A US sen­a­tor calls out a lit­tle biotech for price goug­ing. But will it change any­thing?

A lit­tle known biotech called Strong­bridge Bio­phar­ma has at­tract­ed the at­ten­tion of a promi­nent US sen­a­tor who would like to make the com­pa­ny the lat­est poster child for price goug­ing in the phar­ma world.

Claire Mc­Caskill

Ear­li­er this week the Wash­ing­ton Post pub­lished a re­port which de­tailed how Strong­bridge ob­tained an old and once cheap drug that had nabbed an FDA ap­proval for a rare dis­ease, and jacked a six-fig­ure price for pa­tients. And Mis­souri Sen­a­tor Claire Mc­Caskill says she wants to do some­thing to stop this — and pre­vent oth­ers from fol­low­ing what has be­come a well worn path.

Six­teen years ago, the Post re­port­ed, you could buy 100 pills of Daranide for $50 and use it to treat glau­co­ma. It al­so be­came pop­u­lar among a small group of pa­tients suf­fer­ing from pe­ri­od­ic paral­y­sis. And when Mer­ck dropped the drug, those rare dis­ease pa­tients be­gan to source the treat­ment from over­seas for a few hun­dred dol­lars a month.

Taro then got the drug rights from Mer­ck in 2008 — in­spired by the son of the chair­man, who suf­fered from pe­ri­od­ic paral­y­sis — but then was ac­quired by Sun. The rare dis­ease ap­proval came through in 2015, the name changed to Keveyis and the price went to $13,650 for 100 pills. Then Strong­bridge nabbed the 50-year-old drug and drove the price to $15,001 for 100 pills.

The cost for treat­ing a pa­tient with the drug: $109,500 to $219,000 a year, de­pend­ing on the dose.

The strat­e­gy is sim­i­lar to what Marathon did when it bagged rights to a cheap Eu­ro­pean steroid and then won an FDA ap­proval to sell it for Duchenne mus­cu­lar dy­s­tro­phy af­ter dust­ing off some old da­ta from a long for­got­ten study. In the sub­se­quent con­tro­ver­sy that erupt­ed when they an­nounced a price of $89,000 a year, Marathon sold the drug to PTC Ther­a­peu­tics.

Mar­tin Shkre­li, now in prison await­ing sen­tenc­ing on a fraud con­vic­tion, still draws crit­i­cism for his move to buy an old and close­ly con­trolled ther­a­py and then sim­ply hiked the price more than 5,000%.

“Time and again we’ve seen phar­ma­ceu­ti­cal com­pa­nies ac­quire decades old pre­scrip­tion drugs and gouge con­sumers—and it’s time we ex­plored every pos­si­ble way to pre­vent this prac­tice,” Mc­Caskill said in a state­ment.

Mc­Caskill, though, isn’t the on­ly politi­cian to con­demn such price spikes. But as PTC, Tur­ing and oth­ers have shown, even the sharpest crit­i­cism in Wash­ing­ton DC can do lit­tle to rein in a drug’s price, when the law gives man­u­fac­tur­ers free rein to set what­ev­er price they please.

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.

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.

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.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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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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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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.