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.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.

Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.

Noubar Afeyan (Sebastien Micke/Paris Match/Contour by Getty Images)

As Mod­er­na rose, Flag­ship cashed in for $1.4B — with a lot more wealth still re­main­ing

For nearly a decade, Flagship poured record-setting levels of cash into Moderna, even as they faced setbacks on early programs and skeptics wondered whether the company’s science could ever match its hype.

Now that the science has delivered, Flagship is cashing in.

Over the last 13 months, since the World Health Organization declared a pandemic, Flagship has sold off Moderna shares worth $1.4 billion. The sales, first reported by Forbes, came as the Cambridge biotech’s shares soared from just under $20 per share on Jan. 3, 2020, to $169.50 when markets opened Thursday.

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