Canada's Bausch to pay $300M in an­titrust set­tle­ment; Cardiff re­leas­es da­ta on mCRC tri­al

Cana­di­an phar­ma com­pa­ny Bausch Health has agreed to set­tle an an­titrust class-ac­tion suit from a 2015 price in­crease.

Ac­cord­ing to Reuters, the class-ac­tion law­suit ac­cused Bausch of main­tain­ing an il­le­gal mo­nop­oly on di­a­betes drug Glumet­za, en­abling a price hike of near­ly 800% in 2015 from $5.72 to $51 per tablet.

Lawyers for com­pa­nies that bought Glumet­za and filed the suit against Bausch re­vealed the deal in a court fil­ing on Wednes­day, ask­ing US Dis­trict Judge William Al­sup in San Fran­cis­co to ap­prove it.

The case had been sched­uled to go to tri­al next month.

“Plain­tiffs are pleased with the set­tle­ment, which re­cov­ers for the class a very sub­stan­tial por­tion of the over­charges that they suf­fered,” Steve Shad­owen, a lawyer for the pur­chasers, said in an email.

Cardiff On­col­o­gy an­nounces new da­ta from Phase Ib/II tri­al in KRAS-mu­tat­ed mCRC

Cal­i­for­nia biotech Cardiff On­col­o­gy has new da­ta from its lead clin­i­cal pro­gram eval­u­at­ing their PLK1 in­hibitor on­va­nsert­ib in com­bi­na­tion with stan­dard-of-care chemother­a­pies Folfiri/be­va­cizum­ab for sec­ond-line treat­ment of pa­tients with KRAS-mu­tat­ed metasta­t­ic col­orec­tal can­cer (mCRC).

High­lights of the da­ta as of Ju­ly 2 in the mul­ti-cen­ter and sin­gle arm study in­clude:

  • The com­bi­na­tion of on­va­nsert­ib and SOC chemother­a­pies re­sult­ed in 10% of the pa­tients hav­ing G3 or G4 treat­ment-emer­gent ad­verse events (49/490).
  • Me­di­an pro­gres­sion-free sur­vival rate across evalu­able pa­tients is ap­prox­i­mate­ly 9.4 months (range of 7.8-not yet reached with 95% con­fi­dence).
  • Pa­tients achiev­ing a best re­sponse of par­tial re­sponse showed the great­est de­creas­es in plas­ma KRAS mu­tant al­lel­ic fre­quen­cy (MAF) af­ter 1 cy­cle, or 28 days of ther­a­py.

To be con­sid­ered el­i­gi­ble for the tri­al, pa­tients must have con­firmed metasta­t­ic and un­re­sectable col­orec­tal car­ci­no­ma har­bor­ing a KRAS mu­ta­tion. They must al­so have failed treat­ment with, or be in­tol­er­ant to the Fol­fox reg­i­men (flu­o­ropy­rim­i­dine and ox­ali­platin, with or with­out be­va­cizum­ab).

“Our Phase Ib/II tri­al con­tin­ues to gen­er­ate da­ta sug­gest­ing that the ad­di­tion of on­va­nsert­ib to SOC re­sults in an ob­jec­tive re­sponse rate and me­di­an pro­gres­sion-free sur­vival that sub­stan­tial­ly ex­ceed those pre­vi­ous­ly achieved with SOC alone,” said Cardiff CMO Kather­ine Ruffn­er in a state­ment. “I look for­ward to the tri­al’s con­tin­ued ad­vance­ment and fu­ture da­ta read­outs.”

En­do set­tles New York state opi­oid cas­es

En­do In­ter­na­tion­al and sub­sidiaries have set­tled three cas­es brought by the state of New York and two ma­jor coun­ties for $50 mil­lion in a still-on­go­ing saga re­gard­ing the opi­oid cri­sis.

The Irish phar­ma had been ac­cused along­side oth­er com­pa­nies of de­cep­tive mar­ket­ing prac­tices and down­play­ing the risks of opi­oid ad­dic­tion. A ju­ry tri­al on li­a­bil­i­ty has been on­go­ing since June.

As a re­sult of the set­tle­ment, the state and NY coun­ties have end­ed their cas­es against En­do. En­do does not ad­mit wrong­do­ing.

En­do is now shift­ing its fo­cus to ob­tain­ing a glob­al set­tle­ment, ac­cord­ing to a state­ment put out by the com­pa­ny yes­ter­day. En­do is ex­plor­ing oth­er al­ter­na­tives and said that they may try to im­ple­ment one or more of those al­ter­na­tives if a glob­al set­tle­ment is not pos­si­ble.

Agenus forms new sub­sidiary and im­me­di­ate col­lab­o­ra­tion with Gink­go Bioworks

Agenus an­nounced the launch of its new sub­sidiary SaponiQx to­day.

Its goal is to dri­ve in­no­va­tion in nov­el ad­ju­vant dis­cov­ery and vac­cine de­sign while build­ing saponin mol­e­cules — and to that end, the com­pa­ny is part­ner­ing with Gink­go Bioworks.

Ac­cord­ing to a state­ment put out by Agenus, Gink­go’s ex­pe­ri­ence in meta­bol­ic en­gi­neer­ing, en­zy­mat­ic di­ver­si­fi­ca­tion, and process op­ti­miza­tion can be ap­plied to dis­cov­er nov­el ad­ju­vants and im­prove cur­rent man­u­fac­tur­ing process­es — which is where SaponiQx comes in and ap­plies best prac­tices to­ward de­vel­op­ing bet­ter vac­cines.

“Agenus is pleased for SaponiQx to col­lab­o­rate with Gink­go Bioworks to de­vel­op its nov­el saponin prod­ucts from sus­tain­ably sourced raw ma­te­ri­als, with a goal to meet the cur­rent de­mands placed on the vac­cine in­dus­try for pan­dem­ic vac­cines,” said Garo Ar­men, CEO and Chair­man of Agenus and Ex­ec­u­tive Chair­man of SaponiQx

NCI con­sid­er­ing Sana’s an­ti-CD22 CAR-T ther­a­py for patent li­cense

The Na­tion­al Can­cer In­sti­tute is con­sid­er­ing grant­i­ng an ex­clu­sive patent li­cense to Seat­tle biotech Sana for an an­ti-CD22 CAR-T ther­a­py.

The doc­u­ment, signed on Tues­day by Richard Ro­driguez with the Na­tion­al Can­cer In­sti­tute, will be pub­lished on the fed­er­al reg­is­ter on Mon­day.

The biotech uni­corn went pub­lic ear­li­er this year, when it raised a mas­sive $587.5 mil­lion in its IPO in Feb­ru­ary. It has set big aims to re­make cell ther­a­py with new tar­gets, off-the-shelf prod­ucts and even in vi­vo ad­min­is­tra­tion.

There is no up­date on when Sana’s ther­a­py will be ready for the clin­ic.

Oth­er com­pa­nies have gone af­ter CD-22 be­fore —most no­tably Juno, which worked in con­cert with the NCI. Bris­tol My­ers Squibb, though, has of­fered few up­dates on the can­di­date since buy­ing out the biotech in 2018.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.