CEO Kenji Yasukawa (Astellas)

Astel­las scores a pair of tri­al wins for menopausal hot flash med, rais­ing the pitch of loom­ing Bay­er stand­off

Astel­las took a fli­er on women’s health when it bought out Oge­da and non­hor­mon­al menopause can­di­date fe­zo­line­tant in ear­ly 2017 and then dou­bled down dur­ing a ma­jor re­struc­tur­ing just over a year lat­er. Now, an ear­ly peek at late-stage stud­ies bode well for Astel­las’ chances — and it could be tee­ing up a fight with Bay­er.

In a pair of Phase III stud­ies dubbed SKY­LIGHT 1 and 2, two dos­es of Astel­las’ fe­zo­line­tant topped place­bo in re­duc­ing the fre­quen­cy and sever­i­ty of hot flash­es in menopausal women at one- and three-month check ins, ac­cord­ing to topline da­ta un­veiled Fri­day.

The drug went 4-for-4 on its pri­ma­ry end­points in both stud­ies, which test­ed once-dai­ly, 30- and 45-mg dos­es of fe­zo­line­tant. The tri­als are on­go­ing and will dose pa­tients through 52 weeks.

Fe­zo­line­tant, a NK3R in­hibitor that works by block­ing a key pep­tide as­so­ci­at­ed with down­stream ther­moreg­u­la­tion in the hy­po­thal­a­mus, is an­gling to be­come the first non­hor­mon­al ther­a­py for menopausal hot flash­es, Astel­las said. The full 52-week re­sults of the SKY­LIGHT stud­ies will be pre­sent­ed at a fu­ture med­ical meet­ing.

A late-stage win for Astel­las is set­ting up a bat­tle ahead with Bay­er and its own non­hor­mon­al menopause ther­a­py, NT-814, which the Ger­man drug­mak­er be­lieves could even­tu­al­ly be a block­buster.

Astel­las ac­quired fe­zo­line­tant as part of a $870 mil­lion buy­out of Bel­gian biotech Oge­da back in April 2017. At the time, a Phase IIa study of the drug showed a 93% re­duc­tion in hot flash­es for the fe­zo­line­tant group at week 12 com­pared to 54% on place­bo. The re­duc­tion in sever­i­ty of hot flash­es at week 12 was 70% for the drug arm and 23% in the place­bo group.

Those re­sults were im­pres­sive enough for Astel­las to plop down a big down pay­ment on women’s health, an area that has seen lit­tle in­no­va­tion in re­cent years. With Phase III in the works, fe­zo­line­tant be­came a cen­tral part of the com­pa­ny’s busi­ness plan dur­ing CEO Ken­ji Ya­sukawa’s ex­pan­sive re­struc­tur­ing that was launched in mid-2018.

Mean­while, Bay­er took its own big bet on women’s health R&D in Au­gust when it dropped $875 mil­lion in cash and fu­ture mile­stones for KaNDy Ther­a­peu­tics and NT-814, an NK1/3 in­hibitor an­gling for the same un­der­served mar­ket as fe­zo­line­tant. Phase IIb da­ta for 120- and 160-mg dos­es of the drug at the time showed that it “re­duced the fre­quen­cy and sever­i­ty of VMS and sig­nif­i­cant­ly im­proved qual­i­ty of life, mood and sleep, in post­menopausal women,” KaNDy said.

Bay­er has pinned block­buster as­pi­ra­tions on the med, and with such high hopes a stand­off with Astel­las ap­pears like­ly. How­ev­er, KaNDy CEO Mary Kerr told End­points News in Au­gust she didn’t view Astel­las as a com­peti­tor giv­en the clin­i­cal need.

“It’s an area of huge un­met need and it’s great to see non-hor­mon­al op­tions com­ing in for women,” she said. “Women have wait­ed for this for a long long time, and we hope that fi­nal­ly we get a non-hor­mon­al al­ter­na­tive to mar­ket.”

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.

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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So what hap­pened with No­var­tis' gene ther­a­py group? 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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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.

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.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Ted White, Verrica CEO

Ver­ri­ca hits an­oth­er bump in the road with CMO re­lat­ed let­ter from FDA

The FDA has rejected Verrica’s new drug application for VP-102 again, with the company pinning the CRL on problems at a CMO that it was partnered with, the company announced Monday.

The FDA didn’t raise issues that directly relate to the manufacturing of VP-102, the company said, but raised “general quality issues” at the CMO’s facility. There were also no clinical concerns, it said, or need to collect more data.