Ab­b­Vie nabs pe­di­atric OK for hep C drug Mavyret; Glen­mark launch­es cheap­er SGLT2 in­hibitor in In­dia

→ Build­ing off a sur­prise suc­cess with Mavyret in adults, Ab­b­Vie has nabbed an FDA ap­proval to mar­ket the he­pati­tis C drug for chil­dren ages 12 to 17. The drug — a com­bi­na­tion of gle­capre­vir and pi­brentasvir — racked up $3.438 bil­lion in net rev­enue for 2018, far ex­ceed­ing peak sales ex­pec­ta­tions. The OK was based on a tri­al of 47 HCV pa­tients with geno­types 1-4 sug­gest­ing a 100% cure rate, though it cov­ers all six geno­types.

→ In­dia’s Glen­mark on Tues­day launched a new SGLT2 in­hibitor called Re­mogliflozin. It is the first-ever launch of the di­a­betes drug, which was part­ly de­vel­oped by GSK, and it will be sold in In­dia. SGLT2 in­hibitors, such as Forx­i­ga, In­vokana and Jar­diance, work by pre­vent­ing the kid­neys from re­ab­sorb­ing glu­cose back in­to the blood. Re­mogliflozin, which has shown to be com­pa­ra­bly ef­fi­ca­cious and safe as Forx­i­ga in a late-stage head-to-head study, will be sold at a price of 25 ru­pees (36 cents) per day, a dis­count of more than 50% to ex­ist­ing SGLT2 in­hibitors on the In­di­an mar­ket, a com­pa­ny spokesper­son told End­points News.

→ A day af­ter the FDA added boxed warn­ings to zolpi­dem and oth­er in­som­nia med­i­cines for seem­ing to cause dan­ger­ous be­hav­iors, Ei­sai is go­ing all in on a sleep-wake reg­u­la­tion agent that it says com­pares fa­vor­ably to zolpi­dem. The Japan­ese com­pa­ny was col­lab­o­rat­ing with Pur­due Phar­ma on lem­borex­ant, but now says it will buy out all world­wide de­vel­op­ment and com­mer­cial­iza­tion rights. “Pur­due’s busi­ness pri­or­i­ties have shift­ed since this col­lab­o­ra­tion was ini­ti­at­ed,” CEO Craig Lan­dau said, adding they will now fo­cus on on­col­o­gy, non-opi­oid pain and oth­er CNS pro­grams. Oth­er po­ten­tial in­di­ca­tions in­clude ir­reg­u­lar sleep-wake rhythm dis­or­der in pa­tients with Alzheimer’s Dis­ease.

→ We fi­nal­ly know ex­act­ly how many jobs Mer­ri­mack Phar­ma’s $MACK lat­est pro­gram ter­mi­na­tion cost. In an SEC fil­ing, the com­pa­ny said 13 staffers now re­main, around half of the 27 who sur­vived the last round of lay­offs in No­vem­ber. A few weeks ago Mer­ri­mack an­nounced it was aban­don­ing its ex­per­i­men­tal drug, MM-310, af­ter an ear­ly-stage study in­volv­ing pa­tients with sol­id tu­mors showed that treat­ment with the drug was cu­mu­la­tive­ly tox­ic to pa­tients, de­spite tri­al pro­to­col amend­ments. Its pipeline now con­sists of two pre­clin­i­cal pro­grams.

→ As Mo­tif Bio works to re­solve the FDA’s con­cerns about the safe­ty of iclaprim, it’s dou­bling down on the an­tibi­ot­ic with a new com­bo pro­gram that broad­ens its ap­pli­ca­tion be­yond skin in­fec­tions. The UK biotech is part­ner­ing up with Scot­land’s Lamel­lar Bio­med­ical to test iclaprim along­side LMS-611 for cys­tic fi­bro­sis lung in­fec­tions. Mo­tif Bio says the two drugs have been grant­ed or­phan des­ig­na­tion for Staphy­lo­coc­cus au­reus pneu­mo­nia in pa­tients with CF in the US and Eu­rope, re­spec­tive­ly.

Na­tal­ie Grover con­tributed re­port­ing.


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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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology

ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development

CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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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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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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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.