Say what? Al­ler­gan just agreed to pay a 6X cash pre­mi­um for To­bi­ra and its trou­bled PhI­II NASH drug

A cou­ple of months af­ter a tri­al set­back crushed To­bi­ra’s share price, Al­ler­gan $AGN has swooped in to buy the com­pa­ny for $29.35 a share and up to $49.84 a share in con­tin­gent val­ue rights if its late-stage NASH drug turns out to be a hit.

Brent Saun­ders, Al­ler­gan

That cash price is more than six times what To­bi­ra’s bat­tered stock $TBRA closed at yes­ter­day, a vir­tu­al­ly un­heard of pre­mi­um in a mar­ket that is al­ready ap­ply­ing high val­ues to biotech as­sets. The to­tal val­ue for the com­pa­ny will range up to $1.7 bil­lion. The com­pa­ny stock trad­ed for $4.74 at the close yes­ter­day, with a mar­ket cap of $89 mil­lion.

The buy­out stun­ner comes cour­tesy of Al­ler­gan CEO Brent Saun­ders, who has been on a deal spree that in­cludes the Vi­tae ac­qui­si­tion a few days ago. These kind of bolt-on ac­qui­si­tions are a tempt­ing tar­get for Al­ler­gan’s CEO, es­pe­cial­ly since its merg­er with Pfiz­er fell through. Al­ler­gan re­cent­ly closed on a pact to sell a gener­ics unit to Te­va, leav­ing it with a hefty sum in cash re­serves for deals like this.

An­a­lysts had to do a dou­ble take on the num­bers in­volved.

“In our rec­ol­lec­tion, the up­front alone places the high­est pre­mi­um we’ve ever seen on a deal, and not just in biotech,” not­ed Baird’s Bri­an Sko­r­ney. “Not to men­tion, the val­u­a­tion placed on some of the mile­stones is, in our opin­ion, ex­ces­sive. To­bi­ra has in­di­cat­ed plans to ini­ti­ate a Phase III tri­al next year, on which Al­ler­gan has agreed to pay $13.68 per CVR for en­roll­ment of the first pa­tient.”

The deal al­so marks a big bet on NASH, or fat­ty liv­er dis­ease, which has been grow­ing at an epi­dem­ic pace around the world. Al­ler­gan is adding ceni­crivi­roc and evogliptin to its pipeline, and the com­pa­ny says it will look for ad­di­tions to beef up its new NASH ef­fort.

David Nichol­son, Al­ler­gan

Ceni­crivi­roc flunked a Phase IIb study for NASH in Ju­ly, but the South San Fran­cis­co-based biotech said it got enough pos­i­tive da­ta on a sec­ondary end­point to war­rant a move in­to a piv­otal Phase III pro­gram. To­bi­ra’s shares were crushed by the news, plung­ing 64%.

The pri­ma­ry end­point in the study, which reg­is­tered 289 pa­tients, was a drop in a score for dis­ease ac­tiv­i­ty in NASH. On that point, the drug flopped. It al­so failed a sec­ondary end­point for com­plete res­o­lu­tion of steato­hep­ati­tis.

But To­bi­ra vowed that it had a good rea­son to launch a late-stage pro­gram, look­ing for an im­prove­ment in fi­bro­sis with­out any wors­en­ing of steato­hep­ati­tis. The da­ta for the in­tent-to-treat pop­u­la­tion in Phase IIb was 20% for the drug vs. 10% for place­bo af­ter a year of treat­ment, p=0.02; in oth­er words, twice as many pa­tients on drug had a marked im­prove­ment for fi­bro­sis, but it was a small group.

Still, it was big enough to en­cour­age Al­ler­gan to leap in.

Said Al­ler­gan R&D chief David Nichol­son:

“Im­por­tant­ly, NASH treat­ment may well re­quire a mul­ti-ther­a­peu­tic ap­proach to ad­dress the mul­ti­ple fac­tors of the dis­ease. CVC has been shown in clin­i­cal tri­als to pro­vide sig­nif­i­cant im­prove­ment in liv­er fi­bro­sis, the hall­mark of NASH. Liv­er fi­bro­sis is as­so­ci­at­ed with key long-term out­comes, in­clud­ing over­all mor­tal­i­ty, liv­er trans­plan­ta­tion and liv­er-re­lat­ed events.  Evogliptin, in pre­clin­i­cal mod­els, has been shown to de­crease he­pat­ic glu­cose pro­duc­tion, im­prove he­pat­ic triglyc­eride con­tent and steato­sis, and re­duce his­to­log­ic mark­ers of in­flam­ma­tion of the liv­er. To­geth­er, these pro­grams pro­vide a high­ly com­ple­men­tary po­ten­tial ther­a­peu­tic ap­proach to ad­dress the in­flam­ma­to­ry, meta­bol­ic and fi­brot­ic el­e­ments of NASH that the med­ical com­mu­ni­ty will need to treat this con­di­tion.”

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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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

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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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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