William Heiden, AMAG

Cred­i­bil­i­ty shred­ded, AM­AG jet­ti­sons CEO and 2 drugs as it looks to re­or­ga­nize around a sal­vage plan

With its rev­enue num­bers in a tail­spin and a top drug un­der crit­i­cal re­view at the FDA fol­low­ing a failed con­fir­ma­to­ry study, AM­AG is start­ing the new year with a new plan.

Out go two drugs for women’s health: the con­tro­ver­sial Vyleesi ap­proved last year to stim­u­late women’s sex­u­al de­sire and In­trarosa for the re­lief of pain dur­ing sex. The biotech $AM­AG plans to auc­tion off those drugs to any­one game to try to mar­ket them. Al­so out: CEO William Hei­den, once they find a suc­ces­sor for the helm.

Hei­den is fol­low­ing in the re­treat­ing foot­steps of 110 sales staffers who were cut last year dur­ing an ear­li­er re­or­ga­ni­za­tion.

The CEO had this to say in a pre­pared state­ment:

We con­tin­ue to be­lieve in the sig­nif­i­cant long-term po­ten­tial of In­trarosa and Vyleesi. How­ev­er, the un­cer­tain­ty around the long-term dura­bil­i­ty of Mak­e­na rev­enues makes it chal­leng­ing to in­vest in both our promis­ing pipeline and in the physi­cian and con­sumer mar­ket­ing re­quired to sup­port these two new prod­ucts.

AM­AG has been un­der con­sid­er­able scruti­ny since a ma­jor­i­ty of FDA ad­vis­ers vot­ed to sug­gest that the agency should yank their ap­proval for Mak­e­na. The drug flopped bad­ly in the con­fir­ma­to­ry study the FDA had de­mand­ed as it pro­vid­ed an ac­cel­er­at­ed OK on the drug — way back in 2011.

Now per­suad­ing the FDA to keep the preterm birth drug Mak­e­na on the mar­ket is a top pri­or­i­ty, along with the de­vel­op­ment of cira­paran­tag and AM­AG-423 while “dri­ving the con­tin­ued growth of Fer­a­heme, which funds our two pipeline as­sets.”

An­a­lysts re­mained skep­ti­cal af­ter the an­nounce­ment Thurs­day.

Eun Yang at Jef­feries says sell­ing off the two un­der-per­form­ing as­sets made sense, but didn’t see any quick up­side in terms of rev­enue. The biotech has lost cred­i­bil­i­ty in re­cent years.

Note that in ear­ly-2017, when AM­AG ac­quired Vyleesi ($60M up­front) & In­trarosa ($50M in cash + $13.5M in stock up­front), the Street was gen­er­al­ly skep­ti­cal of the com­mer­cial po­ten­tial and the shares sold off >30% dur­ing that pe­ri­od. From 2016-2019, to­tal rev­enues de­clined by ~40% to ~$325M (our es­ti­mate) & non-GAAP OpEx in­creased by 37% to ~$387M (by our es­ti­mate).

The new CEO is go­ing to have quite a chal­lenge win­ning an­a­lysts back.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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