Janssen Pharmaceutica

Janssen Pharmaceutica is a pharmaceutical company headquartered in Beerse, Belgium and owned by Johnson & Johnson. It was founded in 1953 by Paul Janssen.

Janssen Pharmaceutica
IndustryPharmaceutical
Founded1953 (1953)
FounderPaul Janssen
HeadquartersBeerse, Belgium
ParentJohnson & Johnson
WebsiteJanssenPharmaceuticalsInc.com

In 1961, Janssen Pharmaceutica 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, anaesthesia 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.

History

The early roots of what would become Janssen Pharmaceutica 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-storey 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.[1]

Paul Janssen founded his own research laboratory in 1953 on the third floor of the building in the Statiestraat, still within the Richter-Eurpharma 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 24 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 Pharmaceutica expanded worldwide, and the company grew in size to about 28000 employees worldwide.

From the beginning, Janssen Pharmaceutica 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 Pharmaceutica 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 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.[2] Later in the same month the company announced that Galapagos Pharma and 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).[3]

In May 2016, the company launched a collaboration MacroGenics and their preclinical cancer treatment, MGD015. The deal could net MacroGenics more than $740 million.[4]

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.[5]

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.[6]

Drugs developed
Risperdal tablets
R-code Name Brand name Synthetized 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[7][8] Sublimaze 1960 1963
R4584 benperidol Frenactyl 1961 1965
R4749 droperidol[9] 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[10][11] Hypnomidate 1964 1977
R17635 mebendazole Vermox 1968 1972
R18553 loperamide Imodium 1969 1973
R33800 sufentanil[12] Sufenta 1974 1979
R33812 domperidone Motilium 1974 1978
R35443 oxatomide Tinset 1975 1981
R39209 alfentanil[13][14] Rapifen 1976 1983
R33799 carfentanil[15] 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 Pharmaceutica has developed and brought to the market about 70 new active substances (NCE), of which the most well-known are (name may differ):

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

2020 vaccine development

On March 27, 2020, the U.S. Biomedical Advanced Research and Development Authority (BARDA) allocated $456 million for Janssen to develop a vaccine against the novel coronavirus.[16][17]

In China
Xi'an-Janssen

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

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 Chairman Deng Xiaoping opened China to the West in 1978, Janssen Pharmaceutica sent Paul Appermont and Joos Horsten to set up the project.

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.

Controversies

Juries in several US states have found that Janssen Pharmaceutical and its parent company Johnson & Johnson deceptively promoted the antipsychotic drug Risperdal (risperidone). By 2012, four states had been awarded damages, including Louisiana ($258 million in 2010), South Carolina ($327 million in 2011), Texas ($158 million in 2012), and most notably Arkansas ($1.2 billion in 2012) - whose Attorney General stated: “These two companies put profits before people, and they are rightfully being held responsible for their actions".[18]

In a related issue, Risperdal sales practices resulted in a 2012 provisional settlement totaling $2.3 billion.[19] The United States Department of Justice began investigating Risperdal sales practices in 2004, and in 2010 joined a whistleblowers suit alleging bribes paid to Omnicare, the largest company supplying pharmaceutical drugs to nursing homes.[20][21] The allegations include that Johnson & Johnson and Janssen were warned by the U.S. Food and Drug Administration (FDA) not to promote Risperdal as effective and safe for elderly patients when in fact it is associated with early death, but they did so; and that they in fact bribed Omnicare pharmacists tens of millions of dollars to promote the drug to care home physicians for this unapproved use. A settlement was provisionally agreed with Johnson & Johnson of around $2.2 billion for this and related allegations, with Omnicare having already settled for around $100 million.[19] Former head of sales and president of Janssen, Alex Gorsky, who the Dept of Justice say “was actively involved” in the fraud, nevertheless became the new CEO of Johnson & Johnson in 2012.[22]

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See also

References
  1. 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.
  2. "GEN - News Highlights:Kura Oncology Licenses Janssen's Tipofarnib in Cancer". GEN.
  3. "GEN - News Highlights:Galapagos Regains Rights to GLPG1690 from Janssen". GEN.
  4. "Janssen, MacroGenics Launch Up-to-$740M+ Second Collaboration". GEN.
  5. "Johnson & Johnson, BARDA join forces to prep for pandemic flu, inking deal for vaccine and drug R&D - FiercePharma". www.fiercepharma.com. Retrieved 12 April 2018.
  6. "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. Retrieved 7 March 2019.
  7. 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.
  8. 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.
  9. 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.
  10. 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]". Anaesthesist (in German). 22 (8): 353–66. ISSN 0003-2417. PMID 4584133. Archived from the original on 20 July 2011. Retrieved 27 September 2010.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. 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. Retrieved 27 September 2010.
  16. Brewster, Thomas (30 March 2020). "The U.S. Just Signed A $450 Million Coronavirus Vaccine Contract With Johnson & Johnson". Forbes. Retrieved 2 May 2020.
  17. 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.
  18. J.&J. Fined $1.2 Billion in Drug Case NY Times, By KATIE THOMAS Published: 11 April 2012
  19. J&J Said to Agree to $2.2 Billion Drug Marketing Accord Bloomberg News. By Margaret Cronin Fisk, Jef Feeley & David Voreacos - 11 Jun 2012
  20. Hilzenrath, David S. (16 January 2010). "Justice suit accuses Johnson & Johnson of paying kickbacks". The Washington Post. Retrieved 17 January 2010.
  21. Singer, Natasha (15 January 2010). "Johnson & Johnson Accused of Drug Kickbacks". The New York Times. Retrieved 17 January 2010.
  22. J&J needs a cure: new CEO allegedly had links to fraud Forbes, Erika Kelton, 4/17/2012

Sources
  • Magiels, Geerdt (2004). Paul Janssen – Pionier in farma en in China (in Dutch). Antwerp, Amsterdam: Houtekiet. ISBN 978-90-5240-827-9.
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