On June 8 2020, XPhyto Therapeutics (XPHY.C) announced that its 100% owned German subsidiary, Vektor Pharma, has finalized the formula for its novel transdermal delivery system (TDS) for the neurologic drug Rotigotine.
XPhyto is a biopharma and cannabis science company focused on “formulation, clinical validation, and European imports, distribution & sales”.
The June 8 news focuses on one element of its biopharma pipeline un-related to cannabis.
Vektor is now proceeding with process implementation for the manufacture of Rotigotine patches for human clinical studies.
Rotigotine is a dopamine agonist approved for the treatment of Parkinson’s Disease and restless legs syndrome (RLS) in Europe and the U.S.
An “agonist” is a substance which “initiates a physiological response when combined with a receptor”.
Parkinson’s disease is a long-term degenerative disorder of the central nervous system that has both genetic and environmental factors.
If your uncle has Parkinson’s, you are more likely to get it.
If you have suffered traumatic head injury – you are more likely to get it.
The disease typically initiates in people over the age of 60. Men are 50% more likely to get it than woman. Following diagnosis, the average life expectancy is 9 years.
The main symptoms of Parkinson’s include:
- uncontrollable shaking and tremors
- slowed movement
- balance difficulties and eventual problems standing up
- stiffness in limbs
About 10 million people are afflicted with Parkinson’s world-wide.
Rectal cancer is no barrel of monkeys but it does occasionally go into remission.
Parkinson’s is a malignant stalker that never gives up, never goes away.
In 1999, Canadian actor Michael J. Fox informed a U.S. Senate hearing about the urgent need for more research into Parkinson’s disease.
“It’s a constant balancing – too little medicine causes tremors and stiffness,” recounted Fox, “Too much medicine produces uncontrollable movement and slurring. And far too often Parkinson’s patients wait and wait, as I am right now, for the medicines to kick in.”
“Applying the patch to a different part of the body daily every 14 days is cumbersome,” confirmed a Parkinson’s News Today blog post, “By the time I got to a 1-mg dosage, I had overwhelming fatigue, some depression, and general weakness.”
Rotigotine, the active pharmaceutical ingredient, is a generic “off-patent” drug that is typically formulated as a once-daily transdermal patch which provides a slow and constant supply of the drug over the course of 24 hours.
“We are extremely pleased with the TDS development results thus far,” stated said Dr. Thomas Beckert, founder and managing director of Vektor. “It appears that our goal of optimizing the dosage form efficiency, to reduce the amount of drug required in each patch, and improving overall patch adhesion to the patient’s skin has been achieved.”
For a biopharma company, Xphyto moves fast.
Hell, for a cannabis company, Xphyto moves fast.
Three weeks ago, XPhyto announced a potential collaboration with the renowned German brewery OETTINGER Brauerei, “to pursue the signing of an exclusive definitive agreement, specifically for creating new cannabis-related beverages and products”.
“In partnership with Oettinger and supported by Weihenstephan, we plan to establish ourselves as first-movers in Europe in this important and fast-growing market,” stated Rogers.
Seven weeks ago, XPhyto announced a deal with 3a-Diagnostics GmbH to receive peptide biosensors from 3a for the purpose of adapting them for use with Vektor’s oral dissolvable thin film (ODF) platform.
“We are very pleased to move so quickly from signing the Agreement to product development work,” said Prof. Dr. Thomas Beckert, Managing Director of Vektor. “The XPhyto team shares 3a’s vision of developing screening tools for rapid, low-cost and easy to self-administer detection of pathogens to manage infectious diseases on a population scale.”
Subject to Platform 2.0 activities and COVID-19 evaluation milestones being hit, XPhyto will fund 3a’s R&D up to CAD $1.65 million over an eleven-month period, and also commit CAD $385,000 to 3a’s biosensor Products to Vektor’s ODF platform, over five months.
Parameters for increased manufacturing capacity are currently being evaluated with a final decision expected to be made within 30 days.
Human pilot studies in Europe are scheduled for Q3 2020 with results expected in Q4 2020.
“XPhyto’s Parkinson’s drug patch is an excellent example of XPHY.C ‘s generic drug delivery strategy whereby approved generic drugs can be delivered using Vektor’s novel drug delivery platforms,” stated Hugh Rogers, CEO of XPhyto. “We see the generic drug delivery model as a major opportunity for scalable value creation.”
European sales of Rotigotine patches in 2019 were $250 million, while global sales were about double that – $500 million.
Full Disclosure: Xphyto in an Equity Guru marketing client.