As pow­er shifts hands in Wash­ing­ton, a top an­a­lyst pre­dicts an un­avoid­able war over ris­ing drug prices

The drug in­dus­try has two pow­er­ful rea­sons for buck­ing Pres­i­dent Don­ald Trump’s cam­paign to cap and low­er drug prices. As Bern­stein’s Ron­ny Gal sees it, they have to keep drug prices mov­ing up­ward to meet Wall Street’s ex­pec­ta­tions on their num­bers.

Threat­en­ing to re­al­ly shove prices north is al­so a good bar­gain­ing chip for the price ne­go­ti­a­tions to come in Wash­ing­ton DC, he adds. And the in­dus­try may soon have a long­time al­ly among the De­moc­rats in a key po­si­tion to in­flu­ence any drug pric­ing leg­is­la­tion to come.

Ron­ny Gal

“The drug in­dus­try kind of has to come back to in­creas­ing prices,” Gal wrote in a note. “They will do so cau­tious­ly at first (eg CELG ‘med­ical cost in­fla­tion’ rate). If they don’t they will start miss­ing num­bers — in part be­cause net av­er­age prices will ac­tu­al­ly drop if they don’t as pa­tients grad­u­al­ly shift to low price chan­nels (Med­ic­aid, 340B).”

With the midterms now re­ced­ing in the back­ground, leav­ing the Dems in charge of the House, the bio­phar­ma in­dus­try has good rea­son to keep its pow­der dry as they try to stave off pol­i­cy changes that re­al­ly threat­ens their num­bers.

“Po­lit­i­cal­ly,” Gal writes, “phar­ma does not have to be as nice to PO­TUS now that CMS has pol­i­cy ideas that are an­ti­thet­i­cal to in­dus­try in­ter­est (the IPI, MA for­mu­la­ries). At the very least, threat­en­ing to raise prices gives in­dus­try a bar­gain­ing chip to ne­go­ti­ate some of these poli­cies away.”

An­na Es­hoo

The tidal shift in pow­er in Wash­ing­ton DC could come with a big bonus for in­dus­try lob­by­ists. An­na Es­hoo, a Cal­i­for­nia De­mo­c­rat who has helped craft big com­pro­mis­es on the lengthy ex­clu­siv­i­ty pe­ri­od grant­ed for bi­o­log­ics and more — to BIO’s im­mense sat­is­fac­tion — is mak­ing a bid to be­come chair of the Health Sub­com­mit­tee of the House En­er­gy and Com­merce Com­mit­tee. And she has the se­nior­i­ty to get it.

Frank Pal­lone

Gal, though, notes that Frank Pal­lone is slat­ed for the top seat on E&C, and he has in­di­cat­ed a will­ing­ness to work with Trump on pric­ing — not a pleas­ant prospect from the in­dus­try lob­by­ists’ per­spec­tive. In spe­cif­ic, Pal­lone has ad­vo­cat­ed a change al­low­ing Medicare to ne­go­ti­ate drug prices — rather than put a “Medicare for all” pro­vi­sion up for a vote.

Just be­fore the elec­tion Trump man­aged to rile up PhRMA with a pro­pos­al to es­sen­tial­ly im­port over­seas drug prices, forc­ing Medicare Part B to low­er drug prices to con­form with rates ne­go­ti­at­ed by sin­gle-pay­er na­tions like the UK. In part, that’s be­cause Trump wants to force the in­dus­try to force oth­er coun­tries to pay more for drugs, tak­ing some of the weight off the dom­i­nant US mar­ket. And in part it’s to low­er drug prices af­ter com­plain­ing for the last 2 years about the in­dus­try’s pric­ing strat­e­gy — which is to move high­er on their port­fo­lios year and year.

Pfiz­er moved the is­sue back on­to the pub­lic stage just days ago with its de­ci­sion to raise prices on 41 drugs, which rep­re­sents 10% of its com­mer­cial of­fer­ings, by an av­er­age of 5%. While that would have been a mod­el of re­straint 2 years ago, it trig­gered an im­me­di­ate back­lash from HHS, which has been com­ing up with new price re­forms for the pres­i­dent.

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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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.