Am­plyx grabs $67M to fund a piv­otal dri­ve to the FDA with an an­ti-fun­gal aimed at a lethal threat

Am­plyx Plar­ma­ceu­ti­cals is prep­ping a move in­to a piv­otal Phase II pro­gram for its an­ti-fun­gal drug with a siz­able $67 mil­lion round in hand to pay for the two-year ef­fort ahead. And it’s tack­ling a dan­ger­ous fun­gus with its broad-spec­trum ther­a­py that the CDC has char­ac­ter­ized as a “cat­a­stroph­ic threat.”

Cia­ra Kennedy

Am­plyx CEO Cia­ra Kennedy says that the San Diego-based biotech more than dou­bled its to­tal raise be­fore this round af­ter fin­ish­ing up the Phase I pro­gram. As the gov­ern­ment has steadi­ly upped the in­cen­tives it’s us­ing to en­cour­age de­vel­op­ment of drug-re­sis­tant in­fec­tion fight­ers, law­mak­ers moved the goal post for her com­pa­ny up to Phase II — mak­ing this a “re­al­ly in­ter­est­ing and ex­cit­ing time.”

It’s a big round for Am­plyx, which has 19 staffers. But in ad­di­tion to the pair of Phase II tri­als they’re ready­ing to launch — which will take a cou­ple of years to wrap — the biotech al­so has to com­plete its man­u­fac­tur­ing prep work, tox stud­ies and so on to ready a move in­to the mar­ket if they get a green light.

Kennedy was part of the ex-Lu­me­na gang that found­ed Am­plyx. Ini­tial­ly the COO, Mike Grey had helmed the com­pa­ny at first, then stepped up to ex­ec­u­tive chair­man at the be­gin­ning of this year as Kennedy moved in­to the CEO role. Shire bought out Lu­me­na in a $260 mil­lion-plus deal in 2014, leav­ing the ex­pe­ri­enced group free to do a start­up.

That back­ground sug­gests an­oth­er sale could be in the off­ing, if the da­ta look good. But Kennedy isn’t about to get boxed in to one fate like that. Phase II biotechs like to have choic­es.

“Could we com­mer­cial­ize this our­selves?” she tells me. “Ab­solute­ly.”

The prod­uct is aimed at high vol­ume hos­pi­tals and is in­tend­ed to fill the role of a pre­ferred an­ti-in­fec­tive. Fight­ing drug-re­sis­tant cas­es — sin­gling out the lethal Can­di­da au­rus — will be im­por­tant to its quick suc­cess. But Kennedy sees this as a front-line drug with a new mech­a­nism of ac­tion; a first choice rather than a last chance. It’s some­thing a ded­i­cat­ed sales team could field.

But she isn’t rul­ing a sale out ei­ther. Ei­ther way, now isn’t the right time for a deal.

Says Kennedy: “I think the com­pa­nies that are com­mer­cial­ly ac­tive in the an­ti-in­fec­tive world tend to be the kind of com­pa­ny that pay more lat­er for a de-risked prod­uct.” So at or near the reg­u­la­to­ry fin­ish line works best on tim­ing.

In the mean­time, Am­plyx has a grow­ing and ded­i­cat­ed ven­ture crowd hap­py to bear the risk and wait for the re­wards.

Sofinno­va Ven­ture Part­ners led the Se­ries C, joined by new in­vestors Lund­beck­fonden Ven­tures, Ar­ix Bio­science and Pap­pas Cap­i­tal. Ex­ist­ing in­vestors New En­ter­prise As­so­ci­ates, River­Vest Ven­ture Part­ners, 3×5 River­Vest II and Bio­Med Ven­tures al­so par­tic­i­pat­ed in the fi­nanc­ing. Anand Mehra, M.D., man­ag­ing part­ner at Sofinno­va Ven­tures, and Jo­han Kördel, Ph.D., se­nior part­ner at Lund­beck­fonden Ven­tures, will join the Am­plyxboard of di­rec­tors.

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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