Fac­ing a deep­en­ing po­lit­i­cal cri­sis, PhRMA launch­es a ma­jor coun­ter­at­tack against its le­gion of crit­ics

Un­der the most heat­ed po­lit­i­cal at­tack the drug in­dus­try has ever faced on Capi­tol Hill, the lob­by­ing pow­er­house PhRMA is rolling out its most am­bi­tious pub­lic re­la­tions cam­paign in its his­to­ry.

Just months af­ter rais­ing dues to gen­er­ate an ex­tra $100 mil­lion for its war chest, PhRMA is re­port­ed­ly spend­ing tens of mil­lions of dol­lars on a new cam­paign aimed to win hearts and minds in the grow­ing bat­tle over drug prices. PhRMA’s cam­paign will ini­tial­ly hit hard on the sci­en­tif­ic ad­vances that are be­ing made, spot­light­ing big ad­vances in R&D to the gen­er­al pub­lic. And then they want to spon­sor more dis­cus­sions in pub­lic fo­rums while pur­su­ing their leg­isla­tive agen­da.

The cam­paign has been in the works for months now. But it comes just days af­ter Pres­i­dent Don­ald Trump went on a tirade against the in­dus­try, say­ing that drug mak­ers had been “get­ting away with mur­der” on pric­ing and vow­ing to rein in costs. Lat­er, Trump ex­plained that he planned to al­low Medicare to di­rect­ly ne­go­ti­ate drug prices for the first time, putting Big Phar­ma on no­tice that it would soon lose one of its most prized po­lit­i­cal ac­com­plish­ments.

Hillary Clin­ton had more crit­i­cisms for phar­ma dur­ing the pres­i­den­tial cam­paign, but Trump has made up on any lost ground, adopt­ing what is like­ly to be a wide­ly pop­u­lar stance on drug prices.

The most ex­plo­sive el­e­ment in drug prices, and the most po­tent po­lit­i­cal­ly, has fo­cused on com­pa­nies like Tur­ing, My­lan, Valeant and Mallinck­rodt, which all jacked the price on old meds, un­fet­tered by any laws or reg­u­la­tions that might pro­hib­it price goug­ing. But there has al­so been con­sid­er­able crit­i­cism of the in­dus­try’s wide­spread prac­tice of push­ing an­nu­al price hikes on their port­fo­lio drugs. And the price of many new drugs of­ten reach well in­to six fig­ures, adding to the gen­er­al dis­con­tent that could spawn leg­is­la­tion that would have a wide in­flu­ence on all bio­phar­ma com­pa­nies.

PhRMA CEO Stephen Ubl touched on the up­com­ing cam­paign at a pan­el dis­cus­sion I host­ed at JP Mor­gan a few weeks ago. He said:

At PhRMA and with­in the in­dus­try, we’re fo­cused on two things. First, we’re go­ing to launch a very am­bi­tious, com­pre­hen­sive, na­tion­al com­mu­ni­ca­tions and pub­lic af­fairs ef­fort. One com­po­nent will be ad­ver­tise­ments that are fo­cused on the ex­cit­ing break­throughs in sci­ence that we’ve not been, again, re­port­ing on in my view. But more im­por­tant­ly, it’s not just about ads. The ef­fort is go­ing to be putting the in­dus­try in a lead­er­ship role and con­ven­ing stake­hold­ers to talk about how we move the sys­tem from vol­ume to val­ue and what our role in that is. We need to come to the ta­ble with so­lu­tions, whether they’re FDA re­forms, bar­ri­ers to in­no­v­a­tive con­tract­ing, con­sumer-ori­ent­ed trans­paren­cy.

One of the ma­jor themes in this cam­paign is ex­pect­ed to be the ex­tra­or­di­nary cost in­volved in drug de­vel­op­ment as cheap gener­ics con­tin­ue to lim­it the amount of mon­ey spent on drugs in gen­er­al. Pfiz­er has tak­en that stance al­ready. But even with a high lev­el of bi­par­ti­san sup­port in Con­gress, ev­i­dent in the re­cent pas­sage of the 21st Cen­tu­ry Cures Act, PhRMA and phar­ma face a big and grow­ing deficit of pub­lic trust.

This new cam­paign is like­ly to elic­it com­par­isons to the “Har­ry and Louise” cam­paign that the health in­sur­ance lob­by used to help beat back threat­en­ing leg­is­la­tion. But it will come at many times the cost of that $20 mil­lion ef­fort.

Drug prices may ac­tu­al­ly on­ly ac­count for a frac­tion of the health­care dol­lar, but there’s no ques­tion it’s a high-pro­file item for the pub­lic. A few days ago The Har­ris Poll found that on­ly 9% of Amer­i­cans be­lieve that drug com­pa­nies put pa­tients ahead of prof­its.

That’s a dan­ger­ous­ly weak po­si­tion to be in.

“There are un­de­ni­able rep­u­ta­tion­al risks for phar­ma­ceu­ti­cal and health in­sur­ance com­pa­nies – more so than oth­er parts of the health care ecosys­tem,” said Wendy Sa­lomon, vice pres­i­dent of rep­u­ta­tion man­age­ment and pub­lic af­fairs at Nielsen. “Rep­u­ta­tion mat­ters to pa­tients, care providers, in­vestors, em­ploy­ees, and po­ten­tial hires. Pos­i­tive rep­u­ta­tions can pave the way in times of cri­sis, in times of tran­si­tion – and when it’s crit­i­cal to have a seat at the pol­i­cy-set­ting ta­ble.”


Fangliang Zhang, AP Images

Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom

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.

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.

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.

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.

RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.

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.

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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