Orexo´s partner Gesynta Pharma granted Orphan Drug Designation by the FDA for OX-MPI (GS-248) for the treatment of systemic sclerosis

Uppsala, Sweden – April 27, 2022 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), announces today that the company´s partner Gesynta Pharma AB which owns all the rights to OX-MPI (GS248), a drug candidate for the treatment of systemic sclerosis, has been granted Orphan Drug Designation in the US by the Food and Drug Administration (FDA).

Systemic sclerosis (also known as scleroderma) is a chronic, autoimmune disease that affects, among other things, the body's smallest vessels, the microvasculature, and is associated with great medical needs due to the current lack of safe and effective medicines. OX-MPI (GS-248) has a unique and promising mechanism of action with the potential to help both patients with systemic sclerosis and patients with other chronic inflammatory diseases. The drug candidate is currently being evaluated in a clinical phase 2 trial and data is expected in late 2022.

Orphan Drug Designation is intended to encourage the development of drugs for the treatment of rare diseases. This exclusive classification provides up to seven years of market exclusivity and also gives some financial benefits during the development phase.

Nikolaj Sørensen, CEO & President of Orexo, commented: ”We are very pleased with the progress Gesynta Pharma has made with our former OX-MPI (GS-248) project. Obtaining orphan drug status in the US, is a true milestone to ensure the pharmaceutical reaches the patients suffering from systemic sclerosis as soon as possible. We are looking forward to see the result of the ongoing phase 2 trial later this year. With a successful outcome we are confident Gesynta Pharma, with their experienced and competent management team, are well positioned to develop OX-MPI (GS-248) to a commercial success.”

"The orphan drug designation granted to our drug candidate GS-248 for the treatment of systemic sclerosis provides an opportunity for extended market exclusivity, which is a valuable complement to its strong patent protection. Strengthened by this positive news and our constructive dialogue with the FDA, we continue working towards the goal of being able to offer an effective and safe treatment for patients with systemic sclerosis," says Patric Stenberg, CEO of Gesynta Pharma.

According to the agreement, signed in 2017, Orexo will receive a tiered double digit share of future revenues that Gesynta Pharma generates from the OX-MPI (GS248) project.

For further information, please contact:

About Orexo

Orexo develops improved pharmaceuticals and digital therapies addressing unmet needs within the growing space of substance use disorders and mental health. The products are commercialized by Orexo in the US or via partners worldwide. The main market today is the American market for buprenorphine/naloxone products, where Orexo commercializes its lead product ZUBSOLV® for treatment of opioid use disorder. Total net sales for 2021 amounted to SEK 565 million and the number of employees was 121. 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.

About Gesynta Pharma  
Founded in 2017, Gesynta Pharma bases its R&D on research from the Karolinska Institutet. The most advanced drug candidate, GS-248, reduces inflammation and increases blood flow in the microvasculature, thereby having the potential to provide improved treatments for several serious diseases. In an ongoing clinical Phase II study, GS-248 is being evaluated for its capacity to normalize vascular blood flow and reduce pain in patients with the autoimmune disease systemic sclerosis. Positive results from this study may lead to a rapid broadening of the development program towards additional chronic inflammatory diseases. Major shareholders include Industrifonden, Linc, Hadean Ventures, and a number of successful life science entrepreneurs.

For more information, please visit www.gesynta.se.

The information was submitted for publication at 8.00 CET on April 27, 2022.