Gilead los­es key patent claims for So­val­di in Chi­na, open­ing door to ear­li­er gener­ic en­try

A par­tial patent in­val­i­da­tion by Chi­nese au­thor­i­ties has shak­en the case Gilead has been build­ing for its hep C star So­val­di by re­mov­ing a key bar­ri­er to gener­ic en­try.

The de­ci­sion means knock­offs of the high­ly ef­fec­tive hep C treat­ment can ar­rive as ear­ly as next year — rather than 2024, when the patent was orig­i­nal­ly set to ex­pire — ac­cord­ing to the Ini­tia­tive for Med­i­cines, Ac­cess, and Knowl­edge, or I-MAK. I-MAK filed one of the two re­quests for patent in­val­i­da­tion cit­ed in the rul­ing, to­geth­er with Chi­nese drug­mak­er Fu­jian Co­sunter Phar­ma.

Tahir Amin

Be­cause the patent con­cerns so­fos­bu­vir, a cru­cial base com­pound that’s al­so used to make com­bo drugs like Har­voni and Ep­clusa, this de­ci­sion could af­fect not just one prod­uct but Gilead’s whole hep C fran­chise in the coun­try.

In re­sponse to my ques­tion as to whether Gilead will ap­peal the rul­ing (they have three months to do so), a spokesper­son says the Fos­ter City, CA-based com­pa­ny has not with­drawn their claims to the so­fos­bu­vir com­pound patent ap­pli­ca­tion in Chi­na. Here’s the rest of the re­sponse:

This patent ap­pli­ca­tion is cur­rent­ly be­ing re­viewed by the Patent Re­view Board (PRB). Last week Chi­na’s PRB con­firmed the va­lid­i­ty of claims cov­er­ing the SOF metabo­lites. This de­ci­sion has no im­pact on our SOF com­pound patent ap­pli­ca­tion. Gilead is con­fi­dent in the in­tel­lec­tu­al prop­er­ty cov­er­ing the so­fos­bu­vir com­pound and all its he­pati­tis C med­i­cines, which bring the po­ten­tial of a cure to the vast ma­jor­i­ty of pa­tients suf­fer­ing from chron­ic he­pati­tis C virus (HCV) in­fec­tion. In the mean­time, we will con­tin­ue to work with the Chi­nese gov­ern­ment to fa­cil­i­tate broad ac­cess to Gilead’s he­pati­tis C med­i­cines.

While So­val­di was launched in Chi­na at one-fifth the con­tem­po­rary price in the US — al­most $9,000 for a 12-week regime — its price still fre­quent­ly comes un­der at­tack, as it has in many oth­er coun­tries around the world. In fact, Gilead has drawn crit­i­cism ever since it be­gan sell­ing the drug at $84,000 in the US. And where­as Gilead de­signed li­cens­ing deals with gener­ic com­pa­nies in coun­tries like Ukraine, Be­larus, Thai­land and Malaysia in re­sponse to com­plaints, no such agree­ment was struck in Chi­na.

Back in 2015, two years be­fore So­val­di would be ap­proved in Chi­na, the au­thor­i­ties had re­ject­ed Gilead’s ap­pli­ca­tion for an in­ac­tive pro­drug that is me­tab­o­lized once in the body.

I-MAK, which al­so played a role in that de­ci­sion, has been bring­ing le­gal chal­lenges against Gilead in a num­ber of oth­er coun­tries, in­clud­ing the US. Its co-founder Tahir Amin told STAT that even though Gilead still holds four re­main­ing patent claims on So­val­di and da­ta ex­clu­siv­i­ty in Chi­na, they shouldn’t hin­der gener­ic mak­ers as much as this patent had.

Co­sunter, which mar­ket­ed Chi­na’s first hep B gener­ic, is said to be de­vel­op­ing a copy­cat ver­sion of So­val­di.

Hal Barron and Rick Klausner (GSK, Lyell)

Ex­clu­sive: GSK’s Hal Bar­ron al­lies with Rick Klaus­ner’s $600M cell ther­a­py start­up, look­ing to break new ground blitz­ing sol­id tu­mors

LONDON — Chances are, you’ve heard little or nothing about Rick Klausner’s startup Lyell. But that ends now.

Klausner, the former head of the National Cancer Institute, former executive director for global health at the Gates Foundation, co-founder at Juno and one of the leaders in the booming cell therapy field, has brought together one of the most prominent teams of scientists tackling cell therapy 2.0 — highlighted by a quest to bridge a daunting tech gap that separates some profound advances in blood cancers with solid tumors. And today he’s officially adding Hal Barron and GlaxoSmithKline as a major league collaborator which is pitching in a large portion of the $600 million he’s raised in the past year to make that vision a reality.

“We’ve being staying stealth,” Klausner tells me, then adding with a chuckle: “and going back to stealth after this.”

“Cell therapy has a lot of challenges,” notes Barron, the R&D chief at GSK, ticking off the resistance put up by solid tumors to cell therapies, the vein-to-vein time involved in taking immune cells out of patients, engineering them to attack cancer cells, and getting them back in, and more. “Over the years Rick and I talked about how it would be wonderful to take that on as a mission.”

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First place fin­ish: Eli Lil­ly just moved to fran­chise leader with their sec­ond mi­graine drug OK in 1 year

In a rare twist for Eli Lilly’s historically slow-moving R&D group, the pharma giant has seized bragging rights to a first-in-class new drug approval. And all signs point to an aggressive marketing followup as they look to outclass some major franchise rivals hobbled by internal dissension.

The FDA came through with an OK for lasmiditan on Friday evening, branding it as Reyvow and lining it up — once a substance classification comes through from the DEA — for a major market release. The oral drug binds to 5-HT1F receptors and is designed to stop an acute migraine after it starts. That makes it a complementary therapy to their CGRP drug Emgality, which has a statistically significant impact on preventing attacks.

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Pfizer, South San Francisco — Jeff Rumans for Endpoints News

Pfiz­er takes aim at a flag­ship fran­chise at Sanofi and Re­gen­eron — and scores a few di­rect hits

Count Pfizer in as a top player in the blockbuster game of JAK1 inhibitors.

Over the weekend the pharma giant posted some stellar Phase III efficacy data for their heavyweight contender abrocitinib in atopic dermatitis (eczema) that lines up ahead of a booming Dupixent (dupilumab), a blockbuster in the portfolios of Regeneron and Sanofi. And they put some real distance ahead of Eli Lilly’s trailing Olumiant, which made a delayed initial arrival on the market for rheumatoid arthritis after the FDA hobbled it with some additional hurdles on safety concerns.

JADE-MONO-1 scores well for Pfizer, teeing up what will be an intensely followed breakdown of the JADE MONO-2 data, which the pharma giant recently top-lined as “similar” to the first Phase III when tested against a placebo — a control group that has been easily outclassed by all the drugs in this market niche.

As of now, Pfizer looks to be equipped to run into the review stage — advantaged by a breakthrough therapy designation that is intended to speed up the regulatory process.

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Allogene HQ Open House on September 17, 2019 in South San Francisco. (Jeff Rumans, Endpoints News)

The next 10 years: Where is biotech head­ed?

The last 10 years have seen a revolution in drug development. Timelines have shortened, particularly in oncology. Regulators have opened up. Investment has skyrocketed. China became a player. Biotechs have multiplied as gene and cell therapy has exploded — offering major new advances in the way diseases are treated, and sometimes cured.

So where are we headed from here? I journeyed out to San Francisco in September to discuss the answer to that question at Allogene’s open house. If the last 10 years have been an eye-opener, what does the next decade hold in store?

Patrick Mahaffy, Getty Images

Court green-lights Clo­vis case af­ter de­tail­ing ev­i­dence the board ‘ig­nored red flags’ on false safe­ty and ef­fi­ca­cy da­ta

Clovis investors have cleared a major hurdle in their long-running case against the board of directors, with a Delaware court making a rare finding that they had a strong enough case against the board to proceed with the action.

In a detailed ruling at the beginning of the month that’s been getting careful scrutiny at firms specializing in biotech and corporate governance, the Delaware Court of Chancery found that the attorneys for the investors had made a careful case that the board — a collection of experts that includes high-profile biotech entrepreneurs, a Harvard professor and well-known investigator as well as Clovis CEO Patrick Mahaffy — repeatedly ignored obvious warnings that Mahaffy’s executive crew was touting inflated, unconfirmed data for their big drug Roci. Serious safety issues were also reportedly overlooked while the company continued a fundraising campaign that brought in more than a half-billion dollars. And that leaves the board open to claims related to their role in the fiasco.

The bottom line:

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Bill Gates backs Gink­go Biowork­s' $350M raise to fu­el the buzzy syn­thet­ic bi­ol­o­gy 'rev­o­lu­tion'

If you want to understand Ginkgo Bioworks, the name should suffice: Bioworks, a spin off “ironworks,” that old industrial linchpin devoted to leveraging scale as a wellspring for vast new industries capable of remaking society. Ginkgo wants to be the ironworks for the revolution it’s heralded with as much fanfare as they can, playing off of one of the buzziest technologies in biotech.

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UCB bags a ri­val to Soliris in $2.1B buy­out deal — but will an in­creas­ing­ly vig­i­lant FTC sign off?

UCB is buying out Ra Pharma $RARX, announcing an acquisition deal that rings up at $48 a share, or $2.1 billion net of cash, and puts them toe-to-toe with Alexion on a clinical showdown.

Ra shares closed at $22.70 on Wednesday.

There’s a small pipeline in play at Ra, but UCB is going for the lead drug — a C5 inhibitor called zilucoplan in Phase III for myasthenia gravis (MG) looking to play rival to Alexion’s Soliris. Soliris has the market advantage, though, with a much earlier approval in MG in late 2017 that UCB feels confident in challenging.

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A new play­er is tak­ing the field in a push for a he­mo­phil­ia A gene ther­a­py, and it’s a big one

BioMarin, the execs at Spark (and buyer-to-be Roche) as well as the Sangamo/Pfizer team have a new rival striding onto the hemophilia block. And it’s a big one.

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Stuck with a PhI­II gene ther­a­py fail­ure at 96 weeks, Gen­Sight prefers the up­beat as­sess­ment

Two years after treatment, the best thing that GenSight Biologics $SIGHT can say about their gene therapy for vision-destroying cases of Leber Hereditary Optic Neuropathy is that it’s just a bit better than a placebo — just maybe because one treatment can cover both eyes.

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