Nek­tar sells off roy­al­ties on its 2 ap­proved drugs for $150M in cash, re­dou­bling fo­cus on I-O can­di­dates

A lit­tle less than a year ago, an FDA ad­comm unan­i­mous­ly re­ject­ed Nek­tar Ther­a­peu­tics’ opi­oid pro­gram, ef­fec­tive­ly send­ing it to the chop­ping block. Now, look­ing for a quick cash in­fu­sion to fi­nance clin­i­cal tests for two oth­er can­di­dates, Nek­tar will sell off roy­al­ties for its on­ly two ap­proved US med­i­cines.

Roy­al­ties on fu­ture sales of part­ner meds Adyno­vate and Movan­tik will be turned over to Health­care Roy­al­ty Man­age­ment in ex­change for $150 mil­lion in cash, San Fran­cis­co-based Nek­tar an­nounced Tues­day morn­ing. HCR is ex­pect­ed to make the pay­ment by the end of the year, and Nek­tar said it plans to put the funds to­ward clin­i­cal tri­als for its ear­ly- and late-stage im­mune-on­col­o­gy pro­grams tar­get­ing IL-2 and IL-15.

In­vestors were most­ly mut­ed on the news, with Nek­tar $NK­TR shares up as much as 4% in ear­ly Tues­day trad­ing. But by the clos­ing bell, the stock price had fall­en to most­ly flat.

With the deal, HCR is el­i­gi­ble for roy­al­ty pay­ments of up to $210 mil­lion for each drug through 2025; if that fig­ure isn’t met by then, $240 mil­lion for each. Once those num­bers are reached, roy­al­ty rights will be re­turned to Nek­tar.

Adyno­vate is a he­mo­phil­ia A drug on which Nek­tar part­nered with Bax­al­ta, a for­mer Shire com­pa­ny now owned by Take­da. It’s an ex­tend­ed half-life re­com­bi­nant fac­tor VI­II (rFVI­II) treat­ment. Per the terms of Nek­tar’s col­lab­o­ra­tion with Bax­al­ta, Nek­tar had been el­i­gi­ble for roy­al­ties of 4% to 6% on the first $1.2 bil­lion in year­ly sales, fol­lowed by a flat 13% roy­al­ty on every sub­se­quent dol­lar.

Movan­tik, mean­while, was de­vel­oped in tan­dem with As­traZeneca for opi­oid-re­lat­ed con­sti­pa­tion in adults. Nek­tar had pinned the drug as a po­ten­tial block­buster, but sales got off to a slow start af­ter its 2014 ap­proval. Even­tu­al­ly, As­traZeneca sold most of Movan­tik’s glob­al rights to Red­Hill Bio­phar­ma for $67.5 mil­lion back in Feb­ru­ary.

Un­der its deal with As­traZeneca, Nek­tar was to re­ceive es­ca­lat­ing roy­al­ties on the drug start­ing at 20%.

Nek­tar’s cash in­fu­sion will go main­ly to­ward two of its pro­grams: be­m­pe­galdesleukin (or NK­TR-214) and NK­TR-255. The for­mer is the com­pa­ny’s cur­rent lead pipeline pro­gram, a CD122-pref­er­en­tial IL-2 ag­o­nist, and is be­ing stud­ied in sev­er­al Phase III tri­als in com­bi­na­tion with Bris­tol My­ers Squibb’s Op­di­vo. Some of the in­di­ca­tions be­ing looked at in­clude metasta­t­ic melanoma, re­nal cell car­ci­no­ma and mus­cle-in­va­sive blad­der can­cer.

Re­searchers are al­so look­ing at be­m­pe­galdesleukin as a monother­a­py and in com­bi­na­tion with Keytru­da and oth­er in-house pro­grams, though those stud­ies are ear­li­er in the de­vel­op­ment stages.

NK­TR-255 is an IL-15 re­cep­tor ag­o­nist that Nek­tar says is de­signed to ex­pand NK cells. The can­di­date, whol­ly owned by Nek­tar, is in two Phase II stud­ies — one for non-Hodgkin’s lym­phoma and mul­ti­ple myelo­ma in com­bo with Rit­ux­an or Darza­lex, and an­oth­er in head, neck and col­orec­tal can­cer paired with Er­bitux.

Nek­tar got off to a rough start in 2020 when its opi­oid pro­gram was re­buffed by an FDA ad­comm 27-0 in Jan­u­ary. The for­mer pro­gram, dubbed NK­TR-181, had been billed by the com­pa­ny as a less-ad­dic­tive op­tion to oxy­codone, but reg­u­la­tors as well as ad­comm mem­bers not­ed the de­clin­ing use of opi­oids by physi­cians across the coun­try.

The agency was al­so con­cerned over the fact that the ex­per­i­men­tal drug could still be phys­i­cal­ly ma­nip­u­lat­ed, af­ter which it could be sub­ject to abuse. CEO Howard Robin had laid out a glow­ing sales pitch for the pro­gram in 2017, on­ly to change his plans and spin it out in­to a new sub­sidiary in 2019.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Al Sandrock, Biogen R&D chief (Biogen via YouTube)

UP­DAT­ED: Bio­gen push­es in a fresh stack of chips and starts prep­ping a glob­al R&D game plan af­ter watch­ing the cards turn on ear­ly throm­bolyt­ic da­ta

After patiently steering through a decade-long journey for its early-stage clinical work, a small Tokyo biotech has clinched a deal to out-license its lead thrombolytic agent to US heavyweight Biogen — which sees a potentially game-changing impact on the clot-busting field after taking a careful look at some upbeat Phase IIa data.

Three years after Biogen anted up $4 million to gain an option on the drug from TMS, the big US biotech is making a small bet to beef up its stroke portfolio. The BD team inked a deal to go ahead and grab rights to the drug for $18 million, with another $335 million in milestone cash on the table for a successful outcome.

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Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.