Can a 're­dis­cov­ered' drug from In­dia make it big in US im­munol­o­gy space? Dan Brad­bury and his team at Equi­l­li­um want to prove yes

Biotech com­pa­nies typ­i­cal­ly knock on Nas­daq’s doors with sev­er­al rounds of fi­nanc­ing un­der their belt. Equi­l­li­um, how­ev­er, went straight for it.

Hav­ing reaped a $65.4 mil­lion IPO last month, the San Diego-based biotech is emerg­ing from stealth mode to dis­cuss for the first time that atyp­i­cal route — a some­what un­ex­pect­ed one, CEO Dan Brad­bury would add — and the atyp­i­cal arrange­ment that made it pos­si­ble for an op­er­a­tion that on­ly launched 18 months ago.

Equi­l­li­um li­censed North Amer­i­can rights to its one and on­ly drug, itolizum­ab, from In­di­an biosim­i­lar gi­ant Bio­con. Sold in In­dia as a pso­ri­a­sis treat­ment, the same drug has been rechris­tened EQ001 and is be­ing de­vel­oped for a num­ber of oth­er im­muno-in­flam­ma­to­ry dis­eases.

Brad­bury — who has known Bio­con founder Ki­ran Mazum­dar-Shaw since his days as CEO of di­a­betes drug­mak­er Amylin and cur­rent­ly sits on the Bio­con board — says Equi­l­li­um’s ap­proach is nov­el in the sense that re­cent ad­vances in im­munol­o­gy has al­lowed his team to “re­dis­cov­er” a prod­uct that was de­vel­oped in the 2000s to hit a tar­get, CD6, first dis­cov­ered in the 1980s.

In­hibit­ing CD6, new re­search has found, blocks ef­fec­tor T cell ac­tiv­i­ty with­out tam­per­ing with reg­u­la­to­ry T cells, a se­lec­tive ap­proach com­pared to some “brute force” bi­o­log­ics cur­rent­ly on the mar­ket, he says.

Bruce Steel

At the same time, he adds, since itolizum­ab is al­ready clin­i­cal­ly val­i­dat­ed and man­u­fac­tured at com­mer­cial scale, “it’s ac­tu­al­ly a fair­ly late-stage pro­gram rel­a­tive to many pro­grams that have gone pub­lic in the biotech­nol­o­gy space.”

Soon af­ter Equi­l­li­um li­censed the drug, Bio­con com­plet­ed “a large amount of work” need­ed to demon­strate that the prod­uct it was man­u­fac­tur­ing for Equi­l­li­um was bio­com­pa­ra­ble to what it was sell­ing on the mar­ket, as they are man­u­fac­tured on dif­fer­ent cell lines. It al­so wrapped a Phase I study for both sub­cu­ta­neous and IV forms of EQ001 in Aus­tralia (though part of the tri­al was ter­mi­nat­ed ear­ly, ac­cord­ing to the S-1) and got a thumbs up from the FDA re­gard­ing the man­u­fac­tur­ing fa­cil­i­ty it’s us­ing to make biosim­i­lars to be sold in the US — all good news for Equi­l­li­um.

That’s prob­a­bly part of what at­tract­ed the en­cour­age­ment from pub­lic in­vestors, many of whom had al­so worked with Brad­bury be­fore Amylin was sold to Bris­tol-My­ers Squibb for $5.3 bil­lion. The oth­er part? All the clin­i­cal plans lined up for 2019: Phase Ib/II aGVHD tri­al ear­ly on; Phase II cGVHD tri­al in H1; and proof-of-con­cept in se­vere asth­ma, with a goal to choose an ad­di­tion­al in­di­ca­tion be­fore wrap­ping up the year.

All told, the cash run­way should ex­tend to the next 24 months af­ter go­ing pub­lic at $14, the low end of the range. The stock has edged up, though, and is now rid­ing above $15 per share. The mar­ket cap is a mod­est $277 mil­lion.

Stephen Con­nel­ly

And Equi­l­li­um can do all this with­out wor­ry­ing about man­u­fac­tur­ing: Aside from a 13.9% stake in the com­pa­ny, Bio­con isn’t charg­ing any­thing for sup­ply­ing itolizum­ab for test­ing in up to three or­phan in­di­ca­tions. Pro­duc­tion cost of ad­di­tion­al prod­ucts, the $30 mil­lion promised in reg­u­la­to­ry mile­stones and $565 mil­lion sales pay­ments won’t be due un­til — or if — Equi­l­li­um nabs its first ap­proval in the US.

Mean­while, Brad­bury adds, Equi­l­li­um’s “small but mighty” team of 11 is still on the hunt for ad­di­tion­al as­sets to beef up its im­munol­o­gy pipeline.

Brad­bury and Bruce Steel, a co-founder of the com­pa­ny now serv­ing as pres­i­dent and CBO, own the largest chunks of stocks at 22.1% each. Stephen Con­nel­ly — co-founder, CSO and Steel’s for­mer col­league at Bio­Med Ven­tures — is in for 7.7%.

Im­age: Dan Brad­bury. EQUI­L­LI­UM

RWE chal­lenges for to­day's bio­phar­ma

The rapid development of technology — and the resulting avalanche of data — are catalysts for significant change in the biopharmaceutical industry. This translates into urgent pressures for today’s biopharma, including a need to quickly and affordably develop products with proven therapeutic efficacy and value. This urgency is expedited by the growth of value-based contracting, where access to reimbursement and profit depends on these abilities.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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As shares suf­fer from a lin­ger­ing slump, a bruised Alk­er­mes slash­es 160 jobs in R&D re­struc­tur­ing

With its share price in a deep slump after suffering through a regulatory debacle over their depression drug ALKS 5461, Alkermes CEO Richard Pops is taking the ax to its R&D organization in a restructuring aimed at cutting costs ahead of its next attempt at a rollout in a tough field.

Richard Pops, Endpoints via Youtube

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Acor­da's Ron Co­hen brings the ax back out as new drug sales on­ly trick­le in while cash cow is led to the slaugh­ter

With its new drug earning meager sums and its one-time cash cow reduced to a bony shadow of its former self, Acorda Therapeutics today is rolling out a new restructuring aimed at slashing the staff and cutting costs to get through the hard times ahead.

The biotech is chopping a quarter of its staff today, carving back R&D as well as SG&A expenses. And CEO Ron Cohen is cutting deep.

Under the new austerity budget, Acorda’s R&D expenses for the full year 2019 are expected to be $55 – $60 million, reduced from $70 – $80 million. SG&A expenses for the full year 2019 are expected to be $185 – $190 million, reduced from $200 – $210 million. R&D expenses for the full year 2020 are expected to be $20 – $25 million and SG&A
expenses for the full year 2020 are expected to be $160 – $165 million.

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RAPT Ther­a­peu­tics re­turns to Wall Street to re­vive IPO bid

On May 24, FLX Bio, a small cancer and inflammation biotech with backing from GV, changed its name to RAPT Therapeutics and filed confidentially for an IPO. On July 5th, they filed to raise up to $86 million. On July 22, they announced the IPO with a $75 million goal.  And on August 1, they abruptly and without explanation called it all off.

Now, without explanation, they’re reviving the bid, filing again for a $75 million IPO, this time with a new bookrunner and a new drug candidate in the clinic. The terms will be the same: 5 million shares at $14-$16 per share. It would give them a diluted market value of $351 million.

EY vet set to re­place re­tir­ing Am­gen CFO Meline

Ahead of its third-quarter results next week, Amgen on Tuesday disclosed the planned retirement of David Meline, who has served as the company’s chief financial officer since 2014.

Meline will be replaced by Ernst & Young vet, Peter Griffith, as CFO come January 1, 2020 — but until then Griffith will serve as executive vice president, finance.

“Over the last 5 years at Amgen, Meline instituted many major changes that led to operational efficiencies and margin expansion while successfully returning cash to shareholders. Now that Amgen is on solid footing, it was a good time to step away,” Cowen’s Yaron Werber wrote in a note. “We do not anticipate any major changes to strategy or operations immediately due to this transition as Amgen is on solid footing.”

Eli Lil­ly’s USA, di­a­betes chief En­rique Con­ter­no is head­ing out af­ter 27 years, and he’s be­ing re­placed by a com­pa­ny in­sid­er

Close to 3 years after Eli Lilly CEO Dave Ricks added the title of president of the US operations to Enrique Conterno’s resume, which included his helmsmanship of the diabetes franchise, the Peruvian born exec is set to retire after a 27-year run at the pharma giant.

Lilly put out the news just as it was posting Q3 results, with a mix of upbeat and downbeat results in the latest set of numbers from Lilly.
Conterno — a grizzled, deeply experienced and sometimes gruff veteran of the pharma world — was a high-profile figure at Lilly, stepping up to expanded duties as the company was forced to deal with intense pricing pressure on the diabetes side of the business. He had replaced outgoing US president Alex Azar, who later popped up as head of Health and Human Services in the Trump administration.
As head of the diabetes unit, Conterno had to deal with an extraordinarily competitive field as payers demanded bigger discounts. Trulicity’s success helped generate new revenue for the company, but Q3’s miss on revenue had a lot to do with the need for discounting the drug ahead of Novo Nordisk’s rival therapy, Rybelsus, which was priced on the wholesale level at an almost identical rate.

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No­var­tis hands off $80M in cash to part­ner up with a top biotech play­er in the fi­bro­sis sec­tor

Never underestimate the power of a good showing at a scientific conference.
In a presentation late last year, the researchers at Pliant Therapeutics launched a series of discussions about the preclinical data they were pulling together around their work on their small-molecule integrin inhibitor aimed at transforming growth factor beta, or TGF-β, a key pathway involved in fibrosis.
And they got some serious attention for the work.
“We got interest from pharma partners and at the end Novartis basically made it,” says Pliant CEO Bernard Coulie.

Is there a recipe for M&A suc­cess? The best and worst buy­out deals in the past decade of­fer some keys to suc­cess — and fail­ure

It’s not easy achieving a solid win in M&A in this industry. But if you follow a few simple guidelines, you may be able to increase your odds of success.
Geoffrey Porges and the team at SVB Leerink went about the “notoriously difficult” task of scoring the biopharma buyout of 2009 to 2019. Sizing up current and expected revenue from the products that were gained, they came up with the 5 winners:
Merck/Schering Plough
It says a lot about the field that it’s much easier sorting out the 5 worst deals, though there’s also a lot more competition for that title, notes Porges. As picked by the analysts:

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