BioReg­num: What’s the deal with Bio­gen?

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.

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

Covid-19 roundup: As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Forget 1 billion. AstraZeneca is now promising to supply 2 billion doses of Oxford University’s Covid-19 vaccine around the world per year.

Three new partners are coming on board to help reach that goal, as well as a broader vision to ensure access for nations that have been largely left out of the bargaining table.

CEPI — the coalition that’s been doling out grants to support other vaccine projects — is providing $383 million to support manufacturing of 300 million doses, while Gavi the Vaccine Alliance will chip in $367 million and be in charge of the procurement and distribution, a spokesperson told Wall Street Journal. A separate licensing agreement directs the Serum Institute of India to produce 1 billion doses for low- and middle-income countries, with the first 400 million due before the end of the year.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Michael Gladstone, partner at Atlas Venture

At­las rais­es new $400M fund amid spree of VC rais­es. Here’s what they’ll spend it on

You can add another few hundred million to the now Montana-sized reservoir of cash biotech VCs have raised since the WHO declared Covid-19 a pandemic.

Atlas Venture, the prominent Kendall Square incubator, has raised $400 million for its twelfth biotech fund, their first in 3 years. After a string of mammoth new raises from other major VCs in April and May, the total pot now stands between $5 billion and $6 billion, depending on how you slice it.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

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 — biotech stocks that fit that general description.

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Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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