Sanofi/Re­gen­eron’s one-two punch on PC­SK9 price and health da­ta wins a key con­vert as Ex­press Scripts cre­ates ex­clu­sive for­mu­la­ry deal

Just 7 weeks af­ter Sanofi $SNY and Re­gen­eron $REGN flagged piv­otal da­ta on a clear mor­tal­i­ty ben­e­fit to be had from its PC­SK9 car­dio drug Pralu­ent, they’re back with a chum­my pub­lic self­ie with Ex­press Scripts that swaps a new dis­count price in ex­change for a pledge to dis­man­tle any hur­dles that could pre­vent the PBM’s 20 mil­lion mem­bers from tak­ing ad­van­tage of it.

Len Schleifer

No­body’s talk­ing specifics here, but in March Sanofi/Re­gen­eron pledged to cut its price to $4,460 to $7,975 a year for pay­ers who are will­ing to stop throw­ing up road­blocks to this drug, drop­ping to a price that on the low end is not much high­er than the $10-a-day cost of the old gen­er­a­tion of statins be­fore they went gener­ic. At the high end, it still marks a sharp drop from the $14,000 whole­sale price that had been the mar­ket stan­dard used to peg dis­counts against.

Salt­ing that deal with new mor­tal­i­ty ben­e­fits from longterm use, a goal that elud­ed ri­val Am­gen, ap­pears to be enough for at least one of the most promi­nent phar­ma­cy play­ers to see their way through to drop­ping the com­plex ap­proval process that made this drug a non­event on the bot­tom line. Ex­press Scripts is giv­ing Sanofi/Re­gen­eron an ex­clu­sive place on their for­mu­la­ry — take that, Am­gen — with a pledge to pass along the sav­ings to its mem­bers through low­er out-of-pock­et ex­pens­es.

The blunt Re­gen­eron CEO Len Schleifer said the deal was “de­signed to break the grid­lock so that Pralu­ent is fi­nal­ly able to reach pa­tients most in need. U.S. car­di­ol­o­gists have ex­pe­ri­enced un­prece­dent­ed chal­lenges in se­cur­ing ac­cess for Pralu­ent for pa­tients who were clear­ly ap­pro­pri­ate, but were de­nied cov­er­age. This agree­ment sets a new stan­dard in in­dus­try and pay­er col­lab­o­ra­tion that we hope will serve as a mod­el for how to make in­no­v­a­tive med­i­cines more ac­ces­si­ble and af­ford­able.” 

And ICER chief Steven Pear­son of­fered his en­dorse­ment, hap­py to see some re­al ne­go­ti­at­ing on price and ac­cess. He not­ed:

Fol­low­ing a decades-long trend to­ward dys­func­tion and fin­ger-point­ing, the US health care sys­tem is be­gin­ning to ad­dress its drug pric­ing prob­lem through the emer­gence of a ‘grand bar­gain.’ When a man­u­fac­tur­er is will­ing to re­spon­si­bly price an in­no­v­a­tive med­i­cine in line with its clin­i­cal ben­e­fits, pay­ers should rec­i­p­ro­cate by re­mov­ing the hur­dles that can pre­vent pa­tients from get­ting the drug.

Mike Suesser­man

Sanofi/Re­gen­eron and Am­gen have been duk­ing it out over who owns the patents on PC­SK9, but both have been es­sen­tial­ly side­lined by pay­ers’ per­sis­tent re­fusal to hit a green light on these drugs. With physi­cians star­ing at a pile of pa­per­work and re­peat­ed de­nials, these com­pa­nies nev­er had a chance at the orig­i­nal high price they want­ed to fetch. Re­al­i­ty dawned slow­ly, but the sun is com­ing up on a field that a host of an­a­lysts still res­olute­ly be­lieves is a block­buster mar­ket in the mak­ing.

“We’ve been out on the mar­ket close to three years,” says Mike Suesser­man, VP of the car­diometa­bol­ic and opthamol­o­gy busi­ness unit at Re­gen­eron. They’ve seen lots of feed­back along the way and iden­ti­fied what the crit­i­cal hur­dles are. This deal, he says, ad­dress­es those hur­dles.

“In that sense I think it’s a huge leap for­ward.”

You can bet that more such leaps for­ward are in the works as Am­gen looks to strike back on the phar­ma­cy front.

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.

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.

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.

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.

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.

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.

David Meline (file photo)

Mod­er­na’s new CFO took a cut in salary to jump to the mR­NA rev­o­lu­tion­ary. But then there’s the rest of the com­pen­sa­tion pack­age

David Meline took a little off the top of his salary when he jumped from the CFO post at giant Amgen to become the numbers czar at the upstart vaccines revolutionary Moderna. But the SEC filing that goes with a major hire also illustrates how it puts him in line for a fortune — provided the biotech player makes good as a promising game changer.

To be sure, there’s nothing wrong with the base salary: $600,000. Or the up-to 50% annual cash bonus — an industry standard — that comes with it. True, the 62-year-old earned $999,000 at Amgen in 2019, but it’s the stock options that really count in the current market bliss for all things biopharma. And there Meline did well.

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Por­tion of Neil Wood­ford’s re­main­ing in­vest­ments, in­clud­ing Nanopore, sold off for $284 mil­lion

It’s been precisely one year and one day since Neil Woodford froze his once-vaunted fund, and while a global pandemic has recently shielded him from the torrent of headlines, the fallout continues.

Today, the California-based patent licensing firm Acacia Research acquired the fund’s shares for 19 healthcare and biotech companies for $284 million.  Those companies include shares for public and private companies and count some of Woodford’s most prominent bio-bets, such as Theravance Biopharma, Oxford Nanopore and Mereo Biopharma, according to Sky News, which first reported the sale. It won’t include shares for BenevelontAI, the machine learning biotech once valued at $2 billion.