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".

"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.



Like this

loading...
loading...

Latest


08 February 2018
SS&C Technologies' (NASDAQ:SSNC) Buy Rating Reaffirmed at Needham & Company LLC
Of those insider trades, 0 shares of SS&C Technologies Holdings, Inc. were purchased and 60,000 shares were sold. SS&C Technologies Holdings (NASDAQ: SSNC ) last posted its quarterly earnings data on Thursday, July 27th.

08 February 2018
Apple Music Set To Overtake Spotify in US Subscribers
In its last earnings report released recently, Apple reported its services sector grew 18 per cent from a year ago to US$8.47b. In the race for global music streaming supremacy, the gap between Spotify and Apple Music is getting smaller.

08 February 2018
Cenovus Energy (NYSE:CVE) Earns "Hold" Rating from Desjardins
Highfields Capital Management Lp decreased Allergan Plc stake by 128,500 shares to 37,500 valued at $7.69M in 2017Q3. Burgundy Asset Management Ltd. grew its holdings in shares of Cenovus Energy by 27.6% during the third quarter.

08 February 2018
Stocks grabbing Attention: The Walt Disney Company (DIS), Centene Corp
Leon Lowenstein decreased its stake in Sp Plus Corp (SP) by 9.59% based on its latest 2017Q3 regulatory filing with the SEC. The company has a market cap of $161,140.00, a price-to-earnings ratio of 14.98, a P/E/G ratio of 1.82 and a beta of 1.30.

08 February 2018
BSP, JD(S) announce alliance for Karnataka assembly elections
Bahujan Samaj Party and Janata Dal-Secular on Thursday chose to contest together the forthcoming assembly elections in Karnataka. As per the understanding, the BSP would contest 20 seats out of the total 224, while the JD-S would contest the rest.

08 February 2018
Priyanka breaks silence about her realtionship status
In a recent interview with Filmfare , the usually secretive actor opened up about her relationship status. My mind hasn't exploded, not yet", Priyanka told.

08 February 2018
Dontnod's Action RPG Vampyr To Release In June On PC And Consoles
In Vampyr , players take the role of Jonathan Reid, a doctor who has just returned from The Great War only to be turned into a vampire.

08 February 2018
Erdogan: Turkey has nothing to talk about with Bashar Assad
The operation has been conducted jointly with Free Syrian Army forces. "We will defend ourselves", added coalition commander, Lt.

08 February 2018
Lululemon CEO exits after failing to meet conduct standards
Less than nine months later, founder Chris Wilson blamed women's bodies for their concerns over the quality of Lululemon leggings. In 2013, the year before Potdevin became CEO, it had to recall one style of its yoga trousers because they were see-through.

08 February 2018
Brokerages Set Cott Corp (COT) PT at $17.13
It improved, as 51 investors sold AKAM shares while 138 reduced holdings. 12 funds opened positions while 28 raised stakes. The company reported $0.06 earnings per share (EPS) for the quarter, missing the consensus estimate of $0.14 by ($0.08).