Kalei­do prices $75M IPO well be­low range; Sage rais­es $575M ahead of FDA de­ci­sion

Al­i­son Law­ton

Kalei­do Bio­sciences has raised $75 mil­lion to de­vel­op its mi­cro­bio­me meta­bol­ic ther­a­pies in a down­sized IPO. The fi­nal go­ing price for the 5,000,000 shares was $15 each, falling short of the $20-$22 range CEO Al­i­son Law­ton had pre­vi­ous­ly planned, which would have trans­lat­ed in­to $100 mil­lion.

Trad­ing un­der the sym­bol $KL­DO, the biotech now plans to be­gin two Phase II hy­per­am­mone­mia pro­grams and con­tin­ue work­ing on oth­er treat­ments tar­get­ing mul­tidrug re­sis­tant bac­te­ria, ath­er­o­scle­rot­ic car­dio­vas­cu­lar dis­ease and chron­ic kid­ney dis­ease, though those pro­grams will pre­sum­ably get a small­er chunk of fund­ing than in­tend­ed.

Days ago Seres, an­oth­er mi­cro­bio­me-fo­cused biotech launched by Flag­ship Pi­o­neer­ing, was forced to lay off 30 re­search, man­u­fac­tur­ing and ad­min staffers — in­clud­ing its CSO — as part of its re­cov­ery from a Phase II set­back.

→ With its shares run­ning hot, Sage Ther­a­peu­tics $SAGE has gone out and banked some re­al cash. The biotech  raised $575 mil­lion through the sale of its stock. Sage ap­pears to be on the cusp of launch­ing a mar­ket­ing cam­paign for its in­jectable post­par­tum de­pres­sion ther­a­py, brex­anolone, which is ex­pect­ed to win FDA ap­proval by March.

→ Hav­ing ush­ered the first pre­clin­i­cal can­di­dates from Ab­Cellera in­to fur­ther de­vel­op­ment, De­nali has ex­pand­ed its part­ner­ship with the Van­cou­ver-based dis­cov­ery shop to re­serve eight more slots on its mi­croflu­idic-based screen­ing plat­form to iden­ti­fy leads for neu­rode­gen­er­a­tion tar­gets of its choice. In the pre­vi­ous col­lab­o­ra­tion, Ab­Cellera was able to gen­er­ate a num­ber of leads that pass muster at De­nali for a “high pro­file, top pri­or­i­ty” pro­gram that pre­vi­ous­ly was stuck, CEO Carl Hansen told End­points News — some­thing they are look­ing to repli­cate in the ex­pand­ed deal.

→ US Sen­a­tor and pres­i­den­tial hope­ful Bernie Sanders has asked law­mak­ers to re­sume dis­trib­ut­ing un­brand­ed, low­er-cost ver­sions of the LEMS drug, Fir­dapse, which is cur­rent­ly sold by Cat­a­lyst Phar­ma­ceu­ti­cals $CPRX for a con­tro­ver­sial $375,000 an­nu­al price tag, ac­cord­ing to a Reuters re­port, based on a let­ter from the Ver­mont sen­a­tor’s of­fice re­viewed by the wire agency. The news comes af­ter Sanders ad­mon­ished Cat­a­lyst for “fleec­ing” tax­pay­ers and called out the drug­mak­er for its “cor­po­rate greed”. Some pa­tients with the rare neu­ro­mus­cu­lar dis­or­der have cried foul fol­low­ing the FDA ap­proval in No­vem­ber, say­ing they can no longer ac­cess the com­pound, which was once hand­ed out free to many pa­tients by Ja­cobus Phar­ma­ceu­ti­cals, a lit­tle New Jer­sey-based out­fit that dis­trib­uted the treat­ment via the FDA’s com­pas­sion­ate use pro­gram.

Robert Forrester, Verastem

Ve­rastem CEO For­rester steps to the ex­it as the board hunts com­mer­cial-savvy ex­ec for the be­lea­guered biotech

Robert For­rester is step­ping down as CEO of Ve­rastem On­col­o­gy $VSTM just 8 months af­ter the com­pa­ny nabbed an ap­proval for du­velis­ib, a PI3K drug with a sto­ried past — and what ap­pears as not much of a fu­ture.

The biotech put out word this morn­ing that For­rester will take an ad­vi­so­ry role with Ve­rastem while COO Dan Pa­ter­son steps up to take charge of the lead­er­ship team and the board looks around for a new CEO.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

Ken Frazier appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

Who’s next in line to suc­ceed Ken Fra­zier as CEO of the Keytru­da-blessed Mer­ck?

When Merck waved off a looming forced retirement for Ken Frazier last September, the board cited flexibility in CEO transition as a key factor in the decision. Having Frazier — who’s also chairman of the company — around beyond his 65th birthday in 2019 would ensure they install the best person at the best time, they said.

The board has evidently begun that process with a clear preference for internal candidates, sources told Bloomberg. CFO Robert Davis, chief marketing officer Michael Nally, and chief commercial officer Frank Clyburn are all in the running, according to an insider.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,100+ biopharma pros reading Endpoints daily — and it's free.

In starved an­tibi­ot­ic field, Melin­ta soars as FDA grants speedy drug re­view

Such is the state of af­fairs in an­tibi­ot­ic land that the FDA agree­ing to pri­or­i­ty re­view an ap­pli­ca­tion to ex­pand the use of an an­tibi­ot­ic can rock­et up a stock more than two-fold.

On Wednes­day, Melin­ta Ther­a­peu­tics said its ap­proved an­tibi­ot­ic Baxdela had been grant­ed pri­or­i­ty re­view for use in com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia (CAPB). The FDA is ex­pect­ed to make its de­ci­sion by Oc­to­ber 24. Shares of the Con­necti­cut drug­mak­er $ML­NT cat­a­pult­ed, clos­ing up near­ly 224% at $6.41.

Brent Saunders at an Endpoints News event in 2017 — File photo

An­a­lyst call with Al­ler­gan ex­ecs stokes an­tic­i­pa­tion of a plan to split the com­pa­ny in ‘a month or two’

So what’s up at Al­ler­gan?

Ear­li­er this week the ubiq­ui­tous Ever­core ISI an­a­lyst Umer Raf­fat was on the line with com­pa­ny ex­ec­u­tives to probe in­to the lat­est on the num­bers as well as CEO Brent Saun­ders’ re­cent de­c­la­ra­tion that he’d be do­ing some­thing de­fin­i­tive to help long-suf­fer­ing in­vestors who have watched their shares dwin­dle in val­ue.

He came away with the im­pres­sion that a sig­nif­i­cant com­pa­ny split is on the way. And not on some dis­tant time hori­zon.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
Endpoints News

Basic subscription required

Unlock this story instantly and join 53,100+ biopharma pros reading Endpoints daily — and it's free.

Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,100+ biopharma pros reading Endpoints daily — and it's free.

John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,100+ biopharma pros reading Endpoints daily — and it's free.