GlaxoSmithKline (GSK) and Sepracor Inc. (Nasdaq: SEPR) announced an agreement for the commercialisation of Sepracor’s eszopiclone product for all markets worldwide (excluding the U.S., Canada, Mexico and Japan).
Sepracor’s eszopiclone product will be marketed by GSK in these areas as LUNIVIA for the treatment of insomnia.
Under the agreement, Sepracor is entitled to receive an initial payment of $20 million plus subsequent payments upon accomplishment of various milestones. If all milestones are met, GSK will be obligated to pay Sepracor $155 million in aggregate license and milestone payments. In addition, Sepracor will receive double-digit royalties that escalate upon increased product sales and compensation for supplying the product to GSK.
LUNIVIA is currently under EMEA review for marketing approval under the Centralised Procedure. This procedure provides for the EMEA to conduct a single, coordinated scientific evaluation on behalf of all EU member states, using experts from national regulatory authorities as lead reviewers. Approval of the MAA would authorize the marketing of LUNIVIA for insomnia in as many as 27 EU member countries, subject to national pricing and reimbursement approvals.
“GSK is one of the world’s largest pharmaceutical companies, and we are delighted to have established this alliance with such a renowned organisation that has a strong presence in the EU and other global markets,” said Adrian Adams, President and Chief Executive Officer of Sepracor. GSK’s knowledge, experience and success in the central nervous system area, together with its broad commercialization infrastructure, provide an optimal launch platform from which to expand our LUNIVIA franchise to European and additional international markets. This milestone event is another important step in Sepracor’s overall worldwide strategy to fully leverage our product franchises, drive enhanced research and development productivity and successfully pursue aligned and value-enhancing corporate development and licensing initiatives.”
Andrew Witty, President of Pharmaceuticals Europe, GSK, said: “When untreated, insomnia can have serious health and social consequences. Upon approval, LUNIVIA will be an additional option for people suffering from insomnia – it has a proven benefit in chronic insomnia in helping sufferers get to sleep and stay asleep. We’re pleased to collaborate with Sepracor to provide this new treatment choice for patients in Europe and elsewhere.”
As with any insomnia medication, patients and prescribers need to be aware of the possibilities of drowsiness and/or co-ordination impairment as a result of use of these medicines. The MAA submission contained results from 122 preclinical and 35 clinical studies of eszopiclone. These studies included more than 5,500 adult and older adult (>65 years of age) subjects, including patients with transient or chronic insomnia. In addition to the studies of eszopiclone in patients with insomnia and co-existing conditions, two six-month, placebo-controlled studies in primary insomnia as well as two driving studies showing no effect on next-day driving in healthy subjects or subjects with insomnia were included as part of this submission.
LUNESTA has been commercially available in the U.S. since April 2005 and had product revenues of approximately $566.8 million in 2006. In 2006, the sedative hypnotic market in Europe was worth approximately $500 million. In the five largest European markets, an estimated 45 million people suffer from insomnia, but the current prescription treatment rate is only approximately 24% of this population.