GW Pharmaceuticals Epidiolex Now Exempt From Controlled Drug Requirements

GW Pharmaceuticals plc (Nasdaq: GWPH) said that the UK Home Office has reclassified Epidiolex, the company’s cannabidiol medicine as a Schedule 5 drug. The company said that the change will take effect immediately in all four of the constituent nations of the UK – with Northern Ireland enacting separate legislation – and sees the medicine move from Schedule 2 to Schedule 5 under the Misuse of Drugs Regulations 2001.

“The decision to move Epidiolex to a low level of control is an important one for patients, their families, healthcare professionals, pharmacists and the NHS as a whole – reducing costs and ensuring the medicine can be dispensed more easily,” said Chris Tovey, GW Pharmaceutical‘s Chief Operating Officer. “The extensive pre-clinical and clinical data that GW developed to support the medicine’s approval by regulatory authorities was pivotal to this important schedule change, and we would like to thank the MHRA, ACMD, and Home Office for scrutinizing this data and making this change in such a short timeframe. We remain committed to expanding the high-quality evidence base for cannabis-based medicines and securing further regulatory approvals because doing so is in the interests of patients and healthcare professionals and can support further rescheduling.”

GW Pharmaceuticals said that the ACMD and its Technical Committee recommended the schedule change to Kit Malthouse MP, Minister of State for Crime and Policing late in January 2020. The medicine is approved in the EU for adjunctive therapy of seizures associated with Lennox Gastaut syndrome or Dravet syndrome, in conjunction with clobazam, for patients from 2 years of age and older.

In its recommendation to the Minister, the ACMD cited the “low risk of abuse potential, low risk of dependency and low risk of diversion” as reasons for the reclassification from a schedule 2 controlled drug to a schedule 5 controlled drug. The ACMD also cautioned that GW’s medicine is “distinct from other commercially available CBD containing supplements that have not sought marketing authorization as a medicine” and that the schedule change, therefore, applies exclusively to Epidiolex

This now means that GW Pharmaceutical’s medicine is now exempt from virtually all controlled drug requirements. At a practical level, patients will have more flexibility in the quantity of medicine they can purchase and be able to order repeat prescriptions. Prior to this, the patients faced restrictions every time they ordered a prescription. The benefits also extend to the pharmacists and pharmacies that will have reduced controls around the storage and reporting requirements.

Analyst Response

JP Morgan Cory Kasimov wrote, “Given the Epidyolex’s favorable efficacy/safety profile, the significant unmet need in these diseases, and positive physician feedback, we believe adoption could be both rapid and substantial,” He believes that near-term label expansion opportunities (Tuberous Sclerosis) and the potential for off-label use in the broader population of general epilepsy patients could contribute significantly to the top line. “A respectable pipeline of additional assets across an array of therapeutic indications and a proprietary research/manufacturing platform should enable the company to sustain further growth” the analyst added. He currently has a $187 price target on GWPH

According to CNN Business, 16 analysts offering 12-month price forecasts for GW Pharmaceuticals PLC have a median target of $188.50, with a high estimate of $260.00 and a low estimate of $150.00. The median estimate represents a +49.97% increase from the last price of 125.69. All 16 analysts have a Buy rating on the stock.

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