A few key rea­sons why Bio­gen has now be­come a buzzed about takeover tar­get

Strug­gling with rev­enue and keep­ing in­vestors’ in­ter­est in its pipeline as its CEO heads for the ex­its, Bio­gen has drawn some in­ter­est from two big play­ers about a pos­si­ble takeover. The Wall Street Jour­nal re­port­ed Tues­day af­ter­noon that Al­ler­gan and Mer­ck have both made over­tures to Bio­gen to sound out their in­ter­est in a deal.

Bio­gen’s shares $BI­IB raced up 9%, adding bil­lions in mar­ket cap as the in­vest­ment com­mu­ni­ty looked to jump in­to a pos­si­ble deal in the mak­ing. But by ear­ly Tues­day evening CN­BC was fol­low­ing up with a re­port that Al­ler­gan, which may have had a hard time mak­ing a buy­out work un­der cur­rent tax rules, was un­like­ly to fol­low up.

The Jour­nal piece made it clear that there’s no bid on the ta­ble and may not be one. The over­tures were “in­for­mal and pre­lim­i­nary,” its re­port­ing team not­ed, not sig­ni­fy­ing much in­ter­est in a hos­tile move if nec­es­sary.

CEO George Scan­gos

The ru­mors come just days af­ter Bio­gen CEO George Scan­gos an­nounced plans to ex­it the com­pa­ny, plan­ning to hand over the reins to a new ex­ec­u­tive ready to tack­le the next phase. Scan­gos him­self has down­played any talk of a po­ten­tial takeover, and an­a­lysts have won­dered why he would be leav­ing if the com­pa­ny was about to go in­to an auc­tion, with big po­ten­tial pay­offs for the top team.

In many ways, Bio­gen would make a tempt­ing ac­qui­si­tion, with a mar­ket cap now sit­ting at about $75 bil­lion. It has sev­er­al fran­chise drugs on the mar­ket and a few close­ly-watched pro­grams in the clin­ic, in­clud­ing a new late-stage pro­gram part­nered with Io­n­is that just cleared a Phase III study for spinal mus­cu­lar at­ro­phy. But on­ly a hand­ful of play­ers in the in­dus­try could pull off a deal that size.

Com­pli­cat­ing any buy­out, Bio­gen’s R&D group has made a ma­jor in­vest­ment in fields like Alzheimer’s, where its drug ad­u­canum­ab rep­re­sents an­oth­er big swing at a po­ten­tial­ly enor­mous mar­ket. But it’s in the high­est risk are­na in biotech, mak­ing a val­u­a­tion dev­il­ish­ly hard to reach with­out a de­vice like a CVR, pay­ing off on mile­stones.

Bio­gen’s prob­lem, and the rea­son why it’s vul­ner­a­ble now, is that Scan­gos and his team sad­dled the com­pa­ny with an ul­tra high risk pipeline with few near-term cat­a­lysts able to whet Wall Street’s ap­petite as its Tec­fidera fran­chise fades. That forced the com­pa­ny to ex­e­cute a ma­jor re­or­ga­ni­za­tion last year to cut costs. And a re­cent set­back in its lat­est at­tempt to come up with a new drug that could po­ten­tial­ly re­verse the ef­fects of mul­ti­ple scle­ro­sis sim­ply high­light­ed the fix it is in now.

For many an­a­lysts, that weak­ened po­si­tion made it all the more like­ly that Bio­gen would have to pull off sev­er­al big deals of its own to re­plen­ish the pipeline. In the words of Baird’s Bri­an Sko­r­ney: “We think it’s time for Bio­gen to buy or be bought.”

Al­ler­gan is run by Brent Saud­ers, a deal-mak­ing CEO who just land­ed a big pay­off now that the Te­va gener­ics deal has gone through. And while Mer­ck has its new check­point drug Keytru­da to boast about, it al­so has plen­ty of rea­sons to find val­ue in a com­pa­ny like Bio­gen.

Every­one loves a ru­mored buy­out deal, so ex­pect lots of smoke as every­one tries to fig­ure out if there’s any fire at Bio­gen.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.

Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.

Sanofi, Cel­lec­tis team up to pair Lem­tra­da with al­lo­gene­ic CAR-Ts; Bris­tol My­ers joins Evotec's dri­ve to ad­vance UK sci­ence

Sanofi is partnering up with Cellectis on their allogeneic CAR-Ts.

Cellectis struck a deal to use the French pharma’s drug alemtuzumab (Lemtrada, an MS agent) as part of its lymphodepletion regimen — used to sideline host immune cells and improve CAR-T cell expansion and persistence.

The Sanofi drug is already used in some clinical trials, and now the pharma giant is on the hook for clinical studies as they engage in negotiations over a commercial pact. — John Carroll

Al Sandrock, Biogen R&D chief (Biogen via YouTube)

UP­DAT­ED: Bio­gen push­es in a fresh stack of chips and starts prep­ping a glob­al R&D game plan af­ter watch­ing the cards turn on ear­ly throm­bolyt­ic da­ta

After patiently steering through a decade-long journey for its early-stage clinical work, a small Tokyo biotech has clinched a deal to out-license its lead thrombolytic agent to US heavyweight Biogen — which sees a potentially game-changing impact on the clot-busting field after taking a careful look at some upbeat Phase IIa data.

Three years after Biogen anted up $4 million to gain an option on the drug from TMS, the big US biotech is making a small bet to beef up its stroke portfolio. The BD team inked a deal to go ahead and grab rights to the drug for $18 million, with another $335 million in milestone cash on the table for a successful outcome.

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Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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