Gil Beyen, Erytech CEO

Catal­ent stays hot as it inks deal with French phar­ma that suf­fered PhI­II flop

Just a cou­ple of deals in a cou­ple of days for Catal­ent.

The New Jer­sey-based CD­MO’s lat­est move is a long-term sup­ply agree­ment with Ery­tech Phar­ma, a French clin­i­cal-stage bio­phar­ma, and the pur­chase of its cell ther­a­py man­u­fac­tur­ing site in the moth­er­land.

The deal is good for $44.5 mil­lion, and 40 of Ery­tech’s Prince­ton, NJ em­ploy­ees will be of­fered em­ploy­ment by the site’s new own­er. Catal­ent will now make Ery­tech’s lead can­di­date Gras­pa for clin­i­cal and com­mer­cial sup­ply in the US. Gras­pa is in Phase I tri­als in pa­tients suf­fer­ing from pan­cre­at­ic can­cer right now and is in talks with the FDA for a BLA sub­mis­sion in hy­per­sen­si­tive ALL. That’s tar­get­ed in Q3 2022.

“Ery­tech will now fur­ther fo­cus cap­i­tal re­sources on the de­vel­op­ment of po­ten­tial­ly trans­for­ma­tive ther­a­peu­tics for se­ri­ous dis­eases,” CEO Gil Beyen said in a state­ment. “We are al­so con­tin­u­ing to eval­u­ate fur­ther strate­gic op­tions for the com­pa­ny, in­clud­ing ad­di­tion­al part­ner­ships and ad­di­tion of com­ple­men­tary as­sets, through which we can lever­age our ERYCAPS® plat­form and our de­vel­op­ment and man­u­fac­tur­ing ca­pa­bil­i­ties.”

The deal comes just days af­ter Catal­ent an­nounced that it was dou­bling down on its faith in Bloom­ing­ton, IN as the home of drug sub­stance man­u­fac­tur­ing with $350 mil­lion and the an­nounce­ment that it would add up to 1,000 new jobs in the up­com­ing years. That project builds up­on a pre­vi­ous­ly pledged 600 jobs and $50 mil­lion up­grade that came with ded­i­cat­ing a fill­ing line to Mod­er­na’s Covid-19 jab.

Ery­tech made waves four years ago when it re­vealed im­pres­sive Phase IIb da­ta for Gras­pa, but that hype fiz­zled out a bit when it failed the Phase III piv­otal. That led the stock to fall 30% af­ter the haz­ard ra­tio came in at 0.92 with a p-val­ue of 0.375.

Catal­ent will of­fer up its late-stage and com­mer­cial man­u­fac­tur­ing ex­per­tise to help Ery­tech with pro­duc­tion, reg­u­la­to­ry in­spec­tions and ap­provals. Its 30,900 square-foot site has the flex­i­bil­i­ty to sup­port mul­ti­ple cell ther­a­py pro­duc­tion re­quire­ments and ca­pac­i­ties, and Catal­ent plans on build­ing out that site, us­ing the staff it al­ready has to broad­en its man­u­fac­tur­ing port­fo­lio.

Man­ja Boer­man

Mean­while, Ery­tech will keep its Ly­on, France site. The com­pa­ny re­port­ed 2021 earn­ings of $38.1 mil­lion, and that will jump up to $60 mil­lion up­on the clos­ing of this deal. The sale of the Prince­ton site will al­so cut $7.5 mil­lion a year in op­er­at­ing costs. The deal is ex­pect­ed to fund Ery­tech’s next stage of op­er­a­tions un­til the mid­dle of 2024.

“The tal­ent­ed and ex­pe­ri­enced staff al­ready em­ployed at the fa­cil­i­ty, the ca­pa­bil­i­ties it has in place, and the op­por­tu­ni­ty to quick­ly add fur­ther ca­pac­i­ty on the same site, al­lows Catal­ent to ex­pand rapid­ly to cre­ate a U.S. cam­pus and cen­ter of ex­cel­lence for cell ther­a­py de­vel­op­ment and man­u­fac­tur­ing that will serve cus­tomers around the world,” Catal­ent pres­i­dent of cell and gene ther­a­py Man­ja Boer­man said in a state­ment.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; 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.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.

Pharma ads are showing up on cooler screens at retail pharmacies, including Walgreens and CVS, under a new OptimizeRx deal (OptimizeRx)

Phar­ma brands chill in the phar­ma­cy re­tail aisle with new style ads on re­frig­er­a­tion screens

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

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