Atara seeks new CEO as Isaac Ciechanover ex­its; As­traZeneca's Mark Mal­lon tapped to re­place Pe­ter Hecht at Iron­wood

→ In an abrupt de­par­ture, Isaac Ciechanover is step­ping down from Atara Bio­ther­a­peu­tics $ATRA, the T cell ther­a­py com­pa­ny that he found­ed in 2012 in hon­or of his moth­er. The South San Fran­cis­co biotech gave no rea­son for this change, which will take place by June 30, of­fer­ing on­ly the stan­dard thank you and the vi­sion for its pipeline of off-the-shelf CAR-T pro­grams, al­lied with promi­nent in­ves­ti­ga­tors around the coun­try.

Bahi­ja Jal­lal isn’t the on­ly se­nior As­traZeneca ex­ec head­ing to new biotech fields. Mark Mal­lon — cur­rent EVP in charge of port­fo­lio strat­e­gy — is on his way to take the CEO job at Iron­wood $IR­WD, as that com­pa­ny splits up un­der pres­sure and Pe­ter Hecht leaves to run the R&D spin­out.

→ Hav­ing been groomed for the helm at Al­lena Phar­ma­ceu­ti­cals $AL­NA — el­e­vat­ed to the pres­i­dent role with­in two years of join­ing the com­pa­ny as COO — Louis Bren­ner is of­fi­ciall tak­ing over from founder Alex­ey Mar­golin, who is tran­si­tion­ing to the chair­man role. The New­ton, MA-based biotech is de­vel­op­ing oral en­zyme ther­a­peu­tics to treat meta­bol­ic and kid­ney dis­or­ders, with the lead pro­gram relox­aliase set to be­gin Phase III.

→ Spe­cial­ty phar­ma Avadel Phar­ma­ceu­ti­cals $AVDL is part­ing ways with Michael An­der­son and putting Gre­go­ry Di­vis in charge as the in­ter­im CEO. The tem­po­rary pro­mo­tion comes months af­ter Di­vis as­cend­ed from chief com­mer­cial of­fi­cer to the COO post. Avadel’s port­fo­lio cov­ers urol­o­gy, cen­tral ner­vous sys­tem and sleep drugs.

→ Like a long line of No­var­tis ex­ecs be­fore her, Liz Bar­rett has switched to the biotech side of the in­dus­try — helm­ing Uro­Gen, a com­pa­ny she didn’t know un­til ex­ec­u­tive chair­man Arie Bellde­grun con­vinced her to pay a vis­it to its New York City head­quar­ters. Bar­rett takes over from Ron Bentsur just as the com­pa­ny is an­tic­i­pat­ing fi­nal Phase III da­ta for UGN-101, a spe­cial gel for up­per tract urothe­lial can­cer.

Cash rich and poised to be­gin Phase III with a pso­ri­a­sis drug, Der­ma­vant has scooped Philip Brown from Nestlé’s Gal­der­ma to be­come its CMO. Tap­inarof, a top­i­cal cream de­signed to ac­ti­vate the aryl hy­dro­car­bon re­cep­tor, is al­so be­ing ex­plored for atopic der­mati­tis.

Marie Kosco-Vil­bois has left her lengthy tenure at Novim­mune to take up the CSO po­si­tion at AC Im­mune $ACIU, where she will lever­age a deep back­ground in im­munol­o­gy to di­rect the com­pa­ny’s re­search work in neu­rode­gen­er­a­tive dis­eases — in­clud­ing ef­forts in Alzheimer’s, Down syn­drome and Parkin­son’s.

→ As Lon­don’s Verona Phar­ma gears up for a piv­otal COPD tri­al, it’s tapped a pair of Glax­o­SmithK­line vets to lead its clin­i­cal de­vel­op­ment team. Kath­leen Rickard is com­ing on board as CMO while Tara Rheault has been named VP of R&D op­er­a­tions and glob­al project man­age­ment. Both will di­rect R&D ac­tiv­i­ties from the biotech’s US of­fices. The in­haled treat­ment RPL554 showed promise in both COPD and cys­tic fi­bro­sis, trig­ger­ing a ral­ly for the biotech’s stock $VR­NA last March.

→ Fol­low­ing CFO David Grys­ka’s re­tire­ment, In­cyte $IN­CY has found his re­place­ment in Chris­tiana Sta­moulis, a for­mer in­vest­ment banker who’s tak­en a front seat in biotech at Ver­tex and, more re­cent­ly, Unum Ther­a­peu­tics.  

Nim­bus Ther­a­peu­tics is ready to bring a third pro­gram to the clin­ic in 2019, and it’s of­fi­cial­ly hir­ing Big Phar­ma vet Alan Col­lis get the IND in place. Bring­ing ex­pe­ri­ence from Pfiz­er, No­var­tis and For­ma Ther­a­peu­tics, Collins has worked on the ty­ro­sine ki­nase 2 (Tyk2) pro­gram — part­nered with Cel­gene — since Oc­to­ber. He joins as Hol­ly Whittmore and Ab­bas Kaz­i­mi get pro­mot­ed to CFO and VP of busi­ness de­vel­op­ment, re­spec­tive­ly.

→ Af­ter a stint as chief op­er­at­ing of­fi­cer at Ori­gin Bio­sciences, Er­ic Mos­brook­er is re­turn­ing to the com­mer­cial side of things at fel­low rare dis­ease com­pa­ny Au­dentes Ther­a­peu­tics $BOLD. As CCO, the Alex­ion alum will be in charge of de­vis­ing a strat­e­gy and build­ing out a team for the even­tu­al launch of Au­dentes’ gene ther­a­pies, the most ad­vanced of which is still in Phase I/II.

→ Months af­ter nab­bing rights to de­vel­op and sell a home­grown PD-L1 to sell out­side of Chi­na, Shang­hai-based Har­bour Bio­Med is spread­ing its wings in the US, where it has an out­post in Boston. At­ul Desh­pande, who man­aged the Dupix­ent fran­chise for Sanofi’s Gen­zyme, has been tapped to spear­head this ef­fort as chief strat­e­gy of­fi­cer and head of US op­er­a­tions along­side new­ly pro­mot­ed chief de­vel­op­ment of­fi­cer Xi­aox­i­ang Chen and chief busi­ness of­fi­cer Mai-Jing Liao.

→ As Roche-part­nered SQZ Biotech pre­pares to take its first cell ther­a­py in­to the clin­ic, it’s re­cruit­ed Oliv­er Rosen to over­see the clin­i­cal op­er­a­tion as CMO. Most re­cent­ly serv­ing the same role at De­ci­phera Phar­ma, Rosen’s re­sume spans roles at Mil­len­ni­um, Genen­tech, Am­gen and Roche.

DBV Tech­nolo­gies $DB­VT is reshuf­fling its lead­er­ship fol­low­ing an un­ex­pect­ed an­nounce­ment that it’s re­scind­ing the mar­ket­ing ap­pli­ca­tion for its peanut al­ler­gy drug. With Lu­cia Sep­tien-Velez leav­ing for oth­er op­por­tu­ni­ties, CSO Hugh Samp­son will dou­ble as the in­ter­im CMO. Mean­while, CEO Daniel Tassé will now be get­ting ad­vice from Julie O’Neill, a cur­rent board di­rec­tor for­mer­ly of Alex­ion, on prod­uct de­vel­op­ment, man­u­fac­tur­ing, qual­i­ty as­sur­ance, and end-to-end process op­ti­miza­tion in an ef­fort to re­file its BLA for Vi­askin Peanut.

UP­DAT­ED: Clay Sie­gall’s $614M wa­ger on tu­ca­tinib pays off with solid­ly pos­i­tive piv­otal da­ta and a date with the FDA

Back at the beginning of 2018, Clay Siegall snagged a cancer drug called tucatinib with a $614 million cash deal to buy Cascadian. It paid off today with a solid set of mid-stage data for HER2 positive breast cancer that will in turn serve as the pivotal win Siegall needs to seek an accelerated approval in the push for a new triplet therapy.

And if all the cards keep falling in its favor, they’ll move from 1 drug on the market to 3 in 2020, which is shaping up as a landmark year as Seattle Genetics prepares for its 23rd anniversary on July 15.

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UP­DAT­ED: The FDA sets a reg­u­la­to­ry speed record, pro­vid­ing a snap OK for Ver­tex's break­through triplet for cys­tic fi­bro­sis

The FDA has approved Vertex’s new triplet for cystic fibrosis at a record-setting speed.

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IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

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That $335M JV Bay­er set up on CRISPR/Cas9? They’re let­ting the biotech part­ner car­ry on

Bayer committed $300 million to set up a joint venture on CRISPR/Cas9 tech with CRISPR Therapeutics $CRSP. But they’re handing off control now to the smaller biotech while retaining a couple of opt-ins for programs nearing an IND.

Bayer $BAY made much of the fact that they were going all-in on gene editing when they did their deal 3 years ago with CRISPR Therapeutics, which pitched $35 million in on their end. This was the cornerstone of their plan to set up new JVs that could make some serious leap forwards in hot new R&D spaces. Now CRISPR will have full management control of Casebia as they pursue programs in hemophilia, ophthalmology and autoimmune diseases.
Samarth Kulkarni, the CEO at CRISPR, made it sound like a natural progression.

J&J's block­buster Ste­lara wins US ap­proval for ul­cer­a­tive col­i­tis

J&J’s Stelara, which is set to be in the top ten list of blockbusters come 2025, is now cleared by the FDA for use in ulcerative colitis (UC), an inflammatory disease of the large intestine.

The biologic targets interleukin (IL)-12 and IL-23 cytokines, which are known to play a key role in inflammatory and immune responses. Stelara, which generated about $4.7 billion in the first nine months of 2019, is a key player in the crowded marketplace of drugs to treat autoimmune disorders such as psoriasis, rheumatoid arthritis and Crohn’s disease. AbbVie’s star therapy, Humira, continues to dominate, despite its looming patent cliff in the United States, while others including J&J’s $JNJ own anti-IL23 Tremfya, Lilly’s $LLY anti-IL-17 Taltz and AbbVie’s $ABBV recently approved anti-IL-23 antibody Skyrizi carve out a slice of market share.

Drug com­pa­nies reach $260M set­tle­ment just ahead of opi­oid tri­al; Oys­ter Point set terms for $85M IPO

→ Hours before the first federal opioid trial was set to begin, three drug distributors and an opioid manufacturer agreed to a $260 million agreement settlement, the Wall Street Journal was the first to report. The deal — which will see McKesson, Cardinal Health and AmerisourceBergen pay $215 million to Summit and Cuyahoga counties, and Teva deal out $35 million in cash and addiction treatments — does not resolve the pending, nationwide litigation that may result in a settlement worth upwards of $40 billion. Negotiators in that case, brought by 2,300 tribes, counties and cities nationwide and led by several states’ attorneys general, worked through much of Friday without success. Josh Stein, the attorney general for North Carolina, said they were trying to put together a $48 billion deal.

GSK of­floads two vac­cines in $1.1B deal as it works to re­vive the pipeline

GlaxoSmithKline is leaving the deep dark woods and its viruses behind.

GSK has agreed to divest its vaccines for rabies, RabAvert, and tick-born encephalitis vaccine, Encepur, to Bavarian Nordic, part of the company’s broader efforts to narrow its pipeline and focus on oncology and immunology.

The deal is worth up to nearly $1.1 billion, with a $336 million upfront payment. GSK acquired the vaccines from Novartis as part of an exchange for their late-stage oncology programs in 2015 under former chief Sir Andrew Witty.

Pfiz­er gets some en­cour­ag­ing PhI­II news on a fran­chise sav­ior, but is a dos­ing ad­van­tage worth the $295M up­front?

Close to 3 years after Opko tried to defend itself as shares tumbled on the news that its long-acting growth hormone had failed to outperform a placebo, the Pfizer partner $PFE is back. And this time they’re pitching Phase III data that demonstrate their drug is non-inferior — or maybe a tad better — than their well-known but fading standard in the field.
The comparator drug here is Genotropin, which earned a marginal $142 million for Pfizer last year — down 9% from the year before. Approved 24 years ago, biosimilars are now in development that Pfizer would like to stay out in front of. The market leader here is Norditropin, a growth hormone from Novo Nordisk that uses the same basic ingredient as Genotropin, which the Danish company sells with a kid-friendly self-injectable pen. That would also present some big competition if the new therapy from Opko/Pfizer makes it to the market.
The new data, says researchers, underscore that a weekly injection of somatrogon performed as well or slightly better than Genotropin (somatropin) in young children with growth hormone deficiency. Investigators tracked height velocity at 10.12 cm/year, edging out the older drug’s 9.78 cm/year. That 0.33 difference may not prove compelling to payers, though, who have been known to overlook dosing advantages in favor of lower costs.
That message may have weighed on the stock reaction this morning, with a 30%-plus hike $OPK giving way to more marginal gains.
Back in late 2016, Opko had to defend itself against a devastating Phase III setback as their initial late-stage trial failed against a sugar pill. Opko later blamed that setback on outliers in the study, though it wasn’t able to expunge the failure.

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As­traZeneca's Farx­i­ga scores FDA nod to cut risk of hos­pi­tal­iza­tion for heart fail­ure in di­a­bet­ics

While the FDA recently spurned an application to allow AstraZeneca’s blockbuster drug Farxiga for type 1 diabetes that cannot be controlled by insulin, citing safety concerns — the US regulator has endorsed the use of the SGLT2 treatment to reduce the risk of hospitalisation for heart failure in patients with type-2 diabetes and established cardiovascular disease or multiple CV risk factors.