GW Pharmaceuticals to expand marketing authorization for Sativex to France

GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, "GW" or the "Company"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that it has submitted an application under the European Mutual Recognition Procedure (MRP) seeking to expand the marketing authorization for Sativex® into France for the treatment of spasticity due to Multiple Sclerosis (MS).

This new regulatory application follows a Decree signed by the French Minister of Health in June 2013, which amended national legislation in France so as to permit a prescription cannabis-based medicine, subject to approval by ANSM, the French regulatory authority. As with previous Sativex MRP filings, the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), is acting as the Reference Member State.

Sativex is already approved as a treatment for MS spasticity in 21 countries, including 17 countries in Europe. The medicine is currently available on prescription in the UK,Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden and Italy with launches currently in preparation for a further 8 European countries, as well as Australia and New Zealand.

Sativex meets a significant unmet medical need for patients with Multiple Sclerosis and we look forward to working with the French authorities so as to allow this important medicine to be made available in France," stated Justin Gover, Chief Executive Officer of GW Pharmaceuticals. "The submission of this MRP for Sativex in France builds on the recent commercial launch in Italy and continues the momentum of expanding Sativex availability throughout Europe. We see this growth as important validation of patient and physician acceptance of Sativex in meeting the needs of people with Multiple Sclerosis."

Almirall, an international pharmaceutical company with headquarters in Spain, is the exclusive distribution partner for Sativex in the European Union (excluding the United Kingdom) and E.U. accession countries, as well as Switzerland, Norway, Turkey and Mexico.

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Which Drugs Actually Kill Americans

U.S. drug-related deaths, over time Katie Peek

In 2010, there were 80,000 drug and alcohol overdose deaths in the U.S., according to the Centers for Disease Control and Prevention's WONDER database. The database, maintained by the National Center for Health Statistics, keeps a tally of all the deaths listed on certificates nationwide. They’re classified by the ICD-10 medical coding reference system.

Death reporting in the U.S. requires an underlying cause—the event or disease that lead to the death. This chart represents all those listed in the CDC database as “accidental poisoning,” “intentional self-poisoning,” “assault by drugs,” and “poisoning with undetermined intent.” In addition to the underlying cause, a death certificate has space for up to 20 additional causes. That’s where “cocaine” or “antidepressants” would show up. The subcategories are limited in their detail—many drugs are lumped together, like MDMA and caffeine, which are listed together as “psychostimulants.” And about a quarter of all overdose death certificates don’t have the toxicity test results listed at all, landing them in the “unspecified” stripe.

By adding all those sub-categories up, imperfect as they may be, it’s clear that the rate of reported overdoses the U.S. more than doubled between 1999 and 2010. About half of those additional deaths are in the pharmaceuticals category, which the CDC has written about before. Nearly three-quarters of the pharmaceuticals deaths are opioid analgesics—prescription painkillers like OxyContin and Vicodin. And while cocaine, heroin and alcohol are all responsible for enough deaths to warrant their own stripes on the chart, many popular illegal drugs—including marijuana and LSD—are such a tiny blip as to be invisible.

A few caveats about the statistics: if a person had multiple drugs listed on their death certificate, they’re being counted twice here. Also, the database doesn’t include nonresidents—either undocumented immigrants or U.S. citizens living abroad.

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