Valeant wins first round in $445M gam­ble on bro­dalum­ab ap­proval

Valeant made an un­usu­al ap­pear­ance in front of an FDA ex­pert pan­el on Tues­day, and came out with a clear en­dorse­ment for an FDA ap­proval of their pso­ri­a­sis drug bro­dalum­ab.

The pan­el vot­ed 18 to 0 in fa­vor of ap­prov­ing bro­dalum­ab, de­spite the agency’s in­ter­nal re­view, which linked the drug to 6 sui­cides and sui­ci­dal ideation as well as car­dio risks. Four of the pan­elists rec­om­mend­ed an ap­proval with noth­ing more than a clear la­bel warn­ing on the risks in­volved, 14 vot­ed yes on an ap­proval with a risk man­age­ment plan in place.

Some of the pan­el mem­bers rec­om­mend­ed a black box warn­ing, which could lim­it the drug’s com­mer­cial po­ten­tial.

The pan­el, though, was won over by the ef­fi­ca­cy da­ta, the op­por­tu­ni­ty of adding a new weapon to be used against pso­ri­a­sis and a will­ing­ness to find a way to man­age what most con­sid­ered a mar­gin­al risk of sui­cide. Most of the pan­elists dis­missed any con­nec­tion with MACE or car­dio con­cerns.

“It seems to me the ben­e­fit for this drug has tremen­dous po­ten­tial for these pa­tients who are ab­solute­ly mis­er­able,” says Har­vard’s Lynn Drake, who sits on the FDA’s Der­ma­to­log­ic and Oph­thalmic Drugs Ad­vi­so­ry Com­mit­tee. “I think we have a drug here that is at some lev­els a bit of a game chang­er.” As for the six sui­cides: “It’s a sug­ges­tion, not a sig­nal.”

Valeant, known for its aver­sion to R&D risk, bought the pso­ri­a­sis drug bro­dalum­ab from As­traZeneca for the bar­gain base­ment rate of $100 mil­lion up front, $170 mil­lion in prelaunch mile­stones and an­oth­er $175 mil­lion in sales bonus­es. The big phar­ma un­loaded the drug af­ter its part­ner Am­gen bailed out ear­li­er af­ter a close look at a link be­tween the drug and sui­cides and sui­ci­dal think­ing con­vinced them that the com­mer­cial op­por­tu­ni­ty had been up­end­ed.

Where Am­gen saw fail­ure Valeant smelled op­por­tu­ni­ty, bag­ging the drug ahead of the reg­u­la­to­ry re­view. The com­pa­ny has made a prac­tice of buy­ing con­tro­ver­sial or mar­gin­al drugs, like Provenge and bro­dalum­ab. But in re­cent months its busi­ness mod­el, which de­pends heav­i­ly on ever-high­er prices for port­fo­lio drugs, has wilt­ed un­der a bright spot­light of un­fa­vor­able at­ten­tion, which has wilt­ed its share price.

The FDA usu­al­ly fol­low the guid­ance of its ex­perts, but there’s no guar­an­tee the agency will ap­prove the drug as-is be­fore first re­quir­ing a safe­ty study. That’s the big risk that still re­mains, though the odds in Valeant’s fa­vor clear­ly just im­proved by a wide mar­gin.

Even if Valeant does over­come the safe­ty is­sues and wins a for­mal ap­proval, it will face off against a crowd­ed field of ri­vals: Eli Lil­ly’s ix­ek­izum­ab, ap­proved in March as Taltz, Mer­ck’s MK-3222 and J&J’s IL-23 in­hibitor guselkum­ab. No­var­tis’ was first out in­to the mar­ket, with Cosen­tyx.

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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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.

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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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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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.

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.