The contract development and manufacturing organisation (CDMO) applied for its Kansas City, Missouri site to be registered as an importer of controlled substances in August, and last week the US Drug Enforcement Administration (DEA) approved the request.
“[Catalent Pharma Solutions] is granted registration as an importer of marihuana (7360), a basic class of controlled substance listed in schedule I,” the Agency said in a Federal Notice. “The company plans to import finished pharmaceutical products containing cannabis extracts in dosage form for clinical trial studies.”
The CDMO’s Vice President of Corporate Strategy Cornell Stamoran confirmed the approval and told us the DEA’s US schedule 1 registration renewal related to the support for anticipated customer requirements for clinical trial supplies involving a cannabinoid compound.
Specialised clinical demands
He added the plant is one of a network designed to support specialised demands from drugmakers.
“There is a growing need for special handling capabilities in pharmaceutical development due to the evolving characteristics of pharmaceutical and biotechnology pipeline molecules,” he said, citing the increased prevalence of biologics and highly potent compounds - as well as controlled substances – creating increased challenges for clinical trials sponsors.
“Likewise, as these molecules transition to commercially approved products, similar complexities arise in production and distribution of commercial supplies,” he continued. “Catalent has responded to these demands through continuous investment in specialized handling capabilities and capacity throughout our global network.”
The Kansas City site is one of 22 of Catalent's 31 locations to provide specialised production, storage, and logistics capabilities for controlled substances.
“These sites collectively support clinical trial storage and distribution for Investigational Medicinal Products undergoing clinical trials, as well as commercial dose form manufacturing,” Stamoran said.
Catalent client GW Pharma ramps up manufacturing
One of Catalent’s customers is GW Pharmaceuticals which has a marijuana-based compound, Epidiolex (cannabidiol), in Phase III trials for the treatment of Lennox-Gastaut syndrome (LGS).
“The company ships finished product to a storage facility run by Catalant in the US and investigators draw material from that facility,” a spokesman for the UK-based drugmaker said.
The firm grows its own raw materials – about 200 tonnes of cannabis plants per year - in UK Government-approved greenhouses and extracts the cannabinoids for its marketed spasticity treatment Sativex and its R&D portfolio.
COO Chris Tovey said the firm was “actively scaling and growing our manufacturing of Epidiolex to meet anticipated commercial demand if approved,” during a conference call discussing end of year results this week (transcript here).
“In addition, the several processing steps beyond growing that lead to the final liquid formation of pure CBD finished Epidiolex product are all undergoing scale increases,” he said.
For the financial year to the end of September, GW Pharma’s capital expenditure on manufacturing and growing facility expansion equated to $27.1m (€24.8m).
DEA reforming law
The firm also commented on the Improving Regulatory Transparency for New Medical Therapies Act, which was passed as a House bill in March and signed into law on November 25.
The legislation is intended to accelerate the regulatory process for new drugs needing the DEA’s approval, requiring the Agency to schedule drugs according to a strict timeline with greater predictability for drugmakers.
“For Epidiolex, we now have a clear time line which allows us to plan for launch 90 days following FDA approval. Another important element to this new law is that the period of orphan marketing exclusivity only now begins after DEA scheduling,” said GW Pharma’s President of North America Julian Gangolli.
“This contrasts with the previous situation whereby the orphaned clock, if you will, began to tick upon FDA approval. Even though the product could not be marketed until the DEA rescheduling was complete. This means that the DEA process does now not impact on this orphan exclusivity period and that Epidiolex will benefit from the four to seven years of exclusivity.”