Shire gains a de­layed FDA OK for ‘block­buster’ dry eye drug li­fite­grast

Nine months af­ter the FDA hand­ed Shire $SH­PG a re­jec­tion for its dry eye drug li­fite­grast, the biotech com­pa­ny says it’s bounced back with a de­layed ap­proval from the FDA. And now Shire will set out to see if it can achieve its ear­li­er fore­cast of more than a bil­lion dol­lars in an­nu­al sales.

Shire will be tack­ling a broad mar­ket in­clud­ing more than 16 mil­lion peo­ple who have been di­ag­nosed with dry eye dis­ease. The com­pa­ny plans to get start­ed mar­ket­ing the eye drop ther­a­py in a few months, sell­ing it as Xi­idra.

Flem­ming Orn­skov, CEO of Shire

The ap­proval marks a clear win for CEO Flem­ming Orn­skov, who brought a de­sire to de­vel­op a pipeline of new oph­thalmic drugs when he took the helm at Shire, based in Dublin with an R&D heart cen­tered in Lex­ing­ton, MA. And the mar­ket loved the news, send­ing Shire share up 5%.

Orn­skov made li­fite­grast a key part of his plan to grow sales to $10 bil­lion a year, ahead of his big ac­qui­si­tion of Bax­al­ta. And he’s had some ups and downs along the way.

This ap­proval, though, marks a sig­nal step ahead for the com­pa­ny, if the drug per­forms on the mar­ket. Once the sub­ject of an Ab­b­Vie takeover at­tempt, which was scut­tled by new fed­er­al rules de­signed to de­rail tax in­ver­sions, Orn­skov has re­mained com­mit­ted to mak­ing Shire in­to a glob­al bio­phar­ma force to be reck­oned with.

In this case, Shire will have to con­tend with Brent Saun­ders and Al­ler­gan, which earned more than a bil­lion dol­lars last year for the lead­ing dry eye treat­ment on the mar­ket, Resta­sis (cy­closporin). The bulk of that mon­ey came from the big U.S. mar­ket.

“As Shire’s first FDA-ap­proved med­i­cine in oph­thalmics, this sig­nif­i­cant mile­stone ad­vances our goal of be­com­ing the glob­al leader in this cat­e­go­ry, where there are un­met pa­tient needs,” Orn­skov said in a state­ment. “We have a ro­bust oph­thalmics pipeline, and we look for­ward to lever­ag­ing Xi­idra as our en­trée in­to the space as we con­tin­ue to de­vel­op ad­di­tion­al in­no­v­a­tive eye care treat­ment op­tions.”

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.