Orexo secures at least 75 million for overdose treatment

Orexo is a specialty pharmaceutical company founded with the vision of tackling addiction and dependence. The company's presence in the US market has grown strongly, primarily through its main product Zubsolv against opioid addiction. The drug is manufactured locally in the US through the subsidiary Orexo US – a strategic advantage in a market characterized by trade tariffs and political priorities around abuse issues.

The company's core competence lies in the patented AmorphOXtechnology, a powder-based platform for nasal drug formulations that enables rapid and effective absorption into the body. The technology has been validated in several clinical studies and forms the basis of the company's pipeline, including projects such as OX124 – a high-dose opioid overdose drug that recently received trademark approval from FDA under the name IZIPRY And OX640, a potential treatment for severe allergic reactions that is now being negotiated for partnership.

Vd Nikolaj Sorensen emphasizes in his latest CEO statement the importance of pipeline development:

– We are focused on broadening the AmorphOX platform towards larger molecules and vaccines, with partnerships as the key to future value creation.

Million-dollar grant from American government agency

Then came the news that BARD – The Biomedical Advanced Research and Development Authority, which is part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services – awards Orexo US a grant of 8 million USD, equivalent to approximately 75 million SEK. The money will accelerate the development of OX390, an intranasal rescue medication designed to counteract overdoses of opioids mixed with other dangerous substances.

The agreement, which could potentially grow to as much as $50,9 million (approximately SEK 480 million), is a major step forward for Orexo and underscores the company's potential in one of the most pressing health challenges globally.

The opioid crisis is still ongoing

The opioid crisis in the United States has developed into a public health crisis of epidemic proportions, with three distinct waves since the 1990s. The first was driven by the overprescription of prescription opioids, which oxycodone and hydrocodone, the second of heroin as a cheaper alternative, and the third – the most deadly – ​​of synthetic opioids as fentanyl and its analogues. The substances are often mixed with other drugs, such as the sedative xylazine, which complicates rescue efforts and delays the effect of existing antidotes such as naloxon.

According to the Centers for Disease Control and Prevention (CDC) nearly 80,000 Americans died from opioid-related overdoses in 2023 alone, an average of 217 deaths per day. In total, more than 806,000 lives have been lost to opioid overdoses since 1999, a nearly tenfold increase from levels at the time. Despite a slight decline of 4 percent from 2022 to 2023—the first annual decline since 2018—the numbers remain alarmingly high.

Nearly half of all overdose deaths involve a combination of opioids and stimulants, and the rapid spread of illegally manufactured fentanyl in counterfeit pills and powder form has made traditional rescue methods inadequate. “The crisis requires innovative solutions that can address the new risks,” the CDC notes in its analysis of the epidemic’s evolution.

How OX390 will contribute

This is where OX390 comes in as a potential game changer. The drug candidate, which is a new chemical entity based on AmorphOX, is designed for intranasal administration and specifically targets the reversal of respiratory depression caused by mixed opioids. Or, in plain language, restoring breathing ability to an addict who has overdosed.

Unlike existing treatments, which primarily focus on pure opioids, OX390 is intended to offer a broader range of effects that complement naloxone and other antagonists.

BARDA’s initial $8 million grant funds pre-clinical toxicology studies, human clinical trials, drug and device manufacturing, and will contribute to a regulatory submission to the FDA. The agreement is divided into five stages, with milestones that trigger additional funding up to the total amount. Importantly, Orexo retains all commercial rights upon market approval, opening up significant revenue opportunities.

Funding and validation

Edward Kim, Chief Medical Officer at Orexo US, comments:

– The funding is an important step in tackling the rapid spread of mixed substances, which complicates life-saving efforts for emergency services and voluntary organizations. We are developing the solution in close dialogue with researchers and healthcare professionals.

For Orexo, the agreement not only represents a financial injection but also validation of the company's technology and position in the opioid sector. With federal funding and a focus on community benefit, the company is positioning itself for long-term growth in a market where innovation is key to saving lives.

The market reacted positively to the announcement and the company's shares traded up by just over 12 percent, to 34 from 30,35 SEK. Since then, the price has stabilized around 33 SEK.