Key pos­i­tive da­ta on month­ly HIV reg­i­men of­fer hope for pa­tients sad­dled with stan­dard dai­ly pills

HIV pa­tients have much to cheer about this week. Af­ter re­ports that a sec­ond HIV pa­tient has ex­pe­ri­enced sus­tained re­mis­sion fol­low­ing a bone mar­row trans­plant, a pair of drug­mak­ers on Thurs­day post­ed piv­otal da­ta that showed their month­ly in­jectable treat­ments worked as well as the stan­dard dai­ly three-drug cock­tail in sup­press­ing the virus that caus­es AIDS.

The in­jectable reg­i­men com­pris­ing two drugs — John­son & John­son’s $JNJ rilpivirine (sold as Edu­rant) and Vi­iV Health­care’s ex­per­i­men­tal treat­ment cabote­gravir — was test­ed in a two late-stage stud­ies in more than 1180 pa­tients al­to­geth­er. The to­tal dataset will be used to sub­mit ap­pli­ca­tions to mar­ket the in­jectable for­mu­la­tion to reg­u­la­tors lat­er this year, Vi­iV said.

The best way to thwart the spread of HIV is to use con­doms. But for those al­ready af­flict­ed with the virus, an­ti­retro­vi­ral ther­a­py must be tak­en every sin­gle day to sup­press the virus or un­bri­dled repli­ca­tion can over­whelm the im­mune sys­tem and even­tu­al­ly cause AIDS.

Apart from dras­ti­cal­ly re­duc­ing the num­ber of times treat­ment must be ad­min­is­tered to 12 from 365, the in­jectable reg­i­men — if ap­proved — could in cer­tain parts of the world re­duce the stig­ma of pick­ing up HIV pre­scrip­tions at phar­ma­cies.

Dai­ly pills al­so rack up ex­pen­sive bills in the Unit­ed States, with month­ly ex­pen­di­ture on treat­ment hit­ting thou­sands per month — de­pend­ing on the reg­i­men, in­sur­ance provider and re­bates/dis­counts. End­points News has asked the man­u­fac­tur­ers about their pric­ing plans for the in­jectable month­ly reg­i­men, and is await­ing com­ment.

Ac­cord­ing to the WHO es­ti­mates, 36.9 mil­lion peo­ple were liv­ing with HIV glob­al­ly in 2017.

In­ject­ed every four weeks, 48-week da­ta on the two-drug for­mu­la­tion from both stud­ies — FLAIR and AT­LAS — were pos­i­tive, with about 1% of pa­tients from ei­ther study de­vel­op­ing drug re­sis­tance, sim­i­lar to those who take stan­dard dai­ly ther­a­py, Vi­iV said.

Pos­i­tive AT­LAS da­ta was pub­lished last Au­gust. On Thurs­day, the two drug­mak­ers broke out the de­tailed num­bers for both AT­LAS and FLAIR.

The AT­LAS study found vi­ro­log­ic sup­pres­sion rates at week 48 were sim­i­lar be­tween treat­ment arms — (cabote­gravir + rilpivirine: 285/308 [92.5%]) ver­sus cur­rent an­ti­retro­vi­ral ther­a­py  (294/308 [95.5%]). In the FLAIR study vi­ro­log­ic sup­pres­sion rates at week 48 were al­so sim­i­lar be­tween treat­ment arms — (cabote­gravir + rilpivirine: 265/283 [93.6%]) ver­sus the stan­dard Tri­umeq reg­i­men: (264/283 [93.3%]).

Vi­iV — which was es­tab­lished in 2009 by British drug­mak­er GSK $GSK in part­ner­ship with Pfiz­er $PFE — is al­so test­ing the two-drug in­jectable ver­sion ad­min­is­tered every two months in the AT­LAS-2M study. It al­ready has an ar­se­nal of 13 ap­proved an­ti­retro­vi­ral med­i­cines.

GSK’s ap­proach to grab­bing mar­ket share from Gilead $GILD  — which cur­rent­ly dom­i­nates the HIV mar­ket that is es­ti­mat­ed to hit $22.5 bil­lion by 2025 — is to con­vince reg­u­la­tors, doc­tors and pa­tients to adopt its two-drug reg­i­mens, ver­sus Gilead’s triple-drug cock­tails, that could po­ten­tial­ly re­sult in few­er tox­ic side-ef­fects, re­duce dos­ing fre­quen­cy, and be more cost-ef­fec­tive — al­though crit­ics sug­gest this may not be the most ef­fec­tive strat­e­gy be­cause the virus will on­ly have to fight against two drugs which could cul­mi­nate in drug re­sis­tance. But if the in­jectable month­ly reg­i­men makes it to the mar­ket, Gilead’s crown may be more vul­ner­a­ble than ever.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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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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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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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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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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