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Gilead Sciences : offers its newest HIV drug candidate to patent pool for low-cost production

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10/06/2017 | 12:13pm CEST

Gilead Sciences is licensing its newest HIV drug candidate, bictegravir, to the U.N.-backed Medicines Patent Pool, meaning it will be produced and sold at a lower cost in 116 low- and middle-income countries once it is approved.

Gilead said it will include the HIV-1 candidate in its existing agreements with generic drugmakers Sun Pharmaceutical Industries, Strides Shasun, Mylan and SeQuent Scientific, as a single agent or in fixed-dose combinations with other HIV medicines, upon regulatory approval in the U.S. It also will allow the MPP to sub-license it to other generic producers in India, China and South Africa.

Competition among manufacturers has reduced the lowest price of a Gilead HIV generic therapy by 80 percent since 2006, to as low as $3.50 per patient per month. Ninety-nine percent of people taking Gileads HIV therapies in developing countries receive generic medicine, Gilead said in an announcement today.

Of course, it is the branded version in the U.S. and Europe, where drug approvals are currently pending, that Gilead is most interested in and where it will compete with GlaxoSmithKlines $1.2 billion seller Tivicay (dolutegravir). The FDA has set a Feb.12, 2018 target date for consideration.

Analysts initially believed bictegravir, if approved, was going to be a red-hot competitor to the GSK med but phase 3 data released last spring cooled those expectations somewhat. While four studies of the investigational integrase strand transfer inhibitor hit their primary endpoints by measuring up to Tivicay and other antiretroviral agents, they didnt prove that bictegravir is superior. Then in data released today, it reported the same finding at 48 weeks.

GSK, which has been aggressively building its HIV focused ViiV Healthcare, is taking another tack in its assault on market leader Gileads $10 billion-plus HIV franchise. The U.K.-based company is betting on a two-drug, dolutegravir-containing regimen that could potentially cut down on the side-effect burden of Gileads three-drug approaches, and their cost, too.

(c) International 2006-2017, SANA Provided by SyndiGate Media Inc. (Syndigate.info)., source Middle East & North African Newspapers

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Financials ($)
Sales 2018 20 794 M
EBIT 2018 10 734 M
Net income 2018 6 433 M
Debt 2018 13 028 M
Yield 2018 3,18%
P/E ratio 2018 14,45
P/E ratio 2019 13,16
EV / Sales 2018 5,09x
EV / Sales 2019 5,17x
Capitalization 92 917 M
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Mean consensus OUTPERFORM
Number of Analysts 26
Average target price 85,8 $
Spread / Average Target 20%
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Managers
NameTitle
John F. Milligan President, Chief Executive Officer & Director
John C. Martin Chairman
Robin L. Washington CFO, Principal Accounting Officer & Executive VP
Andrew Cheng Chief Medical Officer & Executive Vice President
John G. McHutchison Chief Scientific Officer
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