956
R516 cinnarizine Stugeron 1955 1958
R875 dextromoramide Palfium 1955 1957
R1132 diphenoxylate Reasec 1956 1960
R1625 haloperidol Haldol 1958 1959
R2498 trifluperidol Triperidol 1959 1961
R3345 pipamperone Dipiperon 1960 1961
R3365 piritramide Dipidolor 1960 1967
R4263 fentanyl[28][29] Sublimaze 1960 1963
R4584 benperidol Frenactyl 1961 1965
R4749 droperidol[30] Dehydrobenzperidol 1961 1963
R4845 bezitramide Burgodin 1961 1971
R6218 fluspirilene Imap 1963 1971
R6238 pimozide Orap 1963 1970
R7904 lidoflazine Clinium 1964 1969
R11333 bromperidol Impromen 1966 1981
R12564 levamisole Ergamisol 1966 1969
R13672 haloperidol decanoate Haldol decanoas 1967 1981
R14889 miconazole nitrate Daktarin 1967 1971
R14950 flunarizine Sibelium 1967 1977
R15889 lorcainide Remivox 1968 1983
R16341 penfluridol Semap 1968 1973
R16470 dexetimide Tremblex 1968 1972
R16659 etomidate[31][32] Hypnomidate 1964 1977
R17635 mebendazole Vermox 1968 1972
R18553 loperamide Imodium 1969 1973
R33800 sufentanil[33] Sufenta 1974 1979
R33812 domperidone Motilium 1974 1978
R35443 oxatomide Tinset 1975 1981
R39209 alfentanil[34][35] Rapifen 1976 1983
R33799 carfentanil[36] Wildnil 1976 1980?
R41400 ketoconazole Nizoral 1976 1981
R43512 astemizole Hismanal 1977 1983
R46541 bromperidol decanoate Impromen decanoas 1978 1984
R49945 ketanserin tartrate Sufrexal 1980 1987
R50547 levocabastine Livostin/Livocab 1979 1989
R51211 itraconazole Sporanox 1980 1986
R51619 cisapride Prepulsid 1980 1989
R64766 risperidone Risperdal 1984 1993
R207910 bedaquiline Sirturo 2004 2012

Janssen Pharmaceuticals has developed and brought to the market about 70 new active substances (NCE), of which the most well-known are (name may differ):

WHO Model List of Essential Medicines

Eight original Janssen drugs have been included on the WHO Model List of Essential Medicines:

Centocor products

In 1984, Centocor developed their first product approved by the U.S. Food and Drug Administration (FDA) – a diagnostic test used to detect the rabies virus.[citation needed]

In 1998, the company launched its top-selling monoclonal antibody Remicade (infliximab) for its first FDA approved indication in Crohn's disease. Subsequently, Remicade's market has expanded with approvals for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, and pediatric Crohn's disease. Remicade was approved for plaque psoriasis in September 2006.

Centocor also markets ReoPro (abciximab), a biologic agent indicated as an adjunct to coronary angioplasty (PTCA).

In 2009, the U.S. FDA approved Simponi, a human monoclonal antibody for treatment for arthritis, which was co-developed with Medarex, Inc.[37]

Risperdal deception

In 2004, the United States Department of Justice began investigating sales practices surrounding the antipsychotic drug risperidone (Risperdal). In 2010, the agency joined a whistleblower suit alleging that despite being warned by the U.S. Food and Drug Administration not to promote Risperdal as effective and safe for elderly patients, in whom it was known to be associated with early death, Johnson & Johnson and Janssen Pharmaceuticals paid pharmacists at Omnicare, the largest supplier of pharmaceuticals to nursing homes, tens of millions of dollars in bribes and kickbacks to promote the drug to physicians for this unapproved use.[38][39]

The lawsuit resulted in a 2012 provisional settlement totaling $2.3 billion,[40] with Omnicare having already settled for around $100 million.[40] Four states were awarded damages: Louisiana ($258 million in 2010), South Carolina ($327 million in 2011), Texas ($158 million in 2012), and Arkansas ($1.2 billion in 2012).[41]

Former head of sales and president of Janssen Alex Gorsky, who according to the Department of Justice "was actively involved" in the fraud, became CEO of Johnson & Johnson in 2012.[42]

See also

References

  1. ^ a b Crissa Shoemaker DeBree (22 June 2011). "Centocor is now Janssen Biotech". The Intelligencer. Gannett Co.
  2. ^ a b "Janssen Vaccines AG". Bloomberg L.P. 2020.
  3. ^ Lopez-Munoz, Francisco; Alamo, Cecilio (2009). "The Consolidation of Neuroleptic Therapy: Janssen, the Discovery of Haloperidol and Its Introduction into Clinical Practice". Brain Research Bulletin. 79 (2): 130–141. doi:10.1016/j.brainresbull.2009.01.005. PMID 19186209. S2CID 7720401.
  4. ^ "Janssen (formerly Crucell)". PATH Malaria Vaccine Initiative. 2020.
  5. ^ "GEN – News Highlights:Kura Oncology Licenses Janssen's Tipofarnib in Cancer". GEN.
  6. ^ "GEN – News Highlights:Galapagos Regains Rights to GLPG1690 from Janssen". GEN. 17 March 2015.
  7. ^ "Janssen, MacroGenics Launch Up-to-$740M+ Second Collaboration". GEN. 18 May 2016.
  8. ^ "Johnson & Johnson, BARDA join forces to prep for pandemic flu, inking deal for vaccine and drug R&D – FiercePharma". fiercepharma.com. Retrieved 12 April 2018.
  9. ^ "Janssen Announces U.S. FDA Approval of SPRAVATO™ (esketamine) CIII Nasal Spray for Adults with Treatment-Resistant Depression (TRD) Who Have Cycled Through Multiple Treatments Without Relief". Janssen. Archived from the original on 25 November 2020. Retrieved 7 March 2019.
  10. ^ Nir, Sarah Maslin (29 June 2021). "Major Trial Against Opioid Suppliers Begins in New York". The New York Times. ISSN 0362-4331. Retrieved 1 July 2021.
  11. ^ Nir, Sarah Maslin (26 June 2021). "Johnson & Johnson to Pay New York $230 Million to Settle Opioid Case". The New York Times. ISSN 0362-4331. Retrieved 1 July 2021.
  12. ^ a b George, John (26 October 1998). "Centocor making its mark in biotech". Philadelphia Business Journal. Retrieved 4 May 2020.
  13. ^ George, John (26 October 2011). "Johnson & Johnson '05 plant explosion: A lesson learned". Philadelphia Business Journal.
  14. ^ "Trend For 1997 Strong Sales Continues In USA – Pharmaceutical industry". thepharmaletter.com. Retrieved 4 May 2020.
  15. ^ Bishop, Todd (24 May 1999). "Centocor profit growth best among Phila. Inc". Philadelphia Business Journal.
  16. ^ Centocor reaches agreement to sell oncology diagnostics business, 1998 press release
  17. ^ Langreth, Robert (22 July 1999). "Johnson & Johnson to Purchase Centocor for $4.9 Billion in Stock". The Wall Street Journal. ISSN 0099-9660. Retrieved 4 May 2020.
  18. ^ Saul, Stephanie (21 February 2007). "Drug Gets a Cameo in a Film Backed by Its Maker". The New York Times. ISSN 0362-4331.
  19. ^ Centocor Ortho Biotech Acquires RespiVert Archived 2010-06-05 at the Wayback Machine News article from InfoGrok.
  20. ^ George, John. "Remicade maker Centocor Ortho Biotech changing name". Philadelphia Business Journal. Retrieved 15 January 2019.
  21. ^ "Janssen Joins MacroGenics in Up-to-$700M Cancer Collaboration". GEN – Genetic Engineering and Biotechnology News. 22 December 2014. Retrieved 11 December 2019.
  22. ^ "Janssen, Isis Pharma Ink Up-to-$835M Antisense Agreement". GEN – Genetic Engineering and Biotechnology News. 5 January 2015. Retrieved 11 December 2019.
  23. ^ "XBiotech Announces Agreement to Sell True Human Antibody Bermekimab Targeting IL-1a to Janssen". BioSpace. Retrieved 4 May 2020.
  24. ^ "Janssen to Acquire Investigational Bermekimab from XBiotech". BioSpace. Retrieved 4 May 2020.
  25. ^ Brewster, Thomas (30 March 2020). "The U.S. Just Signed A$450 Million Coronavirus Vaccine Contract With Johnson & Johnson". Forbes. Retrieved 2 May 2020.
  26. ^ Kuznia, Robert; Polglase, Katie; Mezzofiore, Gianluca (1 May 2020). "In quest for vaccine, US makes 'big bet' on company with unproven technology". CNN. Retrieved 2 May 2020.
  27. ^ a b c Magiels, 2004
  28. ^ Janssen PA, Eddy NB (1960). "Compounds related to pethidine-IV new general chemical methods of increasing the analgesic activity of pethidine" (PDF). Journal of Medicinal and Pharmaceutical Chemistry. 2 (1): 31–45. doi:10.1021/jm50008a003. PMID 14406754. Retrieved 27 September 2010.
  29. ^ Janssen PA, Niemegeers CJ, Dony JG (1963). "The inhibitory effect of fentanyl and other morphine like analgesics on the warm water induced tail withdrawal reflex in rats" (PDF). Arzneimittel-Forschung. 13: 502–7. ISSN 0004-4172. PMID 13957426. Retrieved 27 September 2010.
  30. ^ Janssen PA, Niemegeers CJ, Schellekens KH, Verbruggen FJ, Van Nueten JM (1963). "The pharmacology of dehydrobenzperidol, a new potent and short-acting neuroleptic agent chemically related to haloperidol". Arzneimittel-Forschung. 13: 205–11. ISSN 0004-4172. PMID 13957425.
  31. ^ Doenicke A, Kugler J, Penzel G, Laub M, Kalmar L, Kilian I, Bezecny H (1973). "[Cerebral Function under Etomidate, a New Non-Barbiturate I.V. Hypnotic]". Der Anaesthesist (in German). 22 (8): 353–66. ISSN 0003-2417. PMID 4584133. Archived from the original on 20 July 2011. Retrieved 27 September 2010.
  32. ^ Morgan M, Lumley J, Whitwam JG (1975). "Etomidate, a new water-soluble non-barbiturate intravenous induction agent". The Lancet. 305 (7913): 955–6. doi:10.1016/S0140-6736(75)92011-5. PMID 48126. S2CID 205992130.
  33. ^ Niemegeers CJ, Schellekens JH, van Bever WF, Janssen PA (1976). "Sufentanil, a very potent and extremely safe intravenous morphine-like compound in mice, rats and dogs". Arzneimittel-Forschung. 26 (8): 1551–6. ISSN 0004-4172. PMID 12772.
  34. ^ Spierdijk J, van Kleef J, Nauta J, Stanley TH, de Lange S (1980). "Alfentanil: a new narcotic induction agent". Anesthesiology. 53: S32. doi:10.1097/00000542-198009001-00032.
  35. ^ Niemegeers CJ, Janssen PA (1981). "Alfentanil (R39209)-a particularly short acting intravenous narcotic analgesic in rats". Drug Development Research. 1: 830–8. doi:10.1002/ddr.430010111. ISSN 0272-4391. S2CID 84794527.
  36. ^ De Vos V (1978). "Immobilisation of Free-ranging Wild Animals Using a New Drug". Veterinary Record. 103 (4): 64–8. doi:10.1136/vr.103.4.64. PMID 685103. S2CID 36314586. Retrieved 27 September 2010.
  37. ^ Marcial, Gene (4 May 2009). "Marcial: Medarex, a Bright Spot in Biotech". Bloomberg Businessweek. Archived from the original on 25 September 2014. Retrieved 24 September 2014.
  38. ^ Hilzenrath, David S. (16 January 2010). "Justice suit accuses Johnson & Johnson of paying kickbacks". The Washington Post. Retrieved 17 January 2010.
  39. ^ Singer, Natasha (15 January 2010). "Johnson & Johnson Accused of Drug Kickbacks". The New York Times. Retrieved 17 January 2010.
  40. ^ a b J&J Said to Agree to $2.2 Billion Drug Marketing Accord Bloomberg News. By Margaret Cronin Fisk, Jef Feeley & David Voreacos – 11 June 2012
  41. ^ J.&J. Fined $1.2 Billion in Drug Case NY Times, By KATIE THOMAS Published: 11 April 2012
  42. ^ J&J needs a cure: new CEO allegedly had links to fraud Forbes, Erika Kelton, 4/17/2012

Bibliography

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