As­traZeneca chief is bet­ting the com­pa­ny’s fu­ture on a sin­gle roll of the dice

The view from End­points
As­traZeneca CEO Pas­cal So­ri­ot

Near­ly five years in­to his stint at the helm of As­traZeneca, CEO Pas­cal So­ri­ot has now reached his year of liv­ing dan­ger­ous­ly.

This morn­ing the phar­ma chief out­lined a steadi­ly de­clin­ing rate of rev­enue. Core EPS is ex­pect­ed to slide in the low to mid teens as gener­ics con­tin­ue to chop away at their Crestor fran­chise. All their old block­busters are be­ing dis­en­fran­chised, in a man­ner of speak­ing.

So­ri­ot, not known to wa­ver in times of a cri­sis, wasn’t about to break down now. He an­nounced: “It is an ex­cit­ing time as we rapid­ly ap­proach the in­flec­tion point for our an­tic­i­pat­ed re­turn to long-term growth, built on the sol­id foun­da­tions of a sci­ence-led pipeline.”

In­vestors weren’t very ex­cit­ed by the num­bers, though, send­ing the com­pa­ny’s shares down by close to 3% this morn­ing.

Af­ter a whole slate of clin­i­cal set­backs in 2016, the fi­nan­cial ero­sion at As­traZeneca has fo­cused an un­wa­ver­ing spot­light on the com­pa­ny’s com­bi­na­tion study for the PD-L1 check­point dur­val­um­ab and treme­li­mum­ab, a CT­LA-4, dubbed MYS­TIC.

A late­com­er to the check­point in­hi­bi­tion field, As­traZeneca is mak­ing a high-risk at­tempt at cut­ting in­to the line of heavy­weights com­pet­ing on lung can­cer, look­ing for ev­i­dence that they have a com­bo that can ri­val the ad­vanc­ing for­tunes of Mer­ck’s Keytru­da/chemo com­bi­na­tion, now un­der re­view.

As­traZeneca re­cent­ly tweaked MYS­TIC, adding months to the time­line as the phar­ma com­pa­ny awaits pro­gres­sion-free sur­vival da­ta this year and over­all sur­vival da­ta in 2018. And the move was wide­ly viewed as sig­nal­ing some un­der­ly­ing con­cerns about how the fi­nal da­ta read­out will look.

De­lays of any kind, though, are poi­son to As­traZeneca, as faster com­pa­nies con­tin­ue to cap­i­tal­ize on the first wave of check­points and more com­pa­nies mus­cle in along­side them. Pfiz­er, al­lied with Mer­ck KGaA, al­so has a check­point now un­der re­view at the FDA. Mer­ck, Bris­tol-My­ers and Roche are al­ready well in­to the mar­ket, with their own fol­low-up plans. And Bris­tol-My­ers’ de­ci­sion not to pur­sue an ac­cel­er­at­ed ap­proval for Op­di­vo (PD-1)/Yer­voy (CT­LA-4) in lung can­cer raised even more doubts about the ap­proach at As­traZeneca.

The stakes for As­traZeneca keep get­ting high­er, cre­at­ing a re­mark­able high-wire act for a Big Phar­ma play­er.

Not on­ly does As­traZeneca have to gain an ap­proval now, the com­pa­ny al­so has to be rec­og­nized as a leader in the field, po­si­tioned to grab bil­lions of dol­lars in new sales. Just falling short of ex­pec­ta­tions will be enough to quash hopes for the near-term turn­around that As­traZeneca needs.

“Rarely has a sin­gle tri­al re­sult been so cru­cial to a com­pa­ny the size of As­traZeneca,” said Mick Coop­er of Trin­i­ty Delta.

And how.

Rev­enue in 2016 hit $23 bil­lion in 2016, down from $24.7 bil­lion. But So­ri­ot promised $45 bil­lion in rev­enue by 2023, now just six years away. The com­pa­ny has al­ready start­ed back­ing away from that num­ber, blam­ing cur­ren­cy val­u­a­tions. But even their new goals will rapid­ly evap­o­rate with­out a big score on the I/O front.

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

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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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.

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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