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.

From left to right: Lilian Kim, Associate Director Business Development; John Moller, CEO; Yooni Kim, Executive Director, Asia Operations; Michelle Park, Director South Korea Operations.

Novotech CRO sees 26% growth in Asia tri­al ac­tiv­i­ty from biotechs, but still plen­ty of ca­pac­i­ty

As the Asia-Pacific clinical trials sector continues to grow rapidly, Novotech the Asia-Pacific-based CRO is seeing biotech clinical activity up by 26%. But says there is still plenty of capacity in the region that features advanced medical facilities, supportive regulatory environments, and more than 2.3 billion people, largely treatment naïve, living in urban areas.

China, South Korea and Australia have the most studies registered as recruiting or about to recruit according to ClinicalTrials.Gov.

Pfizer, South San Francisco — Jeff Rumans for Endpoints News

UP­DAT­ED: Pfiz­er takes aim at a flag­ship fran­chise at Sanofi and Re­gen­eron — and scores a few di­rect hits

Count Pfizer in as a top player in the blockbuster game of JAK1 inhibitors.

Over the weekend the pharma giant posted some stellar Phase III efficacy data for their heavyweight contender abrocitinib in atopic dermatitis (eczema) that lines up ahead of a booming Dupixent (dupilumab), a blockbuster in the portfolios of Regeneron and Sanofi. And they put some real distance ahead of Eli Lilly’s trailing Olumiant, which made a delayed initial arrival on the market for rheumatoid arthritis after the FDA hobbled it with some additional hurdles on safety concerns.

JADE-MONO-1 scores well for Pfizer, teeing up what will be an intensely followed breakdown of the JADE MONO-2 data, which the pharma giant recently top-lined as “similar” to the first Phase III when tested against a placebo — a control group that has been easily outclassed by all the drugs in this market niche.

As of now, Pfizer looks to be equipped to run into the review stage — advantaged by a breakthrough therapy designation that is intended to speed up the regulatory process.

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A preda­tor's world? Top an­a­lyst sees the 'haves' and the 'haven't­s' di­verge as biotech bub­bles form — and col­lapse

Josh Schimmer

We’ve all seen the deluge of cash that’s been pouring into biotech from every angle: VCs, IPOs and follow-ons have generated billions in capital for new and emerging drug developers with ready access to some powerful new tech. But Evercore ISI’s Josh Schimmer is asking where we’re headed from here.

His answer is neither apocalyptic nor universally blissful, but if he’s right — and this is a discussion we’re hearing much, much more about at a time of growing economic and industry uncertainty — we may well be at a crossroads that could affect valuations, M&A and the entire global industry that has formed over the past 5 years.

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US mulls tar­iffs on Swiss drug ex­ports, weigh­ing on No­var­tis and Roche –  re­port

The leading Swiss newspaper has reported that the US is considering placing tariffs on pharmaceuticals from Switzerland. Roche and Novartis stock each fell 1% after the news broke.

Neue Zürcher Zeitung reported that US Trade Representative Robert Lighthizer told pharmaceutical representatives the Trump administration was considering the move. Tariffs do not appear to be in the immediate offing, but they would potentially affect Swiss giants Novartis and Roche along with other companies that manufacture in Switzerland, including Merck KGaA and US biotech Biogen, which is currently constructing a new facility in the country.

Neil Kumar, Endpoints

Bridge­Bio drops bid to re­claim Ei­dos af­ter di­rec­tors spurn 3 of­fers

A couple of months ago a newly public BridgeBio turned some heads by disclosing that it had made a bid for subsidiary Eidos Therapeutics in hopes of gobbling up the 34% stake that it doesn’t already own. Two offers later, the parties are calling it off.

A special committee of independent directors at the smaller biotech led by RA Capital’s Rajeev Shah and ex-Portola CEO William Lis first rejected the parent company’s initial offer — which would swap 1.3 BridgeBio shares for each Eidos share — on September 12. In the latest announcement, BridgeBio revealed that it eventually raised the offer to 1.5 shares and made $110 million available for all-cash or mixed consideration options, but Eidos still wasn’t interested.

Mark Foley, Revance

HR vi­o­la­tion push­es Re­vance co-founder out, vault­ing for­mer Zel­tiq chief to the helm

Months after Revance amended the terms of its Botox biosimilar collaboration with Mylan, the Newark, California-based drug developer disclosed its co-founder Dan Browne is stepping down, in what appears to be mysterious circumstances.

The company — which is also developing a rival to Allergan’s formidable Botox franchise — on Monday said Browne is departing “due to misjudgment in handling an employee matter,” that has also culminated in his resignation from Revance’s board of directors.

In-house FDA re­view flags a sus­pi­cious im­bal­ance in deaths as Sh­iono­gi hunts an OK for an­tibi­ot­ic

Shionogi has some big questions to answer if they plan to win an FDA panel’s backing for their new antibiotic.

While investigators have provided positive efficacy data for their new product to treat cases of complex urinary tract infections, an FDA review has flagged an imbalance of deaths between the antibiotic and a control arm. And they want the agency’s outside advisers to take a good hard look at that when they meet on Wednesday.

Cell ther­a­py start­up rais­es $16 mil­lion to fund its quest for the Holy Grail in re­gen­er­a­tive med­i­cine

In 2006, Shinya Yamanaka shook stem cell research with his discovery that mature cells can be converted into stem cells, relieving a longstanding political-ethical blockage and throwing open medical research on everything from curbing eye degeneration to organ printing.

But that process still has pitfalls, including in risk and scalability, and some researchers are exploring another way first hinted at years ago: new technology to convert mature cells directly into other mature cells without the complex and time-consuming process of first making them into stem cells.

Eye­ing $86M, Galera leads a pack of three mod­est biotech IPOs push­ing past high pro­file stum­bles

Exactly one year after kicking off a pivotal Phase III study for its lead drug — a companion for cancer patients receiving radiotherapy — Galera is looking to the Nasdaq for some new cash to complete the clinical work and fuel its commercial drive.

CEO Mel Sorensen has penciled in an $86 million ask, which was filed on the same day as liver disease company 89bio and rare disease diagnostics shop Centogene. The trio marks the first batch of IPO filings in the wake of two highly anticipated but ultimately disappointing public debuts by BioNTech and Vir, signaling dwindling biotech fervor on Wall Street. 89bio and Centogene are seeking $70 million and $69 million, respectively.