Sar­to­rius buys ma­jor­i­ty stake in Ger­man man­u­fac­tur­ing play­er; Cerev­el Ther­a­peu­tics ends the week on a high note, with $350M raise

Sar­to­rius Ste­d­im Biotech ac­quired a ma­jor­i­ty stake in Ger­many-based Cell­Genix GmbH, the com­pa­nies an­nounced Fri­day.

Sar­to­rius has ac­quired 51% of the com­pa­ny for $118.3 mil­lion and an­nounced the plan to ac­quire the re­main­ing shares of the com­pa­ny at the be­gin­ning of 2023 and 2026.

Cell­Genix was start­ed at the Uni­ver­si­ty Med­ical Cen­ter of Freiburg in 1994 and cur­rent­ly em­ploys 70 peo­ple. The com­pa­ny gen­er­at­ed $23.6 mil­lion in sales in 2020.

“For us, Sar­to­rius Ste­d­im Biotech is an ide­al part­ner with a high­ly com­ple­men­tary prod­uct port­fo­lio that will ac­cel­er­ate our de­vel­op­ment with its glob­al sales team, en­abling us to ush­er in our next phase of growth,” Cell­Genix CEO Fe­li­cia Rosen­thal, said in a press re­lease.

Sar­to­rius has a sales sub­sidiary in Cam­bridge, MA, which is lo­cat­ed just 55 miles south of Cell­Genix’s Portsmouth, NH lo­ca­tion. The com­pa­ny plans to ex­pand the Freiburg site and es­tab­lish it as a man­u­fac­tur­er of raw ma­te­ri­als for cell and gene ther­a­py. — Josh Sul­li­van

Cerev­el Ther­a­peu­tics ends the week on a high note, with $350M raise

The good news con­tin­ues for Cerev­el Ther­a­peu­tics. A few days af­ter an ear­ly look at pos­i­tive da­ta in schiz­o­phre­nia sent the biotech’s shares soar­ing, the Pfiz­er spin­out is now un­veil­ing a $350 mil­lion raise.

Cerev­el priced an un­der­writ­ten pub­lic of­fer­ing of 14 mil­lion shares at $25 apiece, the com­pa­ny said on Thurs­day. The news comes af­ter Cerev­el an­nounced that pa­tients who took a 30 mg dose of its CVL-231 once a day saw a mean re­duc­tion from base­line of 19.5 points on the Pos­i­tive and Neg­a­tive Syn­drome Scale (PANSS), a med­ical scale used for mea­sur­ing symp­tom sever­i­ty in those with schiz­o­phre­nia. That group saw a mean re­duc­tion of 12.7 points on the PANSS scale com­pared to the place­bo group, with a p-val­ue of 0.023, ac­cord­ing to the com­pa­ny.

In the 20 mg, twice-dai­ly group, pa­tients who took CVL-231 saw a 17.9-point mean re­duc­tion from base­line, and an 11.1-point mean re­duc­tion com­pared to the place­bo group, with a p-val­ue of 0.047.

Cerev­el was formed a cou­ple of years ago, when Pfiz­er shut down its neu­ro­science di­vi­sion. Bain Cap­i­tal picked up the pieces and de­cid­ed to spin them out in­to a new biotech, bet­ting $350 mil­lion that the as­sets were still valu­able.

Cerev­el’s stock $CERE more than dou­bled on Tues­day, when it re­leased the CVL-231 re­sults. But shares were down about 11% on Fri­day, pric­ing in at $23.77. — Nicole De­Feud­is

FDA hands bad news to Iterum less than a month be­fore PDU­FA goal date

The FDA has iden­ti­fied de­fi­cien­cies with its new drug ap­pli­ca­tion for a uri­nary tract in­fec­tion med­i­cine, which it dis­closed to Iterum Ther­a­peu­tics in a let­ter.

The de­fi­cien­cies were not made known to Iterum, the com­pa­ny said, and the let­ter states that it does not re­flect a fi­nal de­ci­sion for the NDA for su­lopen­em et­zadrox­il/probenecid

“While we are dis­ap­point­ed by this news, we con­tin­ue to be­lieve in the po­ten­tial of su­lopen­em to help ad­dress the grow­ing chal­lenge of an­tibi­ot­ic re­sis­tance,” CEO Corey Fish­man said in a state­ment. “Our goal now is to work with the FDA to iden­ti­fy and re­solve the is­sues as ex­pe­di­tious­ly as pos­si­ble in or­der to con­tin­ue ad­vanc­ing this much need­ed an­tibi­ot­ic.”

The FDA has as­signed a PDU­FA goal date of Ju­ly 25. — Josh Sul­li­van

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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