GW Pharma applies to both EU and US for lead product

pharmafile | January 2, 2018 | News story | Manufacturing and Production, Sales and Marketing GW Pharma, biotech, drugs, pharma, pharmaceutical 

GW Pharmaceuticals had a busy festive period, after it announced that it had submitted to both the EU and the US for marketing authorisation on its lead product, Epidiolex.

The announcement of the two applications came within two days of each other, on 28 and 29 December.

In the US, this sets up GW Pharma to receive a response back before 27 June, while in the EU it is expected to receive a response in early 2019.

As a company that derives its products from cannabis, it will be watched with some interest to determine regulatory reaction. Should either regulatory body see medical benefit to the treatment, it is unlikely that it will not be accepted, however, this would raise questions. In the US, cannabis is a Schedule I drug and is therefore deemed to have no medical benefit.

Though GW Pharma has based its business model around developing treatments through cannabis derivatives, including Epidiolex (a purified from of cannabidiol), it remains cautious that regulators could pull the plug for reasons beyond medical purposes.

In fourth quarter filings, GW Pharma commented: “there can be no assurance that the FDA, EMA or any other regulatory authority will approve Epidiolex or any other product candidate for any indication for several potential reasons.”

GW Pharma is applying to the authorities to have its treatment approved for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome. Both of these conditions are forms of childhood-onset epilepsy that are highly resistant to treatment.

In the same fourth quarter filings, it revealed that its spending had continued to grow and losses had grown to $175 million in 2017, more than double the previous year’s loss of $85 million. As regulatory decisions come closer, the spending the company will undertake will grow in size again.

The decision that the FDA takes is extremely important to determining how much cash could be flowing through the company. It is thought that Epidiolex could become a blockbuster, or come very close to that target, with peak sales estimated to reach $960 million.

Ben Hargreaves

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