Citius Pharmaceuticals: Citius to launch $2.5B in pre-clinical trial on a new drug for Parkinson’s disease
The Citius pharmaceutical company is set to announce a $2 billion pre-market study of its new drug, Axiomel.
The company’s chairman and chief executive officer, James L. Zymanski, will make the announcement at a news conference in Washington Thursday, according to a release from the company.
Axiomelo is a combination of a previously developed compound from its cancer-fighting Axiomil brand, which was developed in collaboration with pharmaceuticals company Cervarix.
Zymanski said Axiomela will be approved by the Food and Drug Administration and begin to be tested in patients around the country in a few weeks.
“We will take a clinical trial to ensure Axiomeli is approved by our regulatory agencies,” Zymansky said in the release.
“We have already seen tremendous results with Axiomels pre-approval by the FDA, so we are confident in the product.”
The company plans to begin clinical trials on Axiomeline, which is a proprietary combination of the drug’s main ingredient, Axoixol.
It will initially begin with a small trial, Zymanksi said.
“A small clinical trial of Axiomelec is a good first step to ensure that AxiomELIs approval is safe and well-received,” he said.
The announcement comes at a time when the nation’s largest pharmaceutical companies are struggling to overcome a shortage of the rare and powerful drug, which has driven up drug prices and raised questions about the efficacy of its FDA-approved treatment.
“The FDA and other regulatory agencies are continuing to examine the safety and efficacy of Axomel, and we look forward to further discussion with FDA regarding the clinical trial,” Zysamanski said.
“This will allow us to accelerate our pre-release program to obtain sufficient clinical data to support our premarket approval.”
Cervarax, the first FDA-approved drug to treat Parkinson’s, has been on the market for almost five years.
In 2016, the drug was approved for the treatment of multiple sclerosis.
Citius PharmaceuticalS, the third-largest pharmaceutical company in the United States, is the biggest US drugmaker, with a market value of $4.4 billion, according, according TOJO.
The company’s shares have climbed nearly 17 percent in 2017, and its stock has risen about 30 percent in the past year.