Appointment of cGMP Manufacturer
VTL has executed a Manufacturing and Supply Agreement with Altipure LLC, a clinical partner of Muscle Feast, LLC in Ohio, USA, after the completion of a pilot manufacturing project which produced clinical study drugs for VTL's two Phase II clinical studies.
In this pilot manufacturing run which has recently been completed, 60,000 doses of active clinical study drug and 60,000 doses of placebo were manufactured and are expected to arrive in Australia in July 2021.
Of the 60,000 doses of active drug, half of the doses are IVB001 for VTL's Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcholic SteatoHeptatitis (NASH) Phase II clinical study and the other half of the doses are IVB003 for VTL's Pancreatic Adenocarcinoma (Pancreatic Cancer) Phase II clinical study. Both IVB001 and IVB003 use the transmuscosal delivery platform for tocotrienols that is protected by VTL's granted patents in Australia, the US and other major markets such as the EU and Japan.
Concurrently with this pilot manufacturing run, Altipure also successfully validated and optimised the manufacturing process for the high throughput mass production of finished nutraceutical products, VTL's NE1-Elite(R) for Delayed Onset Muscle Soreness and muscle recovery and NE1-Heart(R), for maintenance of heart health intended for sale in the US.
VTL's CEO and Managing Director, Dr Glenn Tong said "As we are now launching our nutraceutical products in the US, it is critically important that we build redundancy into our manufacturing capabilities so that if any issues arise with one manufacturer, our supply chain is not unduly interrupted. Altipure was introduced to us by our Scientific Advisory Board Member Dr Jordan Moon and through their manufacture of our clinical study drugs we have been very impressed with the efficiency of their operation and the professionalism of their staff. We now intend to use Altipure for the manufacture of both our clinical study drugs and finished nutraceutical products."
About Azure Health Technology Limited
Azure Health Technology Limited (NSX:VTL) develops and commercializes evidence-based nutraceuticals and pharmaceuticals based on two proprietary and patented delivery platforms for improving the bioavailability and efficacy of tocotrienols (a natural product which is one part of vitamin E).
Azure Health Technology Limited