Ab­b­Vie shares tank on Ro­va-T flop, sud­den re­treat from ac­cel­er­at­ed ap­proval pitch

Ab­b­Vie’s stock $AB­BV is get­ting ham­mered this morn­ing af­ter its $10 bil­lion Ro­va-T pro­gram post­ed poor mid-stage re­sults for third-line small cell lung can­cer, forc­ing the com­pa­ny to scut­tle any plans to seek an ac­cel­er­at­ed ap­proval for the close­ly-watched drug af­ter talks with skep­ti­cal reg­u­la­tors.

Af­ter fan­ning hopes — amid con­sid­er­able skep­ti­cism in some cir­cles — with its pro­jec­tions of a mega-block­buster fu­ture for Ro­va-T, in­ves­ti­ga­tors out­lined a 16% ob­jec­tive re­sponse rate and me­di­an over­all sur­vival of 5.6 months for the drug.

Shares cratered on the terse re­lease, free falling 13% and wip­ing more than $20 bil­lion off its mar­ket cap, which start­ed the day at $178 bil­lion.

Michael Sev­eri­no

The mag­ni­tude of the ORR for the DLL3-high group was dis­mal, leav­ing the fu­ture of the drug in doubt. And by im­pli­ca­tion, some an­a­lysts are won­der­ing just how bad the da­ta are for the full group, ex­pect­ing the fi­nal read out to be even worse.

I queried Ab­b­Vie about the break­down, and a spokesper­son con­firmed the re­sults were for the sub­group.

The da­ta re­port­ed to­day were in pa­tients ex­press­ing high DLL3 com­pris­ing 74 per­cent of the over­all study pop­u­la­tion in TRIN­I­TY.

By fo­cus­ing on DLL3-ex­press­ing can­cers, the mar­ket was ex­pect­ing an ORR in the 40% range. Chemo com­bos are in the 20% area, an­a­lysts note, and IO com­bos are al­so demon­strat­ing ef­fi­ca­cy. So with an IRC as­sess­ment at 16%, Ab­b­Vie is well be­hind the 8 ball, with the FDA chill­ing talk of an ac­cel­er­at­ed ap­proval de­spite the fact that there are no ap­proved op­tions.

Se­vere ad­verse events were record­ed for throm­bo­cy­tope­nia (11%), pho­to­sen­si­tiv­i­ty re­ac­tion (7%) and pleur­al ef­fu­sion (5%).

Ab­b­Vie paid $5.8 bil­lion in cash for this drug, promis­ing up to $4 bil­lion more in mile­stones to ac­quire the lit­tle-known biotech uni­corn Stem­cen­trx. And with mon­ey like that on the ta­ble, ex­pec­ta­tions were run­ning high, fu­el­ing fore­casts that the phar­ma com­pa­ny could get past the even­tu­al loss of patent pro­tec­tion on Hu­mi­ra in style. Ab­b­Vie it­self pro­ject­ed peak sales at $5 bil­lion a year.

To­day, Ab­b­Vie is feel­ing the lash of dis­ap­point­ed an­a­lysts. Here’s Ge­of­frey Porges:

On­col­o­gy is the key growth busi­ness seg­ment for Ab­b­Vie af­ter the loss of ex­clu­siv­i­ty for Hu­mi­ra in 2023, and to­day’s re­sults and reg­u­la­to­ry de­ci­sion call in­to ques­tion the vi­a­bil­i­ty of the com­pa­ny’s cur­rent sol­id tu­mor strat­e­gy.

Com­bined with Bris­tol-My­ers’ Op­di­vo and Yer­voy, Ab­b­Vie was bet­ting that it had a win­ner in small cell lung can­cer, though its first cut of the ear­ly da­ta last year failed to im­press any­one out­side of the com­pa­ny. The drug drops a cy­to­tox­ic bomb right on DLL3-ex­press­ing can­cer cells com­mon in SCLC.

“We con­tin­ue to be­lieve Ro­va-T has po­ten­tial for pa­tients with small cell lung can­cer and oth­er DLL3-ex­press­ing can­cers,” said Mike Sev­eri­no, ex­ec­u­tive vice pres­i­dent of re­search and de­vel­op­ment and chief sci­en­tif­ic of­fi­cer, Ab­b­Vie. “Al­though the re­sults from the study were not what we hoped for, we look for­ward to re­ceiv­ing da­ta from the on­go­ing Phase 3 stud­ies in the first- and sec­ond-line set­tings and re­main com­mit­ted to de­vel­op­ing Ro­va-T for the treat­ment of pa­tients with small cell lung can­cer.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in 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, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Greg Mayes, Antios Therapeutics CEO

An­tios' HBV col­lab axed af­ter clin­i­cal hold, but biotech be­lieves safe­ty in­ci­dent is not treat­ment-re­lat­ed

The FDA has placed a clinical hold on a Phase IIa study of Antios Therapeutics’ investigational hepatitis B med, CEO Greg Mayes confirmed to Endpoints News in an emailed statement.

A safety report was delivered to the biotech on May 17 after a patient dosed in a triple combination cohort of the study had experienced bradycardia and hypotension. The triple combo included Antios’ ATI-2173, Assembly Biosciences’ vebicorvir and Viread, an approved antiviral for HIV and hepatitis B.

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Tim Schoen, BioMed Realty CEO

Life sci­ences de­vel­op­er Bio­Med Re­al­ty buys San Fran­cis­co ho­tel for $75M — re­port

In a somewhat unconventional deal, life sciences real estate developer BioMed Realty has bought a 169-room Hilton Garden Inn in South San Francisco for $75 million, the San Francisco Business Times reported.

BioMed Realty, an affiliate of Blackstone, has multiple life sciences and technology office projects in the Bay Area, including three sites within a five-minute drive of the hotel.

While the sale of the hotel property was announced earlier this month, the sellers, Summit and GIC, did not identify the buyer at the time.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.