Mallinck­rodt's woes per­sist as re­for­mu­lat­ed opi­oid painkiller fails to pass FDA muster

The FDA’s re­luc­tance with pre­scrip­tion painkillers at a time the Unit­ed States is swept by a tsuna­mi of opi­oid abuse, over­dose and ad­dic­tion was on full dis­play on Wednes­day, when the reg­u­la­tor re­ject­ed Mallinck­rodt’s $MNK abuse-de­ter­rent opi­oid painkiller, so­lic­it­ing more da­ta from the UK drug­mak­er.

The drug un­der scruti­ny was a tweaked ver­sion of Rox­i­codone, an im­me­di­ate-re­lease for­mu­la­tion of the com­mon­ly abused opi­oid oxy­codone that was ap­proved by the FDA in 2000. This re­for­mu­la­tion was de­signed to de­ter abuse via snort­ing or in­ject­ing. In its CRL, the agency “pro­vid­ed guid­ance re­gard­ing ar­eas of fur­ther eval­u­a­tion nec­es­sary to re­sub­mit the NDA for fur­ther re­view,” Mallinck­rodt said.

Shares of the Staines-up­on-Thames-based com­pa­ny, which said it would spin off its spe­cial­ty busi­ness last week, were down about 9% pre-mar­ket. The an­nounce­ment fol­lows an­oth­er set­back: one of two late-stage drugs Mallinck­rodt won as part of its $1.2 bil­lion ac­qui­si­tion of Su­cam­po failed a piv­otal study in No­vem­ber.

The CRL for the painkiller does not come as a com­plete sur­prise. In a re­view last month, FDA staff point­ed out that the agency had not made any de­fin­i­tive con­clu­sions re­gard­ing whether the drug could be ma­nip­u­lat­ed for in­tra­venous abuse, as Mallinck­rodt had not yet sub­mit­ted da­ta from sev­er­al key stud­ies as part of its NDA. A pan­el of in­de­pen­dent ex­perts re­view­ing the drug a few days lat­er con­curred, sug­gest­ing the drug be la­beled as an abuse de­ter­rent on­ly via the nasal route.

This could cul­mi­nate in a sim­i­lar sit­u­a­tion to that of En­do’s $ENDP Opana, which was with­drawn from the mar­ket last year at the be­hest of the FDA, af­ter post-mar­ket da­ta showed the re­for­mu­lat­ed opi­oid painkiller was be­ing abused in­tra­venous­ly at a high­er rate, even as rates of nasal abuse fell.

But Mallinck­rodt is plan­ning to plough ahead. The com­pa­ny in­tends to re­quest a meet­ing in the com­ing weeks with the reg­u­la­tor to dis­cuss its next steps, it said on Wednes­day.

On av­er­age, opi­oid over­dos­es kill 115 Amer­i­cans per day, and the eco­nom­ic bur­den of pre­scrip­tion opi­oid mis­use alone is a hefty $78.5 bil­lion each year, in­clud­ing the health­care costs, lost pro­duc­tiv­i­ty, and crim­i­nal jus­tice in­volve­ment, ac­cord­ing to the CDC. As the num­ber of opi­oid-re­lat­ed deaths mount, the FDA has large­ly changed its tune on the oft’ mis­used class of drugs by amend­ing its pre­scrib­ing rec­om­men­da­tions,track­ing the num­ber of pre­scrip­tions, tight­en­ing scruti­ny and re­quir­ing man­u­fac­tur­ers to de­vel­op abuse-de­ter­rent for­mu­la­tions.

How­ev­er, the agency is not quite im­pos­ing a blan­ket ban on all things opi­oid. Last month, it ap­proved Acel­Rx Phar­ma­ceu­ti­cals $ACRX painkiller Dsu­via, a drug 10-times more po­tent than fen­tanyl, which in turn is a syn­thet­ic opi­oid pain re­liev­er that is 50 to 100 times more po­tent than mor­phine. The con­tro­ver­sial ap­proval was sanc­tioned de­spite height­en­ing con­cern and fiery crit­i­cism (from a host of crit­ics in­clud­ing a hand­ful of US sen­a­tors) on the grounds that the drug — which was de­vel­oped in col­lab­o­ra­tion with the De­part­ment of De­fense — is a sub­lin­gual for­mu­la­tion, mak­ing it ide­al for mil­i­tary use, not­ed FDA Com­mis­sion­er Scott Got­tlieb.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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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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Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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