Eye­ing NDA for its di­a­betes drug, Hua Med­i­cine knocks at HKEX's door with an IPO ap­pli­ca­tion

A month af­ter the Hong Kong Stock Ex­change opened its doors to pre-rev­enue biotechs — and re­ceived one guest, As­cle­tis — Hua Med­i­cine has walked in with its own ap­pli­ca­tion to list.

Li Chen

The Shang­hai-based di­a­betes drug­mak­er is seek­ing $200 mil­lion in the IPO, South Chi­na Morn­ing Post re­ports, al­though there was no way to con­firm the num­ber on the heav­i­ly redact­ed ap­pli­ca­tion proof. That would mark a de­crease from the $300 mil­lion to $400 mil­lion that it was pre­vi­ous­ly ru­mored to be seek­ing, but it would get Hua through Phase III tri­als, fur­ther R&D and po­ten­tial launch of its lead drug, dorza­gli­atin, in Chi­na.

Hua bought the drug in 2011, when it first got go­ing, from Roche — for whom founder and CEO Li Chen used to run an R&D cen­ter in Chi­na. Back then, it was an ear­ly-stage can­di­date. To­day, the oral glu­cok­i­nase ac­ti­va­tor is in two Phase III stud­ies in Chi­na.

Tout­ed as a first-in-class drug, dorza­gli­atin treats type 2 di­a­betes by go­ing af­ter the un­der­ly­ing cause: an im­paired “glu­cose sen­sor.” If you fix the en­zyme serv­ing that func­tion, Hua the­o­rizes, you can bet­ter reg­u­late the body’s glu­cose me­tab­o­lism.

It’s a the­o­ry that mar­quee in­vestors from Chi­na and the US alike have bought in­to. In five fi­nanc­ing rounds — capped by a com­bined Se­ries D and Se­ries E that reaped $117 mil­lion just this March — Hua has earned the back­ing of Arch Ven­ture Part­ners, Ven­rock, Eight Roads, F-Prime and WuXi. Pri­or to the IPO, Arch is the largest share­hold­er, hold­ing 15% of the shares, fol­lowed by Ven­rock at 12%. Ge Li’s WuXi has al­most 9% while his fam­i­ly fund al­so chipped for 3%.

If all goes ac­cord­ing to plan, Phase III re­sults for dorza­gli­atin both as a monother­a­py and in com­bi­na­tion with met­formin will come out in the sec­ond half of 2019, fol­lowed by a fil­ing to the CDA (CF­DA no more). Hua is aim­ing for an ap­proval in 2020. In the in­ter­im, the 83 staffers — in­clud­ing 59 sci­en­tists — will keep them­selves busy with more com­bo tri­als for the lead drug and some clin­i­cal work on a pre­clin­i­cal can­di­date.

Here’s the break­down for how they’re go­ing to spend the mon­ey:

  • 24% to com­plete the two Phase III tri­als for dorza­gli­atin
  • 14% for fur­ther R&D — think com­bo and dif­fer­en­ti­a­tion tri­als — of dorza­gli­atin
  • 30% for launch and com­mer­cial­iza­tion of dorza­gli­atin
  • 10% to­ward mGLUR5, a po­ten­tial drug can­di­date for treat­ing dysk­i­ne­sia in­duced by Parkin­son’s ther­a­py lev­odopa
  • 12% for ad­di­tion­al li­cens­ing and part­ner­ship op­por­tu­ni­ties
  • 10% for gen­er­al and cor­po­rate pur­pos­es
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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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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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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