XPhyto Reports Market and Product Developments on Platform-based Rotigotine Transdermal Patch for Parkinson's Disease

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XPhyto Therapeutics Corp. has released a market and product development report on its Rotigotine transdermal patch, designed for Parkinson's disease and restless legs syndrome. This patch, developed via the TDS platform by its subsidiary Vektor, enhances drug bioavailability with a steady 24-hour supply. The global market for Rotigotine patches was valued at approximately US$518 million in 2021 and is projected to exceed US$766 million by 2030. Following a successful bioavailability study, XPhyto plans to advance to a pivotal study in Q4 2022.

VANCOUVER, BC and UTTENWEILER, GERMANY / ACCESSWIRE / April 4, 2022 / XPhyto Therapeutics Corp. (CSE:XPHY / OTCQB:XPHYF / FSE:4XT) ("XPhyto" or the "Company") is pleased to provide a market and product development report on its Rotigotine transdermal ("TDS") patch. The Company's Rotigotine patch is based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH ("Vektor").

Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS) in Europe and the United States. The active pharmaceutical ingredient is not well absorbed via oral delivery and is formulated as a once-daily TDS patch to increase bioavailability and provide a slow and steady supply of the drug over the course of 24 hours. The R&D market for new formulations is competitive; however, there appears to be little success beyond the name brand product launched by the originator in 2007. According to Wissen Market Research, global sales for Rotigotine patches were approximately US$518 million in 2021 with the market expected to surpass US$766 million by 2030.

On May 13, 2021, XPhyto announced successful completion of a European-based human bioavailability study for its Rotigotine TDS product. The comparative study was carried out over an approximately two-week period as an open label, randomized, crossover, two-period, two-sequence, single dose pilot study to assess the relative bioavailability of its product compared to the name brand product. Based on the results of this study, the Company is advancing the product toward a final pivotal study in Q4 2022 and pending positive results of that study, to an application for regulatory approval.

As an interim step to evaluate optimization opportunities prior to the pivotal study, the Company has completed a human cadaver skin permeation study at Vektor's EU GMP laboratory and manufacturing facility in Baden-Württemberg, Germany, to compare Rotigotine absorption between two additional derivative formulas and the name brand product. Analytical results of this study are expected to be finalized and announced in the coming weeks.

XPhyto's Rotigotine transdermal product is a single product based on Vektor's platform technology which represents a scalable opportunity for additional TDS drug development and manufacturing programs. According to Research and Markets, the global transdermal skin patch market had a value of nearly US$6.5 billion in 2020 while Kuick Research, Pharmaceutical and Healthcare, estimate the market will reach approximately US$20 billion by 2028.

Vektor is a German narcotics manufacturer, developer, and researcher located in the district of Biberach, Baden-Württemberg, Germany. For over a decade, the company and its team have been leaders in the design, testing and manufacture of innovative, non-invasive drug delivery systems, particularly transdermal patches and sub-lingual strips for the delivery of active pharmaceutical ingredients for the treatment of pain and neurological conditions. According to Precedence Reseach, the global drug delivery market was valued at US$1,476 billion in 2021 and is expected to grow to US$2,047 billion by 2030.

Executive management of XPhyto's drug formulation business is led by Prof. Dr. Beckert, managing director of Vektor Pharma TF GmbH.

About XPhyto Therapeutics Corp.

XPhyto Therapeutics Corp. is a diversified bioscience accelerator focused on next-generation drug formulation, diagnostic, and new active pharmaceutical ingredient investment opportunities, including: precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and manufacture, standardization, and evaluation of psychedelic compounds for the treatment of neurological conditions. The Company has research and development operations in North America and Europe, with an operational focus in Germany, and is currently focused on regulatory approval and commercialization of medical products for European markets.

XPhyto Therapeutics Corp.

Hugh Rogers, CEO and Director

Investor inquiries:

T: 780-818-6422
E: info@xphyto.com

Forward looking statements

This news release includes statements containing forward-looking information within the meaning of applicable Canadian securities law ("forward-looking statements"). Forward-looking statements are frequently characterized by words such as "develop", "plan", "continue", "expect", "project", "intend", "believe", "anticipate", "estimate", "potential", "propose" and other similar words, or statements that certain events or conditions "may" or "will" occur, and in this release include the statement regarding the Company's goal of building a successful diagnostic, drug delivery, and medical cannabis company. Forward-looking statements are only predictions based on the opinions and estimates of management at the date the statements are made and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements, including: that the Company may not succeed in developing a commercial product; that the sale of products may not be a viable business; that the Company may be unable to scale its business; product liability risks; product regulatory risk; general economic conditions; adverse industry events; future legislative and regulatory developments; inability to access sufficient capital from internal and external sources, and/or inability to access sufficient capital on favourable terms; currency risks; competition; international risks; and other risks beyond the Company's control. The Company is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable law. Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this news release.

SOURCE: XPhyto Therapeutics Corp.

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FAQ

What is XPhyto Therapeutics Corp.'s focus for the Rotigotine transdermal patch?

XPhyto Therapeutics Corp. focuses on developing the Rotigotine transdermal patch for treating Parkinson's disease and restless legs syndrome, improving drug delivery and bioavailability.

When is XPhyto planning to conduct the pivotal study for the Rotigotine patch?

XPhyto plans to advance to the pivotal study for the Rotigotine patch in Q4 2022.

What was the global sales value for Rotigotine patches in 2021?

The global sales value for Rotigotine patches was approximately US$518 million in 2021.

What is the expected market value for Rotigotine patches by 2030?

The market for Rotigotine patches is expected to surpass US$766 million by 2030.

How does the Rotigotine transdermal patch enhance drug absorption?

The Rotigotine transdermal patch enhances drug absorption by providing a sustained release of the active ingredient over 24 hours, increasing bioavailability.