Orexo was founded in 1995 by Thomas Lundqvist, a pharmacist, Anders Pettersson, a physician and clinical pharmacologist , and Christer Nyström, a pharmacist and Professor of Galenic Pharmacy at Uppsala University.
The company’s first product, Diabact® UBT – a breath test for diagnosing the stomach ulcer bacterium, Helicobacter pylori – was registered in 2000.
The name Orexo
In 2003 the company adopted the name Orexo, which derives from Greek and is the future form of the verb "orégo" - "to attain, to extend." Orexo also means appetite. New shareholders contributed financing, thereby raising the level of activity in the company. New development projects were started and a new company management was appointed to lead the company into the next phase.
In 2005, Orexo was listed on the Stockholm Stock Exchange. The company has since then entered into agreements with business partners and the development portfolio includes several potential drug candidates.
EU launch of Abstral®
Abstral was approved for the treatment of breakthrough cancer pain during 2008. The product was launched in Sweden in August 2008 via the joint-venture company ProStrakan AB. In early 2009, Orexo’s partner, Prostrakan, launched Abstral in the UK and Germany. During 2010 Abstral was launched in a further 12 countries in Europe. Today Abstral has been launched in a total of 23 countries.
Launch of Edluar™
In March 2009, the U.S. Food and Drug Administration, FDA, approved Edluar for the treatment of short-term insomnia. Orexo’s partner Meda launched the product on the US market in August 2009 and in Canada in July 2011. Edluar was approved for launch in the EU in June 2012.
Stronger ownership base
During 2010 Novo A/S became a new principal owner of Orexo.
Launch of a new strategy and new development program
In August 2010 the next stage of the strategy was launched: the use of proprietary, patented and proven technologies to develop new proprietary products within the specialty pharma segment. As part of this strategy Orexo initiated three new development programs with the aim of marketing the products through the company’s own marketing and sales organization, with focus on the USA.
US approval of Abstral
During 2011 Abstral was approved by the U.S. Food and Drug Administration, FDA. The product was launched by ProStrakan in the USA.
Renegotiated agreement with ProStrakan
In June 2012 Orexo acquired the commercial rights for Abstral in the USA while ProStrakan acquired the rights in the EU and the rest of the world.
Submission of New Drug Application for Zubsolv™
In September 2012 a New Drug Application was submitted in the USA for Zubsolv for the treatment of opioid dependence. In November the application was approved for review by the FDA and the approval date was set at July 6, 2013.
Abstral in the United States sold to Galena Biopharma, Inc.
In March 2013, Orexo sold Abstral (fentanyl) Sublingual Tablets in the United States to Galena Biopharma, Inc.
US approval of Zubsolv
On July 3, 2013, FDA approved Zubsolv for the maintenance treatment of opioid dependence.