“Vektor continues to build shareholder value by advancing its product development pipeline. Its lead program is now progressing to a pivotal human study in Europe, which is the final major milestone on the path to commercial regulatory approval…The addition of in-house, scalable commercial drug manufacturing capability is expected to add further value and optionality to XPhyto’s drug formulation and manufacturing businesses,” said Hugh Rogers, XPhyto CEO & Director.
XPhyto is committed to the development of innovative cost-effective transdermal and sublingual formulations of approved and new therapeutics. Furthermore, the Company also focuses on drug development with 4 late-stage neurology therapeutics in clinical development and 2 psychedelic medicine programs. With this in mind, XPhyto’s drug formulation and development business is conducted primarily by Vektor Pharma TF GmbH, the Company’s wholly-owned German subsidiary. More specifically, Vektor is focused on the development of generic and hybrid-generic drug formulations for neurological conditions through its transdermal and oral dissolvable drug delivery platforms.
With that being said, XPhyto announced earlier this year on January 28, 2021, that its drug development trial schedule for Q1 2021 was focused on a human bioavailability pilot study for the Company’s rotigotine transdermal patch. Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson’s disease and Europe and the United States. Rotigotine refers to the active pharmaceutical ingredient (API) typically formulated as a once-daily transdermal patch with provides a slow and consistent supply of the drug over 24 hours.
XPhyto’s rotigotine study was completed successfully in March 2021 and generated encouraging study results. Moving forward, the Rotigotine development program will be advanced to a pivotal human trial. Keep in mind, a pivotal trial is a Phase III clinical trial, indicating that XPhyto is now incredibly close to the commercialization of its transdermal patches. Although there are a variety of commercialized rotigotine transdermal patches currently in the market, XPhyto believes its patches will achieve superior bioavailability and adhesion properties.
Additionally, in anticipation of Vektor’s drug product commercialization schedule, XPhyto has signed a purchase and sale agreement for a property in Biberach, Germany. The purchased property will be used to construct a new commercial drug manufacturing facility with an estimated 32,000 square feet of permitted maximum capacity laboratory and manufacturing space.
Products in XPhyto’s development pipeline are targeting some of the largest and fastest growing markets in the bioscience industry. With this in mind, it may be worth keeping an eye on the XPhyto as we inch closer to the commercial release of the Company’s rotigotine transdermal patches. Investors and shareholders can expect an update in the future regarding the commencement of XPhyto’s rotigotine pivotal human trials.
XPhyto Therapeutics’ share price opened at $2.21 and is currently trading at $2.25 as of 9:41AM ET. This Company’s shares are up 1.81% indicating that there has been some change following the news.
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