No­var­tis' $111M bet on IL-17C drug turns sour — but Mor­phoSys, Gala­pa­gos will ex­plore op­tions

Just a year af­ter No­var­tis bought its way in­to Mor­phoSys’ and Gala­pa­gos’ de­vel­op­ment pact for MOR106, the part­ners are writ­ing off the atopic der­mati­tis treat­ment and ex­tin­guish­ing hopes for $1 bil­lion in mile­stones.

MOR106 did not pass an in­ter­im analy­sis for fu­til­i­ty dur­ing the Phase II IGUA­NA tri­al, the two Eu­ro­pean biotechs (Mor­phoSys in Mu­nich and Gala­pa­gos in Meche­len, Bel­gium) dis­closed. No­var­tis was ap­par­ent­ly al­so in­volved in the de­ci­sion af­ter it was de­ter­mined that the study had a low prob­a­bil­i­ty of meet­ing the pri­ma­ry end­point on the eczema area and sever­i­ty in­dex, or EASI, score.

Piet Wiger­inck

“We are ob­vi­ous­ly dis­ap­point­ed with this re­sult with MOR106 in atopic der­mati­tis,” Gala­pa­gos CSO Piet Wiger­inck said in a state­ment. “To­geth­er with our col­lab­o­ra­tion part­ners, we will ex­plore the fu­ture strat­e­gy with MOR106.”

They em­pha­sized that the drug’s fault was en­tire­ly in lack of ef­fi­ca­cy and not about safe­ty.

Be­fore the atopic der­mati­tis pro­gram was ter­mi­nat­ed, MOR106 was be­ing test­ed in two Phase II stud­ies, a Phase I bridg­ing study for a sub­cu­ta­neous for­mu­la­tion, and a Japan­ese eth­no-bridg­ing study.

No­var­tis paid $111 mil­lion up­front — and com­mit­ted to foot­ing the R&D, man­u­fac­tur­ing and com­mer­cial­iza­tion bills — last Ju­ly to gain de­vel­op­ment and mar­ket­ing rights to the IL-17C in­hibitor, which al­so al­lowed them to ex­plore ad­di­tion­al in­di­ca­tions.

Jump­ing in­to the atopic der­mati­tis are­na meant fac­ing Big Phar­ma ri­vals al­ready field­ing their block­buster con­tenders, most no­tably Dupix­ent from Re­gen­eron and Sanofi. The drug, a mon­o­clon­al an­ti­body that tar­gets IL-4 and IL-13, has racked up $920 mil­lion in the first half of the year. Pfiz­er is mount­ing a chal­lenge with its heavy­weight JAK1 in­hibitor abroc­i­tinib, post­ing strong Phase III re­sults (in­clud­ing EASI) against Dupix­ent and Eli Lil­ly’s Olu­mi­ant just days ago.

The Swiss phar­ma gi­ant’s hopes will now be on ZPL389, ac­quired in the Ziar­co buy­out late 2016. In its lat­est quar­ter­ly up­date No­var­tis in­di­cat­ed Phase IIb en­roll­ment has be­gun, and the first reg­u­la­to­ry sub­mis­sions are planned for 2022.

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Por­tion of Neil Wood­ford’s re­main­ing in­vest­ments, in­clud­ing Nanopore, sold off for $284 mil­lion

It’s been precisely one year and one day since Neil Woodford froze his once-vaunted fund, and while a global pandemic has recently shielded him from the torrent of headlines, the fallout continues.

Today, the California-based patent licensing firm Acacia Research acquired the fund’s shares for 19 healthcare and biotech companies for $284 million.  Those companies include shares for public and private companies and count some of Woodford’s most prominent bio-bets, such as Theravance Biopharma, Oxford Nanopore and Mereo Biopharma, according to Sky News, which first reported the sale. It won’t include shares for BenevelontAI, the machine learning biotech once valued at $2 billion.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.