Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 bil­lion Vi­for buy­out, the com­pa­ny post­ed a dip in prof­its, due in part to a drop in plas­ma do­na­tions amid the pan­dem­ic.

How­ev­er, CEO Paul Per­reault as­sured in­vestors and an­a­lysts on the full-year call that the team has left “no stone un­turned” when as­sess­ing op­tions to grow plas­ma vol­umes. The chief ex­ec­u­tive al­so spelled out pos­i­tive re­sults for the com­pa­ny’s mon­o­clon­al an­ti­body garadacimab in hered­i­tary an­gioede­ma (HAE), though he isn’t re­veal­ing the ex­act num­bers just yet.

“Garadacimab has the po­ten­tial to be an­oth­er flag­ship mol­e­cule for CSL,” Per­reault said on the call, adding in a news re­lease that garadacimab met its pri­ma­ry and sec­ondary end­points and showed “fa­vor­able safe­ty and tol­er­a­bil­i­ty.”

The com­pa­ny’s stock on the Aus­tralian Se­cu­ri­ties Ex­change was down 1.3% on Wednes­day, pric­ing at around $202.

CSL prof­its were down rough­ly 6% for the four quar­ters end­ing June 30, Per­reault re­vealed on Wednes­day. A drop in plas­ma do­na­tions in FY21 con­strained sales of the com­pa­ny’s core plas­ma ther­a­pies in FY22, giv­en the long man­u­fac­tur­ing cy­cle, he said.

“The pan­dem­ic has put us two years be­hind pro­ject­ed growth in plas­ma col­lec­tions – which is sub­op­ti­mal for pa­tient care,” Per­reault said in a news re­lease.

CSL’s plas­ma do­na­tions are used to pro­duce ther­a­pies that treat bleed­ing dis­or­ders from HAE to Von Wille­brand dis­ease. CSL’s im­munoglob­u­lin and al­bu­min fran­chis­es re­ly heav­i­ly on do­na­tions.

Though the com­pa­ny has tak­en mea­sures to grow its plas­ma col­lec­tion, that comes at a high­er cost. All in all, plas­ma col­lec­tion is up 24% over the pre­vi­ous fis­cal year, as the re­sult of 27 new plas­ma col­lec­tion cen­ters open­ing. The com­pa­ny al­so aims to launch its plasma­phere­sis plat­form in FY23, which promis­es to re­duce the av­er­age do­na­tion time by about 30%.

“I will say Covid has pre­sent­ed chal­lenges for pa­tients. They have had lim­it­ed ac­cess to treat­ment and di­ag­no­sis. There has al­so been an en­vi­ron­ment of con­strained sup­ply,” Per­reault said on the call. “As the glob­al sup­ply re­cov­ers, we are an­tic­i­pat­ing a strong growth re­bound in the Ig port­fo­lio, with op­por­tu­ni­ties in core in­di­ca­tions of pri­ma­ry im­mune de­fi­cien­cy, sec­ondary im­mune de­fi­cien­cy and CIDP.”

As for garadacimab, Per­reault said full re­sults will be pre­sent­ed at an up­com­ing con­fer­ence, and CSL hopes to be­gin fil­ing with glob­al health au­thor­i­ties by the end of the cur­rent fis­cal year.

The CEO is wait­ing un­til Oc­to­ber to re­veal more in­for­ma­tion about the in­te­gra­tion of Vi­for. The com­pa­nies re­ceived reg­u­la­to­ry clear­ance just a cou­ple of weeks ago — months af­ter ini­tial­ly an­nounc­ing the deal.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

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Pfiz­er sacks phar­ma com­pe­ti­tion in ear­ly NFL TV ad­ver­tis­ing sea­son

If pharma advertising had a fantasy football league, Pfizer would be crushing the competition. A dive into the National Football League’s TV commercial buys across early season games by iSpot shows a hefty lead with its Covid-19 Comirnaty vaccine ads.

More than 175 million impressions with $9.5 million in media spending put Pfizer in the top spot with a 65% share of voice across NFL pharma spending, according to the real-time TV ad tracker. In a distant second place is Bristol Myers Squibb’s Opdivo with 44 million impressions, $5.2 million in spending and a 16% share, followed by BMS’ Zeposia with 31 million impressions, $3.3 million in media buys and an 11% share.

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