Te­va hit by an­oth­er PhI­II set­back on CGRP pain drug fre­manezum­ab, but there’s no pulling back now as ri­vals race ahead

Te­va has al­ready been pushed back to a fol­low-up shot at the CGRP mi­graine drug mar­ket. Now it’s al­so lost a Phase III round that could put the com­pa­ny even fur­ther be­hind the mar­ket lead­ers.

The em­bat­tled com­pa­ny $TE­VA re­port­ed this morn­ing that their late-stage pro­gram for fre­manezum­ab failed in pa­tients with chron­ic clus­ter headaches. They’re aban­don­ing that in­di­ca­tion, but plan to push ahead with their study in episod­ic clus­ter headaches.

Te­va’s late-stage pipeline has been a big prob­lem, with key set­backs in MS. But their CGRP pro­gram has been a stand­out, with Te­va look­ing to leapfrog ri­vals with a quar­ter­ly or month­ly in­jectable. Am­gen and their part­ners at No­var­tis took the lead with the FDA’s ap­proval of Aimovig, and they priced their drug ag­gres­sive­ly, look­ing to take full ad­van­tage of the first-mover po­si­tion they en­joy.

An­a­lysts have es­ti­mat­ed peak sales for Aimovig at about $1.2 bil­lion.

Eli Lil­ly, mean­while, has been chomp­ing at the bit with gal­canezum­ab, which is un­der re­view at the FDA. They al­so tried, and failed, to score on chron­ic clus­ters, but si­mul­ta­ne­ous­ly an­nounced that they hit the pri­ma­ry end­point on episod­ic clus­ter headaches. So Te­va may yet match up on that score.

Te­va, mean­while, has a Sep­tem­ber 16 PDU­FA date, which could put them ahead of Eli Lil­ly, ex­pect­ed to get a de­ci­sion some­time in Oc­to­ber. Te­va’s man­u­fac­tur­ing part­ner, though, has had some prob­lems, lead­ing to one de­lay and rais­ing sus­pi­cions that an­oth­er could fol­low.

Lit­tle Alder, mean­while, is draw­ing up the rear with eptinezum­ab, with their time­line on a de­ci­sion pushed back in­to next year.

Te­va is com­mit­ted on this drug, and they’re still push­ing on fol­low-up in­di­ca­tions. Giv­en the way Phase III mi­graine da­ta have come in for every­one, with com­pa­ra­ble re­sults across the board, the race is al­ready well un­der way to dis­tin­guish them­selves in what is shap­ing up as a crowd­ed mar­ket. That’s prov­ing to be dif­fi­cult, though.

“While we are dis­ap­point­ed with this out­come, we re­main op­ti­mistic that fre­manezum­ab could have clin­i­cal ben­e­fits in ad­di­tion­al con­di­tions, be­yond mi­graine, where cal­ci­tonin gene-re­lat­ed pep­tide (CGRP) plays a con­trib­u­to­ry role in their patho­phys­i­ol­o­gy. We would like to thank the pa­tients and in­ves­ti­ga­tors for their par­tic­i­pa­tion in the Chron­ic Clus­ter Clin­i­cal Tri­al,” said Tushar Shah, the head of glob­al spe­cial­ty clin­i­cal de­vel­op­ment at Te­va.

Im­age: Te­va. SHUT­TER­STOCK

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.