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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Sheldon Koenig, Esperion CEO

Es­pe­ri­on gets out the bud­get ax, chop­ping 170 staffers as its big drug launch sput­ters

Esperion’s executive team spent years insisting that they had found the sweet spot in the market for their cholesterol drug. But that strategy has soured badly, and after struggling to sell its heart disease pill for more than a year, the biotech says it will cut about 40% of its staff over the next few weeks.

The layoffs will take place across the board, from sales and marketing to R&D, CEO Sheldon Koenig told Endpoints News on Monday. While the chief executive declined to elaborate on how many employees will be affected, an SEC filing stated that approximately 170 staffers are on the chopping block.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.