GW Pharmaceuticals’ manufacturing facility for its cannabinoid-based multiple sclerosis (MS) and cancer pain therapy, Sativex®, passed a GMP inspection by U.K. regulatory authorities. The company can now take over full commercial manufacture of the drug in advance of expected European approval.
Although GW Pharm was previously licensed to manufacture the product for clinical trials and named-patient supply, the final stage in bulk GMP manufacture of Sativex has until now been carried out by a CMO. GW Pharm says that the new facility will initially be able to generate enough Sativex to treat 25,000 patients a year, but plans are also in place for expansion as required.
The company recently pointed out that the lead indication for Sativex differs across different regions of the world. In Europe, the primary indication for approval is MS spasticity and in the U.S., cancer pain. Although Sativex has still not been approved outside Canada, the drug can be prescribed as an unlicensed medicine on a named-patient basis. It has now reportedly been exported from the U.K. to 21 countries either for named-patient prescription use or for use in clinical trials.
GW Pharm recently reported that total sales of Sativex were up 15% to £1.3 million, or about $2.13 million. Named-patient sales grew by 47% to £0.9 million, or $1.48 million. Bayer HealthCare, which markets Sativex in Canada, says sales in that country were running at an annual rate of around C$3 million, or $2.69 million.
In May 2009 GW Pharm filed applications with U.K. and Spanish regulatory authorities via the European decentralized procedure for approval of Sativex as a treatment for MS-related spasticity. Regulatory decisions are expected during late 2009 or early 2010. If approved in Europe, the oral spray will be marketed in the U.K. by Bayer HealthCare and in the rest of the EU by Almirall. Marketing approval authorizations in other European countries will be sought after sanction in the U.K. and Spain.
In February 2007 GW and Otsuka signed a long-term strategic cannabinoid alliance, initially based on the development and commercialization of Sativex in the U.S. A Sativex Phase IIb/III cancer pain trial, funded by Otsuka as part of the U.S. development program, is due to end during the second half of this year.
The Canadian authorities approved Sativex for the symptomatic relief of neuropathic pain in MS in April 2005. In August 2007 Health Canada also green-lighted the drug as an adjunctive analgesic for patients with advanced cancer who experience moderate-to-severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.