Pfiz­er bags an FDA OK for PARP play­er ta­la­zoparib — now the hard part be­gins

Pfiz­er has picked up an ap­proval for ta­la­zoparib, its PARP in­hibitor for a ge­net­i­cal­ly de­fined line of breast can­cer. And now the phar­ma play­er can jump in­to a crowd­ed mar­ket where As­traZeneca’s ri­val Lyn­parza is way out in front of the pack.

The Pfiz­er drug, which is hit­ting the mar­ket as Talzen­na, fig­ured promi­nent­ly in Pfiz­er’s $14 bil­lion Medi­va­tion buy­out. The then Medi­va­tion CEO David Hung pitched ta­la­zoparib as a block­buster-to-be as Sanofi stepped up first with an of­fer. Now Pfiz­er gets to find out just how much it can make as the fourth en­try in the field, be­hind Clo­vis and Tesaro as well.

The ap­proval from the FDA marks the 46th new drug ap­proval from CDER this year, ty­ing the record for all of last year and leav­ing the agency poised to surge to an all-time record high well be­fore the end of the year. The FDA help­ful­ly pro­vid­ed a snap run-through for Pfiz­er, putting the drug on a pri­or­i­ty re­view path.

The PARP crowd works along sim­ple lines, dis­rupt­ing DNA mech­a­nisms for self re­pair and putting can­cer cells on a path to de­struc­tion. And this new en­try for BR­CA-mu­tat­ed can­cer won an OK with a mean pro­gres­sion free sur­vival rate of 8.6 months com­pared to 5.6 months for a chemo arm.

That’s all well and good, ex­plain­ing the drug’s pres­ence on CEO Ian Read’s list of late-stage rea­sons why he was con­fi­dent in Pfiz­er’s pipeline. But the OK comes 4 years af­ter As­traZeneca pro­vid­ed the mar­ket-lead­ing OK for a PARP in the US. Since then, it’s al­lied with Mer­ck and con­tin­ued to ex­pand the drug’s la­bel. 

As­traZeneca has al­ready of­fered sim­i­lar risk re­duc­tion fig­ures for breast can­cer, which will make Pfiz­er’s job that much tougher.

In a few days As­traZeneca and Mer­ck will be putting the SO­LO-1 da­ta on dis­play at ES­MO, high­light­ing its ac­tiv­i­ty in ovar­i­an can­cer. And the gi­ant part­ners have more stud­ies un­der­way as they con­tin­ue to build the block­buster in new mar­kets, in­clud­ing Chi­na. 

Bio­Marin, which sold the drug to Medi­va­tion, is get­ting a $15 mil­lion mile­stone pay­ment with the ap­proval to­day.

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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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.

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.