Pox­el, part­ner Sum­it­o­mo Dainip­pon taste suc­cess in first piv­otal test for oral di­a­betes drug

The French meta­bol­ic ex­perts at Pox­el and their Asian part­ners at Sum­it­o­mo Dainip­pon Phar­ma have hit a home run with the first late-stage Japan­ese test of their oral di­a­betes drug imeglim­in, which bodes well for the pair of Phase III tri­als ex­pect­ed to read­out lat­er this year and fu­els the block­buster ex­pec­ta­tions tagged on the mi­to­chon­dr­i­al ther­a­py.

The drug be­longs to a new chem­i­cal class of oral agents called ‘glim­ins’ that si­mul­ta­ne­ous­ly tar­get all three key or­gans in­volved in di­a­betes: the pan­creas, the liv­er and the mus­cles. Imeglim­in is de­signed to work on the two main de­fects seen in pa­tients with type II di­a­betes: by in­creas­ing in­sulin se­cre­tion in the pan­creas, in a glu­cose-de­pen­dent man­ner; and by de­creas­ing the ex­cess pro­duc­tion of glu­cose by the liv­er, while en­hanc­ing ‘in­sulin sen­si­tiv­i­ty’ in the mus­cles.

Thomas Kuhn, Pox­el

The TIMES 1 tri­al test­ed a 1000 mg dose of imeglim­in against a place­bo in 213 Japan­ese pa­tients with type 2 di­a­betes. The drug-in­duced a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion (p<0.0001) in HbA1c — av­er­age blood sug­ar lev­els over a pe­ri­od of weeks/months — at week 24, meet­ing the main goal. The place­bo-cor­rect­ed mean change in HbA1c from base­line was – 0.87%, the com­pa­nies said.

The drug al­so met the main sec­ondary goal of re­duc­ing fast­ing plas­ma glu­cose, and analy­ses of oth­er sec­ondary end­points are on­go­ing.

With an ag­ing pop­u­la­tion and grow­ing rates of obe­si­ty, di­a­betes in Japan has bal­looned, with the num­ber of sus­pect­ed di­a­bet­ics hit­ting a record 10 mil­lion for the first time in 2016, ac­cord­ing to gov­ern­ment es­ti­mates cit­ed by Nikkei.

“The TIMES 1 re­sults con­firm the ro­bust ef­fi­ca­cy com­bined with fa­vor­able safe­ty ob­served in the Phase 2b tri­al in Japan and the po­ten­tial ben­e­fits that Imeglim­in can bring to type 2 di­a­betes pa­tients glob­al­ly,” said Pox­el chief Thomas Kuhn. “The TIMES 1 da­ta is the first ma­jor step to­wards fil­ing the Japan­ese New Drug Ap­pli­ca­tion in 2020. Japan rep­re­sents the sec­ond largest sin­gle mar­ket for type 2 di­a­betes and, Asia, in broad­er terms, is con­sid­ered the most im­por­tant ge­o­graph­ic lo­ca­tion with re­gards to treat­ing the di­a­betes pan­dem­ic in the fu­ture.

In 2016, Pox­el re­port­ed that a Phase IIb tri­al in Japan reg­is­tered he­mo­glo­bin A1c re­duc­tions of 0.52%, 0.94% and 1.00% for the 500 mg, 1000 mg and 1500 mg dose twice-dai­ly. In 2017, the Mer­ck Serono spin­out forked over the Asia rights to the treat­ment to Sum­it­o­mo Dainip­pon Phar­ma in a deal worth up to $300 mil­lion.

Da­ta from TIMES-2 and TIMES-3 are ex­pect­ed lat­er this year. Pox­el (EPA: $POX­EL) out-li­censed the rights to imeglim­in in the Unit­ed States and Eu­rope to Vivek Ra­maswamy’s Roivant Sci­ences last year, with this part­ner fund­ing the ma­jor­i­ty of the cost­ly Phase III pro­gram ex­pect­ed to com­mence this year.

“Imeglim­in has a nov­el mech­a­nism of ac­tion as a mi­to­chon­dr­i­al bioen­er­get­ics en­hancer, po­ten­tial­ly pro­vid­ing a unique po­si­tion in the com­pet­i­tive type II di­a­betes treat­ment land­scape,” Jef­feries an­a­lysts wrote in a note last month. They mod­eled a 60% prob­a­bil­i­ty of com­mer­cial suc­cess for imeglim­in in the US/EU and Asia, with an es­ti­mate of $3.1 bil­lion in glob­al peak sales, in­clud­ing $600 mil­lion in Japan.


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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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