The Shkre­li rule? FDA is ex­plor­ing whether se­lect­ed reim­por­ta­tion could crip­ple the drug prof­i­teers

Mar­tin Shkre­li was hauled in front of law­mak­ers, jailed on fraud con­vic­tions and sub­ject­ed to every known form of le­gal pres­sure af­ter hik­ing the price of Dara­prim by more than 5000%. But none of it worked to force him to back off a per­fect­ly le­gal strat­e­gy to gouge pay­ers on a nar­row­ly con­trolled gener­ic drug — where the sky is the lim­it on the price.

So now the FDA is ex­plor­ing a new op­tion, which in­volves a tac­tic that the drug in­dus­try — and many oth­ers in the gov­ern­ment — have long ab­horred.

In a state­ment out this morn­ing, the FDA says that it is as­sem­bling a work­ing group to con­sid­er whether reim­port­ing drugs from abroad may be the an­swer to the drug prof­i­teers. 

We want to ex­am­ine whether—un­der these nar­row con­di­tions—the ad­di­tion­al mar­ket com­pe­ti­tion from the short-term im­por­ta­tion of for­eign ver­sions of the drug may com­ple­ment the FDA’s cur­rent ef­forts, and help meet near-term pa­tient need in the U.S. un­til new com­pe­ti­tion is able to en­ter the do­mes­tic mar­ket.

Reim­por­ta­tion is noth­ing new. Many De­moc­rats have long sug­gest­ed that pa­tients in the US be al­lowed to buy drugs in for­eign mar­kets where sin­gle-pay­er sys­tems have forced down the price. The Trump ad­min­is­tra­tion and oth­ers, par­tic­u­lar­ly in the in­dus­try, have kicked back, say­ing it wouldn’t pro­vide a safe sup­ply of ther­a­pies. And drug man­u­fac­tur­ers, crit­ics add, wouldn’t al­low it any­way, cut­ting off any sup­pli­ers who might try.

FDA com­mis­sion­er Scott Got­tlieb, though, is pre­pared to con­sid­er us­ing reim­por­ta­tion for any oth­er Shkrelis that come along. 

Any pol­i­cy that in­volves the im­por­ta­tion of drugs would be tem­po­rary un­til ad­e­quate com­pe­ti­tion en­ters these cat­e­gories. Fur­ther­more, any re­sult­ing pol­i­cy would al­so be nar­row­ly tai­lored in or­der not to cre­ate the same risks of coun­ter­feits or oth­er un­safe drugs get­ting in­to the U.S. sup­ply chain as a broad­er im­por­ta­tion pol­i­cy would present. Our ul­ti­mate goal is to seek mul­ti­ple FDA-ap­proved and mar­ket­ed ver­sions of each med­ical­ly im­por­tant drug for which there are no block­ing patents or oth­er ex­clu­siv­i­ties.

That could prove in­ter­est­ing.

Shkre­li, the old Valeant, Mallinck­rodt and oth­ers have been known to spur dra­mat­i­cal­ly high­er prices. Where would the agency draw the line?

Would they go af­ter PTC Ther­a­peu­tics?

PTC bought an old, cheap steroid called de­flaza­cort from Marathon Phar­ma­ceu­ti­cals af­ter Marathon rolled it out for a stun­ning $89,000 an­nu­al price tag. PTC bagged it for $140 mil­lion up front, then set a vague net price of $35,000 based on the pa­tient’s weight — which could take some pa­tients past what Marathon want­ed to charge.

Marathon was ex­co­ri­at­ed for price goug­ing, but PTC has large­ly es­caped no­tice. Mean­while, there’s been grow­ing crit­i­cism of an­nu­al price hikes that are stan­dard in the in­dus­try — but that will al­most cer­tain­ly be off lim­its to reg­u­la­tors.

If the FDA does go for­ward against the prof­i­teers, though, it will be in­ter­est­ing to see where it draws the line.

Im­age: Scott Got­tlieb. AP IM­AGES

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

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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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.