BioReg­num: What’s the deal with Bio­gen?

Bioreg­num
The view from End­points

“We are in a world of eat or be eat­en,” Cowen’s Er­ic Schmidt told the Boston Globe about Bio­gen. “If they don’t re­de­ploy their cash ef­fi­cient­ly or prop­er­ly, there’s al­ways a chance that some­body may come in and mon­e­tize their as­sets for them.”

Sound fa­mil­iar? That was from a year ago, as a set­back on its new Alzheimer’s drug co­in­cid­ed with fal­ter­ing Tec­fidera sales to set the stage for what has be­come a mantra: Bio­gen has to ei­ther get mov­ing and start strik­ing some ma­jor drug deals, or it will face a takeover. So it’s no won­der that with no block­buster-style deals in 12 months, we’re see­ing re­ports pop up now as ex­ec­u­tives at oth­er Big Phar­mas have start­ed sound­ing out Bio­gen’s board mem­bers about their in­ter­est in sell­ing the com­pa­ny.

The big­ger ques­tion: Why did it even take this long?

A new re­port from Reuters adds a few telling de­tails to this week’s hot sto­ry from the Wall Street Jour­nal that Bio­gen has been in­for­mal­ly ap­proached about a pos­si­ble buy­out by Mer­ck and Al­ler­gan. The over­tures were large­ly ca­su­al­ly di­rect­ed at in­di­vid­ual board mem­bers. And they ap­peared most­ly de­signed to see if there was some kind of in­ter­est in a friend­ly merg­er.

Not sur­pris­ing­ly, Mer­ck’s in­ter­est is stronger than Al­ler­gan’s, ac­cord­ing to Reuters. But there was nev­er any­thing for­mal put on the ta­ble.

CEO George Scan­gos

Whether or not Mer­ck or any oth­er com­pa­ny will make an of­fer, the ru­mors are swirling around a com­pa­ny that has be­come dis­tinct­ly vul­ner­a­ble over the past year as its flag­ship drug wanes. Bio­gen doesn’t have the kind of pipeline that gives an­a­lysts cause to cheer near term cat­a­lysts. And with CEO George Scan­gos now stand­ing with one foot out the door, the com­pa­ny will have to un­der­go ma­jor pipeline changes in or­der to win back Wall Street’s en­thu­si­asm for this com­pa­ny.

One way of do­ing that, and mov­ing past the M&A ru­mors, is by fi­nal­ly grab­bing hold of a late-stage deal that has im­pres­sive po­ten­tial. Cel­gene and Gilead have proven sev­er­al times over the past year that there are ma­jor part­ner­ships to be had. And Bio­gen’s slow mo­tion re­sponse may ex­plain why Scan­gos will soon be de­vot­ing more time to the fam­i­ly back on the West Coast. As of now, Bio­gen ex­ecs have on­ly been able to promise land­mark deals, with­out de­liv­er­ing.

Yes, there was an in­ter­est­ing gene ther­a­py col­lab­o­ra­tion at the Uni­ver­si­ty of Penn­syl­va­nia, but that’s a dis­cov­ery deal. There was a pact with Mit­subishi Tan­abe last fall, for a Phase II au­toim­mune drug; not enough to rev up much ex­cite­ment. So we’re left with fresh promis­es to con­sid­er.

Here’s Scan­gos from the Q2 call:

Ac­tu­al­ly, we would look at deals at all stages of de­vel­op­ment from pre-clin­i­cal through Phase 3. And we are cur­rent­ly do­ing that. We’re in a num­ber of dis­cus­sions now, and we hope to bring some of those to con­clu­sion.

We are fo­cused large­ly on neu­rol­o­gy. That’s where we have our core ex­per­tise. And I think we be­lieve that the – you can make more so­phis­ti­cat­ed de­ci­sions about things in ar­eas that you un­der­stand re­al­ly in de­tail. So main­ly we’re look­ing in neu­rol­o­gy. With (R&D chief) Mike (Ehlers’) ar­rival, we have a new per­son here who’s got his own set of ex­per­tise, his own views on things. And I would say we wouldn’t rule out things out­side of neu­rol­o­gy, but the bar gets high­er as they get fur­ther from our cen­ter of ex­cel­lence. As Mike put it yes­ter­day, we want to have kind of laser vi­sion, but we don’t want to have tun­nel vi­sion. We want to be open to things that are in­ter­est­ing and can pro­vide share­hold­er val­ue.

We’re well past the point when it be­came ob­vi­ous that Bio­gen had to eat or be eat­en. It may well need to find some­thing out­side of neu­rol­o­gy as well, which has been Scan­gos’ com­fort zone. And the deal(s) needs to in­volve late-stage as­sets with block­buster po­ten­tial.

The ex­pec­ta­tions keep get­ting high­er and the takeover ru­mors aren’t go­ing away un­til Bio­gen fi­nal­ly de­liv­ers.

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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Distribution of Moderna's Covid-19 Vaccine (Photo by Paul Sancya - Pool/Getty Images)

Opin­ion: Ado­les­cents can wait. The US needs to start do­nat­ing Covid-19 vac­cines to needy coun­tries now.

Now that the US is swimming in Covid-19 vaccines and the supply has officially eclipsed the demand, it’s time for America to lead the world and start shipping these excess doses to countries that desperately need them.

Unlike the IP waiver at the World Trade Organization, which Biden now supports and will likely take years to translate into actual shots in arms, the US could easily donate just a tiny fraction of the more than 60 million doses of Pfizer, Moderna and J&J vaccines sitting on American shelves right now.

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.

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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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.