[Ip-health] Reuters: U.S. FDA approves Gilead triple HIV drug, rival files lawsuit

Thiru Balasubramaniam thiru at keionline.org
Thu Feb 8 07:40:32 PST 2018


https://www.reuters.com/article/us-gilead-sciences-fda/u-s-fda-approves-gilead-triple-hiv-drug-rival-files-lawsuit-idUSKBN1FR3AJ

<SNIP>

Rival ViiV Healthcare, a joint venture majority-owned by GlaxoSmithKline
Plc with Pfizer Inc and Shionogi Ltd, quickly filed a lawsuit alleging that
Gilead was infringing patents on ViiV’s dolutegravir, a component of the
venture’s triple-drug HIV treatment Triumeq.

Viiv is seeking “financial redress,” but is not asking for an injunction
against sales of Biktarvy, according to Glaxo spokeswoman Sarah Spencer.

Gilead, in an emailed statement, said it remained ”steadfast in our opinion
that Biktarvy does not infringe ViiV’s U.S. patent, and that the court
challenge did not affect the U.S. availability of the drug.


--

#HEALTH NEWS
FEBRUARY 7, 2018 / 11:34 PM / UPDATED 13 HOURS AGO

U.S. FDA approves Gilead triple HIV drug, rival files lawsuit

Deena Beasley

3 MIN READ

(Reuters) - The U.S. Food and Drug Administration on Wednesday approved
Biktarvy, Gilead Sciences Inc’s once-daily, triple-combination tablet for
treatment of HIV infection, paving the way for the biotech company to
capture more of the multibillion-dollar HIV drug market.

Biktarvy combines new integrase inhibitor bictegravir with Descovy, an
older medication that combines nucleoside reverse transcriptase inhibitors
emtricitabine and tenofovir alafenamide.

Rival ViiV Healthcare, a joint venture majority-owned by GlaxoSmithKline
Plc with Pfizer Inc and Shionogi Ltd, quickly filed a lawsuit alleging that
Gilead was infringing patents on ViiV’s dolutegravir, a component of the
venture’s triple-drug HIV treatment Triumeq.

Viiv is seeking “financial redress,” but is not asking for an injunction
against sales of Biktarvy, according to Glaxo spokeswoman Sarah Spencer.

Gilead, in an emailed statement, said it remained ”steadfast in our opinion
that Biktarvy does not infringe ViiV’s U.S. patent, and that the court
challenge did not affect the U.S. availability of the drug.

“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.

Wall Street analysts, on average, forecast Biktarvy sales of around $1
billion this year, rising to a peak of nearly $5 billion annually by 2024,
according to Thomson Reuters I/B/E/S.

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
nearly 4 billion pounds ($5.6 billion).

The Gilead drug’s wholesale price, about $36,000 a year, is in line with
current therapies, according to Guggenheim Securities.

The global market for HIV drugs could reach as high as $40 billion a year
by 2021, according to pharmaceutical data company Quintiles IMS Institute,
now known as IQVIA.

The new Gilead drug’s label includes a boxed warning that use could worsen
hepatitis B infection in certain patients.

ViiV said it would seek to prove that Biktarvy infringed ViiV’s U.S. and
Canadian patents covering dolutegravir and many other compounds that
include dolutegravir’s unique chemical scaffold. The U.S. case was filed in
the U.S. District Court for the District of Delaware and the Canadian case
in the Canadian Federal Court in Toronto.

Shares of Gilead, which rose 3 percent to close at $82.76 in regular
trading, were down 1 percent at $82.01 after hours.



-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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