As­traZeneca's star res­pi­ra­to­ry drug runs in­to an­oth­er wall with COPD, but it's not giv­ing up — yet

As­traZeneca’s at­tempt to push its res­pi­ra­to­ry bi­o­log­ic Fasen­ra (ben­ral­izum­ab) in­to the chron­ic ob­struc­tive pul­monary dis­ease field has been foiled by a Phase III flop.

Sean Bo­hen

In the 56-week mul­ti-cen­ter tri­al, Fasen­ra failed to spur a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion of ex­ac­er­ba­tions in pa­tients with mod­er­ate to very se­vere COPD, the pri­ma­ry end­point, com­pared to place­bo.

Cur­rent­ly ap­proved as an add-on treat­ment for se­vere eosinophilic asth­ma in the US, EU, Japan and sev­er­al oth­er coun­tries, Fasen­ra was billed as a block­buster in the mak­ing, with CEO Pas­cal So­ri­ot es­ti­mat­ing peak sales po­ten­tial at $2 bil­lion (Jef­feries an­a­lysts gave it a more mod­est $1.5 bil­lion).

To achieve that, As­traZeneca need­ed to nav­i­gate a mar­ket al­ready staked by Glax­o­SmithK­line’s first-in-class Nu­cala, Te­va’s Cinqair, and No­var­tis’ Xo­lair. It’s too ear­ly to tell whether its com­bi­na­tion of low­er pric­ing, dos­ing fre­quen­cy and de­liv­ery method was enough to start win­ning over large num­bers of physi­cians and pa­tients, and its more en­trenched ri­vals are plan­ning moves of their own. Last Sep­tem­ber, GSK fol­lowed up with an NDA for Nu­cala in COPD — though the case was al­so built up­on shaky da­ta heav­i­ly re­liant on a bio­mark­er.

As­traZeneca went in­to the Phase III Galathea study (as well as an­oth­er one dubbed Ter­ra­no­va) de­spite con­ced­ing de­feat in a PhI­Ia study back in 2014, where Fasen­ra not on­ly failed to im­prove the rate of acute ex­ac­er­ba­tions for se­vere COPD pa­tients but al­so saw a high­er rate of treat­ment-emer­gent ad­verse events. Ex­ecs at the UK phar­ma gi­ant and its bi­o­log­ics unit Med­Im­mune were bet­ting that bet­ter tri­al de­sign and pa­tient se­lec­tion would de­liv­er a des­per­ate­ly need­ed win in this key dis­ease tar­get, but it proved elu­sive.

That said, no new safe­ty or tol­er­a­bil­i­ty is­sues were re­port­ed in this tri­al — per­haps the on­ly good news in the an­nounce­ment.

While the team is still crunch­ing the num­bers for an up­com­ing med­ical meet­ing, CMO Sean Bo­hen has this to say:

COPD is a de­bil­i­tat­ing dis­ease with sig­nif­i­cant un­met need among pa­tients whose dis­ease re­mains un­con­trolled de­spite treat­ment with ex­ist­ing in­haled ther­a­pies. We will now await the re­sults of TER­RA­NO­VA and a full eval­u­a­tion of both tri­als to de­ter­mine next steps for Fasen­ra in COPD.

Ter­ra­no­va is sched­uled to read out this quar­ter.

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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UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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The race to de­vel­op Covid-19 drugs and vac­cines is on — here’s what’s hap­pen­ing in the UK

Weeks away from the results of ongoing US and China trials testing its experimental antiviral remdesivir, Gilead is going to trial the failed Ebola drug in a small group of coronavirus patients in England and Scotland. The United Kingdom is also home to a range of other therapeutic efforts, as the pandemic rages on across the globe.

On Tuesday, Southampton, UK-based startup Synairgen kicked off a mid-stage placebo-controlled study testing its experimental drug, SNG001 — an inhaled formulation of interferon-beta-1a — that has previously shown to be safe and effective in improving lung function in asthma patients with a respiratory viral infection in a pair of Phase II trials.

‘There was a grow­ing weari­ness’: Rush­ing against a pan­dem­ic clock, As­pen Neu­ro­sciences se­cures $70M Se­ries A

Just before Christmastime, Howard Federoff got a tip from Washington: There was a new virus in China. And this one could be bad.

News report of the virus had not yet appeared. Federoff, a neuroscientist, was briefed because years before, he was vetted as part of a group — he didn’t give a name for the group — to consult for the US government on emerging scientific issues. His day job, though, was CEO of Aspen Neurosciences, a Parkinson’s cell therapy startup that days before had come out of stealth mode and gave word to investors they were hoping to raise $70 million. That, Federoff realized, would be difficult if a pandemic shut down the global economy.

FDA puts pe­di­atric aGVHD drug on pri­or­i­ty re­view lane — will they go vir­tu­al with the ad­comm?

Despite worries about regulatory delays due to new work arrangements under Covid-19, the FDA appears intent to go full speed ahead with its everyday work, not only granting priority review to a stem cell therapy for acute graft versus host disease but also plotting an advisory committee meeting for it.

With a PDUFA date of September 30, the journey of the drug — remestemcel-L, or Ryoncil — could shed light on the agency’s capacity to facilitate drug development unrelated to Covid-19.

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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Covid-19 roundup: Trump push­es his new fa­vorite, untest­ed drug; CRISPR out­lines crip­pling im­pact of Covid-19

President Trump has a new favorite Covid-19 drug.

After a conversation with Japanese Prime Minister Shinzo Abe, Politico reports, the president is pressuring the FDA to issue emergency use authorization for favipiravir, a flu drug that showed glimpses of success in China but remains unproven and carries a list of worrying side effects. The push comes after a week-plus in which the White House touted a potentially effective but unproven malaria medication despite the concerns of scientific advisors such as NIAID director Anthony Fauci. And Trump ally Rudy Giuliani has been talking up unproven cell therapy efforts on Twitter.

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ITeos nabs $125M as they prep Keytru­da com­bi­na­tion tri­al — if Covid-19 will let them

For iTeos, it turned out, $75 million could only last so long.

Two years after announcing their eye-catching Series B raise, the Belgian biotech is back with an even larger Series B-2: $125 million.

The now $175 million financing – $25 million of the first B round is considered part of the second – illustrates the vast capital available for those with promising new immuno-oncology compounds, particularly those that might be used in combination with existing therapies. In December, iTeos announced a collaboration with Merck to test its lead compound with Keytruda this year. The proceeds will push forward that trial and help fund the ongoing Phase I/II trials for that compound, EOS-850, and a second one, EOS-448.

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