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.

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.