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.[5]
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 in Baden, the German affiliate in Freiburg, the Austrian one in Vienna, the French one in Paris and the UK affiliate is located in London.[7][failed verification]
In 2006, the company established the Actelion Endothelin Research Award program which supports selected clinical research projects.[citation needed]
In January 2017, Johnson & Johnson announced it would purchase the company for $30 billion.[8] Actelion's research and development unit would also be spun off after the acquisition.[9] The new company Idorsia was created from former Actelion drug discovery operations and early-stage clinical development assets and listed in June 2017 on the SIX Swiss Exchange.[10]
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
Actelion was founded in 1997[11] by husband and wife team Jean-Paul and Martine Clozel[12] together with three colleagues after F. Hoffmann-La Roche cut their funding for Martine's cardiovascular program. They founded Actelion to work on a drugs for rare diseases and retained the rights to the intellectual property from Roche, including the molecule leading to the development of Tracleer, a drug for treating pulmonary arterial hypertension (PAH) which became a billion dollar seller.[13]
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.[citation needed]
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.[14][15] In November 2006, CoTherix and Actelion signed a merger plan, which was subsequently announced publicly; this followed the initiation of negotiations in August 2006.[15] In January 2007, Actelion completed acquisition of all CoTherix stock, and summarily informed Asahi that work on fasudil would be terminated.[15] Now, Actelion had a competitor blockbuster drug on the market, bosentan (Tracleer).[15] Asashi claimed that Actelion's acquisition of CoTherix was directly aimed at removing fasudil as a competitor therapeutic, which it effectively did.[14] 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.[14] This case has served as an exemplar of the notion that a company's contractual obligations persist after that company's acquisition.[14]
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
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]
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.[16]
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.[16] Medicare is a healthcare program for adults who are 65 years and older.[16] 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.[16]
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.[16] 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.[16] 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.[16]
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).[16]
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.[16]
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.[16]
Other Lawsuits
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.[16]
Collaborating with Analytics 4 Life
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
Actelion currently has 10 compounds in its pipeline – including 3 in late-stage development – and 4 medicines on the market for orphan diseases:
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.[18]
Ventavis (iloprost): Ventavis is indicated for the treatment of pulmonary arterial hypertension (WHO Group 1) in patients with NYHA Class III or IV symptoms.[19]
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.[20]
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.[21] 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).[22] 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.[22] 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.[21] 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).[23]
Uptravi (Selexipag): Uptravi was originally it was developed by Nippon Shinyaku to treat people suffering from Pulmonary Arterial Hypertension.[24] It is used to treat people suffering from PAH along with an advanced form of functional limitation.[24] Uptravi is an oral medication that should be used along with a phosphodiesterase-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.[24] Actelion received approval from the Swiss medic for the manufacture and sale of this drug on 16 August 2016.[24]
Valchlor (mechlorethamine): In 2013, Actelion announced that Valchlor could be purchased in the United States.[25] Valchlor is an FDA approved formula drug that can be applied topically every day.[25] 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.[25]
Pipeline
Late-stage drugs in development by Actelion include:
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.[26]
Actelion received the "Prix Hermès de l'innovation" (Hermès Award for Innovation) in April 2011:[30] 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:.[31]
1 2 3 4 Epstein, Richard Allen; Sharkey, Catherine (2016). "14. Economic Harms". Cases and Materials on Torts. Aspen Casebook Series (11thed.). New York: Wolters Kluwer. Section B. Inducement of Breach of Contract: Asahi Kasei Pharma Corp. v. Actelion Ltd. ISBN978-1-4548-7746-2– via Google Books.
1 2 "Actelion receives CRL in USA for CTEPH". R & D Focus Drug News: 1. 18 January 2019.
1 2 "US FDA seeks additional data from Actelion's sNDA for Opsumit to treat CTEPH". PharmaBiz. Athena Information Solutions Pvt. Ltd.: 1 18 January 2019.
Tadalafil, sold under the brand name Cialis among others, is a medication used to treat erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension. It is taken by mouth. Onset is typically within half an hour and the duration is up to 36 hours.
Pulmonary hypertension is a condition of increased blood pressure in the arteries of the lungs. Symptoms include shortness of breath, fainting, tiredness, chest pain, swelling of the legs, and a fast heartbeat. The condition may make it difficult to exercise. Onset is typically gradual. According to the definition at the 6th World Symposium of Pulmonary Hypertension in 2018, a patient is deemed to have pulmonary hypertension if the pulmonary mean arterial pressure is greater than 20mmHg at rest, revised down from a purely arbitrary 25mmHg, and pulmonary vascular resistance (PVR) greater than 3 Wood units.
Icos Corporation was an American biotechnology company and the largest biotechnology company in the U.S. state of Washington, before it was sold to Eli Lilly and Company in 2007. It was founded in 1989 by David Blech, Isaac Blech, Robert Nowinski, and George Rathmann, a pioneer in the industry and chief executive officer (CEO) and co-founder of Amgen. Icos focused on the development of drugs to treat inflammatory disorders. During its 17-year history, the company conducted clinical trials of twelve drugs, three of which reached the last phase of clinical trials. Icos also manufactured antibodies for other biotechnology companies.
Sitaxentan sodium (TBC-11251) is a medication for the treatment of pulmonary arterial hypertension (PAH). It was marketed as Thelin by Encysive Pharmaceuticals until Pfizer purchased Encysive in February 2008. In 2010, Pfizer voluntarily removed sitaxentan from the market due to concerns about liver toxicity.
Bosentan, sold under the brand name Tracleer among others, is a dual endothelin receptor antagonist medication used in the treatment of pulmonary artery hypertension (PAH).
Iloprost, sold under the brand name Ventavis among others, is a medication used to treat pulmonary arterial hypertension (PAH), scleroderma, Raynaud's phenomenon, frostbite, and other conditions in which the blood vessels are constricted and blood cannot flow to the tissues. Iloprost is a prostacyclin mimetic.
Dasatinib, sold under the brand name Sprycel among others, is a targeted therapy medication used to treat certain cases of chronic myelogenous leukemia (CML) and acute lymphoblastic leukemia (ALL). Specifically it is used to treat cases that are Philadelphia chromosome-positive (Ph+). It is taken by mouth.
Ambrisentan, sold under the brand name Letairis among others, is a drug used for the treatment of pulmonary hypertension. It is an endothelin receptor antagonist.
Atrasentan is an experimental drug that is being studied for the treatment of various types of cancer, including non-small cell lung cancer. It is also being investigated as a therapy for diabetic kidney disease.
Fasudil (INN) is a potent Rho-kinase inhibitor and vasodilator. Since it was discovered, it has been used for the treatment of cerebral vasospasm, which is often due to subarachnoid hemorrhage, as well as to improve the cognitive decline seen in stroke patients. It has been found to be effective for the treatment of pulmonary hypertension. It has been demonstrated that fasudil could improve memory in normal mice, identifying the drug as a possible treatment for age-related or neurodegenerative memory loss.
Arena Pharmaceuticals, Inc. is an American biopharmaceutical company founded in 1997 and headquartered in San Diego, California. The company has small molecule drugs in development for possible clinical utility in multiple therapeutic areas. The company's most advanced investigational clinical programs are ralinepag in testing for pulmonary arterial hypertension (PAH), etrasimod in evaluation for inflammatory indications and APD371 for the treatment of pain associated with Crohn's disease. In 2016, the company downsized and shifted its focus to developing new drugs currently being tested in clinical trials. In December 2021, Pfizer announced that it had agreed to acquire Arena for $6.7 billion in cash. In March 2022, it was announced the acquisition by Pfizer had been concluded.
Hermann A. M. Mucke is an Austrian bioscientist with a peer-review publishing record in the fields of molecular biology, neuropsychiatry, cardiology and ophthalmology, mostly from the perspective of drug development. He is also a management consultant and entrepreneur working and publishing in biopharmaceutical strategic knowledge management, intellectual property management, and life science technology assessment.
United Therapeutics Corporation is an American publicly traded biotechnology company and public benefit corporation listed on the NASDAQ under the symbol UTHR. It develops novel, life-extending technologies for patients in the areas of lung disease and organ manufacturing. United Therapeutics is co-headquartered in Silver Spring, Maryland and Research Triangle Park, North Carolina, with additional facilities in Magog and Bromont, Quebec; Melbourne and Jacksonville, Florida; Blacksburg, Virginia; and Manchester, New Hampshire.
Macitentan, sold under the brand name Opsumit, is an endothelin receptor antagonist developed by Actelion and approved for the treatment of pulmonary arterial hypertension (PAH). Macitentan is a dual endothelin receptor antagonist, meaning that it acts as an antagonist of two endothelin (ET) receptor subtypes, ETA and ETB. However, macitentan has a 50-fold increased selectivity for the ETA subtype compared to the ETB subtype.
Selexipag, sold under the brand name Uptravi, is a medication developed by Actelion for the treatment of pulmonary arterial hypertension (PAH). Selexipag and its active metabolite, ACT-333679, are agonists of the prostacyclin receptor, which leads to vasodilation in the pulmonary circulation. It is taken by mouth or administered intravenously.
Idorsia is a Swiss pharmaceutical research company in Allschwil, near Basel, Switzerland.
Sotatercept, sold under the brand name Winrevair is a medication used for the treatment of pulmonary arterial hypertension. It is an activin signaling inhibitor, based on the extracellular domain of the activin type 2 receptor expressed as a recombinant fusion protein with immunoglobulin Fc domain (ACTRIIA-Fc). It is given by subcutaneous injection.
Aprocitentan, sold under the brand name Tryvio, is a medication used to treat hypertension. It is developed by Idorsia. It is taken by mouth.
Macitentan/tadalafil, sold under the brand name Opsynvi, is a fixed dose combination medication used for the treatment of pulmonary arterial hypertension. It contains macitentan, an endothelin receptor antagonist (ERA); and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.
Pulmonary Arterial Hypertension (PAH) is a syndrome in which the blood pressure in the pulmonary arteries and pulmonary arterioles is elevated. This pre-capillary pulmonary artery pressure being elevated is essential, and by definition a mean pulmonary artery pressure greater than 20 mmHg as measured by a right heart catheterization is required for the diagnosis. This pre-capillary pulmonary hypertension is confirmed with measuring pulmonary vascular resistance being greater than 3 Woods Units. A pulmonary artery wedge pressure being less than 15 mmHg excludes post-capillary bed pulmonary hypertension. Pulmonary arterial hypertension is a subgroup of pulmonary hypertension and is categorized as World Health Organization as group 1. PAH is further subdivided into various categories based on the cause, including idiopathic, heritable, drug and toxin induced, PAH associated with specific diseases, PAH that is responsive to vasodilators, PAH with venous or capillary involvement, and persistent PAH in the newborn period.
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