No­var­tis takes Gilenya fight to Supreme Court as gener­ic com­pe­ti­tion looms

No­var­tis stands to lose more than a quar­ter bil­lion dol­lars in sales this year if Gilenya gener­ics are al­lowed to mar­ket. So it’s tak­ing the fight all the way to the Supreme Court.

The Swiss phar­ma gi­ant an­nounced on Wednes­day that a US fed­er­al ap­peals court has re­fused to re­hear its Gilenya patent case against pri­vate Chi­nese biotech HEC Pharm. Next up? No­var­tis plans on pe­ti­tion­ing the Supreme Court to up­hold the va­lid­i­ty of its patent No. 9,187,405, re­ferred to in court doc­u­ments as the ‘405 patent, cov­er­ing a 0.5 mg dos­ing reg­i­men of the mul­ti­ple scle­ro­sis drug.

Gilenya was first ap­proved back in 2010 as a first-line MS treat­ment, ex­pand­ing to the pe­di­atric set­ting eight years lat­er. Sales topped out at near­ly $2.8 bil­lion last year, mak­ing Gilenya No­var­tis’ third-high­est sell­er in its In­no­v­a­tive Med­i­cines seg­ment.

HEC filed for ap­proval of a gener­ic ver­sion back in 2016 and won ap­proval in 2019. No­var­tis quick­ly slapped the com­pa­ny with a hand­ful of law­suits as­sert­ing var­i­ous Gilenya patents, which ex­pire in 2027. The Swiss phar­ma pulled an ear­ly win in the US Dis­trict Court of Delaware in Au­gust 2020, when a per­ma­nent in­junc­tion was grant­ed against HEC’s gener­ic un­til the ‘405 patent ex­pires in De­cem­ber 2027.

A three-judge ap­peals pan­el up­held the de­ci­sion again this Jan­u­ary — but a new pan­el re­versed the de­ci­sion at a re­hear­ing in June, over­turn­ing the Jan­u­ary judg­ment in a 2-1 vote and rul­ing the ‘405 patent in­valid.

Lawyers for No­var­tis filed for an­oth­er re­hear­ing in Ju­ly, call­ing the case “ex­tra­or­di­nary.” Af­ter HEC re­quest­ed a re­hear­ing of the Jan­u­ary de­ci­sion, one mem­ber of the three-judge pan­el re­tired, and a new judge agreed to grant the re­hear­ing and re­verse the court’s pre­vi­ous rul­ing.

“Ap­par­ent­ly for the first time in this Court, a prece­den­tial opin­ion has been ab­ro­gat­ed — and the out­come flipped — on pan­el re­hear­ing based mere­ly on the re­place­ment of one judge,” at­tor­neys for No­var­tis said in court doc­u­ments back in Ju­ly.

HEC isn’t the on­ly phar­ma com­pa­ny that has ap­proached reg­u­la­tors with a Gilenya gener­ic. A suite of oth­er com­pa­nies, in­clud­ing Zy­dus Phar­ma­ceu­ti­cals, Apo­tex, Bion­phar­ma, Em­cure Phar­ma­ceu­ti­cals and oth­ers, has filed AN­DAs. No­var­tis said in a news re­lease on Wednes­day that it’s set­tled with a num­ber of gener­ic ri­vals, who have agreed to hold their launch­es un­til af­ter the dos­ing reg­i­men patent ex­pires in 2027.

The com­pa­ny has al­so sought refuge in court, telling End­points News ear­li­er this year, “We be­lieve that gener­ics are not per­mit­ted to launch while the pe­ti­tion for re­hear­ing re­mains pend­ing and the for­mal man­date clos­ing the ap­peals process has not been is­sued … In the mean­time, our Group guid­ance as­sumes no Gilenya Gx launch­es in the US in 2022.”

As a re­sult of the court’s lat­est de­ci­sion, though, com­peti­tors may hit the mar­ket “im­mi­nent­ly,” No­var­tis not­ed on Wednes­day. The ar­rival of gener­ics could dri­ve Gilenya sales down $0.3 bil­lion this year, the com­pa­ny said.

In 2017, the late Rep. Eli­jah Cum­mings (D-MD) and cur­rent Rep. Pe­ter Welch (D-VT) wrote in a let­ter to for­mer No­var­tis chief Paul Hud­son that the House Com­mit­tee on Over­sight and Gov­ern­ment Re­form was launch­ing an in­ves­ti­ga­tion in­to the ris­ing cost of MS treat­ments. They not­ed that Gilenya prices near­ly dou­bled from $50,775 in 2010 to $91,836 in 2017. Hud­son jumped over to Sanofi in 2019.

Just last week, a fed­er­al judge dis­missed a whistle­blow­er case al­leg­ing that No­var­tis bribed physi­cians to pre­scribe Gilenya through a se­ries of “sham” speak­er pro­grams dis­guised as ed­u­ca­tion­al ses­sions. While that case was dis­missed, No­var­tis did shell out $678 mil­lion to set­tle sim­i­lar claims from the US De­part­ment of Jus­tice back in 2020.

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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#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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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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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.

Mer­ck cel­e­brates an­oth­er win in Janu­via patent bat­tle against Vi­a­tris

Viatris has suffered its second stinging loss in as many weeks in its attempt to challenge Merck’s Januvia and Janumet patents.

A federal appeals court on Thursday upheld Merck’s patent rights related to the dihydrogen phosphate salt of sitagliptin — an active ingredient in the blockbuster diabetes drugs Januvia, Janumet and extended-release formulation Janumet XR — calling Viatris’ claims “unpersuasive.”

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

#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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