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.

UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Covid 19 roundup: Trump push­es his new fa­vorite, untest­ed drug; CRISPR out­lines crip­pling im­pact of Covid-19

President Trump has a new favorite Covid-19 drug.

After a conversation with Japanese Prime Minister Shinzo Abe, Politico reports, the president is pressuring the FDA to issue emergency use authorization for favipiravir, a flu drug that showed glimpses of success in China but remains unproven and carries a list of worrying side effects. The push comes after a week-plus in which the White House touted a potentially effective but unproven malaria medication despite the concerns of scientific advisors such as NIAID director Anthony Fauci. And Trump ally Rudy Giuliani has been talking up unproven cell therapy efforts on Twitter.

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ITeos nabs $125M as they prep Keytru­da com­bi­na­tion tri­al — if Covid-19 will let them

For iTeos, it turned out, $75 million could only last so long.

Two years after announcing their eye-catching Series B raise, the Belgian biotech is back with an even larger Series B-2: $125 million.

The now $200 million financing illustrates the vast capital available for those with promising new immuno-oncology compounds, particularly those that might be used in combination with existing therapies. In December, iTeos announced a collaboration with Merck to test its lead compound with Keytruda this year. The proceeds will push forward that trial and help fund the ongoing Phase I/II trials for that compound, EOS-850, and a second one, EOS-448.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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Dai­ichi Sankyo sinks $200M in­to new gene ther­a­py tech from Ul­tragenyx

In a leap to the gene therapy space, Daiichi Sankyo has dropped $200 million to access Ultragenyx’s manufacturing technology, providing the rare disease biotech with plenty of cash and a stock boost amid a general cash crunch.

For $125 million in cash and a $75 million equity investment, Daiichi Sankyo has bought a non-exclusive license to the IP around two platforms with which it plans to develop AAV-based gene therapy products. The Japanese pharma is purchasing the stock $RARE at $60 per share, more than a third above its current price of $44.43.

It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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