Eli Lil­ly to dou­ble its man­u­fac­tur­ing ca­pac­i­ty for Moun­jaro as it faces fi­nan­cial head­winds go­ing in­to 2023 — re­port

Eli Lil­ly is fac­ing sev­er­al fi­nan­cial head­winds go­ing in­to next year, spurred by the dry­ing up of Covid-19 an­ti­body sales and sup­ply con­straints, ac­cord­ing to a re­port from SVB Se­cu­ri­ties by three of its an­a­lysts who vis­it­ed Eli Lil­ly’s head­quar­ters in In­di­anapo­lis last week.

An an­tic­i­pat­ed “step­down” in Covid-19 an­ti­body sales, af­ter about $2 bil­lion in re­cent sales, due to a lack of pro­tec­tion against the new­er vari­ants, as well as oth­er speed­bumps like Al­im­ta gener­ics, pres­sure from in­fla­tion and in­cre­men­tal costs for man­u­fac­tur­ing were cit­ed as po­ten­tial head­winds.

Po­ten­tial tail­winds for the phar­ma in­clude the Type 2 di­a­betes drug Moun­jaro, which is not ex­pect­ed to have “pay­er ac­cess lev­els” com­pa­ra­ble to Trulic­i­ty un­til lat­er next year.

On the sub­ject of Moun­jaro, which clinched an OK in May, the phar­ma is ex­pect­ed to dou­ble the man­u­fac­tur­ing ca­pac­i­ty for the drug by the end of 2023. Some pro­duc­tion for Moun­jaro is ex­pect­ed to come on­line be­fore then. How­ev­er, Lil­ly did not dis­close to SVB how Moun­jaro’s de­mand com­pares with ex­ist­ing man­u­fac­tur­ing ca­pac­i­ty.

Lil­ly did state to SVB that its abil­i­ty to meet de­mand will de­pend on if it can re­solve sup­ply con­straints of We­govy and Ozem­pic, with the FDA po­ten­tial­ly ap­prov­ing some pro­duc­tion lines at its North Car­oli­na fa­cil­i­ty through­out 2023.

The phar­ma has been mak­ing se­ri­ous in­vest­ments in­to man­u­fac­tur­ing, es­pe­cial­ly in In­di­ana, with $2.1 bil­lion be­ing in­vest­ed in­to two new man­u­fac­tur­ing sites at In­di­ana’s LEAP Lebanon In­no­va­tion and Re­search Dis­trict in Boone Coun­ty, north­west of Lil­ly’s head­quar­ters in In­di­anapo­lis. The two new fa­cil­i­ties will ex­pand Lil­ly’s man­u­fac­tur­ing net­work for ac­tive in­gre­di­ents and new ther­a­peu­tic modal­i­ties, in­clud­ing ge­net­ic med­i­cines.

On the da­ta front, the com­pa­ny’s man­age­ment is re­main­ing “hope­ful” about do­nanemab’s like­li­hood of suc­cess against Alzheimer’s in the sec­ond quar­ter of 2023. How­ev­er, with the lecanemab da­ta from Bio­gen and Ei­sai, which are ex­pect­ed to be seen in full at CTAD on Nov. 29, SVB stat­ed that “Lil­ly is in­ter­est­ed in see­ing de­tails such as strat­i­fi­ca­tion of pa­tient re­sults by dis­ease sever­i­ty (mild cog­ni­tive im­pair­ment vs. mild Alzheimer’s dis­ease) and bio­mark­ers (APOE4 sta­tus). Lil­ly is hop­ing that pa­tients who have the milder dis­ease will ex­pe­ri­ence a greater slow­ing of cog­ni­tive de­cline – be­cause it would sup­port ear­ly treat­ment to slow dis­ease pro­gres­sion.”

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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