Spero strikes $125M roy­al­ty deal for cU­TI drug; French firm launch­es $100M ear­ly biotech fund

French in­vest­ment firm Ad­vent France Biotech­nol­o­gy (AFB) an­nounced to­day the first clos­ing of its sec­ond fund for a to­tal of $102 mil­lion.

In­vestors and par­tic­i­pants in AFB’s fund in­clud­ed the Eu­ro­pean In­vest­ment Fund (EIF) and the Fonds na­tion­al d’amorçage 2 (the French Seed Fund 2), which is man­aged on be­half of the French State by Bpifrance. Oth­er par­tic­i­pants in­clud­ed cor­po­rate ven­ture funds such as Boehringer In­gel­heim’s ven­ture fund.

This new fund will be ded­i­cat­ed to ear­ly-stage in­vest­ments in Eu­ro­pean life sci­ences com­pa­nies with a fo­cus on France.

AFB will con­tin­ue to work close­ly with Eu­ro­pean re­search in­sti­tu­tions and with Eu­ro­pean ven­ture cap­i­tal part­ners to se­lect and back en­tre­pre­neurs and ear­ly-stage com­pa­nies with the po­ten­tial to de­liv­er first- or best-in-class ther­a­peu­tics, the com­pa­ny said in a pre­pared state­ment.

The fund plans to se­lect and fi­nance two star­tups be­fore the end of this year.

“We firm­ly be­lieve that ear­ly-stage fi­nanc­ing is crit­i­cal for the life sci­ences in­dus­try, where the needs are huge and still not met, es­pe­cial­ly in France,” said AFB man­ag­ing part­ner and chair­man Alain Huriez in a state­ment. “This sec­ond fund shows the rel­e­vance of our po­si­tion­ing as en­tre­pre­neur-in­vestors in life sci­ences, con­firmed by the re­newed sup­port of our lim­it­ed part­ners.”

Mass­a­chu­setts biotech en­ters deal with in­vest­ment firm for up to $125 mil­lion on cU­TI drug

Spero Ther­a­peu­tics is en­ter­ing a rev­enue in­ter­est fi­nanc­ing agree­ment with in­vest­ment firm Health­Care Roy­al­ty Part­ners for up to $125 mil­lion for its com­pli­cat­ed Uri­nary Tract In­fec­tion, or cU­TI oral can­di­date.

Spero in­tends to use the pro­ceeds from the agree­ment and ex­ist­ing cash on hand to pre­pare for the an­tic­i­pat­ed launch of oral cU­TI can­di­date tebipen­em HBr, al­so known as Tebi, ac­cord­ing to a pre­pared state­ment.

As part of the agree­ment, Spero will re­ceive $50 mil­lion from Health­Care Roy­al­ty Part­ners by Oct. 21. If the FDA ap­proves Tebi for a cU­TI in­di­ca­tion, Spero will re­ceive an ad­di­tion­al $50 mil­lion, plus an ad­di­tion­al $25 mil­lion up­on an undis­closed com­mer­cial mile­stone.

In ex­change for the po­ten­tial $125 mil­lion, the in­vest­ment firm will re­ceive tiered roy­al­ty on ap­plic­a­ble rev­enue gen­er­at­ed by Tebi and oth­er prod­ucts mar­ket­ed by Spero un­til the amount paid back to Health­Care Roy­al­ty Part­ners® is 2.5 times the to­tal in­vest­ment amount fund­ed.

“We look for­ward to tebipen­em HBr’s an­tic­i­pat­ed NDA fil­ing and reg­u­la­to­ry re­view, along with the ad­vance­ment of Spero’s broad­er clin­i­cal-stage pipeline,” said Health­Care Roy­al­ty Part­ners chair­man and CEO Clarke Futch in a state­ment.

Is­rael’s Geneti­ka+ fin­ished $10 mil­lion Se­ries A for com­pa­ny ex­pan­sion

Is­raeli biotech Geneti­ka+ an­nounced this morn­ing that they closed a $10 mil­lion Se­ries A VC round led by Boston-based Grey­Bird Ven­tures.

Oth­er com­pa­nies such as Meron Cap­i­tal, Jump­speed Ven­tures, and B Cap­i­tal Group joined in on the round.

The biotech, which fo­cus­es on per­son­al­ized treat­ments for neu­ro­log­i­cal and psy­chi­atric dis­eases, will fo­cus its fund­ing on ex­pand­ing clin­i­cal tri­als, in­creas­ing man­u­fac­tur­ing ca­pa­bil­i­ties, and es­tab­lish­ing a clin­i­cal lab in Boston, MA.

No­var­tis an­nounces progress to­ward cli­mate goals

No­var­tis shared progress against its En­vi­ron­men­tal, So­cial and Gov­er­nance (ESG) tar­gets at its eighth an­nu­al ESG in­vestor event host­ed to­day. More specif­i­cal­ly, No­var­tis dis­cussed the com­pa­ny’s more ma­te­r­i­al ESG top­ics, in­clud­ing ac­cess to med­i­cines, pa­tient health and safe­ty, in­no­va­tion and eth­i­cal stan­dards.

Some of the spe­cif­ic goals No­var­tis said the com­pa­ny tar­get­ed in­clud­ed re­duc­ing their car­bon emis­sions by more than 28% since 2016, and pledg­ing $20 mil­lion in col­lab­o­ra­tion with HB­CUs to ad­dress health dis­par­i­ties in the US.

Vas Narasimhan

“ESG is cen­tral to the No­var­tis strat­e­gy and is crit­i­cal to de­liv­er­ing on our pur­pose to reimag­ine med­i­cine to im­prove and ex­tend peo­ple’s lives. Cou­pled with our in­spired, cu­ri­ous and un­bossed cul­ture, we be­lieve ESG ef­forts on our most ma­te­r­i­al top­ics will help dri­ve our over­all per­for­mance as a com­pa­ny and de­liv­er long-term val­ue for our stake­hold­ers,” said No­var­tis CEO Vas Narasimhan.

Ire­land’s Iterum meets with FDA on re­sub­mit­ting NDA for in­ves­ti­ga­tion­al uU­TI can­di­date

Irish biotech Iterum Ther­a­peu­tics said to­day in a state­ment that they held a Type A meet­ing with the FDA in Q3 2021 to dis­cuss the steps re­quired for po­ten­tial re­sub­mis­sion of the New Drug Ap­pli­ca­tion (NDA) for their drug su­lopen­em et­zadrox­il/probenecid (oral su­lopen­em) for the treat­ment of un­com­pli­cat­ed Uri­nary Tract In­fec­tions, or uU­TI.

Back in Ju­ly, Iterum re­ceived a Com­plete Re­sponse Let­ter from the FDA want­i­ng more da­ta to sup­port the ap­proval of oral su­lopen­em for the treat­ment of adult women with a uU­TI.

“We had a suc­cess­ful meet­ing with the FDA and have es­tab­lished var­i­ous po­ten­tial paths for­ward to ad­dress the re­quest in the CRL for ad­di­tion­al da­ta in sup­port of our NDA,” said Iterum CEO Corey Fish­man. “We are cur­rent­ly eval­u­at­ing the op­ti­mal de­sign for an ad­di­tion­al Phase III uU­TI study to be con­duct­ed pri­or to the po­ten­tial re­sub­mis­sion of the NDA. We con­tin­ue to be­lieve in the abil­i­ty of su­lopen­em to treat the grow­ing prob­lem of mul­ti-drug re­sis­tant UTIs in the com­mu­ni­ty.

Adap­tive Phage Ther­a­peu­tics re­ceives $8 mil­lion more in bac­te­rio­phage de­vel­op­ment from DoD

Mary­land biotech Adap­tive Phage Ther­a­peu­tics was award­ed an ad­di­tion­al $8 mil­lion from the US De­part­ment of De­fense for con­tin­ued de­vel­op­ment of their bac­te­rio­phage ther­a­py Phage­Bank for the treat­ment of in­fec­tious dis­eases. The new fund­ing brings the to­tal con­tract award­ed to APT to more than $31 mil­lion.

“We are thank­ful for the op­por­tu­ni­ty to col­lab­o­rate with the U.S. mil­i­tary to cre­ate po­ten­tial­ly life­sav­ing ther­a­pies for our na­tion’s ser­vice mem­bers,” said APT CEO and co-founder Greg Mer­ril in a pre­pared state­ment.

The biotech had closed a $40+ mil­lion Se­ries B back in May for their work on bac­te­rio­phages against drug-re­sis­tant bac­te­r­i­al in­fec­tions.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

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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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.

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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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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.

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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