Company type | Public ( Aktiebolag ) |
---|---|
Nasdaq Stockholm: ORX OTCQX: ORXOY | |
ISIN | SE0000736415 |
Industry | Pharmaceutical |
Founded | 1995 |
Headquarters | Uppsala, Sweden |
Area served | Worldwide |
Products | ZUBSOLV, Abstral, Edluar, MODIA, Vorvida and Deprexis |
Revenue | SEK 624 million (2022) [1] |
SEK -178 million million (2022) [2] | |
Number of employees | 126 (2022) [3] |
Website | Orexo.com |
Footnotes /references Employee and financial data as of 2022 [update] |
Orexo is a Swedish pharmaceutical company that develops improved pharmaceuticals based on innovative formulation technologies that meet large medical needs. Through presence its in the US market, drugs and digital therapies are commercialized to treat opioid use disorder and adjacent diseases. Products targeting other therapeutic areas are developed and commercialized worldwide with partners.
The company was founded in 1995 and their first product Diabact UBT, a breath test for diagnosing the causative agent of stomach ulcers (Helicobacter pylori), was introduced in 2000. [4] In 2003, the company adopted the name Orexo and in 2005 the company was listed on the Stockholm Stock Exchange. [4]
In 2008 the development of Abstral, a drug for the treatment of breakthrough cancer, was finalized. Abstral was the first product developed based on Orexo´s world-leading sublingual platform.
In 2010, through a right issue, Novo A/S became the largest shareholder in Orexo. With the investment from Novo A/S, the Board of Directors reviewed the strategy and created a vision of establishing a commercial business in the US.
In 2013, Orexo established a commercial subsidiary in the US and launched ZUBSOLV, a drug for the treatment of opioid use disorder.
In 2018, the company won a multiyear patent battle against the generic company Teva/Actavis securing patent protection for ZUBSOLV in the US until 2032.
With the intention to grow its business to include evidence-based therapeutics, Orexo started a collaboration with GAIA in 2019. GAIA is a world-leading digital therapeutics company based in Germany. Today Orexo commercializes three digital therapies on the US market, targeting patients within opioid use disorder and adjacent treatment areas. [5] [6] [7] [8]
In 2023, Orexo won another multiyear patent litigation, this time against Sun Pharma, securing ZUBSOLV’s patent protection in the US until 2032 and confirming the strength of the patents protecting the innovation and technology behind ZUBSOLV. [9]
To meet the large need of efficient high-dose opioid overdose medications, such as OX124 and OX125, Orexo has developed the next generation drug delivery technology amorphOX. The technology is scalable and suits with various substances and will serve as a backbone in the future drugs developed by Orexo.
AmorphOX is a clinically proven drug delivery platform that works with various APIs, dosage forms and administration routes. It is integral to the development of innovative pharmaceuticals targeting serious and extensive unmet needs with a focus on providing rapid absorption, high bioavailability, and stability.
Development projects based on the amorphOX platform:
The company also develops OXMPI, a drug candidate for the treatment of endometriosis, together with its partner Gesynta Pharma which owns all rights to the candidate.
Naloxone is an opioid antagonist: a medication used to reverse or reduce the effects of opioids. For example, it is used to restore breathing after an opioid overdose. Effects begin within two minutes when given intravenously, five minutes when injected into a muscle, and ten minutes as a nasal spray. Naloxone blocks the effects of opioids for 30 to 90 minutes.
Hydromorphone, also known as dihydromorphinone, and sold under the brand name Dilaudid among others, is a morphinan opioid used to treat moderate to severe pain. Typically, long-term use is only recommended for pain due to cancer. It may be used by mouth or by injection into a vein, muscle, or under the skin. Effects generally begin within half an hour and last for up to five hours. A 2016 Cochrane review found little difference in benefit between hydromorphone and other opioids for cancer pain.
Biogen Inc. is an American multinational biotechnology company based in Cambridge, Massachusetts, United States specializing in the discovery, development, and delivery of therapies for the treatment of neurological diseases to patients worldwide. Biogen operates in Argentina, Brazil, Canada, China, France, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, Sweden, and Switzerland.
Duloxetine, sold under the brand name Cymbalta among others, is a medication used to treat major depressive disorder, generalized anxiety disorder, obsessive-compulsive disorder, fibromyalgia, neuropathic pain and central sensitization. It is taken by mouth.
Opioid use disorder (OUD) is a substance use disorder characterized by cravings for opioids, continued use despite physical and/or psychological deterioration, increased tolerance with use, and withdrawal symptoms after discontinuing opioids. Opioid withdrawal symptoms include nausea, muscle aches, diarrhea, trouble sleeping, agitation, and a low mood. Addiction and dependence are important components of opioid use disorder.
Buprenorphine, sold under the brand name Subutex among others, is an opioid used to treat opioid use disorder, acute pain, and chronic pain. It can be used under the tongue (sublingual), in the cheek (buccal), by injection, as a skin patch (transdermal), or as an implant. For opioid use disorder, the patient must have moderate opioid withdrawal symptoms before buprenorphine can be administered under direct observation of a health-care provider.
Oxymorphone is a highly potent opioid analgesic indicated for treatment of severe pain. Pain relief after injection begins after about 5–10 minutes, after oral administration it begins after about 30 minutes, and lasts about 3–4 hours for immediate-release tablets and 12 hours for extended-release tablets. The elimination half-life of oxymorphone is much faster intravenously, and as such, the drug is most commonly used orally. Like oxycodone, which metabolizes to oxymorphone, oxymorphone has a high potential to be abused.
A nicotine patch is a transdermal patch that releases nicotine into the body through the skin. It is used in nicotine replacement therapy (NRT), a process for smoking cessation. Endorsed and approved by the U.S. Food and Drug Administration (FDA), it is considered one of the safer NRTs available for the treatment of tobacco use disorder.
Endo International plc is an American Irish-domiciled generics and specialty branded pharmaceutical company that generated over 93% of its 2017 sales from the U.S. healthcare system. While Endo's management, operations, and customers are almost exclusively U.S.–based, in 2013 Endo executed a corporate tax inversion to Ireland to avoid U.S. corporate taxes on their U.S. drug sales, and to avail of Ireland's corporate tax system.
Nalmefene is a medication that is used in the treatment of opioid overdose and alcohol dependence. Nalmefene belongs to the class of opioid antagonists and can be taken by mouth, administered by injection, or delivered through nasal administration.
Naldemedine is a medication that is used for the treatment of opioid-induced constipation in adults with chronic non-cancer pain. It is a peripherally acting μ-opioid receptor antagonist and was developed by Shionogi. Clinical studies have found it to possess statistically significant effectiveness for these indications and to be generally well tolerated, with predominantly mild to moderate gastrointestinal side effects. Effects indicative of central opioid withdrawal or impact on the analgesic or miotic effects of co-administered opioids have only been observed in a small number of patients.
AbbVie Inc. is an American pharmaceutical company headquartered in North Chicago, Illinois. It is ranked sixth on the list of largest biomedical companies by revenue. In 2023, the company's seat in Forbes Global 2000 was 74. The company's primary product is Humira (adalimumab), administered via injection. It is approved to treat autoimmune diseases including rheumatoid arthritis, Crohn's disease, plaque psoriasis, and ulcerative colitis.
Assertio Therapeutics, Inc. is an American specialty pharmaceutical company. It mainly markets products for treatment in neurology, pain and diseases of the central nervous system. Depomed was founded in 1995 and is headquartered in Newark, California. It is a publicly traded company on NASDAQ, with several products approved by the United States Food and Drug Administration (FDA). On August 15, 2018, the company announced its name change from Depomed, Inc., to Assertio Therapeutics, Inc. As of 2019, Assertio markets three products approved by the FDA: Gralise, Cambia, and Zipsor.
Marathon Pharmaceuticals LLC was a privately held biopharmaceuticals company focused on drugs for people with rare diseases. The Illinois-based company developed and manufactured therapeutics and brought them to market. It employed 100 people in four global locations. In 2017, PTC Therapeutics acquired rights to Marathon Pharmaceuticals' drug Emflaza (deflazacort) for $140 million after criticism about their plan to sell the drug at a list price of $89,000 per year to sufferers despite the fact that the same drug was available in Canada and the UK for around $1,000 per year.
Buprenorphine/naloxone, sold under the brand name Suboxone among others, is a fixed-dose combination medication that includes buprenorphine and naloxone. It is used to treat opioid use disorder, and reduces the mortality of opioid use disorder by 50%. It relieves cravings to use and withdrawal symptoms. Buprenorphine/naloxone is available for use in two different forms, under the tongue or in the cheek.
Tonix Pharmaceuticals is a pharmaceutical company based in Chatham, New Jersey that focuses on repurposed drugs for central nervous system conditions and as of 2020 was also pursuing a vaccine for COVID-19 and a biodefense project.
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AptarGroup, Inc., also known as Aptar, is a United States-based global manufacturer of consumer dispensing packaging and drug delivery devices. The group has manufacturing operations in 18 countries.