Iron­wood re­cruits CMO on the eve of split-up; Roche vet Margrit Schwarz joins Genevant

Iron­wood Phar­ma­ceu­ti­cals is fill­ing up its C-suite to pre­pare for the im­pend­ing split up in­to two en­ti­ties. Just a week af­ter tap­ping As­traZeneca’s Mark Mal­lon for the CEO job, the com­pa­ny has ap­point­ed Michael Shet­z­line as CMO of the com­mer­cial-fo­cused unit, tasked with stew­ard­ing ex­ist­ing gas­troin­testi­nal as­sets, in­clud­ing its fran­chise drug Linzess, as well as find­ing new prod­uct op­por­tu­ni­ties in the space. He will re­port to Thomas Mc­Court, the cur­rent chief com­mer­cial of­fi­cer who’s get­ting pro­mot­ed to pres­i­dent as found­ing CEO Pe­ter Hecht leaves to run the R&D spin­out.  

Bo Rode Hansen is bring­ing a fel­low Roche alum to his team at Genevant, the RNA-fo­cused biotech birthed out of a col­lab­o­ra­tion be­tween Roivant and Ar­bu­tus. Margrit Schwarz, most re­cent­ly VP and glob­al head of ex­ter­nal in­no­va­tion at the Swiss phar­ma gi­ant fol­low­ing re­search roles at Am­gen and Boehringer In­gel­heim, joins as CSO and head of R&D. Al­so join­ing the Boston-based com­pa­ny is Pe­te Zorn, who has a back­ground as gen­er­al coun­sel and is tak­ing the COO post.

Pearl Huang, a founder and ear­ly ex­ec at BeiGene, is re­turn­ing to biotech as CEO of Cyg­nal Ther­a­peu­tics. Jump­ing from Roche — where she was the SVP and glob­al head of ther­a­peu­tic modal­i­ties, over­see­ing every­thing from small mol­e­cule to nu­cle­ic acid-based ther­a­pies. A prod­uct of Flag­ship Pi­o­neer­ing’s in­no­va­tion foundry, Cyg­nal is tar­get­ing mech­a­nisms and path­ways as­so­ci­at­ed with the pe­riph­er­al ner­vous sys­tem, a struc­ture of nerves work­ing out­side the cen­tral ner­vous sys­tem, plow­ing a field they call “ex­oneur­al bi­ol­o­gy.”

CRISPR Ther­a­peu­tics has wooed se­nior FDA of­fi­cial John Mar­tin to be­come its head of gov­ern­ment af­fairs. Mar­tin, whose ti­tle was prin­ci­pal as­so­ciate com­mis­sion­er for leg­isla­tive af­fairs, led the agency’s ne­go­ti­a­tion with Con­gress over reau­tho­riza­tion of user fees and sup­port­ed leg­is­la­tion ad­dress­ing the opi­oid abuse epi­dem­ic.

Clau­dia D’Au­gus­ta is the new CFO at Basel, Switzer­land-based Ther­a­chon, a Ver­sant-backed start­up fo­cused on rare ge­net­ic dis­eases. D’Au­gus­ta held the same role at stem cell play­ers TiGenix (un­til Take­da bought it out) and Cel­ler­ix (be­fore it merged with TiGenix).

→ Fol­low­ing some dra­ma with ex-CEO Carsten Thiel — who was oust­ed a mere six months in­to the job — Abeona Ther­a­peu­tics $ABEO has made a pair of pro­mo­tions to “bol­ster fi­nan­cial strat­e­gy and con­trols.” Chris­tine Sil­ver­stein, for­mer­ly SVP of fi­nance and in­vestor re­la­tions, will be­come CFO; Ed­ward Carr will be the chief ac­count­ing of­fi­cer.

→ As de­vel­op­ment of um­bil­i­cal cord blood-de­rived T-reg­u­la­to­ry cel­lu­lar ther­a­pies gets un­der way at Cel­lenkos, the MD An­der­son spin­out has ap­point­ed Eliz­a­beth Read as chief tech­nol­o­gy of­fi­cer to over­see chem­istry, man­u­fac­tur­ing and con­trols as well as reg­u­la­to­ry af­fairs. Read comes to the Hous­ton op­er­a­tion from a slate of roles in the San Fran­cis­co Bay Area, capped by a brief stint at Adicet Bio.

Gavin Ling is sup­ple­ment­ing his PhD in he­mo­phil­ia gene ther­a­pies with a job as chief med­ical of­fi­cer of As­cen­sion Health­care, steer­ing de­vel­op­ment of new he­mo­phil­ia A treat­ments. This marks the first biotech role for Ling, a con­sul­tant hema­tol­o­gist at Guy’s and St Thomas Hos­pi­tal, Lon­don.

Bioa­sis has hired Chris­tine An­ta­lik as CFO, with great ex­pec­ta­tions on her knowl­edge about fi­nanc­ing, busi­ness de­vel­op­ment and growth plan­ning — all cru­cial to li­cens­ing plans for its xB3 plat­form tech­nol­o­gy, which is de­signed to de­liv­er drugs across the blood-brain bar­ri­er.

→ In case you missed it, Paul-Pe­ter Tak has left the lead­ing role in Glax­o­SmithK­line’s im­munol­o­gy unit to be­come a ven­ture part­ner at Flag­ship Pi­o­neer­ing. Ac­cord­ing to his LinkedIn pro­file, the tran­si­tion hap­pened last Oc­to­ber.

Vas Narasimhan. Getty Images

Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine -- and spreads the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

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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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