Orphan drug designation for SER100 in Pulmonary Arterial Hypertension granted in U.S.
Oslo, 25. October 2016 Serodus (OSE: SER) today announced that the Office of Orphan Products Development, United States Food and Drug Administration (FDA) has granted an Orphan Drug Designation for SER100 in pulmonary arterial hypertension (PAH).
”Serodus is delighted to have been granted this designation. While Serodus works to secure financing for its pipeline going forward it is encouraging that the FDA recognizes the potential of SER100 in PAH” said CEO Eva Steiness.
SER100 is an ORL-1 receptor agonist.
Pulmonary arterial hypertension (PAH) is a rare lung disorder. PAH prevalence, in all it’s forms, is estimated around 5 cases per 1.000.000 inhabitants in the US. Patients are severely ill with a life expectancy of few years after the first symptoms have occurred. SER100 will be administered as an iv infusion of short duration in severely ill hospitalized patients with Pulmonary Hypertension.
Subject to financing, Serodus will plan for the first clinical study either in a Phase IIa study or as an adaptive Phase IIa/III (a combination of IIa and III) study in patients with PAH.
For more information, please consult www.serodus.com or contact:
CFO, Serodus ASA
Mobile: +47 959 34 199
Serodus ASA is a Norwegian drug development company, focusing on new therapeutic products for the treatment of diabetes and diabetic comorbidities with large unmet clinical needs. The company's business model is to seek partnering with international pharmaceutical companies after having demonstrated clinical effect in humans. For more information, see www.serodus.com.
This release is an announcement issued pursuant to legal information obligations, and is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. It is issued for information purposes only, and does not constitute or form part of any offer or solicitation to purchase or subscribe for securities, in the United States or in any other jurisdiction.