Amgen’s Otezla notches another PhIII win; Califf earns advocacy groups’ stamp of approval

Am­gen’s block­buster Ote­zla just racked up an­oth­er Phase III win as it looks to con­tin­ue ex­pand­ing on its multi­bil­lion-dol­lar rev­enue stream.

The drug hit the pri­ma­ry end­point in a tri­al re­search­ing its use in mod­er­ate to se­vere gen­i­tal pso­ri­a­sis, Am­gen an­nounced in the topline read­out Wednes­day af­ter­noon. On top of that, all sec­ondary end­points were hit, demon­strat­ing ‘mean­ing­ful and sig­nif­i­cant im­prove­ments,’ the com­pa­ny said.

‘Gen­i­tal pso­ri­a­sis is as­so­ci­at­ed with a high lev­el of stigma­ti­za­tion and bur­den of dis­ease and can be ex­pe­ri­enced in up to 63% of pso­ri­a­sis pa­tients over the course of their dis­ease. De­spite the use of top­i­cal ther­a­pies for the treat­ment of gen­i­tal pso­ri­a­sis, many pa­tients still have chal­lenges man­ag­ing their dis­ease, prompt­ing ex­perts to rec­om­mend the use of sys­temic ther­a­pies,’ Am­gen R&D chief David Reese said in a state­ment.

Ote­zla’s pri­ma­ry end­point in the study was change com­pared to place­bo in a glob­al gen­i­tal pso­ri­a­sis scale af­ter 16 weeks. Among the sec­ondary end­points were oth­er pso­ri­a­sis scales, af­fect­ed body sur­face area, der­ma­tol­ogy life qual­i­ty in­dex and a physi­cian as­sess­ment. Safe­ty and ad­verse events were con­sis­tent with Ote­zla’s over­all pro­file, the com­pa­ny added.

Am­gen ac­quired the block­buster drug af­ter Bris­tol My­ers Squibb bought out Cel­gene in 2019, af­ter reg­u­la­tor con­cerns that the new com­bined com­pa­ny would own a mo­nop­oly in the pso­ri­a­sis mar­ket. The Ote­zla sell-off has re­sult­ed in a fu­ri­ous race to find the drug’s suc­ces­sor be­tween Bris­tol My­ers and Nim­bus Ther­a­peu­tics.

Over the sum­mer, how­ev­er, Nim­bus al­leged in a law­suit that the Bris­tol My­ers fol­low-up drug would be the one cre­at­ing a mo­nop­oly, spurring a po­ten­tial le­gal bat­tle over the new al­losteric TYK2 in­hibitors. And back in 2017, Nim­bus made a deal with Cel­gene to sell all of its TYK2 rights to the big com­pa­ny.

Califf earns sup­port of ad­vo­ca­cy groups for FDA chief

Though Rob Califf, Pres­i­dent Joe Biden’s nom­i­nee for FDA com­mis­sion­er, has faced op­po­si­tion from some cor­ners of Con­gress, he is draw­ing sup­port from a wide ar­ray of ad­vo­ca­cy groups.

Near­ly five dozen pa­tient and physi­cian groups came out with a state­ment Wednes­day vouch­ing for the once-com­mis­sion­er to take the reins again. The group, which in­cludes promi­nent in­sti­tutes and foun­da­tions like AACR, Su­san G. Komen and the Amer­i­can Heart As­so­ci­a­tion, said Califf brings a steady hand to en­sure safe­ty and ef­fi­ca­cy while al­so cul­ti­vat­ing in­no­va­tion.

The next com­mis­sion­er, the state­ment said will al­so have to deal with the on­go­ing pan­dem­ic, and ‘bal­ance that un­prece­dent­ed task with a myr­i­ad of oth­er pri­or­i­ties, in­clud­ing the reau­tho­riza­tion of the user fee pro­grams, de­vel­op­ing a frame­work for ap­pro­pri­ate over­sight of to­bac­co and di­ag­nos­tic tests and de­vel­op­ment of post-mar­ket da­ta to mon­i­tor use of med­ical prod­ucts.’

Biden’s move to nom­i­nate Califf has been met with ap­proval from in­dus­try lob­by­ing groups and luke­warm praise from End­points News read­ers. Some politi­cians, such as Sen­a­tor Joe Manchin of West Vir­ginia, have not proven as ex­cit­ed, how­ev­er. Cit­ing the opi­oid epi­dem­ic, Manchin said he op­pos­es Califf’s nom­i­na­tion be­cause ‘cor­rect­ing the cul­ture at the FDA’ should be the biggest step in stem­ming that cri­sis. Manchin al­so op­posed Califf’s nom­i­na­tion in 2016.

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Merck’s new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO  — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

‘I think it is super worrisome,’ Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, ‘This is not going to be good.’

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Fujifilm Diosynth Biotechnologies is in the middle of a monumental point in the company’s 10-year history, and the CDMO is about to grow even more, as it sets out to be the ‘beating heart’ of the UK’s North East Life Sciences ecosystem.

A site in Billingham, Teeside, UK will receive a $453.72 million investment package from the manufacturer to double the existing footprint and create the largest multi-modal biopharmaceutical manufacturing site in the UK, bringing another 350 jobs to the region by late 2023.

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Samsung Biologics has entered an agreement with South Korean biotech GreenLight BioSciences to manufacture its mRNA Covid-19 vaccine at commercial scale, the two companies announced.

Samsung Biologics, one of the fastest growing manufacturers in the world right now, will use its vaccine manufacturing expertise to help patients in lower-income countries, CEO John Rim said in a press release. This will help expand their capabilities from drug substance to aseptic fill-finish and all the way to commercial release from one site.

Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ‘069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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GenScript, Suzhou Abogen, and Walvax Biotechnology have announced the three companies will be collaborating on a Covid-19 mRNA vaccine project dubbed ABO-O28M.

WalVax will submit a BLA for the project, and GenScript will provide exclusive manufacturing services, according to Asia One.

The project stems form an agreement between Abogen, the  Academy of Military Medical Sciences (AMMS) of the PLA Academy of Military Science and Walvax, which gained clinical trial approval in June 2020. It was one of the first vaccine projects approved by China’s government, and GenScript used its plasmid GMP manufacturing to accelerate into clinical trials.

Lisa Deschamps, AviadoBio CEO

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

‘So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,” he told Endpoints News. 

Radek Spisek, Sotio CEO (Cellestia)

In the rather insular world of biotech, most innovation inevitably comes from a cluster of R&D hubs — Cambridge, San Francisco, etc. But sometimes success stories sprout from rocky soil, which is most certainly the case with Prague-based Sotio Biotech and its suddenly jam-packed pipeline of cancer drugs.

After years in quiet development, Sotio now has $315 million in new funds to play with from parent company PPF Group, an investment group founded in the Czech Republic, as the biotech looks to advance its growing pipeline through early- and mid-stage trials.

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