This is expected to allow for a major ramp-up in production along with an increase in overall product quality and stronger manufacturing compliance for TGA, FDA and EMA.
In recent months technical and business teams at Medlab and TASALK have worked together to transfer NanaBis production and analytical services to TASALK and its Tasmanian facilities.
Manufacture to begin immediately
This agreement will see TASALK immediately begin the manufacture and release of NanaBis™ for global supply as it holds all applicable Office of Drug Control (ODC) and Therapeutic Goods Administration (TGA) medicinal cannabis licences.
The term of the agreement is three years and it can be extended for an additional three years upon mutual agreement.
Medlab CEO Dr Sean Hall said: “The aptitude and capabilities of the people at TASALK make them a tremendous partner.
“TASALK is known globally for their work and this only benefits NanaBis™ and MDC’s pursuit for drug approval in the mid-term.”
Shares have increased more than 6% to 33.5 cents, up from 29 cents on January 13.
NanaBis is supplied under the Australian Government’s Special Access Scheme (SAS) and is the subject of various global opportunities.
NanaBis part of new study
In addition, NanaBis is also part of the recently announced, TGA approved Observational Study, where Medlab is looking to recruit 2,000 patients in the study.
The agreement with TASALK helps facilitate the anticipated growth in demand with its existing GMP experience with European and US regulators providing a stepping-stone for NanaBis to access global markets.
NanaBis is undergoing drug development aimed at meeting the approval requirements of the TGA, FDA and EMA.
“Great potential” in technology
TASALK CEO Dr Ross Murdoch said: “Tasmanian Alkaloids is well placed to be a lead service provider in the Australian and APAC region and we see great potential in Medlab’s technology.
“This agreement has potential to provide benefit for both parties and be the basis of a longer-term partnership, while maintaining our continued freedom to operate across the full supply chain.”
TASALK, a global leader in the extraction and purification of high-value plant-derived products for the pharmaceutical industry, has added medicinal cannabis products and services to its portfolio.
This includes cultivation, manufacturing, formulation, analytical and release for supply.
Based in Tasmania
The innovative research and manufacturing company based in Tasmania is fully integrated from field and factory to the finished goods, employing more than 160 highly skilled scientifically and technically qualified employees.
Medlab Clinical is an Australian-based medical life science company, developing therapeutic pathways for diagnosed chronic diseases.
It is advanced in developing therapies for pain management, depression and obesity as well as earning revenue from sale of nutritional products in Australia and the US.