Thumbs Up. Thumbs Down: On rook­ie mis­takes, a class ac­tion suit and get­ting past fail­ure

 

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

Por­to­la makes a rook­ie mis­take, and gets ham­mered by a CRL

If any com­pa­ny looked to be sit­ting in the right place at the right time with a new drug ap­pli­ca­tion, it was Por­to­la. The FDA had al­ready giv­en the com­pa­ny a break­through des­ig­na­tion, of­fer­ing ready ac­cess that com­pa­ny ex­ecs say they took ad­van­tage of reg­u­lar­ly. But when it came down to the PDU­FA date, the biotech was forced to an­nounce that the agency had re­ject­ed the ap­pli­ca­tion. Why? In a call with an­a­lysts, Por­to­la’s crew sound­ed like they had fun­da­men­tal­ly mis­judged the FDA’s at­ti­tude on man­u­fac­tur­ing and da­ta is­sues. Points they thought could have been clar­i­fied af­ter an ap­proval couldn’t wait. And now it will spend some time an­swer­ing the FDA’s CRL rather than mar­ket­ing its an­ti-an­ti­co­ag­u­lant. This was a sim­ple rook­ie mis­take, but we’ve seen re­peat­ed re­jec­tions this year based on CMC is­sues. Oth­er de­vel­op­ers should take very care­ful note of it.

Some­times, a law­suit may be just what the doc­tor or­dered

Class ac­tion law­suits in the wake of a biotech set­back are a dime a dozen. They clus­ter like flies on an open wound, re­gard­less of what caused the wound. So why did I stop and write up a re­cent bit of lit­i­ga­tion about Juno?  Most­ly be­cause there are still some very im­por­tant unan­swered ques­tions about how the FDA han­dled the deaths of pa­tients from cere­bral ede­ma in Juno’s JCAR015 study. The first death went un­re­port­ed, though Juno ex­ecs talked it over with the agency. More deaths fol­lowed. And when the agency did drop its clin­i­cal hold, it on­ly last­ed for a few days. Juno’s ready ex­pla­na­tion, that adding flu­dara­bine to the reg­i­men for prep­ping pa­tients, was seem­ing­ly swal­lowed whole. The FDA, of course, re­fused to ex­plain their po­si­tion on this. But this is some­thing that needs to be care­ful­ly ex­am­ined and ex­plained. By all means, let Juno pro­ceed with its work. But leav­ing this one in the gray zone is ir­re­spon­si­ble. Maybe a law­suit will help clar­i­fy mat­ters.

Let’s set a high­er bar on bio­phar­ma takeover sto­ries

There was a time when the busi­ness press prid­ed it­self on a good takeover scoop. Se­cret bids. Board­room squab­bles. It made for great read­ing. Now, any old ru­mor will qual­i­fy for a sto­ry: An ex­ec­u­tive at com­pa­ny A asked an ex­ec­u­tive at com­pa­ny B about a pos­si­ble tie up? A bit of wa­ter cool­er chat­ter dur­ing a break? It’s all fod­der for the beast now, with ex­pres­sions of in­ter­est and ca­su­al over­tures, or just sim­ple ru­mors, trig­ger­ing sto­ries and fol­low-up sto­ries. Reuters and Bloomberg have good cause to hus­tle, with both look­ing to get the juicy stuff up on ter­mi­nals first. But there should be some kind of stan­dard on what qual­i­fies for a sto­ry. This is out of con­trol.

Some­times peo­ple fail in biotech. Get over it.

Con­grats to An­drew Hirsch for land­ing a new job as CFO at Agios. Hirsch was left to han­dle the un­wel­come task of putting Bind Ther­a­peu­tics in the ground af­ter it was forced in­to Chap­ter 11. The lead drug proved to be a dis­ap­point­ment. Debt had ac­cu­mu­lat­ed. And this is no time to look for in­vestors to bail you out of a tight spot. Biotech fail­ure is a re­al threat to every­one in this busi­ness, re­gard­less of the size of a com­pa­ny or its lev­el of ex­per­tise. Hirsch dealt with it and moved on. And that’s eas­i­er to do in the US than, say, the UK, where no one ever for­gets. Plus one for the US mod­el. These ex­pe­ri­enced biotech vets have made Boston and San Fran­cis­co in­to thriv­ing glob­al hubs. They’re need­ed to get new gen­er­a­tions of star­tups to the fin­ish line. Let the dead bury the dead. It’s time to move on.

Where are the deals?

Not to be a churl­ish ob­serv­er, but I have to ad­mit I’m more than a lit­tle dis­ap­point­ed by the slow pace of deal­mak­ing we’ve seen this year. There are some big out­fits that have been holed up for far too long. Big com­pa­nies re­ly on the biotech food chain to keep their pipelines in­ter­est­ing. And af­ter the big drop in biotech stocks, this is the time to move. I’m bet­ting that we get hit with a burst of deals in the fall. There’s plen­ty of cash be­hind that dam of de­sire. It’s time to put it in cir­cu­la­tion.

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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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.

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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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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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.