US drugmaker Eli Lilly is buying back sole commercialisation rights to Yentreve/AriClaim (duloxetine) for the treatment of stress urinary incontinence from its partner, German drugmaker Boehringer Ingelheim.
The companies had been marketing the agent together outside the USA since it was first appoved in 2004 but, explaining the move, John Lechleiter, Lilly’s President and Chief Operating Officer, said: “Based on our collective experiences to date in the marketplace, both companies believe that the Yentreve/AriClaim opportunity is best suited and can be best commercialised in markets outside the US with the support of one company. This is about 'right sizing' our investments to address our greatest opportunities and the greatest patient needs.”
In addition, Lilly and BI also announced their decision not to seek marketing approval for Yentreve in the USA, following their withdrawal of the original New Drug Application in January last year after regulators said they could not approve the product based on the data package submitted. “The decision not to pursue approval for Yentreve in the US was a difficult one, given the belief both companies share about the importance of SUI as a medical condition and Yentreve's proven ability to address a significant unmet medical need," Lechleiter noted.
But under the firms’ original pact formed back in 2002, their agreement to market duloxetine outside the USA for major depressive disorder, diabetic peripheral neuropathic pain and other potential indications, under the trademarks Cymbalta/Xeristar, remains intact.
Commenting on the change, Dr Alessandro Banchi, chairman of the Board of Managing Directors at Boehringer Ingelheim, said: “There has been an excellent spirit of collaboration in our alliance with Lilly. Based on this, we are committed to the continued success in our partnership to commercialise duloxetine for indications other than SUI in markets outside the US.”
Meantime, a long-term study of more than 200 patients has shown Cymbalta to be as safe and well-tolerated as current routine care comprising one or more drugs for the management of pain caused by diabetic nerve damage. In addition, the trial found that Cymbalta did not adversely affect the progression of diabetes or many of the complications associated with the illness, such as damage to the nerves, kidneys and eyes, according to Lilly.
The findings, published in the current issue of the Journal of Palliative Medicine, “suggest that with Cymbalta, clinicians can expect a similar level of quality of life without compromising safety or tolerability," commented Dr Tim Smith, a study author and clinical instructor of medicine at the Washington University School of Medicine.