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Actelion

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(Redirected fromCoTherix)
Swiss biopharmaceutical company

Actelion Pharmaceuticals Ltd.
Company typeSubsidiary
IndustryPharmaceuticals/Biotech
Founded1997; 28 years ago (1997)
FoundersJean-Paul Clozel, Martine Clozel, Walter Fischli, André J. Müller and Thomas Widmann
HeadquartersGewerbestrasse 16,,
Switzerland
Area served
Research and Development of medicines for unmet medical need
Key people
Jean-Paul Clozel (CEO)
ProductsTracleer, Ventavis, Zavesca, Veletri, Opsumit
RevenueCHF 2.412 billion(2016)[1]
CHF 992 million(2016)
Number of employees
2,624(2016)
ParentJohnson & Johnson
Websiteactelion.com

Actelion Pharmaceuticals Ltd. is a pharmaceuticals and biotechnology company established in December 1997, headquartered inAllschwil near Basel, Switzerland.[2] The company is part of Johnson & Johnson Innovative Medicine business segment.[3]

Actelion focuses on the manufacture of drugs that treatrare andorphan diseases. Some of the drugs it has produced have been used to treat patients with symptoms related to central nervous system disorders,irregular heart conditions, immune system disorders, and cancer.[4] One of the focuses of Actelion is treating individuals withpulmonary arterial hypertension (PAH), a heart condition that leaves patients with a short life expectancy (7–9 years) even with treatment.[5]

Actelion scientists were among the first to work in the field ofendothelin receptor antagonists.[6] Actelion was initially financed withventure capital provided through a syndicate includingAtlas Venture, Sofinnova andHealthCap.

Actelion develops and sells drugs in the continents of Asia, Europe, and North and South America.[4] Actelion has 29 operative affiliates globally, including in the United States, Canada, Brazil, Australia, Japan, Switzerland, and several EU countries. The Swiss affiliate is located inBaden,[7] the German affiliate inFreiburg,[8] the Austrian one inVienna,[9] the French one inParis[10] and the UK affiliate is located inLondon.[11][failed verification][12]

In 2006, the company established the Actelion Endothelin Research Award program which supports selected clinical research projects.[13]

In January 2017,Johnson & Johnson announced it would purchase the company for $30 billion.[14] Actelion's research and development unit would also be spun off after the acquisition.[15] The new companyIdorsia was created from former Actelion drug discovery operations and early-stage clinical development assets and listed in June 2017 on theSIX Swiss Exchange.[16]

In 2018, Johnson & Johnson announced they would discontinue the development of one of the phase III drugs it acquired during its purchase of Actelion.[2]

History

[edit]

Actelion was founded in 1997[17] by husband and wife team Jean-Paul and Martine Clozel[18] together with three colleagues afterF. Hoffmann-La Roche cut their funding for Martine's cardiovascular program. They founded Actelion to work on a drugs forrare diseases and retained the rights to the intellectual property from Roche, including the molecule leading to the development ofTracleer, a drug for treatingpulmonary arterial hypertension (PAH) which became a billion dollar seller.[19]

Acquisitions

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CoTherix

[edit]
CoTherix, Inc.
Company typeSubsidiary
IndustryPharmaceutical
Founded2000
Defunct9 January 2007; 18 years ago (2007-1-9)
Fateacquired by Actelion
HeadquartersSouth San Francisco, California
Key people
Donald J. Santel, CEO & Director
ProductsVentavis
RevenueUS$63 million
Number of employees
100
Websitewww.cotherix.com

CoTherix was abiopharmaceutical company located inSouth San Francisco, California. CoTherix focused on licensing, developing, and commercializing therapeutic products for the treatment ofcardiopulmonary and other chronic diseases. The company, formerly known asExhale Therapeutics, Inc., was founded in February 2000 by Gerard Turino, MD, a past president of theAmerican Thoracic Society, and Jerome Cantor, MD, a pulmonary pathologist.[citation needed]

CoTherix's commercial product was "Ventavis (Iloprost)", an inhaled therapy forpulmonary artery hypertension (PAH). It was approved by the United StatesFood and Drug Administration in December 2004, two months after the company'sinitial public offering of 5 million shares of common stock.

Fasudil, Tracleer, Asahi and Actelion

Asahi developedfasudil and entered into a licensing and development agreement with CoTherix in July 2006 to pursueregulatory approval and commercialization in the United States and Europe based on their prior track record in this area.[20][21] In November 2006, CoTherix and Actelion signed a merger plan, which was subsequently announced publicly; this followed the initiation of negotiations in August 2006.[21] In January 2007, Actelion completed acquisition of all CoTherix stock, and summarily informed Asahi that work on fasudil would be terminated.[21] Now, Actelion had a competitor blockbuster drug on the market,bosentan (Tracleer).[21] Asashi claimed that Actelion's acquisition of CoTherix was directly aimed at removing fasudil as a competitor therapeutic, which it effectively did.[20] Asahi pursued damages against CoTherix and Actelion initially through arbitration of a breach of contract claim, which netted them US$91 million, then in a jury trial, which resulted in an award of US$580 million in compensatory and punitive damages.[20] This case has served as an exemplar of the notion that a company's contractual obligations persist after that company's acquisition.[20]

On 20 November 2006, CoTherix agreed to be purchased for $420 million in cash by Actelion of Basel, Switzerland. On 9 January 2007, the deal closed with Actelion paying $13.50 for each share of CoTherix stock.

Revenues

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Actelion, headquartered in Switzerland, managed to earn 18.2% more in the year of 2016 than it did in 2015 while reporting an earning of 2,417.9 million Swiss Francs at the end of 2016.[4] After accounting for all costs of production such as raw materials and wages, the company calculated its operating margin (operating profit to net sales ratio) to be 0.5% more in 2016 than it was in 2015.[4]

'Kickbacks' Scandal

[edit]
This article's"criticism" or "controversy" sectionmay compromise the article'sneutrality. Please help rewrite or integrate negative information to other sectionsthrough discussion on thetalk page.(March 2023)

Tracleer was one of the main drugs manufactured and sold by Actelion. It has been used to treat excessively high blood pressure that affect arteries in the lungs and heart. In the years of 2014 and 2015, before Johnson & Johnson acquired the pharmaceutical company, Actelion was accused of pushing up the prices of Tracleer. According to a website known as Goodrx, sixty tablets (one month's supply) of this drug are sold for an average of $14,500.[22]

Actelion was able to do this by illegally providing money to Medicare patients in order for them to be able to fulfill their co-payments for the drug Tracleer.[22] Medicare is a healthcare program for adults who are 65 years and older.[22] Most patients have their prescriptions covered by Medicare, but they must still pay a portion of the amount of the prescription, known as a co-payment. By making sure Medicare patients are still paying a certain amount, drug companies are unable to raise their prices to inordinately large amounts.[22]

However recently many large drug companies, such as Pfizer, Lundbeck, United Therapeutics and now Actelion have been found to be illegally providing cash assistance to charities that help patients with their co-payments in order to increase the demand for their products.[22] Actelion was able to use the charity organization by the name of Caring Voice Coalition to send money only to those people who were receiving prescriptions of Tracleer.[22] When law enforcement was able to catch onto the illegal activities occurring with this organization with relation to two pharmaceutical companies (Actelion and United Therapeutics), it was banned from partaking in any further Medicare related matters.[22]

By ignoring the laws and regulations set by Congress, to prevent pharmaceutical companies from increasing the demand and prices of their drugs, and using information obtained from Caring Voice Coalition to financially support patients who were buying only its own drugs, Actelion was able to increase its drug prices to extraordinarily high amounts (nearly 30% of the inflation rate).[22]

Actelion was also complicit in referring patients to Caring Voice Coalition. Many unknowing patients who were gathering information about organizations that might cover their medical needs were being sent to CVC. Illegally, furthering the high demand for their drug.[22]

While investigations were taking place, Actelion refused to accept that any criminal activity or misconduct had occurred. It has been forced to pay a $360 million as a settlement to the United States government for the malpractice relating to kickbacks to Medicare patients.[22]

Other Lawsuits

[edit]

As of October, 2018, it was also caught in two lawsuit by drug buyers who claimed that Actelion was preventing a generic version of Tracleer to be manufactured so that it could stay in charge of the market as the sole supplier of the drug.[22]

Collaborating with Analytics 4 Life

[edit]

Analytics 4 Life is a company that uses artificial intelligence to develop solutions for medical illnesses while focusing its efforts on coronary artery disease. Actelion has been reported to start working with Analytics 4 Life to use imaging technology with regards to pulmonary hypertension.[5] A study, involving 500 individuals is being conducted to solve this widespread illness.[5] These companies are hoping to be able to accurately assess an individual's cardiac health using imaging technology and thus avoiding the need for an invasive test.[5] Actelion hopes that using this technology will help detect pulmonary hypertension in more people at an earlier age and thus leading to higher chances of success in the treatment.

Medicines

[edit]

Actelion currently has 10 compounds in its pipeline – including 3 in late-stage development – and 4 medicines on the market fororphan diseases:

  • Tracleer (bosentan): Tracleer is one of Actelions best sellers and provides the most income to the company. Tracleer was the first oral treatment approved forpulmonary arterial hypertension, a rare, chronic, life-threatening disorder that severely compromises the functions of the lungs and heart. It is a dualendothelin receptor antagonist, see also:Endothelin receptor antagonist.[23]
  • Zavesca (miglustat): is currently the only approved oral treatment for patients with mild to moderate type 1Gaucher disease for whom enzyme replacement therapy is unsuitable. Type 1 Gaucher disease is a rare and debilitating metabolic disorder.[24]
  • Ventavis (iloprost): Ventavis is indicated for the treatment of pulmonary arterial hypertension (WHO Group 1) in patients withNYHA Class III or IV symptoms.[25]
  • Veletri (epoprostenol for injection): is approved by the U.S. Food and Drug Administration (FDA) for the long-term intravenous treatment ofprimary pulmonary hypertension andpulmonary hypertension associated with thescleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy.[26]

Some other drugs that have been produced by Actelion's to provide for the PAH (Pulmonary Arterial Hypertension) market include:

  • Opsumit (Macitentan): Actelion received approval from the FDA for the manufacture of this drug on 16 January 2019.[27] Opsumit has been manufactured to treat patients with CTEPH (Inoperable Chronic Thromboembolic Pulmonary Hypertension) in order to enhance their ability to exercise and boost their PVR (Pulmonary Vascular Resistance).[28] It is an oral medication for ERA (Endothelin Receptor Antagonist) that has been used to slow down the prohibit the advancement of diseases and PAH.[28] Actelion received approval for the manufacture of this drug by the FDA. Opsumit provides Actelion with its second largest source of sales. This product is available inGermany,Switzerland,Canada andAustralia and the U.S.[27] 15 March 2019, Actelion reported that while evaluating the effects of this drug on patient with PAH, it found a remarkable improvement in the right ventricle and reduced PVR (Pulmonary Vascular Resistance).[29]
  • Uptravi (Selexipag): Uptravi was originally it was developed by Nippon Shinyaku to treat people suffering from Pulmonary Arterial Hypertension.[30] It is used to treat people suffering from PAH along with an advanced form of functional limitation.[30] Uptravi is an oral medication that should be used along with aphosphodiesterase-5 inhibitor, an ERA(endothelin receptor antagonist) or with both for maximum effectiveness. Uptravi's popularity in the PAH market has made it the third most sold drug among all of Actelion's total sales.[30] Actelion received approval from the Swiss medic for the manufacture and sale of this drug on 16 August 2016.[30]
  • Valchlor (mechlorethamine): In 2013, Actelion announced that Valchlor could be purchased in the United States.[31] Valchlor is an FDA approved formula drug that can be applied topically every day.[31] It is a gel that can be used to treat IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (rate type of non-Hodgkin's Lymphoma). It has afflicted around 20,000 U.S. citizens and therefore classifies as an orphan disease.[31]

Pipeline

[edit]

Late-stage drugs in development by Actelion include:

Key figures

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By January 2011, Actelion had 2,467 employees, 392 in research, 640 in development, and 1017 in sales and marketing. In 2010, Actelion's sales amounted to 1,929 million CHF.[32]

Actelion's shares have been listed on the SIX Swiss Exchange (ticker symbol ATLN) since 2000SWX Swiss ExchangeSwiss Leader Index. In September 2008, Actelion shares began trading as part of theSwiss Market Index.[33][34][35]

Awards

[edit]

Actelion received the "Prix Hermès de l'innovation" (Hermès Award for Innovation) in April 2011:[36] The "European Institute for Creative Strategy and Innovation", the creator of the Prix Hermès, was founded in 2003 in France.

The "performance report for Swiss pharma websites" awarded Actelion the first Prize in the second consecutive year:.[37]

Notes and references

[edit]
  1. ^"Acetelion Annual Business Report 2016"(PDF).
  2. ^abTaylor, Nick Paul (17 April 2018)."Johnson & Johnson scraps phase 3 antibiotic program acquired in $30B Actelion takeover".FierceBiotech. Framingham, Massachusetts: Questex. Retrieved5 July 2018.
  3. ^"UNITED STATES SECURITIES AND EXCHANGE COMMISSION, Commission file number 1-3215, Johnson & Johnson jnj-20231231".www.sec.gov. Retrieved12 November 2024.
  4. ^abcd"Actelion Ltd SWOT Analysis".FIU Libraries. MarketLine: 3. 6 November 2018.
  5. ^abcd"Analytics 4 Life and Actelion Join Forces".Health & Beauty Close-Up. 14 December 2018.
  6. ^"ACTELION LTD-REG (ATLN:VX)".Bloomberg Businessweek (Stock Quote & Company Profile). Archived fromthe original on 29 April 2010. Retrieved8 March 2011.
  7. ^"Actelion Pharma Switzerland Ltd Öffnungszeiten".
  8. ^"Actelion Pharmaceuticals Deutschland GmbH". Retrieved17 February 2025.
  9. ^"Actelion Pharmaceuticals Austria GmbH". Retrieved17 February 2025.
  10. ^"Actelion Paris Organisation SAS".
  11. ^"Actelion affiliates". Archived fromthe original on 8 March 2011. Retrieved8 March 2011.
  12. ^"Actelion Pharmaceuticals UK Ltd". Retrieved17 February 2025.
  13. ^doi:10.1164/rccm.201105-0927OC. Quote: "Supported in part by the Legs Poix, the Université Paris-Sud, INSERM, an Actelion Endothelin Research Award (AERA 2007-010)..."
  14. ^Roland, Denise; D. Rockoff, Jonathan (26 January 2017)."Johnson & Johnson to Acquire Actelion in $30 Billion Deal".The Wall Street Journal. Retrieved27 January 2017.
  15. ^Miller, John; Arnold, Paul (26 January 2017)."Johnson & Johnson to buy Actelion for $30 billion, spin off R&D unit".Reuters. Retrieved26 January 2017.
  16. ^Clozel, Jean-Paul."About Idorsia history". www.idorsia.com. Retrieved19 August 2018.
  17. ^Crow, David; Atkins, Ralph (26 January 2017)."Johnson & Johnson to buy Swiss biotech company Actelion for $30bn".Financial Times. Retrieved21 October 2021.
  18. ^Grundlehner, Werner (5 July 2017)."Was plant das Ehepaar Clozel? | NZZ".Neue Zürcher Zeitung (in German). Retrieved21 October 2021.
  19. ^Schmidt, Charlie (1 February 2007)."Profile: Jean-Paul Clozel".Nature Biotechnology.25 (2): 155.doi:10.1038/nbt0207-155.PMID 17287737.S2CID 919216.
  20. ^abcdWolters Kuwer Legal & Regulatory US (2016)."Asahi Kasei Pharma Corp. v. Actelion Ltd.".Torts. Casenote Legal Briefs (11th ed.). New York: Wolters Kluwer.ISBN 978-1-4548-7973-2 – via Google Books.Case reference: 222 Cal. App. 4th 945 (2014)
  21. ^abcdEpstein, Richard Allen; Sharkey, Catherine (2016). "14. Economic Harms".Cases and Materials on Torts. Aspen Casebook Series (11th ed.). New York: Wolters Kluwer. Section B. Inducement of Breach of Contract: Asahi Kasei Pharma Corp. v. Actelion Ltd.ISBN 978-1-4548-7746-2 – via Google Books.
  22. ^abcdefghijkDyer, Owen (10 December 2018)."Actelion Pharmaceuticals pays 360m to settle US government claims of kickbacks to patients".BMJ.363: k5231.doi:10.1136/bmj.k5231.PMID 30530812.S2CID 54474524 – via FIU library.
  23. ^"Tracleer".Medicines (EPAR). European Medicines Agency. 3 December 2019. Retrieved23 February 2020.
  24. ^"Zavesca".Medicines (EPAR). European Medicines Agency. 6 February 2020. Retrieved23 February 2020.
  25. ^"Ventavis".Medicines (EPAR). European Medicines Agency. 10 October 2019. Retrieved23 February 2020.
  26. ^"FDA approves brand name VELETRI for Actelion's epoprostenol for injection therapy".News Medical Lifesciences (Press release). Actelion. 26 August 2010. Retrieved23 February 2020 – via AZoNetworks.[self-published source]
  27. ^ab"Actelion receives CRL in USA for CTEPH".R & D Focus Drug News: 1. 18 January 2019.
  28. ^ab"US FDA seeks additional data from Actelion's sNDA for Opsumit to treat CTEPH".PharmaBiz. Athena Information Solutions Pvt. Ltd.: 1 18 January 2019.
  29. ^"Actelion reports data from Phase IV trial for PAH".R & D Focus Drug News. 18 March 2019.
  30. ^abcd"Thomson Reuters ONE".Actelion Receives Swissmedic Approval for Uptravi (Selexipag) for Treatment of Pulmonary Arterial Hypertension. COMTEX News Network, Inc. 16 August 2016 – via FIU Electronic Database.
  31. ^abc"-ACTELION LAUNCHES VALCHLOR (MECHLORETHAMINE) GEL 0.016% IN THE US".ENP Newswire. Normans Media Ltd. 19 November 2013.
  32. ^"Actelion company homepage". Archived fromthe original on 22 February 2011. Retrieved7 March 2011.
  33. ^"Swiss Market Index". 13 May 2024.
  34. ^"UBS". Archived fromthe original on 5 September 2014. Retrieved27 August 2014.
  35. ^"The Pharmaletter".
  36. ^"Prix Hermès". Archived fromthe original on 21 December 2010.
  37. ^"Prize for Website"(PDF). Archived fromthe original(PDF) on 23 March 2012.

See also

[edit]

External links

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