On sec­ond thought, Al­ler­gan does­n't want to con­sid­er a bid for Shire, leav­ing Take­da in sole pur­suit of $62.5B deal

Hit with swift ret­ri­bu­tion af­ter sig­nal­ing an in­terest this morn­ing in jump­ing in­to a bid­ding war with Take­da and mount­ing a bid for Shire $SH­PG, Al­ler­gan is out.

Al­ler­gan CEO Brent Saun­ders End­points News

The biotech put out a state­ment Thurs­day af­ter­noon in an abrupt about-face — af­ter watch­ing its shares drop 7% — say­ing that it “does not in­tend to make an of­fer for Shire.” The com­pa­ny added:

Al­ler­gan $AGN con­tin­ues its on­go­ing process of eval­u­at­ing a full range of po­ten­tial strate­gic ac­tions that will cre­ate val­ue for share­hold­ers, such as di­vesti­tures, com­bi­na­tions and ac­qui­si­tions.

An­a­lysts quick­ly sig­naled their skep­ti­cism for a merg­er dri­ven by Al­ler­gan, fo­cus­ing on Shire’s grow­ing weak­ness in the face of an ero­sion of the Vy­vanse fran­chise and some stiff new com­pe­ti­tion on the he­mo­phil­ia front from Roche’s Hem­li­bra.

Leerink’s Et­zer Darout not­ed:

In our view, a com­bi­na­tion with SH­PG in­tro­duces some growth chal­lenges in out-years, which are re­flect­ed in the neg­a­tive stock re­ac­tion as well al­so as con­sen­sus sales es­ti­mates for SH­PG with 2019-22E rev­enue CA­GR of +4% but 2019-24E CA­GR of -1%, which as­sumes ero­sion of Vy­vanse start­ing in 2023E and sig­nif­i­cant ero­sion of SH­PG’s he­mo­phil­ia busi­ness with en­try of nov­el ap­proach­es in­clud­ing Roche’s (NR) Hem­li­bra (he­mo­phil­ia A). 

So we’re back to see­ing on­ly Take­da at the ta­ble with a $62.5 bil­lion of­fer that it’s al­so hav­ing trou­ble pitch­ing to an­a­lysts. A bid­ding war now will have to wait the ar­rival of a new play­er, which may yet hap­pen.

In a side note on Thurs­day, Ever­core ISIS’s Umer Raf­fat sent out word that his firm is sus­pend­ing cov­er­age of Al­ler­gan be­cause of the role they were play­ing ad­vis­ing Take­da. Of course, at this point, they may want to do a change-up there as well. Al­ler­gan is the last com­pa­ny now that will want to make a bid for Shire.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotechs that fit that general description.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.