More than 2 years af­ter the ug­ly ro­ci de­ba­cle, Clo­vis says that the SEC is prep­ping civ­il charges

The hot wa­ter that Clo­vis $CLVS has been in with the SEC for the past two years is be­gin­ning to boil.

Clo­vis CEO Patrick Ma­haffy

The biotech to­day alert­ed in­vestors that the SEC has filed a Wells No­tice, sig­nal­ing its in­ten­tion to bring civ­il ac­tions against cur­rent and for­mer ex­ecs at the can­cer drug biotech. The SEC fil­ing did not spec­i­fy what ac­tions it will face, but Clo­vis did say it plans to con­test any charges.

Clo­vis’ 10-K has spot­light­ed an on­go­ing in­ves­ti­ga­tion by the SEC and the Jus­tice De­part­ment in­to an ug­ly in­ci­dent in late 2015 cen­tered on their now de­funct lung can­cer drug rocile­tinib, say­ing it was co­op­er­at­ing with the feds on their probe.

Here’s what hap­pened:

With shares pumped to about $100, Clo­vis stunned in­vestors in late 2015 when it sud­den­ly slashed the re­sponse rate on rocile­tinib for non-small cell lung can­cer to 34% for the 625-mg dose arm, and 28% for the 500-mg dose arm, a plunge of more than 20 points. The news put the drug—un­til then po­si­tioned as a promis­ing ri­val to Tagris­so (AZD9291) backed with peak sales pro­jec­tions of $3 bil­lion—at a dis­tinct dis­ad­van­tage, and the sub­se­quent rout evis­cer­at­ed the biotech’s share price.

Set­backs hap­pen in biotech. But some of the ex­perts who watched this drug say this was not the usu­al kind of clin­i­cal re­ver­sal that can eas­i­ly oc­cur in a risky field like drug de­vel­op­ment.

Clo­vis, run by well-known CEO Patrick Ma­haffy, had been pur­pose­ly mis­lead­ing in­vestors with a false por­trait of the da­ta, they claimed. 

“I feel that the ef­fi­ca­cy da­ta have, con­sis­tent­ly and re­peat­ed­ly, over many years, been mis­rep­re­sent­ed,” R&D ex­pert Kapil Dhin­gra told me months lat­er af­ter he wrote an analy­sis of the da­ta for An­nals of On­col­o­gy. “This is not sim­ply a case of gray zones, this is black and white un­true pre­sen­ta­tion of the da­ta. And it is not just a mi­nor mis­rep­re­sen­ta­tion (such as pho­to­shop­ping a west­ern blot im­age etc that can get a ba­sic sci­en­tist in trou­ble); the true ef­fi­ca­cy is about half of what they rep­re­sent­ed.”

The FDA made short work of Clo­vis’ ap­pli­ca­tion, re­ject­ing the mar­ket­ing bid af­ter a pan­el of ex­perts shook their heads over a risky safe­ty pro­file and a poor­ly de­fined pro­file of ef­fi­ca­cy da­ta. Clo­vis then dumped the drug rather than try to mount a new study, and turned their at­ten­tion to a late-stage PARP ther­a­py, win­ning an OK for Rubra­ca. Just yes­ter­day it won an ex­pand­ed OK to sell the drug as a main­te­nance ther­a­py.

Reg­u­la­tors, though, have a rep for be­ing slow and steady on the en­force­ment front. And they’ve ev­i­dent­ly stayed fo­cused on Clo­vis.

Lessons for biotech and phar­ma from a doc­tor who chased his own cure

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

James Collins, Broad Institute via Youtube

UP­DAT­ED: A space odyssey for new an­tibi­otics: MIT's ma­chine learn­ing ap­proach

Drug development is complex, expensive and comes with lousy odds of success — but in most cases, if you make it across the finish line brandishing a product with an edge (and play your cards right) it can be a lucrative endeavor.

As it stands, the antibiotic market is cursed — it harbors the stink of multiple bankruptcies, a dearth of innovation, and is consequently barely whetting the voracious appetites of big pharma or venture capitalists. Enter artificial intelligence — the biopharma industry’s cure-all for the pesky process of making a therapeutic, including data mining, drug discovery, optimal drug delivery, and addressable patient population.

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Gilead los­es two more patent chal­lenges on HIV pill, set­ting up court­room fight in Delaware

Gilead sustained two more losses in their efforts to rid themselves of an activist-backed patent lawsuit from the US government over a best-selling HIV pill.

Urged on by activists seeking to divert a portion of Gilead’s revenue to clinics and prevention programs, the Department of Health and Human Services made a claim to some of the patents for the best-selling HIV prevention drug, Truvada, also known as PrEP. Gilead responded by arguing in court that HHS’s patents were invalid.

Today, the US Patent and Trademark Office ruled that Gilead was likely to lose the last two of those challenges as well. The USPTO ruled against Gilead on the first two patents earlier this month.

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Jim Scholefield via PR Newswire

Mer­ck los­es its chief dig­i­tal of­fi­cer, spot­light­ing tal­ent hunt for the hottest ti­tle in Big Phar­ma

Over the last few years we’ve seen the chief digital officer title become one of the hottest commodities in Big Pharma as global organizations hunt the best talent to sharpen the cutting edge of their tech platforms.

But Merck just discovered how hard it may be to keep them focused on pharma.

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Kathy High (file photo)

Gene ther­a­py pi­o­neer Kathy High has left Spark af­ter com­plet­ing $4.3B union with Roche

Kathy High dedicated the past seven years of her life shepherding experimental gene therapies she’s developed at Children’s Hospital of Philadelphia toward the market as president and head of R&D at Spark Therapeutics. Now that the biotech startup is fully absorbed into Roche — with an FDA approval, a $4.3 billion buyout and a promising hemophilia program to boast — she’s ready to move on.

Roche confirmed her departure with Endpoints News and noted “she will take some well-deserved time off and then will begin a new chapter in a sabbatical at a university.”

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Bank­rupt an­tibi­otics mak­er Ar­a­digm turns to old part­ner/in­vestor for fi­nal $3M fire sale

Grifols once paid Aradigm $26 million for a stake in its inhaled antibiotics. But with Aradigm now in bankruptcy, the Spanish drugmaker is dishing out a final $3.2 million to buy it all.

The fire sale — which comes one year after Aradigm filed for Chapter 11 following a regulatory trifecta for disaster — will see Grifols obtain assets and IP to Apulmiq (formerly Pulmaquin and Linhaliq in Europe), Lipoquin and free ciprofloxacin. In addition to waiving its claims in the bankruptcy case, Grifols also agreed to milestone payments up to $3 million more upon any regulatory approvals.

DB­V's peanut pre­ven­tion patch ap­proach­es key stage of ap­proval process

Almost a year and a half after DBV Technologies pulled its peanut allergy immunotherapy patch from FDA review, the biotech will get their day in court. The FDA has scheduled an advisory committee hearing for May 15.

In the two-horse race to develop the first immunotherapy for peanut allergy, DBV had the early lead, filing an NDA for their patch in 2018. But on December 20 of that year, the company withdrew their application after, they said, meeting with regulators and determining they had not submitted “sufficient detail regarding data on manufacturing procedures and quality controls.” Aimmune filed their BLA 3 days later and won approval as the first immunotherapy for peanuts this month.

Tal Zaks (Moderna via YouTube)

For two decades, a new vac­cine tech­nol­o­gy has been slow­ly ap­proach­ing prime time. Now, can it stop a pan­dem­ic?

Two months before the outbreak, Moderna CMO Tal Zaks traveled from Cambridge, MA to Washington DC to meet with Anthony Fauci and the leaders of the National Institutes of Health.

For two years, Moderna had worked closely with NIH researchers to build a new kind of vaccine for MERS, one of the deadliest new viruses to emerge in the 21st century. The program was one test for a new technology designed to be faster, cheaper and more precise than the ways vaccines had been made for over a century. They had gathered evidence the technology could work in principle, and Fauci, the longtime head of the National Institute of Allergy and Infectious Diseases and a longtime advocate for better epidemic preparedness, wanted to see if it, along with a couple of other approaches, could work in a worst-case scenario: A pandemic.

“[We were] trying to find a test case for how to demonstrate if our technology could rapidly prepare,” Zaks told Endpoints News.

Zaks and Fauci, of course, wouldn’t have to wait to develop a new test. By year’s end, an outbreak in China would short circuit the need for one and throw them into 24/7 work on a real-world emergency. They also weren’t the only ones with new technology who saw a chance to help in a crisis.

An ocean away, Lidia Oostvogels was still on vacation and relaxing at her mother’s house in Belgium when her Facebook started changing. It was days after Christmas and on most people’s feeds, the news that China had reported a novel virus to the World Health Organization blurred into the stream of holiday sweaters and fir trees. But on Oostvogels’s feed, full of vaccine researchers and virus experts, speculation boiled: There was a virus in China, something contained to the country, but “exotic,” “weird,” and maybe having to do with animals. Maybe a coronavirus.

Lidia Oostvogels

“I was immediately thinking like, ‘Hey, this is something that if needed, we can play a role,'” Oostvogels told Endpoints.

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An­to­nio Gual­ber­to starts post-Ku­ra ca­reer at Ei­sai sub­sidiary H3; eF­FEC­TOR co-founder Siegfried Re­ich jumps to Turn­ing Point

→ Days after Kura Oncology announced the departure of co-founder Antonio Gualberto, we finally know where he wound up. Eisai subsidiary H3 Biomedicine has recruited him as CMO to finding the right patients to its four clinical-stage small molecule assets hitting genomic drivers of cancer.

“Challenges of these and many other precision medicine approaches are on one hand technical — a need for robust and precise diagnostics — and on the other hand derived by the challenge to alter standard clinical practice in settings where patient screening, e.g. by tumor DNA sequencing, is not standard practice,” he wrote to Endpoints News on his way back to Boston from Eisai’s Tokyo offices. “Only compelling clinical activity can drive clinicians and pathologists to modify standard clinical practice.”