Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Am­gen said it was en­cour­aged by the so­lic­i­tor gen­er­al’s an­tic­i­pat­ed re­view of its Supreme Court pe­ti­tion to re­hear a Repatha patent case. They’re like­ly much less op­ti­mistic about the out­come now.

So­lic­i­tor Gen­er­al Eliz­a­beth Prel­og­ar wrote in a re­cent 27-page brief that Am­gen’s ar­gu­ments “lack mer­it and fur­ther re­view is not war­rant­ed.”

The case traces back to a suit filed in 2014 against Sanofi and Re­gen­eron’s Pralu­ent, which end­ed up beat­ing Am­gen’s PC­SK9 block­buster Repatha to mar­ket by a month just a year lat­er.

Both an­ti­body drugs are de­signed to con­trol LDL cho­les­terol, of­ten called “bad cho­les­terol” be­cause it can in­crease pa­tients’ risk of heart dis­ease and stroke. They work by pre­vent­ing PC­SK9, a nat­u­ral­ly oc­cur­ring pro­tein, from bind­ing to and even­tu­al­ly caus­ing the de­struc­tion of LDL re­cep­tors in the liv­er.

Am­gen ini­tial­ly sued Sanofi and Re­gen­eron be­fore the drugs went to mar­ket, seek­ing to block the sale of Pralu­ent. De­spite sales com­ing in high­er than Pralu­ent’s, nei­ther drug reached ex­pec­ta­tions com­ing out of the gate, and both com­peti­tors cut their prices sig­nif­i­cant­ly a few years ago. Pralu­ent sales reached about $124 (€128 mil­lion) last quar­ter, while Repatha earned $154 mil­lion.

Am­gen scored a win in 2019, but a fed­er­al judge in Delaware lat­er over­turned that ver­dict and ruled in fa­vor of Sanofi and Re­gen­eron. That de­ci­sion was then up­held in the Court of Ap­peals for the Fed­er­al Cir­cuit.

“It has been our long­stand­ing be­lief that all of Am­gen’s as­sert­ed U.S. PC­SK9 patent claims are in­valid, and we are pleased that the So­lic­i­tor Gen­er­al rec­om­mends that the Supreme Court not grant Am­gen’s pe­ti­tion for cer­tio­rari,” a Re­gen­eron spokesper­son said in an email on Fri­day. Am­gen did not re­spond to a re­quest for com­ment as of press time.

Am­gen took the case all the way to the Supreme Court, which back in April called on the so­lic­i­tor gen­er­al to weigh in. The phar­ma gi­ant ar­gued in its pe­ti­tion that the low­er court’s de­ci­sion would have a dev­as­tat­ing im­pact on in­no­va­tion, and sev­er­al com­pa­nies filed a “friend of the court” brief in sup­port, in­clud­ing Bio­gen, Bris­tol My­ers Squibb and Mer­ck.

“If left un­changed, the de­ci­sion be­low could slow the pace of re­search and de­vel­op­ment and hin­der in­no­va­tion, to the detri­ment of pa­tients and the pub­lic at large,” they wrote. “The paten­tee, hav­ing in­vest­ed enor­mous sums in dis­cov­er­ing the un­der­ly­ing tar­get, has pro­vid­ed a blue­print for oth­ers who, now aware of the tar­gets, can quick­ly make their own ver­sion of an ef­fec­tive an­ti­body.”

A pan­el of judges pre­vi­ous­ly ruled that “[d]raw­ing a broad fence around sub­ject mat­ter, with­out fill­ing in the holes, is not in­vent­ing the genus.”

“Am­gen is en­cour­aged by the Supreme Court’s re­quest for the So­lic­i­tor Gen­er­al’s views on the is­sues pre­sent­ed in Am­gen’s pe­ti­tion,” a spokesper­son told End­points News in April. “Am­gen is seek­ing re­view by the Supreme Court be­cause we, and oth­ers in our in­dus­try, view the is­sues we present as vi­tal­ly im­por­tant in sup­port­ing in­no­va­tion.”

Now it’s up to the Supreme Court to de­cide whether to take the case — though if you ask Prel­og­ar, the an­swer is no, it shouldn’t.

“Pe­ti­tion­ers con­tend that the court of ap­peals erred by treat­ing en­able­ment as a ques­tion of law and by ex­am­in­ing the full scope of the claims in as­sess­ing whether they are ful­ly en­abled,” she wrote. “Those ar­gu­ments lack mer­it and fur­ther re­view is not war­rant­ed.”

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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New in­fla­tion-linked drug re­bates go in­to ef­fect on Sat­ur­day

Beginning tomorrow, biopharma companies can be charged rebates for any new drug price increases rising faster than the rate of inflation.

The new rebates are part of the newly signed Inflation Reduction Act, which introduces this new requirement that manufacturers pay rebates to Medicare for Part D drugs whose price increases exceed inflation, and in January 2023, the same will occur with Part B drugs.

#AAO22 conference in Chicago (Photo credit: Associate editor Kyle LaHucik)

#AAO22: In bid for first FDA nod in ge­o­graph­ic at­ro­phy, Apel­lis claims an­oth­er first in eye dis­ease field

CHICAGO — Eight weeks before patients and industry find out if the FDA approves the first treatment for geographic atrophy, an advanced form of age-related macular degeneration, the biotech behind the drug is out with some new data on a secondary endpoint.

In what study investigator Charles Wykoff called the “first direct evidence of function preservation by slowing GA growth” in an investigational treatment, Apellis Pharmaceuticals’ drug pegcetacoplan led to less loss of retinal sensitivity versus sham  within 250 microns on either side of the GA lesion over 24 months.

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BioCryst's new website for its HAE unbranded campaign encourages patients to take charge of treatment decisions.

BioCryst launch­es aware­ness cam­paign around man­age­ment of rare vas­cu­lar dis­ease

While hereditary angioedema (HAE) is rare, treatment options for the condition have become much more common. So BioCryst Pharmaceuticals is taking a new angle in its recently launched HAE awareness campaign encouraging patients to take control of their disease management.

“Hereditary angioedema (HAE) isn’t the author of your story — you are … #cHAEngetheplan. Not the goal,” the US campaign website advises.

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EMA makes new rec­om­men­da­tions for Im­bru­vi­ca, med­i­cines with ter­li­pressin over res­pi­ra­to­ry and car­dio­vas­cu­lar risks

The EMA is handing out a new recommendation surrounding J&J and AbbVie’s cancer drug Imbruvica and some medicines containing terlipressin.

On Friday, the EMA’s safety committee (PRAC) stated that it has taken new measures to reduce the risk of respiratory failure and sepsis when medicines containing terlipressin that are used to treat people with hepatorenal syndrome (HRS-1), particularly for patients with advanced acute-on-chronic liver disease or advanced kidney failure.