Co­herus looks to dis­rupt Am­gen’s $4B Neu­las­ta fran­chise as an­a­lysts look for a deep dis­count on its copy­cat price

De­spite be­ing the run­ner-up in the race to a US ap­proval for a biosim­i­lar of Neu­las­ta, an­a­lysts are watch­ing to see if lit­tle Co­herus could gain quick trac­tion if they sell theirs at a big dis­count to My­lan’s ri­val.

On Fri­day, Co­herus said it had se­cured the FDA’s nod for a copy­cat ver­sion of Am­gen’s block­buster prod­uct — com­ing sec­ond to My­lan $MYL and In­di­an part­ner Bio­con in the race to mar­ket a biosim­i­lar for Neu­las­ta in the more lu­cra­tive US mar­ket. Co­herus’ biosim­i­lar, Uden­cya, was grant­ed Eu­ro­pean ap­proval in Sep­tem­ber.

Ken Cac­cia­tore

Neu­las­ta, which is used to thwart in­fec­tions in can­cer pa­tients, ac­count­ed for near­ly a fifth of Am­gen’s net prod­uct sales in the third quar­ter, bring­ing in about $1.05 bil­lion but this ap­proval has added more pres­sure to the drug’s al­ready weak­en­ing rev­enue out­look. Mean­while, No­var­tis $NVS is al­so plan­ning to re­sub­mit an ap­pli­ca­tion to mar­ket its once-re­ject­ed Neu­las­ta biosim­lar next year.

Out­side of the US, Neu­las­ta on­ly rep­re­sents a rough­ly $500 mil­lion op­por­tu­ni­ty, which mean the core fo­cus is on the sig­nif­i­cant­ly more lu­cra­tive $4 bil­lion US mar­ket and even mod­est pen­e­tra­tion with this as­set alone could mean­ing­ful­ly stem Co­herus’ cash burn — and/or po­ten­tial­ly lead to prof­itabil­i­ty, said Cowen an­a­lyst Ken Cac­cia­tore in a note. “Even at a 40%+ price dis­count, on­ly 10% of the mar­ket would al­low Co­herus…to turn cash-flow breakeven while still sup­port­ing a ro­bust de­vel­op­ment pipeline.”

The FDA ap­proval for Co­herus’ Uden­cya comes lat­er than ex­pect­ed as the reg­u­la­tor de­clined to ap­prove the drug last June, ask­ing the com­pa­ny to con­duct a re-analy­sis of ex­ist­ing da­ta with a more sen­si­tive as­say. De­tails on the drug’s com­mer­cial­iza­tion plan will be pro­vid­ed on the com­pa­ny’s Nov. 8 quar­ter­ly earn­ings call, the Red­wood City, Cal­i­for­nia-based com­pa­ny said in a state­ment.

“The list price of Neu­las­ta has near­ly tripled since ap­proval in 2002 and now rep­re­sents a $4 bil­lion an­nu­al cost bur­den in the U.S…and Udeny­ca will play an im­por­tant role in curb­ing that spend when launched,” said Co­herus chief Den­ny Lan­fear.

Jim Has­sard

In Co­herus’ sec­ond quar­ter con­fer­ence call in Au­gust, se­nior VP of mar­ket­ing Jim Has­sard not­ed that the list price of Neu­las­ta is about $6200 per pre-filled sy­ringe, and its av­er­age sell­ing price — as pub­lished by CMS — is about $4200. My­lan came to the mar­ket with a price that is about 6% low­er than the av­er­age sell­ing price, he said, and an­a­lysts con­curred that My­lan’s launch had thus been fair­ly ane­mic due to its mod­est dis­count.

Over­all, Co­herus man­age­ment has in­di­cat­ed Uden­cya could be in a po­si­tion to cap­ture rough­ly 10-20% of the cur­rent US mar­ket fol­low­ing the first full year of launch, not­ed Cowen’s Cac­cia­tore. “Al­though there still re­mains some con­tro­ver­sy about po­ten­tial pen­e­tra­tion rates and pric­ing/con­tract­ing strate­gies, we be­lieve this is a rea­son­able ex­pec­ta­tion. We con­tin­ue to find it dif­fi­cult to be­lieve that if the sup­ply is con­sis­tent, and if there is a per­cep­tion that the qual­i­ty of the prod­uct is high, that there will not be mean­ing­ful share that would be will­ing to move to a sig­nif­i­cant­ly dis­count­ed prod­uct (40% +).”

Ge­of­frey Porges, Leerink

Al­though Co­herus’ pric­ing strat­e­gy is un­clear, they have been in ac­tive dis­cus­sion with pay­ers and oth­er stake­hold­ers, and ap­pear to have more than enough sup­ply in place in tan­dem with a man­u­fac­tur­ing ca­pac­i­ty that is pow­ered to sup­port a mar­ket share of 28%, Leerink’s Ge­of­frey Porges wrote in a note, adding that an­oth­er per­ceived ad­van­tage Co­herus has is that all its prod­ucts are man­u­fac­tured in the US, un­like My­lan’s Neu­las­ta copy­cat Ful­phi­la that is made by Bio­con in In­dia.

“Co­herus al­so learned the les­son from Am­gen to pro­vide billing and co-pay as­sis­tance to physi­cians and pa­tients, re­spec­tive­ly, and is aim­ing to match the ‘white glove’ ser­vice Am­gen pro­vides…they could con­tribute to greater-than-ex­pect­ed ear­ly share gains for Co­herus, should they match Am­gen’s sales sup­port,” he said.

Am­gen last year sued Co­herus, ac­cus­ing the com­pa­ny of a mas­sive con­spir­a­cy by poach­ing its em­ploy­ees and spurring them to use their trade se­crets to stim­u­late the de­vel­op­ment of Co­herus’ slate of biosim­i­lars. Lan­fear pre­vi­ous­ly served as Am­gen’s VP of mar­ket de­vel­op­ment, while Co­herus’ chief sci­en­tif­ic of­fi­cer and chief tech­ni­cal of­fi­cer have al­so both worked at Am­gen. Co­herus de­nied the charges.

Co­herus’ shares were up about 5.7% in pre­mar­ket trad­ing on Mon­day.

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

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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Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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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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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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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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Novus Ther­a­peu­tics plunges deep in­to pen­ny stock ter­ri­to­ry af­ter failed ear tri­al

After a more than 15-year run, a California-based biotech is exploring options, including a sale, after its lead experimental therapy failed an exploratory mid-stage study in patients with middle ear infections characterized by a build-up of fluid behind the eardrum.

The company, initially called Tokai Pharmaceuticals but which subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM).

Federico Mingozzi (Spark)

Spark touts an­i­mal da­ta for a so­lu­tion to AAV gene ther­a­py's an­ti­body prob­lem

Among all the limitations of using an adeno-associated virus as a vector to deliver a gene — still the most established modality in gene therapy given years of trial and error and finally success — the presence of neutralizing antibodies, whether pre-existing or induced, looms large.

“When I think about the immune responses in AAV, I try to sort of layer them,” Federico Mingozzi, the CSO at Spark Therapeutics, told Endpoints News. “The antibody is the first layer. It’s the first block that you find when you’re trying to do gene transfer.”