Mum­bai-based Lupin gets FDA warn­ing for two man­u­fac­tur­ing sites; Io­n­is pro­motes in­ot­ersen head as new COO

→ In­di­an drug man­u­fac­tur­er Lupin re­ceived a warn­ing let­ter from the FDA claim­ing that it had vi­o­lat­ed good man­u­fac­tur­ing prac­tices, the com­pa­ny dis­closed in a fil­ing to the Bom­bay Stock Ex­change. Two fa­cil­i­ties in Goa and In­dore, which pro­duce prod­ucts that make up more than 40% of Lupin’s sales, were named in the let­ter. “This is a big neg­a­tive for the com­pa­ny… The warn­ing let­ter will not on­ly de­lay new ap­provals, thus im­pact­ing US rev­enues, but al­so in­crease re­me­di­a­tion cost that will put pres­sure on mar­gins,” bro­ker­age firm Edel­weiss Se­cu­ri­ties is quot­ed as say­ing. That would take a di­rect hit on the Mum­bai-based com­pa­ny, as al­most half of its sales comes from the US. Stocks plunged 17% af­ter the news broke.

Brett Mo­nia

→ As cur­rent chief op­er­a­tion of­fi­cer Lynne Par­shall tran­si­tions in­to a strate­gic ad­vis­er role at Io­n­is Phar­ma­ceu­ti­cals while Brett Mo­nia, head of drug dis­cov­ery, will as­sume the COO po­si­tion. A found­ing mem­ber of Io­n­is $IONS, Mo­nia al­so leads the in­ot­ersen pro­gram, which was filed for a mar­ket­ing ap­proval with the FDA to­day. His new re­spon­si­bil­i­ties in­clude mov­ing re­search pro­grams in­to de­vel­op­ment, reg­u­la­to­ry, pa­tient ad­vo­ca­cy, hu­man re­sources and busi­ness func­tions. “The board and I are con­fi­dent that Brett is the ide­al choice to be chief op­er­at­ing of­fi­cer and is ful­ly pre­pared to as­sume these new re­spon­si­bil­i­ties,” said CEO Stan­ley Crooke in a state­ment.

→ Hous­ton, TX-based On­coRe­sponse an­nounced to­day that it has com­plet­ed the ac­qui­si­tion of Cal­i­for­nia’s Pa­gani­ni Bio­phar­ma and all its as­sets — the most note­wor­thy among them be­ing ON­CR-201, an an­ti-ep­ithe­lial mem­brane pro­tein 2 (EMP2) mon­o­clon­al an­ti­body that has shown promise in the pre­clin­i­cal stage. First-in-hu­man stud­ies are ex­pect­ed ear­ly 2019. “We are thrilled to put our tech­nol­o­gy and an­ti­bod­ies in the hands of strong drug de­vel­op­ers and look for­ward to see­ing this med­i­cine reach can­cer pa­tients,” said Pa­gani­ni CEO Gary Lazar in a state­ment. Fi­nan­cial de­tails of the deal were not dis­closed.

Take­da has struck a deal to col­lab­o­rate with Cam­bridge, MA-based Por­tal In­stru­ments on the nee­dle-free de­liv­ery tech it de­vel­oped out of the lab of MIT’s Ian Hunter. Por­tal gets an up­front and mile­stones to­tal­ing $100 mil­lion.

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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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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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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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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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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Zai Lab inks Chi­na deal with Turn­ing Point with $25M up­front; Xen­cor, Atre­ca team up on bis­pecifics

Zai Lab is paying out a $25 million upfront for the rights to sell Turning Point Therapeutics’ lead drug repotrectinib in Greater China. The San Diego-based biotech is also in line for up to $151 million in milestones, along with mid-to-high teen royalties. Zai plans to add sites to the Phase II trial of the drug, which is designed to treat ROS1-positive advanced NSCLC in patients who were not previously treated with a TKI.

FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

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