No­var­tis scores a quick FDA OK for its new can­cer drug Lu­tathera, picked up in $4B buy­out

It didn’t take long for No­var­tis’ $NVS $4 bil­lion ac­qui­si­tion of Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions to pay off. The FDA has pro­vid­ed its stamp of ap­proval for their drug Lu­tathera, which us­es ra­dioiso­topes to tar­get cer­tain neu­roen­docrine tu­mors.

Vas­ant Narasimhan, No­var­tis

The piv­otal da­ta for the drug — used to treat gas­troen­teropan­cre­at­ic neu­roen­docrine tu­mors that af­fect the pan­creas or gas­troin­testi­nal tract — from the NET­TER-1 study 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. The FDA had ini­tial­ly bat­ted back the ap­pli­ca­tion on Lu­tathera at the end of 2016, ask­ing for some ad­di­tion­al work on the da­ta, which de­layed the ap­proval.

There are about 7 cas­es of these tu­mors per 100,000 peo­ple in the US, a group which in­clud­ed Ap­ple founder Steve Jobs.

Now No­var­tis — which bought out the French biotech in late Oc­to­ber — can build on their OK for Afin­i­tor in ear­ly 2016 as a treat­ment for neu­roen­docrine tu­mors, as well as its mar­ket­ing of San­do­statin. The Basel-based phar­ma gi­ant al­so scored a pipeline that in­cludes 177Lu-PS­MA-R2, which is now en­ter­ing a Phase I/II study.

Su­sanne Schaf­fert

The deal rep­re­sents a sweet spot for the com­pa­ny as Vas Narasimhan tran­si­tions to the top job at the com­pa­ny. Ex­ecs want to stick with eco­nom­i­cal bolt-ons like this with a clear com­mer­cial pay­back in the cards.

“As the first PRRT (Pep­tide Re­cep­tor Ra­dionu­clide Ther­a­py) ever ap­proved in the US, Lu­tathera is in­tro­duc­ing a ma­jor ad­vance­ment in the treat­ment par­a­digm for these pa­tients that we hope will im­prove many lives,” said AAA pres­i­dent Su­sanne Schaf­fert. “We be­lieve nu­clear med­i­cine has the po­ten­tial to of­fer many ben­e­fits to can­cer pa­tients and will use this ap­proval as a foun­da­tion for the de­vel­op­ment of ad­di­tion­al tar­get­ed can­cer treat­ments uti­liz­ing ra­di­o­la­beled lig­ands.”

Baad­er Helvea an­a­lyst Bruno Bu­lic has been bull­ish on this drug, not­ing its po­ten­tial for re­plac­ing San­do­statin and go­ing on to earn about $2 bil­lion in peak sales.

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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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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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.