Too much suc­cess? A boom­ing biotech pipeline will spur in­tense ri­val­ries — an­a­lyst

Over the last 5 years biotech has been boom­ing. And that could pose a big prob­lem for every­one in­volved.

Ge­of­frey Porges

Like oth­ers in the in­dus­try, Leerink’s Ge­of­frey Porges hasn’t over­looked ev­i­dence that every hot new tar­get in drug dis­cov­ery quick­ly at­tracts a clus­ter of bio­phar­ma com­pa­nies. At ASH, he count­ed at least a dozen BC­MA drugs in the pipeline. So Porges de­cid­ed to quan­ti­fy the trend, break­ing it down in­to 15 ther­a­peu­tic ar­eas.

Over the last 5 years, as mon­ey has been pour­ing in­to drug de­vel­op­ment, Porges found that there was an av­er­age in­crease in com­pet­i­tive­ness of 65% across the board, with a mean jump from 4 to 7 drugs per in­di­ca­tion.

But you haven’t seen any­thing yet.

Just look­ing at what’s in the pipeline, Porges fac­tors in a 35% ap­proval rate for late-stage drugs — a con­ser­v­a­tive fig­ure — and es­ti­mates that the lev­el of com­pe­ti­tion will jump by an av­er­age of 120% over the next 5 years. Bro­ken down by in­di­ca­tion, the in­creas­es range from 10% to 250%.

HIV is on the low end of that spec­trum, with PNH, atopic der­mati­tis and oth­er dis­eases on the high end.

Stat­ed an­oth­er way, com­pet­i­tive in­ten­si­ty in es­tab­lished and emerg­ing ther­a­peu­tic cat­e­gories is in­creas­ing, but more im­por­tant­ly, it ap­pears that the rate of in­crease in com­pet­i­tive in­ten­si­ty is ac­cel­er­at­ing. By the be­gin­ning of 2024 it ap­pears that many of these emerg­ing in­di­ca­tions could see up to three times as many nov­el med­i­cines as they do to­day.

These drugs will be pour­ing in­to a com­mer­cial sys­tem that is like­ly to re­ward in­fe­ri­or drugs priced at low­er rates, dis­rupt­ing the mar­ket in ways that could have a big im­pact on pric­ing and rev­enue po­ten­tial for every­one in­volved.

In ad­di­tion, this trend isn’t just lim­it­ed to the big dis­eases that com­mand big bucks, like lung can­cer. Com­pe­ti­tion is grow­ing every­where, with a rapid es­ca­la­tion in dis­eases like SMA and pem­phi­gus.

These dis­eases are like­ly to go from un­der­served five years ago, to high­ly com­pet­i­tive with many treat­ment op­tions, in the course of a 5 to 10 year span. Con­cern about the com­mer­cial risks from this in­creased com­pet­i­tive in­ten­si­ty has cre­at­ed val­u­a­tion over­hangs for two of our cov­er­age com­pa­nies pri­mar­i­ly in­vest­ed in these mar­kets, Bio­gen (BI­IB, MP) and Prin­cip­ia (PRNB, OP), and sim­i­lar con­cerns al­ready weigh on the val­u­a­tion out­look for com­pa­nies de­vel­op­ing drugs for oth­er rare, and rel­a­tive­ly rare, dis­ease in­di­ca­tions.

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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Covid-19 roundup: Mod­er­na dos­es first pa­tients in PhII vac­cine tri­al; Eli Lil­ly touts clin­i­cal en­try of Ab­Cellera-dis­cov­ered an­ti­body

With an eye on kick-starting Phase III for its mRNA vaccine in July, Moderna said it’s dosed the first participants of each age cohort enrolled in the Phase II study.

Moderna is responsible for the whole trial, which is designed to recruit 600 healthy volunteers — 300 between the ages of 18 and 55, and another 300 older than 55. Two doses (50 μg and 100 μg) will be tested alongside placebo, and each participant receives two shots.

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Roche nabs front­line OK for Avastin/Tecen­triq in com­mon liv­er can­cer, best­ing an old Bay­er drug

For the first time in 12 years, the FDA has approved a new frontline treatment for the most common form of liver cancer.

The agency okayed a combination of Roche’s anti-VEGF antibody Avastin and their immunotherapy Tecentriq for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The approval comes two weeks after Roche and their big biotech sub Genentech published Phase III results showing the combo improved both progression-free survival and, crucially, helped patients live longer than the long-running standard-of-care, Bayer’s Nexavar.

Jean-Jacques Bienaime, 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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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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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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Ver­sant-backed, Bris­tol My­ers-stamped Re­pare Ther­a­peu­tics guns for $100M IPO

With a Bristol Myers Squibb endorsement in tow, Versant-backed cancer drug developer Repare Therapeutics has set its sights on a Nasdaq debut.

On Friday, the Montreal-based company with operations in Cambridge, Massachusetts that is yet to enter the clinic, unveiled plans for a $100 million IPO, banking on its “synthetic lethality” platform.

The basic idea is to target the genetic basis of tumors, a common idea across precision oncology medicines. But instead of targeting the perpetrator mutation directly, the compound is designed to go after the other gene in the gene pair. The rationale is based on the decades-old genetic principle that indicates two mutations are lethal only when combined together.

Lynn Seely, Myovant CEO

My­ovant’s re­l­u­golix wins a piv­otal prostate can­cer show­down with an old stan­dard — com­ing down to the wire on ap­provals

Myovant $MYOV has rounded the final turn in its development race to get relugolix down to the regulatory wire at the FDA. And the biotech joined the virtual crowd at ASCO with the kind of data needed to keep the investor crowd’s attention.

Much of the attention on the drug has been focused on uterine fibroids, where AbbVie just scored a regulatory win for their rival drug Oriahnn (elagolix) as the biotech posted results in prostate cancer at the ASCO meeting.

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