As­traZeneca throws down the gaunt­let with a PhI­II vic­to­ry in head-to-head PARP war with Tesaro

Sean Bo­hen, As­traZeneca

As­traZeneca has post­ed an­oth­er suc­cess in its cam­paign to ex­pand the use of its PARP in­hibitor Lyn­parza (ola­parib).

In what has be­come a head-to-head show­down with Tesaro, which has a ri­val PARP un­der re­view at the FDA, As­traZeneca to­day her­ald­ed a top-line suc­cess for Lyn­parza in a Phase III study of HER2-neg­a­tive metasta­t­ic breast can­cer har­bor­ing germline BR­CA1 or BR­CA2 mu­ta­tions.

Like Tesaro, As­traZeneca’s piv­otal study fo­cused on a com­par­i­son with physi­cian’s choice of chemother­a­pies, with Lyn­parza com­ing out ahead on pro­gres­sion-free sur­vival.

Lyn­parza got an ear­ly start in the mar­ket, thanks to FDA re­view­ers who were will­ing to look past the rel­a­tive­ly weak da­ta that As­traZeneca $AZN had post­ed for this drug. Richard Paz­dur’s team was anx­ious to get a PARP in­to the mar­ket for ovar­i­an can­cer, where Tesaro is lin­ing up its first shot on their fran­chise drug. A few back­ers on the sell side have pro­ject­ed bil­lions in peak sales for Tesaro’s drug, but they’ll have to get around As­traZeneca to get it.

As we re­port­ed a few days ago, ni­ra­parib sits high on a list of 15 po­ten­tial block­busters ready to hit the mar­ket this year, with 2022 sales rev­enue pro­ject­ed at $1.8 bil­lion for the ovar­i­an can­cer mar­ket. And that has kept the fo­cus on on­go­ing buzz about a po­ten­tial buy­out for Tesaro.

An­a­lysts will have to wait for the ac­tu­al da­ta, though, on an in­di­ca­tion that they say could be worth a block­buster bil­lion dol­lars in an­nu­al rev­enue for Tesaro. Sea­mus Fer­nan­dez called it a clear win for the phar­ma gi­ant:

This is the first Phase 3 read­out for a PARP in­hibitor in breast can­cer and will like­ly have pos­i­tive read-through for sim­i­lar­ly de­signed tri­als of PFE’s (MP) ta­la­zoparib (EM­BRA­CA tri­al; da­ta ex­pect­ed in 1H:17) and TSRO’s (MP) ni­ra­parib (BRA­VO tri­al; da­ta ex­pect­ed in 2H:17). Im­por­tant­ly, this rep­re­sents a win for AZN, which is build­ing its DNA Dam­age Re­sponse (DDR) port­fo­lio around Lyn­parza, as well as pro­vid­ing the first val­i­da­tion for the PARP in­hibitor class out­side of ovar­i­an can­cer. We con­tin­ue to view AZN as our top pick with a num­ber of high-im­pact cat­a­lysts on the hori­zon. Re­it­er­ate OP.

Shares of As­traZeneca jumped 1.7% on the news.

The suc­cess is a key win for As­traZeneca, which has been work­ing hard to fol­low up on Lyn­parza’s ap­proval with sol­id ev­i­dence of its broad­er po­ten­tial. The drug has proven to be one of the few big bright spots for the phar­ma gi­ant as it awaits com­bo da­ta on the check­point in­hibitor dur­val­um­ab and treme­li­mum­ab.

These aren’t the on­ly two PARPs in the pipeline. Pfiz­er ac­quired ta­la­zoparib in its $14 bil­lion buy­out of Medi­va­tion while Clo­vis achieved an ap­proval for Rubra­ca last De­cem­ber.

As­traZeneca CMO Sean Bo­hen said:

These re­sults are pos­i­tive news for pa­tients with BR­CA-mu­tat­ed metasta­t­ic breast can­cer, a dis­ease with a high un­met need, and are the first pos­i­tive Phase III da­ta for a PARP in­hibitor be­yond ovar­i­an can­cer. This is high­ly en­cour­ag­ing for the de­vel­op­ment of our broad port­fo­lio which aims to treat mul­ti­ple can­cers by tar­get­ing DNA dam­age re­sponse path­ways.

Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

Sarepta has a friend in the FDA after all. Four months after the agency determined that it would be wrong to give Sarepta an accelerated approval for their Duchenne MD drug golodirsen, regulators have executed a stunning about face and offered the biotech a quick green light in any case.

It was the agency that first put out the news late Thursday, announcing that Duchenne MD patients with a mutation amenable to exon 53 skipping will now have their first targeted treatment: Vyondys 53, or golodirsen. Having secured the OK via a dispute resolution mechanism, the biotech said the new drug has been priced on par with their only other marketed drug, Exondys 51 — which for an average patient costs about $300,000 per year, but since pricing is based on weight, that sticker price can even cross $1 million.

Sarepta shares $SRPT surged 23% after-market to $124.

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Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Paul Biondi (File photo)

Paul Biondi's track record at Bris­tol-My­ers cov­ered bil­lions in deals of every shape and size. Here's the com­plete break­down

Paul Biondi was never afraid to bet big during his stint as business development chief at Bristol-Myers Squibb. And while the gambles didn’t all pay out, by any means, his roster of pacts illustrates the broad ambitions the pharma giant has had over the last 5 years — capped by the $74 billion Celgene buyout.

On Thursday, we learned that Biondi had exited the company. And Chris Dokomajilar at DealForma came up with the complete breakdown on every buyout, licensing pact and product purchase Bristol-Myers forged during his tenure in charge of the BD team at one of the busiest companies in biopharma.

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This image shows a lab technician measuring the zone of inhibition during an antibiotic sensitivity test, 1972. The zone of inhibition is measured and compared to a standard in order to determine if an antibiotic is effective in treating the bacterial infection. (Gilda Jones/CDC via Getty Images)

Bio­phar­ma has aban­doned an­tibi­ot­ic de­vel­op­ment. Here’s why we did, too.

Timing is Everything
When we launched Octagon Therapeutics in late 2017, I was convinced that the time was right for a new antibiotic discovery venture. The company was founded on impressive academic pedigree and the management team had known each other for years. Our first program was based on a compelling approach to targeting central metabolism in the most dangerous bacterial pathogens. We had already shown a high level of efficacy in animal infection models and knew our drug was safe in humans.

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Amid Shehnaaz Suliman’s lengthy resume it could be easy to miss her stint leading early-stage Alzheimer’s R&D at Genentech, where she oversaw a program for the ill-fated crenezumab and initiated one of the first prevention studies around the devastating neurodegenerative disease. But it is this experience that she — after thinking long and hard about her next career move over the past months — will be leaning heavily on as the first president and COO of Alector.

PhII fail­ure in rare neu­rode­gen­er­a­tive dis­ease? No mat­ter, Bio­gen will mo­tor on in Alzheimer's

Biogen’s fierce focus on disorders of the brain has hit another roadblock.

On Friday, the US drugmaker — which recently resurrected its amyloid-targeting Alzheimer’s drug, aducanumab — said its anti-tau drug, gosuranemab, failed a mid-stage study in patients with progressive supranuclear palsy (PSP), a rare brain disorder that results from deterioration of brain cells that control movement and thought.

A USP­TO le­gal ad­vis­er is off con­tro­ver­sial Gilead HIV case af­ter ac­tivists al­lege tweets show bias

Last week, a top legal adviser in the US Patent and Trademark Office working on the high-profile Gilead HIV PrEP case tweeted at Sen Bernie Sanders (I-VT) “What proof????” and then at activists “Do facts even matter to you?”

Now, STAT reports, she’s off of the case.

Activists in the coalition PrEP4All filed a petition to the USPTO on December 9 asking longtime senior legal advisor Mary Till be removed from the Gilead case, saying her tweets showed a bias toward Gilead. PrEP4All requested earlier this month the agency reject Gilead’s three-year patent extension for TAF (tenofovir alafenamide), a component of one of the HIV prevention regimens often referred to as PrEP. They allege the pharma giant delayed developing the drug in order to “game” the system and hold off generics.

What's next for Sarep­ta? A third DMD ap­proval, an­a­lysts pre­dict

What Sarepta wants, Sarepta usually gets.

In dramatic fashion on Thursday, the approval of Vyondys 53 — to treat a subset of Duchenne muscular dystrophy (DMD) patients — was unveiled, four months after the FDA’s initial rejection. With two drugs now approved on the basis of ~1% expression of dystrophin — the missing protein that causes DMD — Sarepta is in a prime position to take its third DMD drug to the regulator, analysts said, predicting healthier odds of success.

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Roche's triplet in­volv­ing Tecen­triq clears the PFS bar for melanoma when added to BRAF/MEK com­bo

In a “check the box” exercise, Roche said it has shown that adding Tecentriq to a combo of Cotellic and Zelboraf was effective in extending progression-free survival in melanoma patients compared to placebo plus the two drugs.

Patients with previously untreated BRAF V600 mutations were recruited to the Phase III study, dubbed IMspire150.

Cotellic (which was initially developed by Roche partner Exelixis) and Zelboraf are already approved to treat BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma. While the latter blocks some BRAF kinases, the former is believed to help break treatment resistance by also inhibiting MEK1/2.