No­vo Nordisk's new obe­si­ty da­ta tip the scales in semaglu­tide's fa­vor as land­mark piv­otal pro­gram looms

No­vo Nordisk has rolled out new da­ta points to back its be­lief that their new­ly ap­proved GLP-1 di­a­betes drug semaglu­tide al­so has the in­side track on a block­buster des­ig­na­tion for obe­si­ty.

No­vo’s re­searchers took cen­ter stage at the En­docrine So­ci­ety’s an­nu­al con­fer­ence in Chica­go with a new round of Phase II num­bers show­ing that the drug spurred weight loss of up to 13.8% among a group of obese adults.

Al­to­geth­er 83% of peo­ple treat­ed with semaglu­tide 0.4 mg lost greater than or equal to 5% of their body weight — com­pared to 23% with place­bo and 66% with li­raglu­tide (Sax­en­da) 3 mg, which al­so fac­tored in the study. Right at 2 of every 3 pa­tients lost at least 10% of their body weight, com­pared to 10% in the place­bo arm and half that in the li­raglu­tide group.

Mads Krogs­gaard Thom­sen

No­vo Nordisk al­ready has sol­id ef­fi­ca­cy da­ta on weight loss among the di­a­bet­ics it treat­ed dur­ing its de­vel­op­ment pro­gram for the drug, which helped in­spire the com­pa­ny to make a big in­vest­ment in obe­si­ty.

Those col­lec­tive num­bers help set the stage for a big Phase III piv­otal pro­gram, which in­cludes 4,500 obese pa­tients and a mas­sive car­dio out­comes study in­volv­ing 12,500 peo­ple.

No­vo has set out to win in a field where there’s been noth­ing but dis­ap­point­ment and fail­ure for more than a decade. Just a few days ago Orex­i­gen was forced to file for bank­rupt­cy af­ter rack­ing up in­ad­e­quate sales of Con­trave. And that drug had al­ready beat­en out Qsymia and Belviq, two oth­er ther­a­pies from the same class of biotechs that com­pet­ed for the FDA’s at­ten­tion 5 years ago. Con­trave al­so out­per­formed No­vo’s Sax­en­da, which has a more mod­est im­pact on weight.

No­vo has plans to go be­yond semaglu­tide, work­ing on com­bi­na­tion ther­a­pies that may be able to trim as much as 25% of body weight, which would ri­val the per­for­mance of some pop­u­lar weight-loss pro­ce­dures.

Some an­a­lysts es­ti­mate the drug could be worth more than $2 bil­lion a year in sales 5 years from now. And No­vo will like­ly tout the weight loss that di­a­bet­ics can ex­pect as they launch a ma­jor mar­ket­ing cam­paign trig­gered by the FDA’s ap­proval of the drug last De­cem­ber as Ozem­pic. In this field man­u­fac­tur­ers look for every ad­van­tage they can get to beat the com­pe­ti­tion, which in this case is pri­mar­i­ly Eli Lil­ly and Sanofi.

“In line with our long-term com­mit­ment, we plan to start the STEP phase 3 clin­i­cal de­vel­op­ment pro­gramme lat­er this year to ex­plore the po­ten­tial of once-week­ly semaglu­tide as a treat­ment for peo­ple with obe­si­ty,” said Mads Krogs­gaard Thom­sen, ex­ec­u­tive vice pres­i­dent and chief sci­ence of­fi­cer of No­vo Nordisk.

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Andre Kalil, AP Images

A 9/11-era Om­a­ha fa­cil­i­ty, an old Ebo­la drug, and the ubiq­ui­tous Dr. Fau­ci: In­side the first US nov­el coro­n­avirus tri­al

The first 11 coronavirus patients who arrived in Omaha last week, airlifted across the globe after two weeks quarantined on a cruise ship, showed only minor symptoms or none at all. And then one of them — or one of the couple of Americans who arrived later — got worse. He developed pneumonia, a life-threatening complication for coronavirus patients.

In a biocontainment room at the University of Nebraska Medical Center on Friday, doctors infused him with an experimental Gilead drug once developed for Ebola, called remdesivir. Or they gave him a placebo. For the first time in the US, neither he nor the doctors knew.

The first US novel coronavirus trial was underway and with it, a mad dash for an answer. Sponsored by the NIH, the study marked a critical point in the epidemic. Since the start of the outbreak, the agency had helped lead a global effort to contain the virus. Now, as it spread worldwide and the CDC issued warnings the US could see a major internal outbreak, they were looking at home.

“We don’t have too much time,” Andre Kalil, the trial’s lead investigator, told Endpoints News. “Everything’s moving really fast.”

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Dan O'Day (AP Images)

A name emerges out of the Gilead M&A ru­mor mill, and it’s a can­cer biotech

After months of questions and speculation about when and if Gilead will make a major acquisitions, a name has emerged.

The California-based drugmaker has approached Forty Seven Inc, a cancer biotech, with a takeover offer, Bloomberg News reports. With Forty Seven’s market cap at $2.3 billion, an acquisition would likely be Gilead’s largest since they acquired Kite Pharma for $11.9 billion in 2017.

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Biogen head of R&D Al Sandrock, Sangamo CEO Sandy Macrae

UP­DAT­ED: Bio­gen makes an­oth­er bold Alzheimer’s bet, drop­ping $350M up­front to part­ner with genome-edit­ing fo­cused Sang­amo

While the fate of Biogen’s resurrected Alzheimer’s drug aducanumab remains uncertain, the Cambridge, MA-based drugmaker is joining forces with genome editing company Sangamo Therapeutics to develop therapies for neurological conditions.

Sangamo is set to receive a meaty $350 million upfront in cash and stock and is eligible to receive up to $2.37 billion in milestone payments, in addition to royalties. In return, Biogen gets the rights to two Sangamo preclinical compounds: ST-501 (for use in tauopathies including Alzheimer’s disease) and ST-502 (for synucleinopathies including Parkinson’s disease).

“The partnership represents a lower-cost way to expand its work in neurologic disease,” Credit Suisse’s Evan Seigerman said in a note, referring to Biogen.

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Spark los­es an­oth­er top ex­ec in the wake of $4.3B takeover by Roche — re­port

Days after bidding farewell to co-founder Kathy High, Spark Therapeutics — now operating under Roche — has one more opening on its C-suite.

Kathy Reape

Kathy Reape, who joined the Philadelphia-based biotech in 2016 as head of clinical R&D and became chief medical officer in 2018, is reportedly set to leave.

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'The head­lines are the head­lines, but': Bio­Marin talks up po­ten­tial sav­ings as he­mo­phil­ia gene ther­a­py launch looms

BioMarin execs are still staying tight-lipped about their pricing plans for what is poised to be the world’s first hemophilia gene therapy. But as the company enters the final regulatory stretch and approaches a potential launch this summer, they are also dropping more hints to get investors ready.

First thing to know: They really, really don’t expect an advisory committee to be convened for valrox, which is under priority review, to pop up before its PDUFA date on August 21.

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Vlad Coric (Photo Credit: Andrew Venditti)

Bio­haven scores CGRP OK for acute mi­graine — can the com­mer­cial team catch up with Al­ler­gan on its de­but?

Seven years after spinning out of Yale, Biohaven has entered the ranks of commercial-stage biotechs.

The FDA handed down an OK for its CGRP drug, rimegepant, as an acute treatment. Dubbed Nurtec, the orally dissolving pill will join Allergan’s (soon to be AbbVie’s) Ubrelvy and Lilly’s Reyvow on the market amid a new wave of migraine therapies reshaping the disease space.

In a pivotal Phase III trial, Nurtec hit the co-primary endpoints on pain freedom and freedom from most bothersome symptoms at two hours post dose, proving superior to placebo.

Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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