Daniel Faga (L) and Joseph Leveque (Mirati)

Weeks in­to CEO shake­up, Mi­rati bids adieu to a pair of C-suit­ers with KRAS drug fil­ing around the cor­ner

Mi­rati is on the cusp of emerg­ing as the sole chal­lenger against Am­gen in the sud­den­ly hot KRAS in­hibitor mar­ket and thinks it has the man to take it across the fin­ish line. But new lead­er­ship of­ten means shake­ups, and now two Mi­rati ex­ecs are be­ing shown the door.

Mi­rati CMO Joseph Lev­eque and Daniel Fa­ga, the biotech’s chief op­er­at­ing of­fi­cer and prin­ci­pal fi­nan­cial of­fi­cer, have both de­part­ed the com­pa­ny as it en­ters the home­stretch for fil­ing its KRAS drug ada­gra­sib with the FDA, Mi­rati re­vealed in an SEC fil­ing Mon­day.

De­tails on the de­par­tures are slim, with Mi­rati not­ing the de­ci­sions on both po­si­tions were made Oct. 28. In Fa­ga’s place, Mi­rati ac­count­ing lead Vick­ie Reed will step in­to the prin­ci­pal fi­nan­cial of­fi­cer role with­out an in­crease in pay, the biotech said.

David Meek

The shake­up comes a lit­tle over a month af­ter Mi­rati ap­point­ed David Meek, a for­mer CEO at Fer­Gene and Ipsen, to the head role, re­plac­ing found­ing CEO Charles Baum.

Meek, who was most­ly re­cent­ly oust­ed from Fer­Gene af­ter the biotech im­plod­ed in spec­tac­u­lar fash­ion ear­li­er this year, came on board right as Mi­rati races to an ex­pect­ed fil­ing for ada­gra­sib this quar­ter, look­ing to keep the heat on Am­gen and its own KRAS in­hibitor Lumakras. The com­pa­ny rolled out Phase II da­ta for ada­gra­sib in non-small cell lung can­cer in Sep­tem­ber it says will serve as the ba­sis for that fil­ing, as well as win­ning mid-stage colon can­cer da­ta at ES­MO21.

Lev­eque had served as CMO at Mi­rati since May 2020, jump­ing over from Syn­thorx, where he served as CMO for a lit­tle un­der two years. Pri­or to that, Lev­eque jumped around be­tween a spate of biotechs and Big Phar­mas, in­clud­ing EMD Serono, Bris­tol My­ers Squibb, Onyx and Am­gen.

Fa­ga had been with Mi­rati since Jan­u­ary 2020, pre­vi­ous­ly hold­ing the chief busi­ness of­fi­cer role at Spark Ther­a­peu­tics for more than three years. He was pre­vi­ous­ly a man­ag­ing di­rec­tor at Cen­ter­view Part­ners and an as­so­ciate at Mer­rill Lynch.

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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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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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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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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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).

SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

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