Armed with deals, dol­lars and the promise of up­com­ing da­ta, Zymeworks files $75M IPO

Ali Tehrani, Zymeworks ac­cepts@BIOTE­Cana­da Gold Leaf award (CRED­IT:@bio­ge­nius­CA)

A lit­tle more than a year ago, as Zymeworks CEO Ali Tehrani was reel­ing in a $61.5 mil­lion crossover round, the biotech CEO told me that he had a two-year run­way and a shot at be­ing op­por­tunis­tic in fil­ing for an IPO. This morn­ing, Tehrani con­clud­ed that the time was right—or at least nec­es­sary.

Zymeworks $ZYME has been blitz­ing its way through a se­ries of part­ner­ships and ex­pan­sion projects fo­cused on its bis­pe­cif­ic an­ti­bod­ies and armed AD­Cs, two plat­forms Zymeworks will now de­pend on to raise at least $75 mil­lion in an IPO.

Zymeworks has built its rep­u­ta­tion around a slate of big bio­phar­ma deals. In ad­di­tion to Lil­ly and Cel­gene, Glax­o­SmithK­line and Mer­ck have jumped on board the biotech’s pri­ma­ry Azy­met­ric drug de­vel­op­ment plat­form. Dai­ichi Sankyo was the last com­pa­ny to jump on the plat­form. And Zymeworks re­cent­ly added a 10,000-square-foot lab in its Van­cou­ver base.

Their lead pro­gram—ZW25—now in the clin­ic us­es their bis­pe­cif­ic tech “to ad­dress pa­tient pop­u­la­tions with all lev­els of HER2 ex­pres­sion,” reads the F-1, “in­clud­ing those with low to in­ter­me­di­ate HER2-ex­press­ing tu­mors, who are oth­er­wise lim­it­ed to chemother­a­py or hor­mone ther­a­py.”

Zymeworks now joins a short list of com­pa­nies that are try­ing to make a leap in­to the pub­lic mar­ket. While Tehrani want­ed to pick his time, the biotech IPO mar­ket has been shaky in ear­ly 2017, with some suc­cess­es and some fail­ures. We’re a long way from the boom days of 2014.

The biotech, though, has a long list of back­ers. The co-lead in­vestors in the last round were BDC Cap­i­tal and Lu­mi­ra Cap­i­tal, first timers, with ex­ist­ing in­vestors CTI Life Sci­ences Fund and the Fonds de sol­i­dar­ité FTQ jump­ing in. New in­vestors in the lat­est fi­nanc­ing in­clud­ed Per­cep­tive Ad­vi­sors, Teralys Cap­i­tal, North­leaf Ven­ture Cat­a­lyst Fund, Brace Phar­ma Cap­i­tal, Mer­lin Nexus and oth­ers.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.