With hep C fran­chis­es lan­guish­ing, Mer­ck’s MK-3682 goes from block­buster to bomb

A lit­tle less than three years af­ter ac­quir­ing the he­pati­tis C drug MK-3682 (up­ri­fos­bu­vir) in its $3.85 bil­lion buy­out of Idenix, Mer­ck’s prospects in the field have cooled dra­mat­i­cal­ly, and its once great hopes for the drug have been re­duced to near­ly noth­ing.

Af­ter the mar­ket closed on Thurs­day, Mer­ck says it is tak­ing a pre-tax $2.9 bil­lion “in­tan­gi­ble as­set im­pair­ment charge” for the drug and re­duc­ing it on the books to a mar­gin­al $240 mil­lion — and even that may not last long.

Its 8-K filed to­day at the SEC notes:

The Com­pa­ny de­ter­mined that re­cent changes to the prod­uct pro­file, as well as changes to its ex­pec­ta­tions for pric­ing and the mar­ket op­por­tu­ni­ty, tak­en to­geth­er con­sti­tut­ed a trig­ger­ing event that re­quired the Com­pa­ny to eval­u­ate the up­ri­fos­bu­vir in­tan­gi­ble as­set for im­pair­ment. Uti­liz­ing mar­ket par­tic­i­pant as­sump­tions, and con­sid­er­ing dif­fer­ent sce­nar­ios, the Com­pa­ny con­clud­ed that its best es­ti­mate of the cur­rent fair val­ue of the in­tan­gi­ble as­set re­lat­ed to up­ri­fos­bu­vir was $240 mil­lion….The Com­pa­ny con­tin­ues to eval­u­ate op­tions with re­spect to the up­ri­fos­bu­vir clin­i­cal de­vel­op­ment pro­gram and will mon­i­tor the re­main­ing $240 mil­lion in­tan­gi­ble as­set for fur­ther im­pair­ment.

Back in 2014 when Mer­ck bought Idenix, hep C was one of the hottest dis­eases in bio­phar­ma. New cock­tails in de­vel­op­ment at the mar­ket leader Gilead as well as Ab­b­Vie had made the field a deal­mak­er’s par­adise, and as­set val­u­a­tions soared. Even in late 2015 Mer­ck was talk­ing up the drug, used in a cock­tail aimed at faster cures.

To­day, though, hep C has been pain­less­ly cured with a num­ber of very ef­fec­tive, and in­creas­ing­ly cheap cock­tails. Gilead’s for­tune is ex­pect­ed to melt away by as much as half this year, as com­pe­ti­tion and cure rates have be­gun to evis­cer­ate a flag­ship port­fo­lio. And Mer­ck’s great ex­pec­ta­tions are a bust.

Ac­cord­ing to Leerink, Mer­ck ex­ecs point­ed out last night that “a de­clin­ing ad­dress­able pa­tient pop­u­la­tion and a more dif­fi­cult pric­ing en­vi­ron­ment since the Idenix ac­qui­si­tion.” But there is al­so a ques­tion about tim­ing now, as Mer­ck’s de­vel­op­ment pro­gram has been se­ri­ous­ly de­layed.

Mer­ck has been in­formed by reg­u­la­tors that it will need to com­plete sep­a­rate tri­als, and show an added ben­e­fit, with the triple, over its high dose dou­blet of MK3682 + MK8408. This sug­gests that com­pa­ny will need to wait for da­ta from the high-dose dou­blet (which is fur­ther be­hind in Phase 2) and de­lays the tim­ing of the triple ma­te­ri­al­ly.

That doesn’t mean, though, that the phar­ma gi­ant is stop­ping any of the on­go­ing tri­als for the drug. Late Thurs­day Mer­ck sent me a state­ment say­ing that the write down had noth­ing to do with the drug’s ef­fi­ca­cy or safe­ty. Mer­ck added:

We’ve had a com­mit­ment to he­pati­tis C for sev­er­al decades.   En­roll­ment in the cur­rent clin­i­cal tri­als for up­ri­fos­bu­vir will con­tin­ue. We al­so re­main en­cour­aged by our progress with the launch of ZEPATI­ER, in­clud­ing our abil­i­ty to gain ac­cess across pub­lic and pri­vate pay­ers in the Unit­ed States and ini­tial up­take in the Eu­ro­pean Union and Japan.

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.

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

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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