A fi­nal flop sig­nals the bit­ter end to Cir­cas­sia’s big plans for al­ler­gy R&D

Cir­cas­sia CEO Steve Har­ris

Re­mem­ber the big plans Cir­cas­sia {LSE: CIR} had for its al­ler­gy drug pipeline when it went pub­lic, rais­ing $333 mil­lion in 2014 with promis­es of big things to come for in­vestors?

It didn’t work out. In fact, it was a com­plete bust.

Their Phase IIb has now wrapped for a house dust mite al­ler­gy rem­e­dy, and it failed like the rest of the stud­ies. So Ox­ford, UK-based Cir­cas­sia is pack­ing it in, and switch­ing over to a res­cue strat­e­gy pre­sent­ed by As­traZeneca.

Here’s CEO Steve Har­ris’ pre­pared eu­lo­gy:

We re­main con­vinced that the tech­nol­o­gy has bi­o­log­ic ac­tiv­i­ty, but we al­so be­lieve the dif­fi­cul­ty in over­com­ing the place­bo ef­fect us­ing the field study de­signs re­quired by reg­u­la­tors rep­re­sents a sig­nif­i­cant hur­dle, and con­se­quent­ly we will make no fur­ther in­vest­ment in our al­ler­gy port­fo­lio.  As in­di­cat­ed pre­vi­ous­ly, we will now fo­cus on our wider res­pi­ra­to­ry busi­ness, in par­tic­u­lar our new US com­mer­cial col­lab­o­ra­tion with As­traZeneca, our mar­ket-lead­ing NIOX fran­chise and the de­vel­op­ment of our broad­er res­pi­ra­to­ry port­fo­lio.

As­traZeneca hand­ed over a pair of res­pi­ra­to­ry drugs to Cir­cas­sia last month in a $300 mil­lion deal. The phar­ma gi­ant got Tu­dorza as well as Du­ak­lir, once held up as a top prospect at the phar­ma gi­ant. But the res­pi­ra­to­ry busi­ness is a crowd­ed field, and As­traZeneca bowed out in ex­change for some cash and a promise of a fu­ture rev­enue stream from Cir­cas­sia.

Cir­cas­sia’s IPO helped mark a resur­gence of the biotech in­dus­try in the UK. But biotech IPOs have fad­ed in the UK and Eu­rope, where in­vestors have long mem­o­ries when it comes to R&D fail­ure. Cir­cas­sia seems de­ter­mined to make the tran­si­tion to a com­mer­cial play­er, though, and isn’t rolling over to play dead.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

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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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.

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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Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

Andy Kidd, Aptinyx CEO

‘The place­bo caught up’: Months af­ter di­a­bet­ic nerve pain fail, Aptinyx sees an­oth­er pain tri­al fall through

In 2019, Aptinyx’s stock cratered after it reported that its lead candidate failed a diabetic nerve pain trial. After some ‘further analysis,’ the biotech re-upped with that same non-opioid pain drug in two more mid-stage studies — another diabetic nerve pain trial and later a fibromyalgia trial.

In April, Aptinyx reported that its second diabetic nerve pain trial also fell through. However, the Illinois-based penny stock biotech had one more shot for its NMDA-modulating drug, dubbed NYX-2925, in fibromyalgia.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Randall Schatzman, Bolt CEO

Bolt throws a wrench in the pipeline, look­ing to con­serve cash

A meltdown in the biotech market is making most execs cautious, including Bolt Biotherapeutics’ CEO, as the company hits the brakes on one preclinical asset and pauses other early-stage work to extend cash reserves by two years.

The pipeline re-org will keep Bolt’s lights on through 2025 so the biotech can focus on its clinical-stage HER2 solid tumor drug candidate, which the company should have early-stage data on and a recommended Phase II dose by year’s end. The biotech also wants to focus on its preclinical asset BDC-3042, an immune-stimulating antibody conjugate (ISAC), for KRAS and TP53 mutated tumors.