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.”

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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In a win for Re­gen­eron, No­var­tis' sy­ringe for AMD drug de­clared 'un­patentable'

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.

'Tis the sea­son: GSK ad­dress­es win­ter virus surges with celebri­ty and in­flu­encer vac­cine aware­ness cam­paigns

GSK is rounding up the usual suspects this winter — flu, respiratory syncytial and even shingles viruses — for multiple marketing efforts all aimed at encouraging vaccinations.

Mom influencers take center stage in its “Flu is a Family Affair” campaign to reach family decision-makers or “chief health officers.” GSK is asking them in the digital campaign to take care of themselves, and take the family along, when they go to the pharmacy or doctor’s office for a flu vaccine.

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Bris­tol My­ers claims win with CAR-T ther­a­py Breyanzi in leukemia

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

FDA takes next step in Tor­rent Phar­ma­ceu­ti­cal­s' trou­bled In­dia plant saga, is­sues OAI

The FDA has handed Torrent Pharmaceuticals an official action indicated (OAI) status for a previously inspected manufacturing facility in India.

Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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