An­a­lysts as­sess the dam­age — and next steps — af­ter Re­gen­eron/Sanofi get slammed in court

A fed­er­al judge’s de­ci­sion to or­der Re­gen­eron and Sanofi to pull their PC­SK9 drug Pralu­ent from the mar­ket man­aged to stun some of the most griz­zled ob­servers of the biotech world.

These patent dis­putes are not at all un­usu­al and are al­most al­ways set­tled with a share of the roy­al­ties when there’s a case to be made. And the court ac­knowl­edged that cre­at­ing a mo­nop­oly here was not in the pub­lic’s best in­ter­est. But the judge came down square­ly for Am­gen, say­ing:

(P)lain­tiffs have demon­strat­ed ir­repara­ble harm, as well as the in­ad­e­qua­cy of mon­ey dam­ages.

In­vestors clear­ly didn’t like the sound of any of this. Re­gen­eron’s shares $REGN dropped 7% — about $3 bil­lion in mar­ket cap — and Sanofi saw its stock slide 3%, about the same in mar­ket cap. Am­gen’s stock, mean­while, jumped 4.5%.

The first re­sponse, which every­one an­tic­i­pat­ed, was word from Re­gen­eron/Sanofi that the part­ners would ap­peal the de­ci­sion. But the very re­al pos­si­bil­i­ty ex­ists that an ap­peals court may not be quick to over­turn a rul­ing that came af­ter Re­gen­eron/Sanofi’s los­ing ar­gu­ment was flat­tened by the court. And the pos­si­bil­i­ty that Am­gen will pre­vail here got some top an­a­lysts think­ing over­time about the im­pli­ca­tions and pos­si­ble out­comes. We’ve gath­ered a few be­low.

Ge­of­frey Porges, Leerink

Sales of these new cho­les­terol drugs have not been im­pres­sive. But de­spite the slow take­off, a num­ber of an­a­lysts still be­lieve that these drugs will grad­u­al­ly build up a mar­ket worth bil­lions. Ge­of­frey Porges at Leerink crunched the num­bers if Am­gen’s win sticks:

As­sum­ing that AMGN cap­tures the ma­jor­i­ty of the fu­ture ~$2bn US Pralu­ent sales and main­tains a sim­i­lar mar­gin struc­ture with these in­cre­men­tal sales, our DCF val­ue for AMGN in­creas­es by $13, or 8%. This rep­re­sents a cash flow in­crease of $600mm in 2020E grow­ing to a $950mm ben­e­fit in 2025E, which AMGN could use for con­tin­ued div­i­dend growth, share buy­backs, or fu­ture ac­qui­si­tions.

Bri­an Sko­r­ney, Baird an­a­lyst

Bri­an Sko­r­ney at Baird be­lieves a roy­al­ty deal is the most like­ly out­come. He writes:

Though the rul­ing does in­di­cate that if Sanofi/Re­gen­eron do not file to ap­peal the de­ci­sion with­in 30 days, Pralu­ent will be pulled from the mar­ket, we doubt that will be the re­al­i­ty in the long run. The U.S. Court sys­tem is clear­ly cre­at­ed to in­still com­pe­ti­tion, not cre­ate mo­nop­o­lies. The Judge’s opin­ion clear­ly notes that “the pub­lic gen­er­al­ly is bet­ter served by hav­ing a choice of avail­able treat­ments. There­fore, the court finds it­self be­tween a rock and a hard place…tak­ing an in­de­pen­dent­ly de­vel­oped, help­ful drug off the mar­ket does not ben­e­fit the pub­lic.” The Judge al­so clear­ly hopes fur­ther pro­ceed­ings with “en­cour­age the par­ties to each an ap­pro­pri­ate busi­ness res­o­lu­tion.” As a re­sult, we think a hefty set­tle­ment is like­ly, pos­si­bly to the tune of 20%+ roy­al­ties to Am­gen. As a re­sult, we are rais­ing our price tar­get to $165.

If it does go to an ap­peals court, Biren Amin at Jef­feries doesn’t like the odds for Sanofi/Re­gen­eron.

Re­call in Ju­ly, we wrote about AMGN’s fil­ing an ap­peal case WBIP v. Kohler in­volv­ing low-emis­sion house­boat gen­er­a­tors in which the Ap­peals Court va­cat­ed the judg­ment of the Dis­trict Court deny­ing WBIP a per­ma­nent in­junc­tion. In this case, the Dis­trict Court felt that a PI would de­prive the con­sum­ing pub­lic “a po­ten­tial­ly life-sav­ing prod­uct.” The Ap­peals Court ar­gued that the pub­lic in­ter­est ar­gu­ment alone was not suf­fi­cient to de­ny a PI for a life-sav­ing good and specif­i­cal­ly cit­ed phar­ma­ceu­ti­cal drugs as an ex­am­ple in its rul­ing. If the Ap­peals Court is con­sis­tent with the WBIP v. Kohler rul­ing, it would mean a low like­li­hood that an ap­peal will be grant­ed.

 

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

Sen. Eliz­a­beth War­ren urges FTC to 'scru­ti­nize' two phar­ma buy­outs

Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.