Zealand takes on Takeda's IBD drug with tiny buy­out

Af­ter years de­vel­op­ing a pep­tide to treat short bow­el syn­drome (SBS), Zealand Phar­ma is join­ing the hunt for the white whale of the gas­troin­testi­nal track: in­flam­ma­to­ry bow­el dis­ease.

The Dan­ish biotech is buy­ing out Toron­to-based En­cy­cle Ther­a­peu­tics for up to $80 mil­lion to ac­quire their lead pep­tide, ET3764, along with a bank of ap­prox­i­mate­ly 5,000 unique pep­tide macro­cy­cles. The pre­clin­i­cal drug has the same mech­a­nism as En­tyvio (vedolizum­ab), Take­da’s block­buster ul­cer­a­tive col­i­tis and Crohn’s dis­ease treat­ment – both forms of IBD. The big pitch is that En­cy­cle’s drug is oral, as op­posed to the En­tyvio in­fu­sion.

The deal will pay En­cy­cle up to $80 mil­lion in earnouts, with $10 mil­lion payable when a Phase II study is com­plet­ed. Zealand can choose whether to pay the earnouts, which are based on­ly on the lead drug and not the rest of the ac­quired li­brary, in cash or eq­ui­ty. The small­er biotech may al­so earn a mid-sin­gle dig­it roy­al­ty on net glob­al sales.

Em­manuel Du­lac

Zealand has long billed it­self as a com­pa­ny fo­cused on gas­troin­testi­nal dis­eases as a key area, even as its on­ly big de­vel­op­ment in that sub­field was a pep­tide for SBS, now in Phase III test­ing. The buy­out will see the mid-sized com­pa­ny, which al­so de­vel­ops drugs for hy­po­glycemia and obe­si­ty and di­a­betes, en­ter one of gas­troen­terol­o­gy’s biggest and most crowd­ed mar­kets.

Like En­tyvio, ET3764 works by cut­ting off the in­flammed gut tis­sue from white blood cells. It does so by in­hibit­ing the al­pha-4-be­ta-7 in­te­grin pro­tein from in­ter­act­ing with the a pro­ten in the GI tract called in­testi­nal mu­cos­al ad­dressin cell ad­he­sion mol­e­cule 1.

The ac­qu­si­tion comes as Zealand re­struc­tures its C-suite and moves in­to new head­quar­ters. In March, they poached Al­ny­lam’s Em­manuel Du­lac as CEO. In Au­gust, they hired Matthew Dal­las as CFO and in Sep­tem­ber they be­gan mov­ing in­to new of­fices in Søborg.

Al­though pep­tide ther­a­pies are at least as old as the first in­sulin treat­ments for di­a­betes in the 1920s, they’ve re­cent­ly grown in pop­u­lar­i­ty, with Roche and J&J, among oth­ers, bet­ting on the class. Part of that has to do with ad­vance­ments in chem­istry and man­u­fac­tur­ing: In the 1980s, most pep­tides were few­er than 10 amino acids long, and the av­er­age length has in­creased in each sub­se­quent decades. Trendy and po­ten­tial­ly trans­for­ma­tive ther­a­pies such as B class GPCRs are de­pen­dent on these more com­plex chains.

Be­liev­ers say they of­fer the sta­bil­i­ty of small mol­e­cule drugs with the se­lec­tiv­i­ty of an­ti­bod­ies.

Pep­tide macro­cy­cles — so named be­cause they’re formed from a ring of at least 12 atoms — have held par­tic­u­lar in­ter­est over the last decade amid ad­vance­ments in de­sign­ing and syn­the­siz­ing the struc­tures. Cy­closporine, the fun­gus-de­rived im­muno­sup­pre­sant for or­gan trans­plant re­cip­i­ents, is a nat­u­ral­ly oc­cur­ing macro­cy­cle.

En­cy­cle Ther­a­peu­tics – and pre­sum­ably the pep­tide bank Zealand ac­quired – fo­cused on a sub­set of mol­e­cules called aziri­dine alde­hyde-based macro­cy­cles.

So­cial im­age: Zealand Phar­ma

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

NextCure’s turn as the Cinderella of cancer-focused biotechs was short-lived.
Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
The focus at NextCure is centered on NC318, an antibody that is intended to shut down the immunosuppressive Siglec-15 — or S-15 — target. After adding a small group of patients to the readout, investigators circled 2 clinical responses, a complete and partial response, along with 4 stable disease cases in non-small cell lung cancer.

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Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Third time un­lucky: Lipocine's lat­est quest to mar­ket their oral testos­terone drug snubbed again by FDA

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

UP­DAT­ED: De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche's SMA chal­lenge to Bio­gen's Spin­raza fran­chise looms larg­er with piv­otal win

Roche has just landed a crucial advance in scoring a come-from-behind win on the spinal muscular atrophy field, giving Novartis and Biogen a run for their money.

The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

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Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.