Paratek shares shoot up on a pos­i­tive PhI­II and a slow-mo shot at FDA/EMA OK for its an­tibi­ot­ic

Chem­i­cal Struc­ture

Shares of Paratek shot up 30% $PRTK in af­ter-mar­ket trad­ing on Mon­day as in­vestors re­act­ed to the Boston biotech’s procla­ma­tion of a clean sweep for its piv­otal test of its new an­tibi­ot­ic omada­cy­cline. Ex­ecs said that their broad spec­trum an­tibi­ot­ic hit its pri­ma­ry and sec­ondary end­points for the FDA as well as the co-pri­maries need­ed for the EMA in their sec­ond pos­i­tive late-stage tri­al.

Re­searchers went look­ing for ev­i­dence that omada­cy­cline matched up with mox­i­floxacin in the treat­ment of pa­tients with com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia (CABP). And that’s what they got, with ear­ly clin­i­cal re­sponse rates scor­ing 81.1 % and 82.7% in new and old an­tibi­otics.

Evan Loh, Paratek

The co-pri­ma­ry end­points for the EMA were non-in­fe­ri­or­i­ty in the in­tent-to-treat group and the evalu­able CABP pop­u­la­tions in those pa­tients with Pneu­mo­nia Sever­i­ty In­dex (PORT) III and IV at the post treat­ment eval­u­a­tion time point. And the safe­ty pro­file looked com­pa­ra­ble as well. Fol­low­ing a suc­cess­ful Phase III for skin in­fec­tions, Paratek has the two pos­i­tive stud­ies it needs to sat­is­fy the FDA.

This an­tibi­ot­ic is start­ed as an IV and doc­tors can then switch to an oral ver­sion.

An­tibi­ot­ic de­vel­op­ment, though, can be a slow process and Paratek says it has around a year left on the clock be­fore it files for an ap­proval. The ap­pli­ca­tions may ar­rive at the FDA “as ear­ly as” Q1 2018, the com­pa­ny says, with the EMA on the re­ceiv­ing end some­time af­ter that.

With ap­pli­ca­tions that late, don’t look for any po­ten­tial ap­provals be­fore late 2018.

While the threat of drug re­sis­tant bac­te­ria has in­creased the need for new an­tibi­otics, Paratek is one of on­ly a hand­ful of biotechs which dived in­to this area. There are a num­ber of cheap, gener­ic an­tibi­otics avail­able for front­line use. And any new an­tibi­ot­ic is go­ing to face an up­hill bat­tle gain­ing trac­tion in this mar­ket.

Leerink not­ed re­cent­ly:

For 2025 we cur­rent­ly mod­el ~$230MM and ~$330MM op­por­tu­ni­ties in skin and pneu­mo­nia and al­so in­clude a small amount of risk-ad­just­ed (at 15%) cred­it for uri­nary tract in­fec­tion.

Paratek and its US part­ner Al­ler­gan $AGN post­ed pos­i­tive da­ta from two Phase III stud­ies of sara­cy­cline for ac­ne. But Al­ler­gan con­trols the bulk of the rev­enue, and the com­pa­ny ex­pects peak sales to tap out around $275 mil­lion. That FDA ap­pli­ca­tion will ar­rive soon­er, though, with reg­u­la­tors get­ting the pack­age in the sec­ond half of this year.

“We now have ex­pe­ri­ence with omada­cy­cline in more than 1,500 pa­tients in our clin­i­cal pro­gram and we are very pleased with the safe­ty, tol­er­a­bil­i­ty, and ef­fi­ca­cy pro­file that we have seen to date,” said Evan Loh, pres­i­dent and CMO at Paratek.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Covid-19 roundup: As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Forget 1 billion. AstraZeneca is now promising to supply 2 billion doses of Oxford University’s Covid-19 vaccine around the world per year.

Three new partners are coming on board to help reach that goal, as well as a broader vision to ensure access for nations that have been largely left out of the bargaining table.

CEPI — the coalition that’s been doling out grants to support other vaccine projects — is providing $383 million to support manufacturing of 300 million doses, while Gavi the Vaccine Alliance will chip in $367 million and be in charge of the procurement and distribution, a spokesperson told Wall Street Journal. A separate licensing agreement directs the Serum Institute of India to produce 1 billion doses for low- and middle-income countries, with the first 400 million due before the end of the year.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Michael Gladstone, partner at Atlas Venture

At­las rais­es new $400M fund amid spree of VC rais­es. Here’s what they’ll spend it on

You can add another few hundred million to the now Montana-sized reservoir of cash biotech VCs have raised since the WHO declared Covid-19 a pandemic.

Atlas Venture, the prominent Kendall Square incubator, has raised $400 million for its twelfth biotech fund, their first in 3 years. After a string of mammoth new raises from other major VCs in April and May, the total pot now stands between $5 billion and $6 billion, depending on how you slice it.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.

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.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.