Mark Timney (via YouTube)

Ex-Pur­due Phar­ma chief Mark Tim­ney, named in dozens of opi­oid law­suits, nabs an­oth­er biotech CEO gig

Fac­ing hun­dreds of law­suits over its role in fu­el­ing the US opi­oid epi­dem­ic, Pur­due Phar­ma is in the midst of full-scale tear­down — but that doesn’t mean its for­mer lead­ers aren’t mak­ing off well. Com­ing off a stint dri­ving RNAi ther­a­py in­clisir­an to a buy­out, for­mer Pur­due CEO Mark Tim­ney has found a new home at the helm of a small biotech.

On Mon­day, At­tralus Ther­a­peu­tics an­nounced Tim­ney’s hire as CEO amid a flur­ry of ad­di­tions to the biotech’s brain trust.

As the CEO dri­ving Pur­due dur­ing some of the worst years of the opi­oid epi­dem­ic, Tim­ney has been named in dozens of law­suits against the Oxy­Con­tin mak­er. He joined The Med­i­cines Com­pa­ny as its CEO in De­cem­ber 2018 af­ter four years as the pres­i­dent and CEO of Pur­due. In 2019, he snagged an $84 mil­lion wind­fall when that com­pa­ny was bought by No­var­tis for $9.7 bil­lion.

In a state­ment, Tim­ney said that he was ex­cit­ed about At­tralus’ pan-amy­loid re­moval ther­a­pies for pa­tients with sys­temic amy­loi­do­sis, cit­ing the ex­ten­sive un­met needs sur­round­ing the dis­ease. Nei­ther he nor At­tralus men­tioned any­thing about his time at Pur­due in the press re­lease, ex­cept for a brief men­tion that he held a se­nior role there.

The state­ment tout­ed his years of ex­pe­ri­ence in the in­dus­try and his lead­er­ship of The Med­i­cines Com­pa­ny through late-stage clin­i­cal de­vel­op­ment and max­i­mized the po­ten­tial for in­clisir­an, a siR­NA cho­les­terol low­er­ing ther­a­py.

“These ac­tions in­creased share­hold­er re­turn more than three-fold with­in one year and cul­mi­nat­ed in the com­pa­ny’s ac­qui­si­tion by No­var­tis,” the state­ment said.

Dur­ing his time at Pur­due, Tim­ney al­leged­ly di­rect­ed sales reps to pro­mote Oxy­Con­tin’s “abuse-de­ter­rent prop­er­ties,” even though he didn’t dis­close that those prop­er­ties didn’t help with over­con­sump­tion of the drug, the AP said. Tim­ney and his pre­de­ces­sor John Stew­art were ac­cused of par­tic­i­pat­ing di­rect­ly in de­cep­tive prac­tices and al­leged­ly gave pre­sen­ta­tions that ac­knowl­edged that the an­ti-abuse tech­nol­o­gy was un­like­ly to work. He is named as a de­fen­dant in more than 30 law­suits against Pur­due from over 1,000 cities and states, in­clud­ing Col­orado, Mass­a­chu­setts and Con­necti­cut.

Richard Gaster

So far, Pur­due has reached a num­ber of set­tle­ments, in­clud­ing one in March 2019 for $270 mil­lion with the state of Ok­la­homa. The com­pa­ny is cur­rent­ly mired in a court-su­per­vised re­struc­tur­ing.

Nei­ther At­tralus nor Tim­ney re­spond­ed by press time.

“We are pleased to wel­come Mark Tim­ney as CEO of At­tralus, as he brings a track record for de­liv­er­ing val­ue for pa­tients, health care sys­tems and in­vestors,” At­tralus board mem­ber Richard Gaster said in the re­lease.

Rahul Kakkar, a biotech en­tre­pre­neur and the CEO of Pan­dion Ther­a­peu­tics be­fore it was ac­quired by Mer­ck, was named as an At­tralus board mem­ber Mon­day. Gre­go­ry Bell comes to the com­pa­ny to fill the role of CMO from KAI Phar­ma­ceu­ti­cals. Glen Fire­stone was named the CBO, Kr­ish­na Gor­ti was named the head of cor­po­rate de­vel­op­ment and Michael Klein was named the head of chem­istry, man­u­fac­tur­ing and con­trols.

At­tralus’ pan-amy­loid re­moval ther­a­peu­tic is de­signed to di­rect­ly bind and re­move tox­ic amy­loid in or­gans and tis­sues, and has the po­ten­tial to treat pa­tients with all types and stages of amy­loi­do­sis.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, 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.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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