Mar­ket slack­er Cel­gene does some­thing good for a change, look­ing to turn the cor­ner on past mishaps

At this point Cel­gene has been so bat­tered over its poor per­for­mance of the past year you have to do a dou­ble take to con­vince your­self when some­thing good hap­pens to it.

But there was some con­sid­er­able good news to be had in its Phase III study of fran­chise drug Revlim­id in com­bi­na­tion with Roche’s Rit­ux­an in two forms — fol­lic­u­lar and mar­gin­al zone — of in­do­lent lym­phoma. 

Ac­cord­ing to re­searchers, they tracked a “high­ly sta­tis­ti­cal­ly sig­nif­i­cant” im­prove­ment in pro­gres­sion-free sur­vival in the study, open­ing the door to some near-term mar­ket­ing ap­pli­ca­tions that at least one promi­nent an­a­lyst spec­u­lates could be worth more than $1 bil­lion in added sales.

Cel­gene’s shares were up 1.6% in ear­ly trad­ing Tues­day.

Ge­of­frey Porges, Leerink

We don’t have the da­ta yet, and rarely do in these re­leas­es as the com­pa­nies hold the num­bers for a sci­en­tif­ic con­fer­ence. And over­all sur­vival re­sults have yet to be reached. But no one missed the im­pli­ca­tions of its boast on sta­tis­ti­cal sig­nif­i­cance. 

Cel­gene’s pipeline is stuffed with so many shots like this, some an­a­lysts say it can’t mess up every­thing. In ad­di­tion, it still has an R&D group filled with some of the best re­searchers in the busi­ness and a pipeline that boasts a group of po­ten­tial break­throughs, like bb2121 or JCAR017. So don’t think for a sec­ond that the com­pa­ny doesn’t have plen­ty of sup­port­ers around the in­dus­try.

Leerink’s Ge­of­frey Porges — who of­fered the up­beat in­cre­men­tal sales es­ti­mate with­out will­ing to change the com­pa­ny’s rev­enue fore­cast just yet — is al­so hap­py to give Cel­gene a thumbs up af­ter its many no­table set­backs. He not­ed:

(T)he pos­i­tive re­sult em­pha­sizes the op­tion­al­i­ty that ex­ists in many parts of the com­pa­ny’s pipeline. De­spite re­cent his­to­ry, not every­thing in the com­pa­ny’s port­fo­lio will fail, nor every op­er­a­tional re­sult dis­ap­point. This pes­simism about the com­pa­ny and its stock sug­gests op­por­tu­ni­ty to us, and the op­tion­al­i­ty of the mid- to late stage pipeline is a sig­nif­i­cant rea­son be­hind our con­tin­ued out­per­form rat­ing for the stock, de­spite the many de­vel­op­ment and op­er­a­tional stum­bles in the last year.

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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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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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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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.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.