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

James Love james.love at keionline.org
Thu Feb 8 07:45:58 PST 2018


"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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