[via AP]

My­lan wins ten­ta­tive US ap­proval for gener­ic ver­sion of Lil­ly's Al­im­ta — it could be years be­fore it can be sold

Lil­ly may have fend­ed off com­pe­ti­tion from a pla­toon of gener­ic drug mak­ers and their patent chal­lenges on its chemother­a­py Al­im­ta, but that has not stopped My­lan from se­cur­ing ten­ta­tive US ap­proval for a copy­cat ver­sion.

Al­im­ta was first ap­proved by the FDA in 2004, and the drug’s la­bel has since seen sev­er­al ex­pan­sions. It’s cleared for use in sev­er­al com­bi­na­tions — in­clud­ing with Mer­ck’s star check­point in­hibitor Keytru­da — in cer­tain pa­tients with NSCLC, as well as some pa­tients with ma­lig­nant pleur­al mesothe­lioma. The treat­ment has al­ready gone off-patent in parts of Eu­rope, and its US patents are set to ex­pire in 2022.

On Wednes­day an FDA fil­ing in­di­cat­ed My­lan’s $MYL gener­ic ver­sion of Al­im­ta had been grant­ed ten­ta­tive ap­proval, which is grant­ed by the agency when a prod­uct meets its safe­ty, ef­fi­ca­cy, and man­u­fac­tur­ing qual­i­ty stan­dards — but is pre­clud­ed from mar­ket­ing due to le­gal pro­tec­tions.

Al­im­ta is Lil­ly’s $LLY third top-sell­er — the drug gen­er­at­ed about $578 mil­lion in the sec­ond quar­ter. As the drug march­es to­wards a patent cliff, the US drug­mak­er has been work­ing on fill­ing the rev­enue gap it will even­tu­al­ly face.

In Jan­u­ary, the In­di­anapo­lis drug­mak­er agreed to pay $8 bil­lion for Loxo On­col­o­gy, which man­aged to get a drug — a site-ag­nos­tic can­cer treat­ment — ap­proved in a rel­a­tive­ly spright­ly five years. But the main at­trac­tion for Lil­ly is Loxo’s ex­per­i­men­tal LOXO-292, which has sig­nif­i­cant com­mer­cial po­ten­tial in pa­tients with NSCLC. Up­on the an­nounce­ment, Stifel an­a­lysts sug­gest­ed the trans­ac­tion was strate­gic: “(A)ap­prox­i­mate­ly 55-60% of the end-mar­ket for LOXO-292 – the val­u­a­tion cen­ter­piece of this trans­ac­tion per LLY – is rep­re­sent­ed by RET-fu­sion NSCLC and thus rep­re­sents a read­i­ly-ac­ces­si­ble op­por­tu­ni­ty re­quir­ing min­i­mal in­fra­struc­ture build-out.”

In March, an­oth­er Lil­ly drug showed po­ten­tial for use in the lu­cra­tive NSCLC mar­ket. The com­pa­ny’s Cyra­mza, in com­bi­na­tion with Roche’s Tarce­va, helped stem the spread and growth of can­cer as an ini­tial treat­ment in cer­tain pa­tients with metasta­t­ic NSCLC in a piv­otal study.

Ear­li­er this month, Lil­ly said a US Court of Ap­peals for the Fed­er­al Cir­cuit ruled in its fa­vor, con­firm­ing that Al­im­ta’s patent would be in­fringed by Pfiz­er’s $PFE Hos­pi­ra and Dr. Red­dy’s ver­sions. My­lan, along with Nep­tune Gener­ics and No­var­tis’ $NVS San­doz unit was hit with the same road­block in April in re­sponse to their le­gal chal­lenge.

If the patent is ul­ti­mate­ly up­held through all re­main­ing cas­es, Al­im­ta will main­tain US ex­clu­siv­i­ty un­til May 2022.

The home run count: The $100M+ mega-round boom in biotech in­spired a $6.7B 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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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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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.

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

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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UP­DAT­ED: 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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Covid-19 roundup: CDC de­bat­ing who should get first avail­able vac­cines; EU in Gilead talks af­ter US gob­bled first remde­sivir dos­es

The federal government has now spent billions of dollars accelerating the development of a Covid-19 vaccine, and yet they’ve remained hush-hush on who, precisely, would actually get inoculated once the first doses are approved and available. Internally, though, they have been debating it.

The CDC and an advisory committee of outside health experts have been working since April to devise a ranking system that would determine who receives a vaccine and when, The New York Times reported. The question of who is first in line for inoculation is important because no matter how many doses developers can make or how quickly they can make them, doses will still come out in batches; 300 million inoculations will not appear overnight.

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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Ed Engleman (Stanford Blood Center)

Stan­ford star on­col­o­gy sci­en­tist Ed En­gle­man helped cre­ate the im­munother­a­py field. Now he wants to shake up neu­rode­gen­er­a­tion R&D

Over the last generation of drug R&D, Ed Engleman has been a standout scientist.

The Stanford professor co-founded Dendreon and provided the scientific insights needed to develop Provenge into a pioneering — though not particularly marketable — immunotherapy. He’s spurred a slate of startups, assisted by his well-connected perch as a co-founder of Vivo Capital, and took the dendritic cell story into its next chapter at a startup called Bolt.

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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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