Merck, Lundbeck end development of Phase III insomnia drug

Share this article:
Merck and Lundbeck have scrapped their joint-development program for insomnia treatment gaboxadol. In a joint-statement, the companies said data from recently completed clinical studies suggests the overall clinical profile for gaboxadol “does not support further development.” As a result Merck and Lundbeck said they will not file a new drug application (NDA) with the FDA or other regulatory agencies. Ongoing clinical studies are to be terminated. In October, Lundbeck and Merck extended the target date to submit a NDA for gaboxadol with the FDA to mid-2007 from the first quarter of 2007, because of slower than anticipated enrollment in ongoing Phase III trials. The companies agreed in 2004 to collaborate on the development and commercialization of gaboxadol in the US Lundbeck would have received a milestone payment of $75 million from Merck if it moved forward with an application for US registration of gaboxadol.
Share this article:
You must be a registered member of MMM to post a comment.

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...