The Med­i­cines Com­pa­ny brings out the ax, look­ing to jet­ti­son hun­dreds of jobs in top-to-bot­tom re­struc­tur­ing

The Med­i­cines Com­pa­ny CEO Clive Mean­well is cir­cling all the wag­ons around its late-stage PC­SK9 de­vel­op­ment plans for in­clisir­an.

Clive Mean­well, The Med­i­cines Com­pa­ny

The Al­ny­lam part­ner said to­day that once the biotech com­pletes an ef­fort to sell off its in­fec­tious dis­ease group, the com­pa­ny — which had 410 staffers in Feb­ru­ary — will chop its re­main­ing work force down to a more af­ford­able group of less than 60 staffers.

Mean­well had al­ready put out word that he was look­ing for the best deal pos­si­ble for the in­fec­tious dis­ease busi­ness as the Par­si­pan­ny, NJ-based biotech ze­roes in on an LDL low­er­ing ther­a­py that has the po­ten­tial to over­take the lead­ers in the field: Re­gen­eron and Sanofi as well as their chief ri­val Am­gen.

The com­pa­ny’s stock $MD­CO jumped 8% on the re­struc­tur­ing plans an­nounced this morn­ing.

Last sum­mer the biotech re­port­ed that their drug — in-li­censed from Al­ny­lam — suc­cess­ful­ly slashed bad lev­els of LDL for up to a year with just two in­jec­tions. That’s a key fea­ture of its plan to sup­plant lead­ing PC­SK9 drugs al­ready on the mar­ket when its piv­otal stud­ies are up in 2019. In the mean­time, the biotech has been re­struc­tur­ing its busi­ness, sell­ing off or shelv­ing drugs and go­ing all in on LDL, which would ap­pear more valu­able as more stud­ies — like Mer­ck’s anace­trapib tri­al — high­light the im­por­tance of cut­ting LDL over boost­ing HDL in de­liv­er­ing longterm car­dio ben­e­fits.

Right af­ter the da­ta dropped in Au­gust, the FDA ap­proved their an­tibi­ot­ic Vabomere (meropen­em-vabor­bac­tam), which is part of the in­fec­tious dis­ease group now up on the sales block.

Mean­well had this to say in a state­ment to­day:

(W)e con­tin­ue to ex­pect to an­nounce a trans­ac­tion to di­vest the (in­fec­tious dis­ease) busi­ness be­fore the end of the year. In the mean­time, in­de­pen­dent of that trans­ac­tion, we are fi­nal­iz­ing plans to sig­nif­i­cant­ly re­struc­ture the re­main­der of The Med­i­cines Com­pa­ny. We an­tic­i­pate that the re­struc­tur­ing, which we in­tend to sub­stan­tial­ly im­ple­ment with­in the next 45 days, will re­duce head­count to less than 60 peo­ple at The Med­i­cines Com­pa­ny (ex­clud­ing the ID Busi­ness), sig­nif­i­cant­ly re­duc­ing go-for­ward an­nu­al op­er­at­ing ex­pens­es.

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.

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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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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