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4-Traders Homepage  >  Equities  >  Nyse  >  Allergan plc    AGN   IE00BY9D5467

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Evolus investors frown as FDA declines to approve Botox rival

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05/16/2018 | 05:07pm CEST
A view shows the U.S. Food and Drug Administration (FDA) logo at its headquarters in Silver Spring

(Reuters) - U.S. health regulators on Wednesday declined to approve Evolus Inc's rival product to Allergan Plc's Botox, citing deficiencies related to the chemistry and manufacturing of its potential treatment for frown lines, sending its shares down as much as 35 percent.

The deficiencies cited by the U.S. Food and Drug Administration were "manageable", according to Chief Executive Officer David Moatazedi, who joined the company earlier this month after serving as U.S. head of Allergan's medical aesthetics business.

"They are all questions we have considered and contemplated prior to the response from the FDA," Moatazedi said on a call with analysts, but refused to specify the exact questions asked by the FDA.

The company said it was committed to getting its DWP-450, which is being developed to treat glabellar lines or frown lines in adult patients, to the market by spring 2019.

Evolus expects to respond to the FDA with a complete submission within 90 days.

The deficiencies cited by the FDA were isolated to items related to chemistry, manufacturing, and controls processes, and none related to clinical or non-clinical matters, the company said.

The deficiencies were communicated in a so-called complete response letter related to Evolus' marketing application for DWP-450, a Botox-like treatment.

Allergan's Botox is the market leader for treatment of wrinkles and frown lines, but the threat of looming competition for the blockbuster treatment has put some pressure on the drugmaker.

Revance Therapeutics in February teamed up with Mylan NV to develop a biosimilar to Botox.

A likely delay for Evolus' treatment sent Allergan's shares up 2.1 percent in morning trading.

The FDA's decision on DWP-450 was widely anticipated by analysts, after the agency had issued a "form 483", which outlined violations at the company's facility following inspections in 2017.

Also on Wednesday, the company said that its partner Daewoong Pharmaceutical Co received a favorable inspection report of its manufacturing facility, which makes DWP-450.

Shares of Evolus, which went public about three months ago, were down 31 percent at $10.18 in morning trading.

(Reporting by Manas Mishra in Bengaluru; Editing by Shailesh Kuber)

By Manas Mishra

Stocks mentioned in the article
ChangeLast1st jan.
EVOLUS INC 14.62% 19.36 Delayed Quote.0.00%
MYLAN NV 1.07% 39.63 Delayed Quote.-6.33%
REVANCE THERAPEUTICS INC 0.49% 30.55 Delayed Quote.-14.55%
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Financials ($)
Sales 2018 15 291 M
EBIT 2018 7 369 M
Net income 2018 -1 127 M
Debt 2018 23 991 M
Yield 2018 1,76%
P/E ratio 2018 -
P/E ratio 2019
EV / Sales 2018 5,03x
EV / Sales 2019 4,74x
Capitalization 52 877 M
Duration : Period :
Allergan plc Technical Analysis Chart | AGN | IE00BY9D5467 | 4-Traders
Technical analysis trends ALLERGAN PLC
Short TermMid-TermLong Term
Income Statement Evolution
Mean consensus OUTPERFORM
Number of Analysts 23
Average target price 204 $
Spread / Average Target 31%
EPS Revisions
Brenton L. Saunders Chairman, President & Chief Executive Officer
Wayne R. Swanton Executive Vice President-Global Operations
Matthew M. Walsh Chief Financial Officer & Executive Vice President
C. David Nicholson Chief Research & Development Officer
Paul M. Bisaro Director
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