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

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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