Much crit­i­cized Mallinck­rodt bows out of PhRMA ahead of some tight­ened re­stric­tions on mem­ber­ship

Mark Tyn­dall, Mallinck­rodt

Just ahead of some new, more mus­cu­lar rules gov­ern­ing who can be a part of the in­dus­try lob­by­ing or­ga­ni­za­tion PhRMA, one of its most heav­i­ly crit­i­cized mem­bers is pulling out.

PhRMA con­firmed to me Wednes­day af­ter­noon that Mallinck­rodt — at the cen­ter of a lin­ger­ing drug pric­ing scan­dal — has re­signed from the trade group.

Just a few months ago, Mallinck­rodt agreed to pay a $100 mil­lion fine to re­solve a probe of the long, rather sor­did his­to­ry be­hind Ac­thar, an in­fan­tile spasm drug which cost $28,000 a vial when Mallinck­rodt picked it up in the $5.6 bil­lion ac­qui­si­tion of Quest­cor. Quest­cor had been jack­ing up the price on Ac­thar when it paid No­var­tis $135 mil­lion to gain US rights to a ther­a­py that posed a di­rect threat to its drug fran­chise. And Mallinck­rodt was forced to pay the fine for il­le­gal­ly main­tain­ing a drug mo­nop­oly — not the kind of sanc­tion PhRMA likes to see for mem­bers.

To­day, a lit­tle more than two years lat­er, the FTC says Ac­thar costs $34,000 a vial. Over 15 years the price on Ac­thar has gone up 85,000%. Mallinck­rodt earned $1.16 bil­lion on Ac­thar last year, when it spent a to­tal of $262 mil­lion on R&D, 7.7% of its net rev­enue of $3.4 bil­lion.

This was all play­ing out when Marathon Phar­ma­ceu­ti­cals grabbed an FDA ap­proval for an old steroid, de­flaza­cort, specif­i­cal­ly for Duchenne mus­cu­lar dy­s­tro­phy and priced the ther­a­py — avail­able from UK sources at around $1,000 a year — at $89,000. Marathon CEO Jeff Aronin, who still sits on PhRMA’s board, ducked low when a con­tro­ver­sy burst out over the price as well as ques­tion­able claims about what it spent on re­search­ing the steroid and lat­er sold de­flaza­cort to PTC Ther­a­peu­tics for $140 mil­lion, plus a roy­al­ty stream and a po­ten­tial $50 mil­lion mile­stone.

Stephen Ubl, PhRMA CEO

PhRMA, mean­while, was rolling out a mul­ti­mil­lion dol­lar ad cam­paign aimed at im­prov­ing pub­lic opin­ion about drug­mak­ers. The pub­lic has reg­is­tered on­ly no­to­ri­ous­ly low sup­port for phar­ma com­pa­nies over­all. The group launched a re­view of its mem­ber­ship rules, sug­gest­ing that Marathon and oth­ers might not stay mem­bers once they tight­ened the cri­te­ria for join­ing, clear­ly pre­fer­ring to stick with big play­ers who tra­di­tion­al­ly in­vest heav­i­ly in R&D.

For Mallinck­rodt’s part, the de­par­ture was rou­tine and am­i­ca­ble. A spokesper­son tells me:

Mallinck­rodt rou­tine­ly eval­u­ates its en­gage­ment in trade as­so­ci­a­tions and pol­i­cy or­ga­ni­za­tions and has con­clud­ed that the sig­nif­i­cant fi­nan­cial and time com­mit­ment re­quired as a full PhRMA mem­ber out­weighs its di­rect pol­i­cy val­ue to us at this time, giv­en our present size and staff foot­print. We con­tin­ue to sub­scribe to the PhRMA Code of Con­duct, sup­port many of the group’s po­si­tions and ini­tia­tives and look for­ward to con­tin­u­ing our pos­i­tive work­ing re­la­tion­ship with PhRMA and its mem­bers.

Mallinck­rodt was singing a dif­fer­ent tune when they joined in ear­ly 2015.

“We are proud to be sit­ting at the same ta­ble as most of the top in­no­v­a­tive phar­ma­ceu­ti­cal com­pa­nies in the world, which puts us in a po­si­tion to help shape our in­dus­try in a way that sup­ports pa­tients and providers for the com­ing decades,” said Mark Tyn­dall, Vice Pres­i­dent of Gov­ern­ment Af­fairs, Pol­i­cy and Ad­vo­ca­cy, at the time.

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.

So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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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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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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