Arde­lyx scraps PhI­II drug af­ter re­searchers raise a safe­ty is­sue for hy­per­kalemia pa­tients

The roller coast­er ride at Arde­lyx is con­tin­u­ing to­day with news that one of their late-stage as­sets is be­ing scrapped.

With their lead drug tena­panor be­ing slow­ly guid­ed to reg­u­la­tors and a hoped-for mar­ket show­down for ir­ri­ta­ble bow­el syn­drome, Arde­lyx $ARDX re­port­ed that it has de­cid­ed to scut­tle its Phase III pro­gram for RDX7675 in pa­tients with hy­per­kalemia af­ter track­ing a safe­ty is­sue — drug-re­lat­ed re­duc­tion in serum bi­car­bon­ate, which can trig­ger a de­ci­sion to stop treat­ment — which es­sen­tial­ly blew up its plans to mar­ket this treat­ment for chron­ic cas­es.

The set­back, though, didn’t seem to faze in­vestors. Arde­lyx shares, which have fol­lowed a neck-snap­ping pace of ups and downs, are up a bit this morn­ing. And Leerink’s Sea­mus Fer­nan­dez tells us why:

“(O)ur re­cent ini­ti­a­tion and en­thu­si­asm for ARDX is geared al­most en­tire­ly to­ward the oppt’y for tena­panor in hy­per­phos­phatemia. Mgmt ex­pects the ter­mi­na­tion of ‘7675 to re­sult in cash sav­ings of ~$40M and be­lieves the com­pa­ny now has cash run­way in­to 2019.”

Mike Raab

“The goal for RDX7675 was to de­vel­op a palat­able prod­uct that could be tak­en chron­i­cal­ly to ad­dress an im­por­tant med­ical need for pa­tients with hy­per­kalemia (high blood lev­els of potas­si­um). We are pleased by the ac­tiv­i­ty ob­served; how­ev­er, the unan­tic­i­pat­ed bi­car­bon­ate side ef­fect cre­ates a bar­ri­er for RDX7675, which we be­lieve could lim­it its chron­ic use,” said Mike Raab, chief ex­ec­u­tive of­fi­cer of Fre­mont, CA-based Arde­lyx, in a state­ment.

The biotech has plen­ty left to do. There’s an ear­ly-stage ther­a­py for hy­per­kalemia called RDX013 that will be moved up. And the next Phase III pro­gram for tena­panor for hy­per­phos­phatemia in end-stage re­nal dis­ease pa­tients on dial­y­sis is be­ing en­rolled, with a con­trol arm be­ing added af­ter reg­u­la­tors told them they need­ed more safe­ty da­ta. An ap­pli­ca­tion for tena­panor as a new treat­ment for IBS-C is al­so in the works.

When Arde­lyx ex­ecs rolled out their first round of Phase III da­ta on their IBS drug tena­panor, they were con­fi­dent that they were play­ing a win­ning hand, with sta­tis­ti­cal­ly sig­nif­i­cant re­sults in beat­ing out a place­bo for eas­ing ab­dom­i­nal pain and in­creas­ing bow­el move­ments.

In­stead they were crushed af­ter some an­a­lysts could bare­ly sti­fle a yawn over per­fect­ly ap­prov­able da­ta that didn’t mea­sure up so well against new da­ta from a ri­val drug from Syn­er­gy $SGYP called Tru­lance as well as Iron­wood’s fran­chise $IR­WD drug Linzess. Then, a few weeks ago, the stock rock­et­ed up on bet­ter com­par­i­son da­ta.

There’s nev­er a dull mo­ment at Arde­lyx.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Two biotech uni­corns swell pro­posed IPOs, eye­ing a $600M-plus wind­fall

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.

No­var­tis holds back the copy­cat brigade's at­tack on its top drug fran­chise — for now

A fed­er­al judge has put a gener­ic chal­lenge to No­var­tis’ block­buster mul­ti­ple scle­ro­sis drug Gilenya on hold while a patent fight plays out in court.

Judge Leonard P. Stark is­sued a tem­po­rary in­junc­tion ear­li­er this week, forc­ing My­lan, Dr. Red­dy’s Lab­o­ra­to­ries and Au­robindo Phar­ma to shelve their launch plans to al­low the patent fight to pro­ceed. He ruled that al­low­ing the gener­ics in­to the mar­ket now would per­ma­nent­ly slash the price for No­var­tis, even if it pre­vails. 

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

FDA re­jects Ac­er's rare dis­ease drug, asks for new tri­al — shares crater

Ac­er Ther­a­peu­tics’ bid to re­pur­pose celipro­lol — a be­ta-block­er on the mar­ket for hy­per­ten­sion — as a treat­ment for a rare, in­her­it­ed con­nec­tive tis­sue dis­or­der has hit a se­vere set­back. The New­ton, Mass­a­chu­setts-based com­pa­ny on Tues­day said the FDA re­ject­ed the drug and has asked for an­oth­er clin­i­cal tri­al.

The com­pa­ny’s shares $AC­ER cratered near­ly 77% to $4.47 in Tues­day morn­ing trad­ing.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Top an­a­lyst finds a sil­ver lin­ing in Ab­b­Vie’s $63B Al­ler­gan buy­out — but there’s a catch

Af­ter get­ting beat up on all sides from mar­ket ob­servers who don’t much care for the lat­est mega-deal to ar­rive in bio­phar­ma, at least one promi­nent an­a­lyst now is start­ing to like what he sees in the num­bers for Ab­b­Vie/Al­ler­gan.

But it’s go­ing to take some en­cour­age­ment if Ab­b­Vie ex­ecs want it to last.

Ab­b­Vie’s mar­ket cap de­clined $20 bil­lion on Tues­day as the stock took a 17% hit dur­ing the day. And SVB Leerink’s Ge­of­frey Porges can see a dis­tinct out­line of an up­side af­ter re­view­ing the fun­da­men­tals of the deal.

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