Actelion — BrandWiki

Actelion

Overview

Actelion Pharmaceuticals Ltd.

type	Subsidiary
foundation	1997
founders	Jean-Paul Clozel, Martine Clozel, Walter Fischli, André J. Müller and Thomas Widmann
location city	Allschwil, Basel-Landschaft
location country	Switzerland
location	Gewerbestrasse 16
key people	Jean-Paul Clozel (CEO)
area served	Research and Development of medicines for unmet medical need
industry	Pharmaceuticals/Biotech
products	Tracleer, Ventavis, Zavesca, Veletri, Opsumit
revenue	CHF 2.412 billion (2016)‡R1R‡
operating income	CHF 992 million (2016)
num employees	2,624 (2016)
parent	Johnson & Johnson
homepage	actelion.com

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

Actelion focuses on the manufacture of drugs that treat rare and orphan 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 with pulmonary arterial hypertension (PAH), a heart condition that leaves patients with a short life expectancy (7–9 years) even with treatment.

Actelion scientists were among the first to work in the field of endothelin receptor antagonists.[5] Actelion was initially financed with venture capital provided through a syndicate including Atlas Venture, Sofinnova and HealthCap.

Acquisitions

CoTherix

CoTherix was a biopharmaceutical company located in South San Francisco, California. CoTherix focused on licensing, developing, and commercializing therapeutic products for the treatment of cardiopulmonary and other chronic diseases. The company, formerly known as Exhale Therapeutics, Inc., was founded in February 2000 by Gerard Turino, MD, a past president of the American Thoracic Society, and Jerome Cantor, MD, a pulmonary pathologist.

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

Asahi developed fasudil and entered into a licensing and development agreement with CoTherix in July 2006 to pursue regulatory approval and commercialization in the United States and Europe based on their prior track record in this area.[19][20] In November 2006, CoTherix and Actelion signed a merger plan, which was subsequently announced publicly; this followed the initiation of negotiations in August 2006.[20] In January 2007, Actelion completed acquisition of all CoTherix stock, and summarily informed Asahi that work on fasudil would be terminated.[20] Now, Actelion had a competitor blockbuster drug on the market, bosentan (Tracleer).[20] Asashi claimed that Actelion's acquisition of CoTherix was directly aimed at removing fasudil as a competitor therapeutic, which it effectively did.[19] 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.[19] This case has served as an exemplar of the notion that a company's contractual obligations persist after that company's acquisition.[19]

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.

Fasudil, Tracleer, Asahi and Actelion

'Kickbacks' Scandal

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.[21]

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.[21] Medicare is a healthcare program for adults who are 65 years and older.[21] 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.[21]

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.[21] 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.[21] 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.[21]

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).[21]

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.[21]

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.[21]

Medicines

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

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

Tracleer (bosentan): Tracleer is one of Actelions best sellers and provides the most income to the company. Tracleer was the first oral treatment approved for pulmonary arterial hypertension, a rare, chronic, life-threatening disorder that severely compromises the functions of the lungs and heart. It is a dual endothelin receptor antagonist, see also: Endothelin receptor antagonist.[23]
Zavesca (miglustat): is currently the only approved oral treatment for patients with mild to moderate type 1 Gaucher 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 with NYHA 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 of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy.[26]

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 in Germany, Switzerland, Canada and Australia 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]

Pipeline

Late-stage drugs in development by Actelion include:

Cadazolid for Clostridioides difficile-associated diarrhea
Macitentan for pediatric PAH and portopulmonary hypertension

Actelion

History

Acquisitions

CoTherix

Revenues

'Kickbacks' Scandal

Other Lawsuits

Collaborating with Analytics 4 Life

Medicines

Pipeline

Key figures

Awards

See also

External links

References