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ABBVIE (ABBV)
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AbbVie : FDA moves the goal line on AbbVie`s endometriosis drug elagolix

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04/11/2018 | 10:43am CEST

The FDA is pushing back the PDUFA date for AbbVie and Neurocrine`s drug for endometriosis-linked pain by three months, saying it needs more time to review the results of liver function tests. The agency is now expected to make a decision on the candidate in the third quarter this year.

The pair teamed up on elagolix in 2010, back when AbbVie was still part of Abbott. The pharma company took over development, forking over $75 million up front, with an additional $500 million in milestone payments on the line. The treatment nabbed a priority review designation at the end of 2017, setting it up for a Q2 approval.

The NDA for elagolix is based on what AbbVie calls the largest prospective randomized clinical trials that have been conducted for endometriosis, a disease where tissue that normally grows inside the uterus begins to grow outside that organ. About 1,700 women with moderate to severe endometriosis were enrolled in two studies, which reported topline results in February 2016. The drug is also being evaluated in the treatment of uterine fibroids.

"We are pleased with the outcomes of the pivotal trials thus far. AbbVie will continue to pursue Elagolix as a potential new treatment for the disease`s most common symptoms, including pain related to menstruation and chronic pelvic pain throughout the menstrual cycle," said Michael Severino, chief scientific officer at AbbVie, at the time.

Trial data showed that elagolix was well-tolerated and significantly reduced the three types of endometriosis-associated pain: daily menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse.

"Based on our review of the data, we remain confident in our New Drug Application for elagolix in the treatment of endometriosis-associated pain," Severino said. "Elagolix has the potential to be an important new treatment option for women suffering from endometriosis and we are committed to working with the FDA to bring this therapy to patients."

(c) 2018 Arab Finance Brokerage Company All rights reserved. Provided by SyndiGate Media Inc. (Syndigate.info)., source Middle East & North African Newspapers

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Financials ($)
Sales 2018 32 886 M
EBIT 2018 14 518 M
Net income 2018 10 600 M
Debt 2018 29 401 M
Yield 2018 3,99%
P/E ratio 2018 13,59
P/E ratio 2019 12,09
EV / Sales 2018 5,07x
EV / Sales 2019 4,76x
Capitalization 137 B
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Number of Analysts 20
Average target price 110 $
Spread / Average Target 19%
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Managers
NameTitle
Richard A. Gonzalez Chairman & Chief Executive Officer
Azita Saleki-Gerhardt Senior Vice President-Operations
William Joseph Chase Chief Financial Officer & Executive Vice President
Michael E. Severino Chief Scientific Officer & Executive VP
Robert J. Alpern Independent Director
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