Thanks to Supreme Court de­ci­sion, Mer­ck gets an­oth­er chance to throw out Fos­amax claims

In a tem­po­rary re­lief for Mer­ck amid on­go­ing le­gal dra­ma sur­round­ing its os­teo­poro­sis drug Fos­amax, the Supreme Court has va­cat­ed the judg­ment of a low­er court and di­rect­ed it to re­con­sid­er a rul­ing that al­lowed law­suits to go to tri­al.

While the jus­tices did not weigh in on the mer­its of those law­suits, the de­ci­sion re­vives Mer­ck’s hopes of throw­ing out hun­dreds of pa­tients claims, which ac­cuse the phar­ma gi­ant of vi­o­lat­ing state laws by ne­glect­ing to warn them of risks as­so­ci­at­ed with Fos­amax for over a decade. Even though sci­en­tists had spec­u­lat­ed that Fos­amax — a bis­pho­s­pho­nate de­signed to pre­vent os­teo­porot­ic frac­tures — could in­crease the risk of atyp­i­cal femoral frac­tures be­fore the FDA ap­proved the drug in 1995, the la­bel did not fea­ture a warn­ing on that score. De­spite sub­se­quent ev­i­dence from pa­tient re­ports con­firm­ing the risk, a warn­ing was not added un­til 2010 fol­low­ing an or­der from reg­u­la­tors.

Why didn’t Mer­ck do any­thing about it dur­ing that time? It’s not for lack of try­ing, the com­pa­ny ar­gues. Rather, its at­tempt to add a warn­ing to the la­bel was re­ject­ed by the FDA, free­ing it of any le­gal re­spon­si­bil­i­ty for fail­ure to warn.

Stephen Brey­er

Key to val­i­dat­ing that ar­gu­ment is a le­gal prin­ci­ple in fed­er­al-state re­la­tions known as pre-emp­tion. In this case — fol­low­ing a 2009 prece­dent set in Wyeth v. Levine — it means that when there is “clear ev­i­dence” that the FDA would not have ap­proved the warn­ing that state law re­quires, the drug man­u­fac­tur­er could not be blamed for fail­ing to com­ply with that state law.

The plain­tiffs might dis­agree on whether that cri­te­ria is met. In fact, Jus­tice Stephen Brey­er ac­knowl­edged in the ma­jor­i­ty opin­ion that the FDA turned down Mer­ck’s pro­posed change on the grounds that it was “in­ad­e­quate” and in­vit­ed them to re­sub­mit an ap­pli­ca­tion to ful­ly ad­dress its de­fi­cien­cies. But that’s up for a judge, not a ju­ry, to de­cide — con­tra­dict­ing the de­ci­sion of the 2017 rul­ing by the Court of Ap­peals for the Third Cir­cuit.

That’s where the case, 17-290 Mer­ck Sharp & Dohme Corp. v. Al­brecht, is head­ed back now.

From the head­note sum­ming up the unan­i­mous rul­ing:

The ques­tion of agency dis­ap­proval is pri­mar­i­ly one of law for a judge to de­cide. The ques­tion of­ten in­volves the use of le­gal skills to de­ter­mine whether agency dis­ap­proval fits facts that are not in dis­pute. More­over, judges, rather than lay ju­ries, are bet­ter equipped to eval­u­ate the na­ture and scope of an agency’s de­ter­mi­na­tion, and are bet­ter suit­ed to un­der­stand and to in­ter­pret agency de­ci­sions in light of the gov­ern­ing statu­to­ry and reg­u­la­to­ry con­text. While con­test­ed brute facts will some­times prove rel­e­vant to a court’s le­gal de­ter­mi­na­tion about the mean­ing and ef­fect of an agency de­ci­sion, such fac­tu­al ques­tions are sub­sumed with­in an al­ready tight­ly cir­cum­scribed le­gal analy­sis and do not war­rant sub­mis­sion alone or to­geth­er with the larg­er pre-emp­tion ques­tion to a ju­ry.

Law­suits against Mer­ck on Fos­amax first emerged around 2009, af­ter the drug had gone gener­ic. It still gar­nered $209 mil­lion in sales last year, ac­cord­ing to fi­nan­cial re­ports.

Im­age source: Shut­ter­stock

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.

José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.