Breast can­cer ap­proval in tow, As­traZeneca, Dai­ichi armed an­ti­body scores in key gas­tric can­cer study

As­traZeneca kicked off Mon­day with a flur­ry of good news. Apart from un­veil­ing pos­i­tive re­sults on its stroke tri­al test­ing its clot-fight­er Bril­in­ta, and wel­com­ing its ex­per­i­men­tal IL-23 in­hibitor brazikum­ab back from Al­ler­gan — the British drug­mak­er al­so dis­closed some up­beat gas­tric can­cer da­ta on its HER2-pos­i­tive on­col­o­gy ther­a­py it is col­lab­o­rat­ing on with Dai­ichi Sankyo.

Buoyed by the per­for­mance of its on­col­o­gy drugs, last March As­traZeneca chief Pas­cal So­ri­ot bet big to part­ner with Dai­ichi on the can­cer drug, with $1.35 bil­lion up­front in a deal worth up to rough­ly $7 bil­lion. Rough­ly 8 months lat­er, as 2019 drew to a close, the FDA swift­ly ap­proved the drug — trastuzum­ab derux­te­can — for use in breast can­cer, months ahead of the ex­pect­ed de­ci­sion date.

Trastuzum­ab derux­te­can, brand­ed as En­her­tu, is an an­ti­body-drug con­ju­gate (ADC) — ther­a­peu­tics in which a can­cer-killing tox­in is at­tached to a spe­cif­ic an­ti­body us­ing a biodegrad­able link­er — for can­cers that ex­press HER2, a pro­tein as­so­ci­at­ed with ag­gres­sive dis­ease that of­ten re­sides on cer­tain breast can­cer cells. Rough­ly one in five gas­tric can­cers are HER2 pos­i­tive, As­traZeneca said.

The piv­otal mid-stage tri­al, DES­TINY-Gas­tric01, test­ed En­her­tu against chemother­a­py in 189 pa­tients from Japan and South Ko­rea with HER2-ex­press­ing ad­vanced gas­tric can­cer or gas­troe­sophageal junc­tion ade­no­car­ci­no­ma, whose dis­ease pro­gressed de­spite two or more pri­or treat­ment reg­i­mens in­clud­ing flu­o­ropy­rim­i­dine and plat­inum chemother­a­py and trastuzum­ab.

The tri­al met the main goal of in­duc­ing sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in ob­jec­tive re­sponse rate (ORR), as well as the key sec­ondary end­point of over­all sur­vival. De­tailed da­ta are still to come.

Whilst a small­er in­di­ca­tion than HER2+ metasta­t­ic breast can­cer, this still rep­re­sents a sig­nif­i­cant op­por­tu­ni­ty with an es­ti­mat­ed rough­ly 10,000 HER2+ metasta­t­ic gas­tric can­cer pa­tients in the US, top 5 EU mar­kets and Japan, Jef­feries’ an­a­lyst Pe­ter Welford wrote in a note.

Welford’s $2.05 bil­lion in risk-ad­just­ed glob­al peak sales for En­her­tu is pre­dom­i­nant­ly based on the ther­a­py’s oth­er in­di­ca­tions, par­tic­u­lar­ly metasta­t­ic breast can­cer, he said, adding that just $330 mil­lion of that ac­counts for gas­tric can­cer.

Most pa­tients di­ag­nosed with gas­tric can­cer present with ad­vanced, in­cur­able dis­ease — trastuzum­ab in com­bi­na­tion with chemother­a­py is typ­i­cal­ly the first line of de­fense in pa­tients with metasta­t­ic HER2-pos­i­tive gas­tric and gas­troe­sophageal can­cer. Once the dis­ease no longer re­sponds to trastuzum­ab — pa­tients have lim­it­ed op­tions.

Dai­ichi, which ex­pects the drug to reap peak sales up to $4.5 bil­lion across dif­fer­ent in­di­ca­tions, is on track to take for­ward the drug’s ap­pli­ca­tion ini­tial­ly in Japan where gas­tric can­cer is high­ly preva­lent. En­her­tu is an HER2-tar­get­ed ADC with a topoi­so­merase I in­hibitor pay­load — a chemother­a­peu­tic agent de­signed to in­ter­rupt DNA repli­ca­tion in can­cer cells, and is al­so be­ing test­ed in oth­er can­cers.

In 2015, Roche’s Kady­cla, known chem­i­cal­ly as trastuzum­ab em­tan­sine, failed to elic­it any ben­e­fit in pa­tients pre­vi­ous­ly treat­ed for HER2-pos­i­tive ad­vanced gas­tric can­cer. Last April, Mer­ck’s star PD-1 ther­a­py Keytru­da failed to po­si­tion it­self in the front­line gas­tric can­cer set­ting, al­though it has al­ready se­cured ap­proval as a third-line treat­ment.

Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb fought

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $7.3B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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Top biotech an­a­lyst projects a gloomy out­look for Pfiz­er's JAK port­fo­lio

Many in the pharma world are hoping — better yet, expecting — JAK inhibitors to provide one of the next big boons for the industry. Few have invested as heavily in this area as Pfizer, which boasts a portfolio including Xeljanz and at least five mid-to-late stage candidates in the pipeline.

But a top Wall Street analyst is pumping the brakes on just how much good fortune is in store for the Big Pharma.