Abbott enters endometriosis deal

Abbott has partnered with the San Diego-based drug-development company Neurocrine Biosciences to develop and commercialise a new drug for endometriosis-related pain, and potentially other related drugs as well, in a deal that could be worth more than $575m.

The therapy at the center of the partnership, called elagolix, is a first-in-class oral gonadotropin-releasing hormone (GnRH) antagonist, which has recently completed a phase IIb study in endometriosis and will also be developed for the treatment of uterine fibroids. Elagolix has so far completed 18 clinical trials enrolling a total of more than 1,000 subjects, the companies noted.

The deal gives Abbott worldwide exclusive rights to develop and commercialise elagolix and all next-generation GnRH antagonists for women's and men's health in return for an upfront payment of $75m and potential development, regulatory and commercial milestone payments totalling about $500m.

In addition, Abbott will fund all ongoing development activities, pay certain internal collaboration expenses, and make royalty payments on future product sales.

During a conference call with investors and the media, Neurocrine president and CEO, Kevin Gorman, said that he believed the milestones to be realistic and obtainable, and noted that the "vast majority" were tied to development goals rather than commercialisation goals.

"From a strategic standpoint, this is really an ideal fit," Gorman said of the partnership. "Abbott has not only an appreciation for this mechanism of action and what it is capable of, but also they are absolutely dedicated to bringing this important medication to women suffering from endometriosis and women with uterine fibroids."

Gorman said Neurocrine plans to request an end of phase II meeting with the US Food and Drug Administration (FDA) in the near future regarding the endometriosis indication, with the hope of being ready to begin phase III studies by the end of 2010. The phase III studies should take about two years, with the goal of filing a New Drug Application (NDA) by 2013.

"There is also a commitment to move rapidly into uterine fibroids as a phase II program," the CEO added, noting that some of the safety data from the endometriosis program should be usable to help support the fibroid indication, shortening that process somewhat.