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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.