From part­ner to knight in shin­ing ar­mor: Cas­tle Creek to buy Fi­bro­cell

In April, Cas­tle Creek swooped in to part­ner with the em­bat­tled gene and cell ther­a­py Fi­bro­cell to shep­herd its lead gene ther­a­py for a type of “but­ter­fly” dis­ease in­to late-stage de­vel­op­ment. Now, the New Jer­sey-based der­ma­tol­ogy com­pa­ny is ac­quir­ing its part­ner in a deal worth $63.3 mil­lion.

Cas­tle Creek CEO Greg Wu­jek

Penn­syl­va­nia-based Fi­bro­cell last year ini­ti­at­ed a re­view of strate­gic al­ter­na­tives, in­clud­ing a sale.

Its lead drug FCX-007 is en­gi­neered to treat the un­der­ly­ing cause of re­ces­sive dy­s­troph­ic epi­der­mol­y­sis bul­losa, which is caused by the de­fi­cien­cy of the pro­tein COL7. Cells are ex­tract­ed from the pa­tient, ge­net­i­cal­ly mod­i­fied, and then used to treat wounds by lo­cal in­jec­tion, avoid­ing sys­temic dis­tri­b­u­tion.

A late-stage study for FCX-007 was kicked off in Ju­ly, and if all goes well, a mar­ket­ing ap­pli­ca­tion for the treat­ment is ex­pect­ed to be sub­mit­ted in 2021, Fi­bro­cell said on Thurs­day. The com­pa­ny, which al­so counts In­trex­on $XON as a part­ner, has an ex­per­i­men­tal gene ther­a­py FCX-013 in ear­ly-stage de­vel­op­ment for mod­er­ate to se­vere lo­cal­ized scle­ro­der­ma.

Epi­der­mol­y­sis Bul­losa (EB) is a group of ge­net­ic skin con­di­tions that cause the skin to blis­ter and tear due to min­i­mal con­tact — in­fants born with the dis­ease are called ‘but­ter­fly chil­dren’ as their skin is con­sid­ered as frag­ile as a wing of a but­ter­fly.

Cas­tle Creek Phar­ma­ceu­ti­cals — one of for­mer Marathon chief Jeff Aronin’s port­fo­lio com­pa­nies un­der his flag­ship in­vest­ment en­gine Paragon Bio­sciences — has its own EB drug in de­vel­op­ment: CCP-020 is a late-stage top­i­cal oint­ment un­der de­vel­op­ment for use in epi­der­mol­y­sis bul­losa sim­plex. The drug is a re­pur­posed an oral or­phan treat­ment called di­ac­ere­in, which is ap­proved to treat joint swelling or pain in the EU, but its use is re­strict­ed due to the risks of di­ar­rhea and liv­er prob­lems.

“Fol­low­ing our li­cens­ing agree­ment to de­vel­op and com­mer­cial­ize FCX-007, our ex­pe­ri­ence work­ing to­geth­er on rare der­ma­to­log­i­cal con­di­tions caused us to quick­ly re­al­ize that Cas­tle Creek and Fi­bro­cell could achieve even greater syn­er­gies by com­bin­ing the com­pa­nies in­to one,” said Greg Wu­jek, CEO of Cas­tle Creek Phar­ma­ceu­ti­cals, in a state­ment.

Cas­tle Creek has agreed to pay $3 per Fi­bro­cell share $FC­SC, which is a near­ly 64% pre­mi­um to the com­pa­ny’s Thurs­day clos­ing. The deal, in which Cas­tle Creek will ab­sorb Fi­bro­cell’s debt, is ex­pect­ed to close by the fourth quar­ter.

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.

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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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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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.