Daniel Catenacci

Caught with in­sid­er trad­ing, for­mer Five Prime in­ves­ti­ga­tor makes case for light sen­tence

For­mer Five Prime tri­al in­ves­ti­ga­tor Daniel Cate­nac­ci stared down a max­i­mum 25-year prison sen­tence when he plead­ed guilty to se­cu­ri­ties fraud three months ago. Now he’s mak­ing the case that he shouldn’t go to prison at all.

Cate­nac­ci’s at­tor­neys re­quest­ed a sen­tence of time served plus two years pro­ba­tion, as rec­om­mend­ed by the US Pro­ba­tion Of­fice, ac­cord­ing to court doc­u­ments filed last Wednes­day.

The de­fense team ar­gued that Cate­nac­ci, a for­mer Uni­ver­si­ty of Chica­go as­so­ciate pro­fes­sor and on­col­o­gy di­rec­tor, “deeply re­grets his con­duct,” and that a non-cus­to­di­al sen­tence is “in the pub­lic’s best in­ter­est” so that Cate­nac­ci can con­tin­ue his “life­sav­ing ser­vices as an on­col­o­gist.”

“Dr. Cate­nac­ci is a first-time of­fend­er who im­me­di­ate­ly ac­cept­ed re­spon­si­bil­i­ty for his con­duct, co­op­er­at­ed with the gov­ern­ment, and has al­ready sat­is­fied his for­fei­ture oblig­a­tion,” court doc­u­ments read.

The case traces back to No­vem­ber 2020, when Cate­nac­ci pur­chased 8,743 shares of Five Prime’s stock af­ter see­ing in­sid­er da­ta for the com­pa­ny’s ex­per­i­men­tal gas­troin­testi­nal can­cer drug be­mar­ituzum­ab. Cate­nac­ci claims he didn’t fin­ish read­ing an email from Five Prime’s CMO, which ex­plic­it­ly stat­ed that he wasn’t al­lowed to trade based on the non-pub­lic in­ter­im Phase II re­sults.

“His un­der­stand­ing, up­on read­ing the sub­ject line and the open­ing sen­tence, was that he was not to com­mu­ni­cate to oth­ers the non-pub­lic in­for­ma­tion he had re­ceived from Five Prime,” court doc­u­ments state.

Once Five Prime an­nounced the re­sults, Cate­nac­ci sold his shares, prof­it­ing about $134,000 with­in 24 hours, ac­cord­ing to the sen­tenc­ing mem­o­ran­dum.

When the FBI showed up at Cate­nac­ci’s door half a year lat­er, he con­fessed and “im­me­di­ate­ly wrote a per­son­al check to the Unit­ed States Mar­shals Ser­vice and hand­ed it to the FBI Spe­cial Agents to re­turn the prof­its from his trad­ing.”

Am­gen snapped up be­mar­ituzum­ab last March when it ac­quired Five Prime for $1.9 bil­lion, and a month lat­er, the FDA grant­ed the drug break­through des­ig­na­tion.

Cate­nac­ci ini­tial­ly sought to en­ter an “Al­ford plea,” a com­mon tac­tic in which a de­fen­dant en­ters a guilty plea but main­tains their in­no­cence. The on­col­o­gist con­tin­ues to as­sert that he was un­aware at the time that he vi­o­lat­ed any laws, and the most re­cent court fil­ing con­cedes that he’s a self-taught trad­er with no for­mal train­ing in se­cu­ri­ties. How­ev­er, the court de­nied that mo­tion and Cate­nac­ci en­tered a full guilty plea back in April.

At the time, he faced a max­i­mum sen­tence of 25 years in prison, a fine or both.

“This was not a pre­med­i­tat­ed crime. There was no con­spir­a­cy or mal­ice afore­thought to ex­ploit the mar­ket. Dr. Cate­nac­ci re­ceived sur­prise good news about the re­sults of the clin­i­cal tri­al that he took part in, made a bad de­ci­sion to buy stock in the com­pa­ny, and then sold it, all with­in a pe­ri­od of about 24 hours,” at­tor­neys said in the sen­tenc­ing mem­o­ran­dum.

Can­te­nac­ci’s at­tor­neys de­clined to com­ment at this time. Sen­tenc­ing is sched­uled for Aug. 3.

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Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

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Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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David Reese, Amgen R&D chief

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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GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.