Al­ler­gan ax­ing 1,000-plus jobs, prep­ping for a painful on­slaught of Resta­sis knock­offs

Al­ler­gan $AGN is slash­ing more than a thou­sand jobs and elim­i­nat­ing 400 open po­si­tions as it braces for the painful im­pact of gener­ic com­pe­ti­tion to its big Resta­sis fran­chise.

Al­ler­gan CEO Brent Saun­ders has been slap­ping back at crit­ics af­ter try­ing to guard its IP on its $1.5 bil­lion eye drug Resta­sis by trans­fer­ring the patents to a Mo­hawk In­di­an tribe, which claimed sov­er­eign im­mu­ni­ty on the patent front. But in a sep­a­rate case a fed­er­al judge re­cent­ly de­cid­ed to in­val­i­date the patents, leav­ing Al­ler­gan ex­posed to a painful hit.

Al­ler­gan has a work force of 18,000 staffers, says a spokesper­son, with 9,000 en­gaged in mar­ket­ing. The cuts will slash about 8% of the to­tal job count.

Al­ler­gan hasn’t for­mal­ly thrown in the tow­el yet on the $14 mil­lion Mo­hawk deal, but its re­struc­tur­ing to­day in­di­cates that the com­pa­ny is prep­ping for a mar­ket slap down. The fed­er­al judge had this to say about the com­pa­ny’s at­tempt­ed end run on sov­er­eign im­mu­ni­ty:

The Court has se­ri­ous con­cerns about the le­git­i­ma­cy of the tac­tic that Al­ler­gan and the Tribe have em­ployed. The essence of the mat­ter is this: Al­ler­gan pur­ports to have sold the patents to the Tribe, but in re­al­i­ty it has paid the Tribe to al­low Al­ler­gan to pur­chase—or per­haps more pre­cise­ly, to rent—the Tribe’s sov­er­eign im­mu­ni­ty.

If that ploy suc­ceeds, any paten­tee fac­ing IPR pro­ceed­ings would pre­sum­ably be able to de­feat. But sov­er­eign im­mu­ni­ty should not be treat­ed as a mon­e­ti­z­able com­mod­i­ty that can be pur­chased by pri­vate en­ti­ties as part of a scheme to evade their le­gal re­spon­si­bil­i­ties.

The bulk of the cuts are be­ing aimed at com­mer­cial op­er­a­tions as­so­ci­at­ed with Resta­sis, ac­cord­ing to an SEC fil­ing. Al­ler­gan ex­pects to in­cur $125 mil­lion in costs as­so­ci­at­ed with the move, pri­mar­i­ly for sev­er­ance pay. And it’s count­ing on $300 mil­lion to $400 mil­lion in sav­ings this year.

A spokesper­son for Al­ler­gan de­clined to elab­o­rate to End­points News on where the ax is falling.

Im­age: Brent Saun­ders. AP Im­ages

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Ted White, Verrica CEO

Ver­ri­ca hits an­oth­er bump in the road with CMO re­lat­ed let­ter from FDA

The FDA has rejected Verrica’s new drug application for VP-102 again, with the company pinning the CRL on problems at a CMO that it was partnered with, the company announced Monday.

The FDA didn’t raise issues that directly relate to the manufacturing of VP-102, the company said, but raised “general quality issues” at the CMO’s facility. There were also no clinical concerns, it said, or need to collect more data.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.