Thumbs Up/Thumbs Down: The FDA backs an­oth­er R&D scheme, Kite shows its speed while Eli Lil­ly and As­tra stum­ble again


End­points as­sess­es the big bio­phar­ma R&D sto­ries of the week, with a lit­tle added com­men­tary on what they mean for the in­dus­try.

An­oth­er price-goug­ing alert for the FDA

Let’s face it. Bio­phar­ma has a bad rep. New drugs come along with jaw-drop­ping prices and the pub­lic feels like it’s get­ting fleeced. The prob­lem, though, has noth­ing to do with tru­ly in­no­v­a­tive new drugs or their price. The US can well af­ford the high cost of in­no­va­tion – with all its ben­e­fits. It’s be­ing tak­en to the clean­ers for the ever ris­ing price of old meds that needs to be the fo­cus. This week’s sto­ry on Marathon’s move to gain an ap­proval for an an­cient steroid called de­flaza­cort sums it all up. Nev­er ap­proved in the U.S., Marathon test­ed it as a mus­cle strength­en­er for Duchenne mus­cu­lar dy­s­tro­phy. And they have scored a slew of ad­van­tages at the FDA, in­clud­ing its se­lec­tion as a rare pe­di­atric ther­a­py. You can be sure that Marathon plans to charge much more than the buck-a-pill price charged by on­line phar­ma­cies in Cana­da. The agency should re­serve its fa­vors for re­al­ly great new drugs. And the in­dus­try needs to learn how to shape an ar­gu­ment that can ac­tu­al­ly win the pub­lic over.

Kite Phar­ma takes the CAR-T lead.

A week can make a huge dif­fer­ence in biotech. Or six days. That’s how long Juno’s JCAR015 was on hold, and it end­ed up push­ing back its launch plans from 2017 to 2018. Kite, rac­ing ahead on man­u­fac­tur­ing op­er­a­tions, says it could be ready to go lat­er this year, af­ter an­nounc­ing an ag­gres­sive plan for a 30-day re­view of the first 50 pa­tients en­rolled in its piv­otal tri­al. Rush­ing ahead can in­crease the risk of a bad stum­ble, but Kite ap­pears con­fi­dent that it can quick­ly cap­i­tal­ize on its break­through rep and score a pi­o­neer­ing ap­proval well be­fore its ri­vals show up. That’s a bold move.

Eli Lil­ly’s lat­est pipeline stum­ble

The phar­ma gi­ant has sur­vived its trek through a leg­endary R&D drought, com­ing up with some im­por­tant late-stage ef­forts that de­serve a re­assess­ment of Lil­ly’s prospects. But when its CDK 4/6 drug abe­maci­clib failed to hit pay­dirt at the in­ter­im analy­sis, this drug lost a con­sid­er­able amount of sheen. Pfiz­er got to the mar­ket first with an ear­ly win for Ibrance. No­var­tis looks to be right on track af­ter end­ing its ri­val piv­otal study ear­ly. And now Lil­ly won’t be able to file be­fore next year, un­able to de­clare a sim­i­lar win. For long­time ob­servers, it’s an­oth­er sign of the slows at a com­pa­ny that needs bad­ly to move fast.

Here’s a thumbs-up to a clear mes­sage mak­er.

Al­ler­gan’s Brent Saun­ders went right back to singing the same tune about deals once the merg­er with Pfiz­er fell through. He’s go­ing to stay fo­cused on key ar­eas, snap up pro­grams prefer­ably af­ter Phase II and (with­out hit­ting this too hard) stay­ing away from dis­cov­ery work and most of the nit­ty-grit­ty in Phase I. He likes to buy things, rather than rent-to-own, and he’s think­ing high deal vol­ume, not one big, knock­out M&A punch. Those ru­mors about buy­ing Bio­gen? Not go­ing to hap­pen. Oh, and he has lots of cash for the right kinds of deals. Got it? OK then.

As­traZeneca now 0 and 2 on selume­tinib

The UK com­pa­ny’s stock has en­joyed a re­nais­sance re­cent­ly af­ter some ru­mors about a pos­si­ble No­var­tis takeover be­gan to cir­cu­late. But this com­pa­ny has a his­to­ry of mis­steps in the pipeline that con­tin­ues to dog its R&D rep. This week, its can­cer drug selume­tinib raised its head for the sec­ond time as a Phase III los­er. And that, once again, raised Pas­cal So­ri­ot’s pre­dic­tion that this drug is a block­buster in the mak­ing. So­ri­ot has been wrong about a lot of things in the pipeline, with the ex­cep­tion of Tagris­so. Chances are that this drug will ei­ther be cut loose or sold for scrap, like bro­dalum­ab and lesin­u­rad.

The End­points 100

For­give us our unashamed self-pro­mo­tions. We’re halfway through the re­cruit­ment process for our new, on­go­ing quar­ter­ly con­fi­dence sur­vey of the biotech in­dus­try, bring­ing to­geth­er 100 top in­dus­try ex­ecs to track hir­ing trends, ac­cess to cap­i­tal, the reg­u­la­to­ry en­vi­ron­ment and more. Cov­er­ing this in­dus­try can’t re­ly sole­ly on re­port­ing the news as it hap­pens. We aim to keep our thumb on the pulse.

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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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.

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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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.

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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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.