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4-Traders Homepage  >  Equities  >  London Stock Exchange  >  Hikma Pharmaceuticals    HIK   GB00B0LCW083

HIKMA PHARMACEUTICALS (HIK)
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1386.5 GBp   -0.36%
06/15Mylan expecting another delay for generic Advair
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Mylan expecting another delay for generic Advair

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06/15/2018 | 11:21am CEST

Mylan N.V. (NASDAQ:MYL) said it expects to receive a second complete response letter from FDA for an ANDA of a generic version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (NYSE:GSK; LSE:GSK).

Any delay would be a reprieve for GSK, which reported worldwide Advair sales of £3.1 billion ($4.2 billion), including U.S. sales of £1.6B ($2.2 billion), last year.

Mylan said the agency has identified "minor deficiencies." The ANDA has priority designation, which allows approval prior to the standard 90-day time period following the company's response to a CRL, according to Mylan.

At least two other companies have submitted ANDAs to FDA for generic Advair products.

In February, the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) received a CRL from FDA on its ANDA for the generic (see BioCentury Extra, Feb. 8).

On its 1Q18 earnings conference call in April, Novartis CEO Vasant Narasimhan said it plans to conduct a bioequivalence bridging study of the generic and expects to launch next year.

Vectura Group plc (LSE:VEC) and partner Hikma Pharmaceuticals plc (LSE:HIK) received a CRL last year for their Advair generic VR315.

In March, Hikma said FDA is requesting another clinical study, and the company plans to submit the data to FDA "as early as possible" next year with a launch slated for 2020.

Advair comprises an adrenergic receptor beta 2 (ADRB2) agonist (LABA) and a corticosteroid. It is approved for asthma and chronic obstructive pulmonary disease (COPD).

According to Orange Book, most of the patents on Advair aerosol metered dose inhaler are slated to expire this year. The last U.S. patent will expire in 2026.

.

(C) 2018 M2 COMMUNICATIONS, source M2 PressWIRE

Stocks mentioned in the article
ChangeLast1st jan.
HIKMA PHARMACEUTICALS 0.36% 1396.5 Delayed Quote.22.66%
NOVARTIS -0.65% 73.2 Delayed Quote.-8.25%
VECTURA GROUP PLC -0.89% 80.925 Delayed Quote.-30.16%
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Financials ($)
Sales 2018 1 911 M
EBIT 2018 308 M
Net income 2018 185 M
Debt 2018 438 M
Yield 2018 1,72%
P/E ratio 2018 23,70
P/E ratio 2019 20,92
EV / Sales 2018 2,56x
EV / Sales 2019 2,41x
Capitalization 4 461 M
Chart HIKMA PHARMACEUTICALS
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Hikma Pharmaceuticals Technical Analysis Chart | HIK | GB00B0LCW083 | 4-Traders
Technical analysis trends HIKMA PHARMACEUTICALS
Short TermMid-TermLong Term
TrendsBullishBullishNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus HOLD
Number of Analysts 12
Average target price 16,6 $
Spread / Average Target -10%
EPS Revisions
Managers
NameTitle
Sigurdur Oli Olafsson Chief Executive Officer & Director
Said Samih Taleb Darwazah Executive Chairman
Khalid Walid Hosni Nabilsi Chief Financial Officer
Surendera Tyagi Chief Scientific Officer, Global Head-R&D
Bryan Hotston Chief Information Officer
Sector and Competitors
1st jan.Capitalization (M$)
HIKMA PHARMACEUTICALS22.66%4 461
JOHNSON & JOHNSON-12.25%328 858
PFIZER0.39%212 690
NOVARTIS-8.25%193 446
ROCHE HOLDING LTD.-14.06%183 969
MERCK AND COMPANY10.24%166 880