Ger­man ra­dio­phar­ma forms an­oth­er Chi­na joint ven­ture; Urovan­t's Gemte­sa pass­es blood pres­sure study

Ger­man biotech ITM is form­ing a joint ven­ture with Chi­nese ra­dio­phar­ma play­er Cheng­du Gao­tong Iso­tope.

This ven­ture fol­lows a strate­gic part­ner­ship be­tween ITM and the Chi­na Iso­tope and Ra­di­a­tion Cor­po­ra­tion (CIRC) which was ini­tial­ly formed in 2010 and fur­ther ex­tend­ed in No­vem­ber 2019.

The new­ly formed com­pa­ny is sched­uled to start op­er­a­tions by the end of the year and will be lo­cat­ed in Cheng­du, Chi­na. This will be ITM’s sec­ond lo­ca­tion in Chi­na af­ter open­ing its first sub­sidiary in Shang­hai ear­li­er this year.

“We are com­mit­ted to fur­ther ex­pand­ing our suc­cess­ful, long-term part­ner­ship with CIRC and are look­ing for­ward to in­creas­ing our glob­al foot­print in Chi­na,” said ITM CEO Stef­fen Schus­ter.

Fur­ther de­tails of the agree­ment were not dis­closed. — Paul Schloess­er

Urovant’s over­ac­tive blad­der drug Gemte­sa pass­es safe­ty test 

Cal­i­for­nia biotech Urovant’s Gemte­sa has no clin­i­cal­ly rel­e­vant ef­fect on blood pres­sure and heart rate, ac­cord­ing to the biotech.

Urovant showed da­ta from an out­pa­tient study at the year­ly meet­ing of the Amer­i­can Uro­log­i­cal As­so­ci­a­tion show­ing blood pres­sure and heart rate be­ing sim­i­lar be­tween two groups of pa­tients: one with a place­bo for 28 days, and the oth­er on dai­ly Gemte­sa.

“We are de­light­ed to present these im­por­tant ad­di­tion­al da­ta con­firm­ing the ef­fi­ca­cy and safe­ty pro­file of Gemte­sa,” said Urovant CMO Cor­nelia Haag-Molken­teller in a state­ment.

Ac­cord­ing to the study, sys­tolic blood pres­sure, di­as­tolic blood pres­sure, and heart rate were gen­er­al­ly sim­i­lar be­tween the two groups. There were no sta­tis­ti­cal­ly sig­nif­i­cant or clin­i­cal­ly rel­e­vant dif­fer­ences in mean day­time or mean 24-hour am­bu­la­to­ry sys­tolic blood pres­sure, di­as­tolic blood pres­sure, or heart rate af­ter 28 days of treat­ment with Gemte­sa com­pared with place­bo.

Part of Vivek Ra­maswamy’s fam­i­ly of com­pa­nies, the biotech’s over­ac­tive blad­der drug Gemte­sa hit the mar­ket late last year as Urovant’s first ap­proved prod­uct. — Paul Schloess­er

MiMedx shows mixed re­sults in md­HACM clin­i­cal stud­ies

Geor­gia re­gen­er­a­tive med­i­cine biotech MiMedx has re­sults from two late-stage clin­i­cal tri­als on its treat­ment (mi­cronized de­hy­drat­ed Hu­man Am­nion Chori­on Mem­brane, or md­HACM) for knee os­teoarthri­tis and plan­tar fasci­itis.

The tri­als, in Phas­es IIb and III, re­spec­tive­ly, did not hit the pri­ma­ry end­points in ei­ther study. The os­teoarthri­tis study did re­veal var­ied ef­fi­ca­cy sig­nals be­tween pa­tients eval­u­at­ed pre- and post-study, which will lead MiMedx to at­tempt con­fir­ma­to­ry stud­ies. As for the study on plan­tar fasci­itis, MiMedx will not pur­sue a BLA with the FDA.

“We look for­ward to fur­ther dis­cus­sions with the FDA un­der the Re­gen­er­a­tive Med­i­cine Ad­vanced Ther­a­py process, and re­view­ing our next steps for con­tin­ued clin­i­cal study of Pu­ri­on processed md­HACM as a plat­form for re­gen­er­a­tive med­i­cine,” said MiMedx CEO Tim­o­thy Wright in a state­ment.

MiMedx was in hot wa­ter late last year af­ter the CEO and the COO at the time were re­spec­tive­ly con­vict­ed of se­cu­ri­ties fraud and con­spir­a­cy. This hap­pened af­ter the FBI al­leged that the com­pa­ny was fraud­u­lent­ly boost­ing its sales. — Paul Schloess­er

Adap­ti­m­mune sees 36% re­sponse rate in Phase I #ES­MO21 tease

Fresh off a $3 bil­lion deal with Roche to de­vel­op off-the-shelf T cell ther­a­pies, Adap­ti­m­mune is cap­i­tal­iz­ing on the mo­men­tum with a new da­ta re­lease it ex­pects to present at #ES­MO21 this week­end.

In a Phase I study look­ing at 22 evalu­able pa­tients with MAGE-A4+ tu­mors “in the con­text of HLA-A*02,” Adap­ti­m­mune saw sev­en par­tial re­spons­es and one com­plete re­sponse, good for an over­all re­sponse rate of 36.4%. The re­spons­es spanned five dif­fer­ent in­di­ca­tions in­clud­ing ovar­i­an, head and neck, esoph­a­gogas­tric junc­tion and blad­der can­cers, as well as syn­ovial sar­co­ma.

“It is no longer a ques­tion of whether our SPEAR T-cells are ef­fec­tive against a range of MAGE-A4 ex­press­ing tu­mors — they un­doubt­ed­ly are,” CEO Adri­an Raw­cliffe said in a state­ment. “Now, our fo­cus is on turn­ing them in­to ap­proved ther­a­pies.”

An­oth­er 11 pa­tients saw their dis­ease sta­bi­lized on the ther­a­py, while three saw dis­ease pro­gres­sion. Adap­ti­m­mune re­port­ed that the da­ta cut­off was Au­gust 2, say­ing 25 to­tal pa­tients had re­ceived the ther­a­py at that point while 22 of the 25 made up Mon­day’s da­ta read­out.

The biotech al­so not­ed it was en­cour­aged by the ini­tial dura­bil­i­ty re­sults. Of the eight re­spon­ders, five re­main pro­gres­sion-free af­ter a min­i­mum of 24 weeks. — Max Gel­man

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.

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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