With Al­ler­gan's ri­val on the reg­u­la­to­ry ropes, Ab­b­Vie posts more promis­ing late-stage da­ta for elagolix

Ab­b­Vie picked a good day to un­veil an­oth­er pos­i­tive set of late-stage da­ta from their uter­ine fi­broid pro­gram for elagolix, now on the mar­ket as Orilis­sa for a dif­fer­ent in­di­ca­tion.

Just hours af­ter Al­ler­gan re­vealed that their ap­pli­ca­tion for a ri­val ther­a­py had been hit with a re­jec­tion let­ter from the FDA, the Ab­b­Vie team says their Phase III ELARIS UF-EX­TEND ex­ten­sion study of elagolix hit a clin­i­cal re­sponse rate of 88%. That comes on top of two clear­ly up­beat Phase III read­outs show­ing a high rate of re­spons­es, de­fined by a sig­nif­i­cant drop in men­stru­al blood loss.

Women of­ten de­vel­op uter­ine fi­broids with­out any symp­toms oc­cur­ring, but rough­ly 1 in 4 do have some se­ri­ous is­sues to deal with, in­clud­ing heavy men­stru­al bleed­ing, painful pe­ri­ods, vagi­nal bleed­ing at times oth­er than men­stru­a­tion, and ane­mia. Re­searchers plan to de­tail the da­ta at a sci­en­tif­ic con­fer­ence lat­er in the year, with a reg­u­la­to­ry fil­ing fol­low­ing in 2019.

Right now, the road to claim­ing the lead in the field is wide open as Al­ler­gan deals with the CRL it re­ceived on Tues­day.

Al­ler­gan has been forced to rein in its mar­ket­ing on their drug — sold as Es­mya — in Eu­rope as reg­u­la­tors raised con­cerns about the risk of rare but se­ri­ous liv­er dam­age. The Eu­ro­pean group has re­strict­ed sales “fol­low­ing re­ports of se­ri­ous liv­er in­jury, in­clud­ing liv­er fail­ure lead­ing to trans­plan­ta­tion” which were linked to the drug. And that raised a bar on safe­ty that Al­ler­gan couldn’t clear at the FDA.

Ab­b­Vie got this drug in a $575 mil­lion deal it struck in 2010 with Neu­ro­crine $NBIX, which stands to earn a roy­al­ty pay­out on an ap­proval. The FDA ap­proved the drug for en­dometrio­sis just a few weeks ago. Ab­b­Vie ex­ecs have a very high opin­ion of its prospects, with many an­a­lysts peg­ging an­nu­al sales well over the $1 bil­lion block­buster mark.

 

 

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.

Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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UP­DAT­ED: No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabriva Therapeutics suffered a setback after the FDA rejected its antibiotic for complicated urinary tract infections — the Novartis spinoff has now had some better luck with the US agency, which on Monday approved its other drug for community-acquired bacterial pneumonia.

The drug, lefamulin, has been developed as an intravenous and oral formulation and been tested in two late-stage clinical trials. The semi-synthetic compound, whose dosing can be switched between the two formulations, is engineered to inhibit the synthesis of bacterial protein by binding to a part of the bacterial ribosome.