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

Melissa Barber melissajoybarber at gmail.com
Thu Feb 8 08:09:26 PST 2018


It’s not possible to upload an image to iphealth, but I’ve uploaded a slide
accessible from the link below for sales of HIV drugs by Gilead, GSK, BMS,
Abbvie/Abbot, J&J, and Merck 2002-2016 (in USD billions). Among these
companies, the market was at 24 bn in 2016.


https://www.researchgate.net/publication/323015637_Sales_
of_HIV_drugs_by_GileadGSK_BMS_AbbvieAbbot_JJ_and_Merck_2002-
2016_in_USD_billions?tab=overview


On Thu, Feb 8, 2018 at 10:45 AM, James Love <james.love at keionline.org>
wrote:

> "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."
>
>
> $40 billion per year is a lot of money for an areas where companies come up
> with about one new molecular entity per year, over the past 30+ years.
>
>
>
> On Thu, Feb 8, 2018 at 10:40 AM, Thiru Balasubramaniam <
> thiru at keionline.org>
> wrote:
>
> > 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
> > _______________________________________________
> > Ip-health mailing list
> > Ip-health at lists.keionline.org
> > http://lists.keionline.org/mailman/listinfo/ip-health_lists.
> keionline.org
> >
>
>
>
> --
> James Love.  Knowledge Ecology International
> http://www.keionline.org/donate.html
> KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
> +41.76.413.6584, twitter.com/jamie_love
> _______________________________________________
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