Health Care

Gilead Pops After FDA Approves Glaxo-Rivaling HIV Drug

Gilead Pops After FDA Approves Glaxo-Rivaling HIV Drug”

Gilead's new combination therapy Biktarvy has been approved by the US Food and Drug Administration for the treatment of HIV.

The lawsuit has been submitted in the U.S. and Canada and is seeking to prove that bictegravir infringes on intellectual property held by ViiV for its rival integrase inhibitor Tivicay (dolutegravir), which was first approved in the United States in 2013 and is a key component of ViiV's latest HIV product launches including three-drug combo Triumeq and recently-approved Juluca.

Pharmaceutical firm GlaxoSmithKline PLC said Thursday its subsidiary ViiV Healthcare has filed patent infringement proceedings against Gilead Sciences Inc in the United States and Canada.

The approval of Gilead's pill along with GSK's from November could shake up the $22 billion HIV drug market.

ViiV says Biktarvy infringes its U.S. and Canadian patents covering "dolutegravir and many other compounds that include dolutegravir's unique chemical scaffold".

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"We believe that a modest royalty could be possible far down the road if Gilead were to lose" the patent case, Jefferies analyst Michael Yee said in a research note.

Dolutegravir, sold under the brand name Tivicay and as a component of Triumeq, is a key growth driver for Glaxo, posting fiscal 2017 sales of almost 4 billion pounds ($5.6 billion).

The new approval could shake up the $22 billion HIV drug market.

The pill, made by Gilead Sciences, contains bictegravir, along with emtricitabine and tenofovir alafenamide, two drugs that are considered the "backbone" of HIV treatments.

Biktarvy's label warns it could exacerbate hepatitis B symptoms in some patients and requires liver function monitoring in those patients. The United States case is filed in the U.S. District Court for the District of DE and the patent is U.S patent No. 8,129,385.



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