Feb 19 (Reuters) - Chelsea Therapeutics International Ltd’s shares were set to open 33 percent higher on Wednesday, a day after U.S. regulators approved the company’s drug to treat a rare low blood pressure disorder.
The drug, Northera, was approved to treat neurogenic orthostatic hypotension, a disease associated with neurological disorders such as Parkinson’s and is characterized by dizziness and fainting upon standing.
Analysts said Northera, Chelsea’s first approved drug, could attract partnership interest from other companies developing drugs for neurological conditions.
“While we anticipate that the company will explore all strategic alternatives including a licensing deal or being acquired, we also expect them to prepare to launch Northera on their own,” Wedbush analyst Liana Moussatos wrote in a note.
She said the drug, which Chelsea plans to launch in the second half of the year, could generate $430 million in peak sales worldwide.
Northera was approved on Tuesday on an “accelerated basis”, which provides patients earlier access to promising new drugs while the company conducts additional studies.
Chelsea said it had reached a preliminary agreement with the U.S. Food and Drug Administration to conduct a post-market study in 1,400 patients to show that Northera, which has not demonstrated effectiveness beyond two weeks, has a durable benefit.
“We do not see the post-approval trial commitment as a major impediment for drug adoption and/or a potential collaboration or M&A activity,” Ladenburg Thalmann analyst Juan Sanchez wrote in a note.
Chelsea’s shares were trading at $6.55 before the bell. They closed at $4.95 on the Nasdaq on Tuesday. (Reporting By Vrinda Manocha in Bangalore; Editing by Saumyadeb Chakrabarty)