Tesaro v Myr­i­ad: Ni­ra­parib part­ners squared off in court as Tesaro tried to quash a con­trary press re­lease

When Tesaro re­leased their da­ta on the PARP drug ni­ra­parib a few days ago, the biotech was de­ter­mined to make a case for a broad ap­proval, with­out any need for a di­ag­nos­tic test to dis­tin­guish pa­tients with a par­tic­u­lar bio­mark­er for ovar­i­an can­cer.

Not every­body, of course, bought in to that ar­gu­ment, with some crit­ics say­ing that the da­ta were iffy at best. One key ob­jec­tion, though, came from Myr­i­ad Ge­net­ics, which de­vel­oped the com­pan­ion di­ag­nos­tic test Tesaro used in Phase III and now wants to see put in­to use. And Tesaro wound up tak­ing them to court in a failed at­tempt to shut it down.

Livid over a pro­posed re­lease from Myr­i­ad which made an ar­gu­ment against Tesaro’s case, the biotech filed for an in­junc­tion in US Dis­trict Court in New York on Oc­to­ber 7, claim­ing that the Myr­i­ad PR in­clud­ed “false and mis­lead­ing state­ments” about the da­ta. It ve­he­ment­ly ob­ject­ed to re­marks about the “over­all tox­i­c­i­ty pro­file” and quotes from some peo­ple who, they claimed, had nev­er seen the da­ta.

The judge, said Tesaro’s lawyers, should shut it down as a vi­o­la­tion of their part­ner­ship agree­ment.

Judge Richard Sul­li­van, though, didn’t buy in­to that ar­gu­ment, not­ing that Tesaro was al­ready plan­ning to pub­lish the da­ta, Myr­i­ad wasn’t breach­ing their agree­ment in any case, and Tesaro wasn’t go­ing to suf­fer ir­repara­ble harm.

Mo­tion de­nied. PR is­sued.

A spokesper­son for Tesaro, though, says they were al­so able to set­tle their dis­agree­ment over the re­lease.

“We had a dis­agree­ment with Myr­i­ad about mes­sag­ing in Myr­i­ad’s pro­posed ES­MO press re­lease, so we filed a com­plaint to stop it from be­ing is­sued un­til we could mu­tu­al­ly agree on the con­tent,” she said in an email to End­points News. “Once the con­tent was agreed up­on, the news re­lease was is­sued, and the suit was dropped.”

Tesaro is left in the same po­si­tion it was ear­li­er, work­ing to prove that the ef­fi­ca­cy da­ta for ni­ra­parib qual­i­fies for an ap­proval for use in pa­tients who are ei­ther HRD pos­i­tive or HRD neg­a­tive. But they’re al­so in a po­si­tion of be­ing op­posed by a part­ner who has a sol­id busi­ness case for ar­gu­ing that the drug should be re­served for pa­tients who would be most like­ly to ben­e­fit. And there are a num­ber of an­a­lysts who are sid­ing with Myr­i­ad on this one.

The ben­e­fit nar­rows pro­gres­sive­ly by that last step, and the 3.1-month pro­gres­sion sur­vival ben­e­fit for the HRD-neg­a­tive group in the Phase III — 6.9 months ver­sus 3.8 months — will get plen­ty of scruti­ny by reg­u­la­tors.

The ar­gu­ing now will move from the courts to the FDA, where the two col­lab­o­ra­tors can square off against each oth­er once again. The out­come will dic­tate just how much each com­pa­ny stands to make from this drug.

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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