Back from the dead: Nek­tar hunts a block­buster deal as opi­oid '181 looks less ad­dic­tive than oxy

Af­ter whip­ping up some up­beat an­a­lyst as­sess­ments in March with a pos­i­tive late-stage ef­fi­ca­cy study for their mu-opi­oid pain ther­a­py NK­TR-181, Nek­tar Ther­a­peu­tics has now put the fin­ish­ing touch­es to its deal pack­age on the drug with more Phase III da­ta to po­si­tion this as a first-of-its-kind opi­oid that ad­dicts can’t abuse, no mat­ter what they do to it, while ef­fec­tive­ly com­bat­ing pain.

With a big fo­cus on on­col­o­gy, Nek­tar $NK­TR has made it clear that they don’t plan to han­dle this so­lo, look­ing to ei­ther li­cens­ing it out com­plete­ly or work­ing on a co-mar­ket­ing pact. But CEO Howard Robin clear­ly wants to do this on the ba­sis that NK­TR-181 is the so­lu­tion to the opi­oid cri­sis that has been grab­bing head­lines from coast-to-coast.

And that calls for a block­buster deal, to hear him tell it.

“We’re go­ing to be fair­ly soon tak­ing all of our da­ta to the FDA,” Robin tells me.  “We have fast track sta­tus and there’s cer­tain­ly a great de­sire at the agency to see our re­sults. The reg­u­la­to­ry au­thor­i­ties un­der­stand that this is po­ten­tial­ly a so­lu­tion to the opi­oid abuse in our coun­try. No oth­er mol­e­cule like this is avail­able.”

In March the news from Nek­tar was that NK­TR-181 beat out a place­bo in re­duc­ing pain. The com­par­i­son da­ta weren’t stel­lar, but it was sig­nif­i­cant. To­day, Nek­tar wants you to know that a wide range of com­par­isons on lik­a­bil­i­ty with a range of dos­es in a head-to-head with oxy demon­strat­ed that there was a con­sis­tent and sig­nif­i­cant­ly low­er at­tach­ment to their opi­oid. Again, the da­ta points didn’t hit the ball out of the park, but they came in pos­i­tive — with the ex­cep­tion of one com­par­i­son with a 40 mg dose of oxy.

Study the end­points, says Robin, and it’s clear that this drug takes much longer than mar­ket­ed opi­oids to take ef­fect. So there’s no im­me­di­ate rush that ad­dicts are look­ing for.

“If some­one wants to abuse a drug,” he says, “they don’t want to wait 3 hours to get there. They want that 10-minute rush.”

That’s some­thing a ma­jor mar­ket­ing group could do well with in the on­go­ing cri­sis en­vi­ron­ment.

“First, you know this is pret­ty much a pri­ma­ry care mar­ket,” says Robin, and Nek­tar’s not in a po­si­tion to mar­ket to a large pri­ma­ry care au­di­ence. We’re an R&D com­pa­ny at this stage, look­ing for a part­ner who can do this. While it is an opi­oid, it’s nov­el and dif­fer­ent.” A deal “could range from a pure out-li­cens­ing agree­ment with a very sig­nif­i­cant up­front and very sig­nif­i­cant back end, or a joint ven­ture and we keep our hand in sales and mar­ket­ing.”

“This is not a for­mu­la­tion or a coat­ing,” adds the CEO. “It’s tak­en as a tablet or liq­uid with the ex­act same ef­fect. There’s re­al­ly no way to al­ter its prop­er­ties. Ap­ply any chem­istry you like. You can make it in­ef­fec­tive but you can’t sep­a­rate the opi­oid from the over­all mol­e­cule. No eu­pho­ria is as­so­ci­at­ed with 181. Chop it up. Dice it up. Turn it in­to a liq­uid. In­ject it… It’s a new opi­oid mol­e­cule that is high­ly ef­fi­ca­cious and just not like­able. For me it is a ma­jor break­through; a crit­i­cal step.”

Re­mark­ably, ‘181 failed a Phase II study in 2013. But Jef­feries’ David Stein­berg not­ed af­ter the ef­fi­ca­cy da­ta came out in March that this one was back from the dead. This pain ther­a­py could be par­tic­u­lar­ly ef­fec­tive deal­ing with chron­ic pain, es­pe­cial­ly low­er back pain. He not­ed:

As such, peak sales could be in the $1B+ range and pos­si­bly much high­er. Our new mod­el as­sumes NDA sub­mis­sion in late 2019, launch in 2H20 and 30% roy­al­ty (sim­i­lar to Amikacin In­hale) with a sig­nif­i­cant up­front and mile­stones in ex­cess of $200M.

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.

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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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.

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.

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.

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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