Orexo provides information about its new proprietary drug delivery platform – amorphOX™

• amorphOX™ is a novel and inventive drug delivery platform that can be used to develop highly differentiated products with various active ingredients and administration routes               
• The amorphOX™ platform provides for excellent chemical and physical stability, commonly a significant problem for amorphous drug compositions
• Development of products based on amorphOX™ will be conducted by Orexo or in partnership with other pharmaceutical companies

Uppsala, Sweden – November 26, 2021 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY) today provides information about its new proprietary drug delivery platform, amorphOX™, a novel and inventive powder-based technology with significant potential. Several new patent applications directed to amorphOX™ have now been filed, which should serve to protect the technology until 2042.

The amorphOX™ powder technology is made up of particles which are built using a unique combination of a drug, carrier materials and, optionally, other ingredients. The particles are presented as an amorphous composite of the various ingredients providing for excellent chemical and physical stability, commonly a significant problem with amorphous drug compositions.

Significantly, the amorphOX™ platform has been shown to work for a broad scope of different active ingredients enabling drug development in many different fields. Drug products using amorphOX™ display nearly instant dissolution even in very limited amounts of liquids, making it an ideal choice for the development of drugs targeting administration sites such as the nasal and sublingual cavities. Rapid dissolution of drug products provides for important opportunities when, for example, developing drugs requiring a rapid onset of action.

The amorphOX™ platform has been validated in various in vivo studies, including human clinical trials, demonstrating rapid and extensive absorption of various drugs. The platform is well-tolerated and shows a low degree of inter-patient variability. Orexo’s first product based on the amorphOX™ platform, OX124 - an overdose rescue medication - has been shown to provide superior pharmacokinetic properties compared to the market leading liquid-based nasal spray product. The commercial supply chain established for OX124 will help shorten timelines and reduce risk of future products based on nasal delivery.

Development of products based on the amorphOX™ platform will be conducted by Orexo or in partnership with other pharmaceutical companies.

Robert Rönn, SVP and Head of R&D of Orexo AB, said: “Over the last few years, Orexo has taken important steps to continue its pioneering work developing scalable technologies that are helping to create highly differentiated drug products for the treatment of significant unmet medical needs. The development of a proprietary drug delivery platform based on an amorphous drug composition, showing remarkable chemical and physical stability, is a significant invention from the scientists at Orexo and an opportunity for us to continue to develop improved drugs.”

For further information, please contact:

Orexo AB (publ.)

About Orexo

Orexo develops improved pharmaceuticals and digital therapies addressing unmet needs within the growing space of substance use disorders and mental illness. The products are commercialized by Orexo in the US or via partners worldwide. The main market today is the US market for buprenorphine/naloxone products, where Orexo commercializes its lead product, ZUBSOLV®, for treatment of opioid use disorder. Total net sales for Orexo in 2020 amounted to SEK 664 million and the number of employees was 138. Orexo is listed on the Nasdaq Stockholm Mid Cap (ORX) and is available as ADRs on OTCQX (ORXOY) in the US. The company is headquartered in Uppsala, Sweden, where research and development activities are performed.

For more information about Orexo please visit, www.orexo.com. You can also follow Orexo on Twitter, @orexoabpubl, LinkedIn and YouTube.

The information was submitted for publicationat 8.00 am CET on November 26, 2021.