Am­gen los­es ap­peal in patent suit against Sanofi/Re­gen­eron’s Pralu­ent. It’s a bum­mer for Bris­tol My­ers Squibb and Mer­ck, too

In a co­da to a six-year le­gal fight on the PC­SK9 ter­rain, the US Fed­er­al Court of Ap­peals has ruled that Am­gen’s patent claims for PC­SK9 an­ti­bod­ies as a class are in­valid, hand­ing a win to Sanofi and Re­gen­eron.

The im­pli­ca­tions, though, may re­ver­ber­ate far be­yond Am­gen.

The Thou­sand Oaks, CA-based com­pa­ny, whose Repatha was ap­proved a month af­ter Pralu­ent in 2015, may take com­fort in the fact that its sales have con­sis­tent­ly eclipsed Sanofi or Re­gen­eron’s, al­though nei­ther has climbed any­where near the block­buster ex­pec­ta­tions de­vel­op­ers and an­a­lysts had.

Am­gen first took Sanofi and Re­gen­eron to court be­fore those drugs went on the mar­ket, seek­ing to block the sale of Pralu­ent. While a ju­ry and a judge have pre­vi­ous­ly sided with Am­gen — go­ing so far as to grant an in­junc­tion against Sanofi and Re­gen­eron (a stay was soon is­sued) — in late 2019, a US judge over­turned that ver­dict and ruled in fa­vor of the heavy­weight drug part­ners. It was a bit­ter loss for Am­gen’s fa­mous­ly ag­gres­sive lawyer corps, which has scored high-pro­file vic­to­ries such as the megablock­buster case against No­var­tis’ gener­ics arm San­doz.

That de­ci­sion, by the US Dis­trict Court in Delaware, was up­held in the Court of Ap­peals for the Fed­er­al Cir­cuit.

Joseph LaRosa, EVP, gen­er­al coun­sel and sec­re­tary at Re­gen­eron, said the rul­ing helps to “pro­vide clo­sure” on the patent is­sue now that they have fend­ed off all five of Am­gen’s as­sert­ed claims against Pralu­ent.

But in an am­i­cus brief filed in March, Bris­tol My­ers Squibb and Mer­ck sug­gest­ed it sends an un­wel­come mes­sage not just for Am­gen but oth­er “in­no­va­tor com­pa­nies” who care about patent pro­tec­tion.

The tough­est part of cre­at­ing a suc­cess­ful an­ti­body drug, they ar­gued, is to find the right tar­get and ap­pli­ca­tion; once those are iden­ti­fied, “it is easy to cre­ate vari­a­tions.” From the fil­ing:

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. The scope of the in­ven­tion in this space is there­fore the genus of an­ti­bod­ies that suc­cess­ful­ly binds the tar­get, rather than any par­tic­u­lar an­ti­body that serves as an ex­am­ple. […]

The Court’s con­clu­sion ig­nores the in­volved time, ef­fort, and cre­ativ­i­ty that it took the in­ven­tors to come up with the con­cept in the first place, to test it again and again to make sure it is ro­bust, and then to pro­vide their roadmap to the world.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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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.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

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Pfiz­er sacks phar­ma com­pe­ti­tion in ear­ly NFL TV ad­ver­tis­ing sea­son

If pharma advertising had a fantasy football league, Pfizer would be crushing the competition. A dive into the National Football League’s TV commercial buys across early season games by iSpot shows a hefty lead with its Covid-19 Comirnaty vaccine ads.

More than 175 million impressions with $9.5 million in media spending put Pfizer in the top spot with a 65% share of voice across NFL pharma spending, according to the real-time TV ad tracker. In a distant second place is Bristol Myers Squibb’s Opdivo with 44 million impressions, $5.2 million in spending and a 16% share, followed by BMS’ Zeposia with 31 million impressions, $3.3 million in media buys and an 11% share.

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