Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long bat­tle for biosim­i­lars in the can­cer space be­gin.

Am­gen has launched its Avastin and Her­ceptin copy­cats — li­censed from the pre­de­ces­sors of Al­ler­gan — al­most two years af­ter the FDA had stamped its ap­proval on Mvasi (be­va­cizum­ab-awwb) and three months af­ter the Kan­jin­ti OK (trastuzum­ab-anns). While the biotech had been field­ing biosim­i­lars in Eu­rope, this marks their first for­ay in the US — and the first on­col­o­gy biosim­i­lars in the coun­try.

The part­ners are set­ting the WAC, or whole­sale ac­qui­si­tion cost, of both drugs 15% low­er than their ref­er­ence prod­ucts: $677.40 / 100 mg and $2,709.60 / 400 mg for Mvasi and $3,697.26 / 420 mg for Kan­jin­ti. The WAC, of course, rarely ends up be­ing the fi­nal price; re­bates, dis­counts and as­sis­tance pro­grams of­ten cut a big slice off be­fore mon­ey ex­changes hands. Am­gen and Al­ler­gan at­tempt­ed to take that in­to ac­count by look­ing at the av­er­age sell­ing price (ASP); on that front Mvasi is still 12% cheap­er than Avastin and Kan­jin­ti 13% be­low Her­ceptin.

“We note that the launch of these prod­ucts is slight­ly ahead of our 2020 as­sump­tion for both prod­ucts,” Cred­it Su­isse an­a­lyst Evan Seiger­man wrote in a note. “Still de­spite some un­knowns about the com­mer­cial­iza­tion of these as­sets, we are en­cour­aged with this progress and see >$500M across these two prod­ucts alone in the US.”

Bil­lions more are on the line. An­oth­er biosim­i­lar for Rit­ux­an, the fi­nal of Roche’s block­buster can­cer trio, is com­ing; Cred­it Su­isse fore­cast more than $3 bil­lion in to­tal sales at peak, much of which will go to Am­gen while Al­ler­gan — soon to be swal­lowed by Ab­b­Vie — col­lects roy­al­ties and mile­stones.

If they can con­vince physi­cians and pay­ers to switch, that is. No­tably, while Kan­jin­ti is ap­proved to treat every dis­ease on Her­ceptin’s la­bel, Mvasi is on­ly ap­proved for five of Avastin’s sev­en in­di­ca­tions.

Aside from the dis­counts, Seiger­man notes that the com­pa­nies will like­ly adopt oth­er strate­gies to com­pete with the brand-name prod­ucts:

We note that Am­gen ap­pears to be of­fer­ing pa­tient as­sis­tance pro­grams for these as­sets, es­sen­tial­ly sell­ing them more like a brand­ed prod­uct vs. a tra­di­tion­al gener­ic. We think that con­tract­ing/ ac­cess in ad­di­tion to pol­i­cy around J-codes (will dif­fer­ent biosim­i­lars to a spe­cif­ic prod­uct have one J-code or mul­ti­ple) and in­ter­change­abil­i­ty will al­so im­pact up­take curves.

It won’t be fast, com­ment­ed Scott Got­tlieb, who cheered on Mvasi’s ap­proval dur­ing his tenure at the FDA.

So­cial im­age cred­it: Am­gen

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

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Iterum's fu­ture looks un­cer­tain, af­ter lead an­tibi­ot­ic fails con­sec­u­tive piv­otal stud­ies

While the market for antibiotics remains in tatters — unlike many of its bankrupt (or at the brink of bankruptcy) peers — Iterum is suffering not because its antibiotic isn’t selling, but because the compound has now failed back-to-back late-stage studies.

The experimental drug, sulopenem, was designed to tackle drug-resistant infections with an outpatient focus (in addition to hospitals), to avert those reimbursement challenges that incentivize hospitals to prescribe cheaper, generic broad-spectrum antibiotics.

Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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IPOs abound in the time of coro­n­avirus, as For­ma Ther­a­peu­tics pen­cils in $150M Nas­daq de­but

The IPO engine is thriving, never mind the rampage of the coronavirus crisis on R&D timelines.

On Friday, along with synthetic lethality-focused biotech Repare Therapeutics, another Bristol Myers partner Forma Therapeutics also unveiled its plans to vault on to the Nasdaq — penciling in a target of $150 million.

The Watertown, Massachusetts-based company — which poached senior Genentech executive Frank Lee to take over the reins last year after more than a decade under founder Steve Tregay — raised a plump $100 million late last year, while shepherding its sickle cell disease (SCD) drug through an early-stage trial.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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