Orexo develops improved pharmaceuticals addressing large medical needs. In the work to develop new drugs, well-known substances are combined with innovative proprietary drug delivery technologies, such as amorphOX®.

amorphOX® is a novel and scalable technology platform. It possesses unique properties that support highly differentiated pharmaceuticals and amorphOX® will form the backbone of the company’s future drugs.

Pharmaceuticals
Project – API – Indication - Platform and/or partner
Exploratory
research
Preclinical
research
Phase
1
2
3
Registration
Approved and/or Launched
US
EU
RoW
OX124 Naloxone, Opioid overdose/
OX125 Nalmefene, Opioid overdose/
OX338 Ketorolac, Moderate to moderately severe pain
OX640 Adrenaline, Allergic reactions/
OX-MPI BI102953, Microvascular disease

Pipeline projects

OX124 - Opioid overdose rescue medication

Short facts  
API

Naloxone

Technology

Powder technology, nasal delivery

Indication

Opioid overdose

Development phase

Published positive results from the pivotal trial, OX124-002. Commercial manufacturing established while mandatory stability study is ongoing and is expected to be finalized in H2 2022.

Expected filing with FDA

In H2 2022

Expected launch

US market in H2 2023

In-house or partnership

In-house

Unmet need
Available rescue medications have been developed for heroin overdoses, but most patients are dying from synthetic opioids like fentanyl today.

Our aim
Based on Orexo´s novel intranasal formulation technology, the aim is to develop a rescue medication that is faster and longer-acting, and thus effective in reversing overdoses caused by synthetic opioids.

Differentiation
Results from the exploratory pharmacokinetic study (PK-study) in healthy volunteers showed significantly better PK-profile, such as faster and longer-acting, when compared to the market leading product. Novel, proprietary drug delivery technology with patent protection until 2039.

OX125 - Opioid overdose rescue medication

Short facts  
API

Naloxone

Technology

Nasal

Indication

Rescue medication, opioid overdose

Development phase

Finalized phase 1

Expected filing with FDA

-

In-house or partnership

In-house

Unmet need
Available rescue medications have been developed for heroin overdoses, but most patients are dying from synthetic opioids like fentanyl today.

Our aim
Based on Orexo´s novel intranasal formulation technology, the aim is to develop a powerful rescue medication for situations where very long-lasting effect is required, e.g., in remote areas, as response to long-acting opioids or for anti-terror stockpiling.

Differentiation
Results from the first exploratory human PK-study in healthy volunteers showed extensive and rapid absorption of nalmefene across all three OX125 formulations. As nalmefene has a longer half-life than naloxone, OX125 has the potential to be an effective response to the increased use of potent, long- acting synthetic opioids as well as protecting against renarcotization (second overdose) as the antagonist wears off. Novel, proprietary drug delivery technology with patent protection until 2039.

OX338 - Moderate to moderately severe pain

Short facts  
API

Ketorolac

Technology

Sublingual

Indication

Moderate to moderately severe pain

Development phase

Finalized phase 1

Expected filing with FDA

-

In-house or partnership

In-house

Unmet need
Opioids are still used unnecessarily in many situations, further fueling the opioid crisis.

Our aim
Based on Orexo´s novel oral formulation technology, the aim is to develop an opioid-level pain relief treatment for short-term pain (up to 5 days) without the risk of addiction.

Differentiation
Results from the exploratory PK-study in healthy volunteers showed significant better PK-profile, such as faster uptake and higher peak, when compared to nasal spray available on the market.

OX640 - Emergency treatment of allergic reactions

Short facts  
API Adrenaline
Technology amorphOX®, nasal powder technology
Indication Emergency treatment of allergic reactions
Development phase Expects to perform first explorative human clinical pharmacokinetic study in the second half of 2022.
Expected filing with FDA -
In-house or partnership Currently in-house, partnership will be assessed during the development phase and for commercialization.

Unmet need
Today, allergic rescue products are needle-based auto injectors that administer adrenaline to reverse life-threatening reactions (anaphylaxis). Whether self-administered or with the help of others, applying needle injections correctly is often intimidating, with the potential loss of precious life-saving minutes. Current solutions are costly and devices must be replaced frequently because adrenaline rapidly degrades during storage.

The aim
With decades of no innovation, products like EpiPen dominates the market. Orexo will strive to bring to market a more fast-acting intranasal product, which is key in life-saving situations. Additionally, the single-dose nasal administration is easy to use and easy to teach others and easy to learn for caregivers.

Differentiation
Built on our amorphOX® platform, OX640’s dry-powder, single-use, intranasal delivery will provide rapid and extensive absorption with the potential of doubling the stability and shelf-life of current solutions. Moreover, OX640 is preservative-free with no sodium metabisulfite or other stability agents currently needed in today’s devices. These preservatives can in itself cause allergic reactions.

OX-MPI - Microvascular disease

Short facts  
API BI1029539
Technology -
Indication Microvascular disease
Development phase Phase 2
Expected filing with FDA -
In-house or partnership In partnership with

Unmet need
Several severe microvascular complications currently have few or no approved pharmacological treatment options.

The aim
Gesynta Pharma, who owns all the rights to OX-MPI (GS-248), aims to develop a treatment for the microvascular diseases in chronic inflammatory conditions.

Differentiation
More effective and/or safer than currently approved treatments.

3 Questions with Robert Rönn, SVP and Head of R&D

It has been an intensive and fruitful year where we have made important progress in several areas. Our commit- ment to help patients in the addiction field continues and our naloxone product for the treatment of opioid overdose, OX124, passed a significant milestone with the successful completion of a pivotal clinical study. In parallel, our focus on the development of innovative drug delivery solutions has resulted in amorphOXTM, yet another important technology platform for Orexo. With amorphOXTM, I see significant opportunities even beyond the addiction field and it has already enabled us to further progress our pharma pipeline with the addition of OX640, a nasal adrenaline product for the treatment of allergic reactions.

Our main priority is to complete the development
of OX124 and file for approval in the US. We will also advance the development of OX640 and perform the first human clinical study. Furthermore, the development of OX125, our nalmefene product for opioid overdoses will continue.

My vision is to develop several new drugs based on the amorphOXTM platform. In five years’ time, Orexo has initiated and led the development of multiple new pharma products approaching the market and we have a wide pipeline of development programs in various phases.

Within the business area HQ and Pipeline out-licensed pharmaceuticals are included, such as ZUBSOLV® for the EU market as well as Abstral® (break-through cancer pain) and Edluar® (insomnia). These drugs are developed, based on the company´s sublingual drug delivery platform.

Partnerships for out-licensed drugs

EU Market

ZUBSOLV's product website

Worldwide ex the US and EU where patents have expired

Abstral's product website

Worldwide

Product website not available