Garo Armen, Agenus CEO

Agenus to move Cal­i­for­nia op­er­a­tions to new bio­man­u­fac­tur­ing clus­ter in Va­cav­ille

In Oc­to­ber 2020, Va­cav­ille, CA launched a mas­sive bio­man­u­fac­tur­ing clus­ter that is ex­pect­ed to bring in 10,000 jobs and $2 bil­lion in de­vel­op­ment. Genen­tech had al­ready es­tab­lished its head­quar­ters in the city 50 miles north­east of San Fran­cis­co in 1994.

Now, the com­pa­ny will get a neigh­bor from the East Coast.

Lex­ing­ton, MA-based Agenus has bought a 120-acre lot near the ex­ist­ing Genen­tech fa­cil­i­ty and plans to build its own fa­cil­i­ty of 400,000 square feet, the San Fran­cis­co Busi­ness Times re­port­ed Wednes­day. It will help fill the void in the man­u­fac­tur­ing space that was opened up when a No­var­tis fa­cil­i­ty shut down in 2015 and then a J&J plant in 2019.

Russ Mo­roz

The city gov­ern­ment has tried to es­tab­lish it­self as a home to biotech, but has of­ten been over­shad­owed by oth­er Bay Area hubs like South San Fran­cis­co and Emeryville, Mar­cus & Mil­lichap’s Russ Mo­roz, who rep­re­sent­ed the sell­er in the Agenus deal, told the San Fran­cis­co Busi­ness Times.

Agenus will move its CMO op­er­a­tions and 70-plus em­ploy­ees from Berke­ley, CA, 45 min­utes away from the coast, CEO Garo Ar­men said in an email to End­points News. The new build­ing used to be­long to Cal­i­for­nia biotech Xo­ma, and many of Agenus’ cur­rent em­ploy­ees ac­tu­al­ly moved over to the com­pa­ny from Xo­ma be­fore it shut down, he said.

“The city is will­ing to work with us as part­ners. We will cer­tain­ly ex­pand our an­ti­body man­u­fac­tur­ing fa­cil­i­ties,” Ar­men said. “We will al­so have a man­u­fac­tur­ing cam­pus and process de­vel­op­ment, and we can al­so put our plant-de­rived prod­uct ex­pan­sion there as well …The city want­ed us to be the new own­er, in­stead of com­pa­nies look­ing to build shop­ping cen­ters or re­tail, since we are adding val­ue to the area, and adding skilled jobs to the area.”

Agenus is a clin­i­cal stage im­muno-on­col­o­gy com­pa­ny look­ing to make can­cer treat­ment more wide­ly avail­able through the com­bi­na­tion of ther­a­pies. In May, it signed a deal with Bris­tol My­ers Squibb to li­cense its pre­clin­i­cal bis­pe­cif­ic an­ti­body that tar­gets TIG­IT and an­oth­er undis­closed tar­get. That deal was worth $200 mil­lion up front, and $1.36 bil­lion in mile­stones. That deal closed on Tues­day, and Phase I dos­ing is ex­pect­ed to start at the be­gin­ning of Q3.

Va­cav­ille’s 300-acre “Cal­i­for­nia Bio­man­u­fac­tur­ing Cen­ter” was es­tab­lished at the same time as a non­prof­it with the same name, in­tend­ed to ac­cel­er­ate the growth of biotech through col­lab­o­ra­tion with part­ners in the in­dus­try. Its cam­pus is po­si­tioned in be­tween the cam­pus­es of the Uni­ver­si­ty of Cal­i­for­nia-Berke­ley and Davis, has been a home to the man­u­fac­tur­ing in­dus­try since the 1980s, the North Bay Busi­ness Jour­nal re­port­ed. Near­by Solano Com­mu­ni­ty Col­lege has of­fered a de­gree in bio­man­u­fac­tur­ing since 2017.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Bay­er starts work on $43M+ ex­pan­sion of OTC man­u­fac­tur­ing site in Penn­syl­va­nia

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.

US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).