Botanix Pharma's partner in the US, Purisys, has received confirmation from the DEA that synthetic CBD has been officially removed from Schedule 1 of the Controlled Substances Act.
There was monumental news today from the Australian clinical stage synthetic cannabinoid developer, Botanix Pharmaceuticals Limited (ASX: BOT), after the company announced that its US-based partner, Purisys, has been advised by the US Drug Enforcement Administration (DEA) that BOT's synthetic cannabidiol is no longer scheduled as a controlled substance.
On Friday, Purisys received confirmation from the DEA that the company's ultra-high purity synthetic cannabidiol CBD—which is used by Botanix—has been removed from Schedule 1 of the Controlled Substances Act, along with all degradants, metabolites and analytical reference standards related to synthetic CBD.
This is a huge development, as all synthetic CBD usage—which included manufacturing, storage shipping and clinical and non-clinical studies—required licensing and express approval from the DEA.
This change in the regulation of synthetic CBD in the US will make a major difference to the speed of developing Botanix products and greatly reduces the risks and costs of clinical development.Executive Chairman and President, Vince Ippolito
As a result, this created significant management and cost overheads for Botanix's clinical investigative clinical activities, which previously required the maintenance of licenses and physical safes for the storage of study materials.
This also caused additional complications during transport across State and international borders, which were tightly controlled and did not allow for the reimportation of CBD into the US.
The Executive Chairman and President of Botanix Pharmaceuticals, Vince Ippolito, commented that the company's, "ability to manufacture at one site and distribute nationally and internationally means our supply chain is significantly simplified and our ability to recruit the best clinical sites (regardless of DEA license status) is greatly enhanced. "
"The change in regulation has come at a favourable time, where the Company is actively preparing for large late-stage studies across our dermatology programs," he said.
The supply agreement with Purisys was signed by Botanix earlier this year in November, covering BOT's requirements for immediate clinical and future commercial supplies of synthetic CBD.
As part of the agreement, Botanix and Purisys have committed to collaborate on setting the future volume requirements, as well as negotiating manufacturing scale up and optimisation.
However, Botanix was able to secure preferential pricing for its supply of synthetic CBD, along with a commitment for both companies to work together to create increased value as the manufacturing process for CBD is realised and raw material savings begin to accrue.
The CEO of Purisys, Jim Mish, lauded the DEA's decision, saying that it will allow for greater clinical research.
"Now that our CBD products are no longer subject to DEA Schedule 1 status, our pharmaceutical customers are able to more easily conduct research that will be important to the use of cannabinoids in a wide range of products."
"At Purisys, we stand ready to back this research, with our applications support, analytical reference standards and cGMP manufacturing. This is further backed by our world-scale supply capability for commercial production," Mish said.
Botanix also used the announcement to update the market on the progress of its current Phase II studies.
The company recently completed the Phase II trial for its BTX 1503 acne drug and is currently preparing for an end of study meeting with the FDA. Meanwhile, its phase II atopic dermatitis drug is in late stage enrolment, with plans to commence two additional studies in the coming months.
Botanix is also in the process of planning for later stage studies, as well as engaging in preparation for product registration scale up. Commercial sales are also progressing in parallel, so the de-scheduling of synthetic CBD should allow the company to considerably expand its revenue intake.
To learn more about Botanix Pharma visit their Company HQ here.
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