Would Ab­b­Vie’s top ex­ecs re­al­ly pull the trig­ger on a $30B M&A deal? Why, yes, ac­tu­al­ly

Ja­mi Ru­bin

Leave it to Ja­mi Ru­bin to put the Big Phar­ma CEO on the spot. 

On Fri­day’s call with the top team at Ab­b­Vie, the salty Gold­man Sachs an­a­lyst asked Ab­b­Vie CEO Rick Gon­za­lez point blank about an ear­li­er com­ment that he had made about his will­ing­ness to do a $20 bil­lion to $30 bil­lion M&A deal.

What fol­lowed was a good deal of bob­bing and weav­ing, with caveats and qual­i­fi­ca­tions aplen­ty. But Gon­za­lez al­so made it clear that if the right block­buster came along, he would pull the trig­ger on a big ac­qui­si­tion.

When we find the right kind of op­por­tu­ni­ty, that we think fits strate­gi­cal­ly that we be­lieve we can get a good re­turn for our in­vestors, fits in­to what we’re good at, then we’ve shown, we’re not shy, we’ll act on those.

Richard Gon­za­lez

A lit­tle over three years ago, Ab­b­Vie snapped up Phar­ma­cyclics for $21 bil­lion, along with rights to Im­bru­vi­ca. But $20 bil­lion to $30 bil­lion deals these days are rare for a rea­son. Val­u­a­tions are sky high and it’s hard to find the right as­set at the right price at that lev­el of M&A. And no­body wants a rep for act­ing reck­less­ly in this mar­ket.

Gon­za­lez:

I mean my ob­jec­tive there was to frame how we viewed large bolt-ons like a Phar­ma­cyclics-like as­set. As we look at, at how we’re go­ing to build this busi­ness go­ing for­ward. We ob­vi­ous­ly have a com­mit­ment … that we’re go­ing to de­liv­er top tier per­for­mance and we’re go­ing to do it over the long-term and we’re go­ing to grow through the biosim­i­lar im­pact (on Hu­mi­ra) that we knew we were to face from day one. 

So there’s noth­ing on the hori­zon right now, but don’t rule it out. Ab­b­Vie is think­ing in block­buster terms for when it faces gener­ic com­pe­ti­tion on Hu­mi­ra in 2023, blow­ing a multi­bil­lion-dol­lar hole in its top line.

Im­bru­vi­ca’s sales growth is help­ing Gon­za­lez make that case, and the new ap­proval for Orilis­sa is help­ing prove that the ag­gres­sive Ab­b­Vie is mov­ing for­ward where it counts in new prod­uct de­vel­op­ment. But af­ter Ro­va-T flopped, af­ter they spent a painful $6 bil­lion on the up­front, Ab­b­Vie’s top team re­mains cu­ri­ous about the big fish that are still out there in the glob­al pipeline. And they have the cash to back it up.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.

FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Al­ta­sciences, true to its word, ex­pands its foot­print with ac­qui­si­tion of Penn­syl­va­nia CRO

A Canadian CDMO with roots in Seattle is coming to the east coast.

Altasciences announced the acquisition of Calvert Laboratories Wednesday, a preclinical CRO in Pennsylvania. The move will complement Altasciences’ Seattle-area operations.

Headquartered in Laval, Canada, Altasciences operates six facilities that run the gamut on early drug development: preclinical safety testing, clinical pharmacology, bioanalytical, CRO services, and even CDMO capacity. Novo Holdings scooped them up in February with the goal of courting small and medium-sized biopharma clients. CEO Chris Perkin said back in February that the move would help the company foster its ambitious growth plan, and this acquisition and the presence it brings to the east coast is evidence.

Johnson Lau (front), Athenex CEO (Derek Gee/Buffalo News via AP Images, Pool)

Bounc­ing back from a shock­ing CRL, Athenex shares soar with buy­out of nat­ur­al killer T cell play­er

Several weeks after Athenex was hit with a surprise CRL for its oral chemotherapy candidate — and a class-action lawsuit to boot — the company’s stock is getting a much-needed boost as it snatches up a natural killer T cell player.

Athenex is shelling out $70 million upfront (primarily in equity) to buy out Kuur Therapeutics, the companies announced on Tuesday. In response, the company’s stock $ATNX soared more than 49% on Wednesday morning, pricing in around $5 apiece. In addition to the upfront payment, Kuur stands to pocket another $115 million in milestones, either in cash or common stock, at Athenex’s discretion.

Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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