Who’s de­lay­ing gener­ic com­pe­ti­tion? FDA pub­lish­es a long list of drug­mak­ers they say gamed the sys­tem

Mak­ing good on the ad­min­is­tra­tion’s promise to name and shame drug­mak­ers  — most re­cent­ly re­it­er­at­ed in HHS Sec­re­tary Alex Azar’s speech Mon­day — the FDA has re­leased a list of them, all ac­cused of un­fair­ly with­hold­ing ref­er­ence sam­ples of their drugs in or­der to block gener­ic en­try.

Scott Got­tlieb

On a list of 52 ref­er­ence list­ed drugs (RLDs) post­ed Thurs­day, the FDA de­tailed the names and de­vel­op­ers of each one, along­side the num­ber of ac­cess in­quiries the agency has re­ceived in re­la­tion to them. The pub­li­ca­tion of this list, which you can see be­low, is part of the FDA’s drug com­pe­ti­tion ac­tion plan as it com­mits to ad­dress and im­prove “trans­paren­cy about this and oth­er gam­ing tac­tics that de­lay the gener­ic com­pe­ti­tion Con­gress in­tend­ed.” With­out sam­ple drugs, gener­ic com­pa­nies can­not con­duct bioe­quiv­a­lence stud­ies — a fun­da­men­tal part of any AN­DA.

Ac­cess in­quiries are sub­mit­ted when a com­pa­ny ex­press­ing an in­tent to de­vel­op a gener­ic drug is un­able to ob­tain nec­es­sary sam­ples of the orig­i­nal. Thus, the list is es­sen­tial­ly a doc­u­ment of al­le­ga­tions — the FDA has not in­de­pen­dent­ly in­ves­ti­gat­ed or con­firmed the ac­cess lim­i­ta­tions de­scribed in the in­quiries.

The FDA made a point to dis­tin­guish be­tween those drugs shield­ed un­der the Risk Eval­u­a­tion and Mit­i­ga­tion Strat­e­gy (REMS) pro­gram and cas­es where drug­mak­ers used con­trac­tu­al claus­es to pre­clude dis­trib­u­tors, whole­salers or spe­cial­ty phar­ma­cies from sell­ing to would-be com­peti­tors.

Rough­ly half of the drugs cit­ed falls un­der the purview of REMS with el­e­ments to as­sure safe use (ETA­SU), which brand­ed drug­mak­ers could em­ploy in a num­ber of ways to block ac­cess. In those cas­es, the FDA points out, it has a process in place where­by the RLD spon­sors could pro­vide their prod­ucts to gener­ic ap­pli­cants with­out vi­o­lat­ing the REMS. Giv­en it finds the com­pa­ny’s safe­ty pro­tec­tions sat­is­fac­to­ry, that au­tho­riza­tion would come in the form of a safe­ty de­ter­mi­na­tion let­ter.

Ac­cord­ing to the list, nine out of the 52 drugs have been in­volved in such a let­ter, with the ear­li­est one is­sued in 2009.

Alex Azar

Acte­lion’s Tr­a­cleer, the pi­o­neer­ing pul­monary artery hy­per­ten­sion drug that now be­longs to J&J, tops the list with 14 ac­cess in­quiries. To­geth­er with No­var­tis, the for­mer Swiss biotech has the high­est num­ber of prod­ucts — four — that gener­ic com­peti­tors have claimed to have trou­ble ac­cess­ing. The list was not short of big names, fea­tur­ing Cel­gene (for Revlim­id, Poly­mast and Talo­mid), Glax­o­SmithK­line (Pro­mac­ta), Roche (Ac­cu­tane) and gener­ic gi­ant Te­va (Clar­avis).

In re­sponse, in­dus­try group PhRMA said it’s con­cerned that the list lacks “prop­er con­text” and “con­flates” sev­er­al is­sues. There is an im­por­tant dif­fer­ence, for in­stance, be­tween prod­ucts men­tioned in com­plaints and those for which the FDA has re­ceived a re­quest for a safe­ty de­ter­mi­na­tion let­ter,

“Ad­di­tion­al con­text is es­sen­tial and we be­lieve the Agency should give in­no­va­tor com­pa­nies the op­por­tu­ni­ty to sub­mit their ap­pro­pri­ate­ly redact­ed re­sponse to the re­cip­i­ent of a safe­ty de­ter­mi­na­tion let­ter,” a spokesper­son said in an email to STAT.

Cel­gene, whose Revlim­id got 13 ac­cess in­quiries, told Reuters that all three of its prod­ucts on the FDA list all re­quire rig­or­ous safe­ty con­trols due to the sever­i­ty of their side ef­fects, and that two of them al­ready have gener­ic ver­sions set to en­ter the mar­ket in com­ing years.

Go­ing af­ter these tac­tics has been a ral­ly­ing point for FDA Com­mis­sion Scott Got­tlieb, who point­ed­ly called on brand­ed name drug com­pa­nies to “end the shenani­gans” at a pan­el a few months ago. Got­tlieb was backed up by Azar dur­ing his Mon­day speech, in which he called for sham­ing drug mak­ers that refuse to make sam­ples avail­able for gener­ic man­u­fac­tur­ers to use for their de­vel­op­ment work.

We might see how ef­fec­tive the strat­e­gy is when the list gets up­dat­ed in half a year.

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.

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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.”

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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.

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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).

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.

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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.

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