No­var­tis builds can­cer pipeline with a new plat­form/drug buy­out, bag­ging Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions for $3.9B

No­var­tis has just bought it­self a new can­cer ther­a­py as well as a new tech plat­form for $3.9 bil­lion in cash, bag­ging the French biotech Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions $AAAP.

The phar­ma gi­ant is pay­ing a mod­est 44% pre­mi­um over the biotech’s mar­ket val­u­a­tion from Sep­tem­ber 28, when Bloomberg re­port­ed that No­var­tis was kick­ing the tires and run­ning the num­bers on the biotech’s drug Lu­tathera (177Lu-DOTATATE).

The drug is a ra­dio­phar­ma­ceu­ti­cal — us­ing ra­dioiso­topes to tar­get neu­roen­docrine tu­mors — a fo­cus where No­var­tis has con­sid­er­able ex­pe­ri­ence. The phar­ma play­er tout­ed the piv­otal da­ta for the drug from the NET­TER-1 study, which demon­strat­ed a 79% re­duc­tion in the risk of dis­ease pro­gres­sion, with an in­ter­im me­di­an pro­gres­sion-free sur­vival rate of 8.4 months that had yet to max out.

No­var­tis al­so gets a pipeline of drugs off the new plat­form with some near-term po­ten­tial it likes. That line­up on AAA’s ex­per­i­men­tal meds in­cludes 177Lu-PS­MA-R2, which is now en­ter­ing a Phase I/II study.

Ap­proved in Eu­rope, the FDA forced the biotech in­to the wait­ing line late last year af­ter shak­ing its head at the way the com­pa­ny had pre­sent­ed some of the da­ta in its ap­pli­ca­tion, forc­ing a re­jec­tion at the time. An ap­proval would build on No­var­tis $NVS OK for Afin­i­tor in ear­ly 2016 as a treat­ment for neu­roen­docrine tu­mors, as well as its mar­ket­ing of San­do­statin.

Bruno St­rig­i­ni

Now the biotech is wait­ing for an­oth­er dead­line to loom on the de­layed ap­pli­ca­tion, and No­var­tis clear­ly be­lieves that this time reg­u­la­tors should clear it for mar­ket­ing.

The deal falls right in­to No­var­tis’ sweet spot. Out­go­ing CEO Joe Jimenez — soon to be re­placed by R&D chief Vas Narasimhan — has said sev­er­al times that the com­pa­ny is pri­mar­i­ly in­ter­est­ed in adding bolt-ons in the $2 bil­lion to $5 bil­lion range. This deal beefs up its can­cer pipeline and port­fo­lio af­ter a ma­jor swap with Glax­o­SmithK­line land­ed the UK phar­ma gi­ant’s ad­vanced on­col­o­gy drugs.

Pe­ter Welford at Jef­feries likes this deal, start­ing the peak sales fore­cast at $650 mil­lion a year for Lu­tathera, with a chance to add on about $285 mil­lion through added ap­provals.

Im­pres­sive Phase III NET­TER-1 da­ta, clin­i­cian feed­back, and a pro­pri­etary US physi­cian sur­vey all un­der­pin our con­fi­dence in Lu­tathera. The prod­uct is based on a well known con­cept of so­mato­statin ana­logues for NETs, has al­ready treat­ed >3,000 pa­tients, and ad­dress­es an un­met med­ical need. We fore­cast $650m peak sales treat­ing midgut GEP-NETs for $30/ADS NPV at 100% prob­a­bil­i­ty, as­sum­ing AAA com­mer­cialis­es it­self in US/EU tar­get­ing the spe­cial­ist cen­tres. Adop­tion to treat oth­er types of NETs could of­fer sig­nif­i­cant po­ten­tial up­side, with on­ly $7/ADS NPV cur­rent­ly as­signed as­sum­ing 60% prob­a­bil­i­ty and $285m in­cre­men­tal peak sales.

“No­var­tis has a strong lega­cy in the de­vel­op­ment and com­mer­cial­iza­tion of med­i­cines for neu­roen­docrine tu­mors where sig­nif­i­cant un­met need re­mains for pa­tients,” said Bruno St­rig­i­ni, the head of No­var­tis On­col­o­gy. “With Lu­tathera we can build on this lega­cy by ex­pand­ing the glob­al reach of this nov­el, dif­fer­en­ti­at­ed treat­ment ap­proach and work to max­i­mize Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions broad­er RLT pipeline and an ex­cit­ing tech­nol­o­gy plat­form.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Paul Hudson, Sanofi CEO (Raphael Lafargue/Abaca/Sipa USA; Sipa via AP Images)

In­side look: How a po­ten­tial part­ner­ship turned in­to a $1.9B buy­out for Sanofi

A couple of months before the FDA was set to make a decision on Kadmon’s so-called “knock-your-socks-off kind of results” for its chronic graft-versus-host disease drug, Sanofi put out feelers for a potential collaboration. But an early approval triggered an offer to buy the company outright — and Sanofi didn’t win without a fight, according to an inside look.

Sanofi’s head of business development and licensing Matthieu Merlin reached out to Kadmon on June 26 with a simple request: He wanted to introduce himself and explore potential partnerships, according to an SEC filing. It had been several months since Kadmon’s belumosudil arrived on the FDA’s doorstep, and after delaying their decision once, regulators said they’d have an answer by Aug. 30. But Sanofi wasn’t the only company interested in getting to know the execs over at Kadmon.

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Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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