With eye on Heron's ri­val prod­uct, Paci­ra to buy MyoScience to for­ti­fy its Ex­par­el fran­chise

As Paci­ra braces it­self ahead of the FDA de­ci­sion of Heron Ther­a­peu­tics’ ri­val non-opi­oid treat­ment, the com­pa­ny is beef­ing up its pain man­age­ment fran­chise, by ac­quir­ing a sys­tem that us­es in­tense­ly cold ther­a­py on a spe­cif­ic nerve to re­lieve pain, to com­ple­ment its flag­ship Ex­par­el treat­ment.

Paci­ra $PCRX on Tues­day said it was ac­quir­ing pri­vate­ly-held med­ical tech­nol­o­gy com­pa­ny MyoScience for $120 mil­lion up­front to se­cure ac­cess to the lat­ter’s iover­aº sys­tem — an FDA-ap­proved hand­held de­vice used to de­liv­er pre­cise, con­trolled dos­es of cold tem­per­a­ture on­ly to tar­get­ed nerves, which are thus thwart­ed from send­ing pain sig­nals — eas­ing pain and al­low­ing for de­creased opi­oid con­sump­tion. Pain re­lief can last up to three months, as the nerve re­gen­er­ates over time and re­sumes sig­nal­ing. The sys­tem is ap­proved for symp­toms as­so­ci­at­ed with os­teoarthri­tis of the knee as well as gen­er­al sur­gi­cal use.

Paci­ra, which counts J&J $JNJ as a part­ner, is plan­ning ahead for po­ten­tial com­pe­ti­tion for its main­stay non-opi­oid treat­ment Ex­par­el. Heron Ther­a­peu­tics’ $HRTX ri­val HTX-011 has won pri­or­i­ty re­view and the FDA is ex­pect­ed to an­nounce its de­ci­sion on the prod­uct by April 30.

Heron’s prod­uct de­liv­ers bupi­va­caine and a low dose of meloxi­cam over 72 hours, re­duc­ing in­flam­ma­tion at the wound site in or­der to main­tain pH, al­low­ing the bupi­va­caine to work bet­ter. Mean­while, Ex­par­el’s main in­gre­di­ent is al­so bupi­va­caine and the drug has been ap­proved by the US reg­u­la­tor since Oc­to­ber 2011 as a treat­ment for post­sur­gi­cal anal­ge­sia, and re­mains the sole FDA-ap­proved long-act­ing, non-opi­oid painkiller.

Mea­sures to re­duce the pre­scrip­tion of opi­oid painkillers are be­ing tak­en, but re­search, de­vel­op­ment and the even­tu­al ap­proval of equal­ly pain al­le­vi­at­ing prod­ucts will go a long way in turn­ing the tide of opi­oid-re­lat­ed deaths.

Var­i­ous an­a­lysts have sug­gest­ed that the da­ta in­di­cate Heron’s prod­uct is su­pe­ri­or to Ex­par­el.

In a note ear­li­er this month, Leerink an­a­lysts wrote that while “Ex­par­el does a good job re­duc­ing opi­oid use for post-op pain; HTX-011 could do this bet­ter,” cit­ing a KOL sur­vey. “…it (Ex­par­el) has done a good job in re­duc­ing opi­oid use and hos­pi­tal­iza­tion time in its post-op­er­a­tive pa­tients, the du­ra­tion of ef­fi­ca­cy is in the 24-36 hour range. As such, this KOL be­lieves the longer po­ten­tial du­ra­tion of ef­fi­ca­cy and the in­stil­la­tion method of HTX-011 will re­sult in ini­tial use of the prod­uct. But up­on avail­abil­i­ty of both prod­ucts, this KOL be­lieves hos­pi­tals will run their own pi­lot stud­ies in var­i­ous sur­gi­cal mod­els to see how they com­pare to one an­oth­er.”

It re­mains to be seen whether HTX-011 — if ap­proved — will bag the cov­et­ed opi­oid spar­ing claim. As for Paci­ra, it ex­pects that the MyoScience prod­uct will com­ple­ment Ex­par­el and to­geth­er pro­vide an “ef­fec­tive, non-opi­oid mul­ti­modal reg­i­men that can help mit­i­gate or even elim­i­nate the use of opi­oids for man­ag­ing pain be­fore, dur­ing and af­ter surgery.”

The deal, ex­pect­ed to close in April, of­fers MyoScience share­hold­ers po­ten­tial­ly up to $100 mil­lion in mile­stone pay­ments.

Andre Kalil, AP Images

A 9/11-era Om­a­ha fa­cil­i­ty, an old Ebo­la drug, and the ubiq­ui­tous Dr. Fau­ci: In­side the first US nov­el coro­n­avirus tri­al

The first 11 coronavirus patients who arrived in Omaha last week, airlifted across the globe after two weeks quarantined on a cruise ship, showed only minor symptoms or none at all. And then one of them — or one of the couple of Americans who arrived later — got worse. He developed pneumonia, a life-threatening complication for coronavirus patients.

In a biocontainment room at the University of Nebraska Medical Center on Friday, doctors infused him with an experimental Gilead drug once developed for Ebola, called remdesivir. Or they gave him a placebo. For the first time in the US, neither he nor the doctors knew.

The first US novel coronavirus trial was underway and with it, a mad dash for an answer. Sponsored by the NIH, the study marked a critical point in the epidemic. Since the start of the outbreak, the agency had helped lead a global effort to contain the virus. Now, as it spread worldwide and the CDC issued warnings the US could see a major internal outbreak, they were looking at home.

“We don’t have too much time,” Andre Kalil, the trial’s lead investigator, told Endpoints News. “Everything’s moving really fast.”

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Dan O'Day (AP Images)

A name emerges out of the Gilead M&A ru­mor mill, and it’s a can­cer biotech

After months of questions and speculation about when and if Gilead will make a major acquisitions, a name has emerged.

The California-based drugmaker has approached Forty Seven Inc, a cancer biotech, with a takeover offer, Bloomberg News reports. With Forty Seven’s market cap at $2.3 billion, an acquisition would likely be Gilead’s largest since they acquired Kite Pharma for $11.9 billion in 2017.

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Biogen head of R&D Al Sandrock, Sangamo CEO Sandy Macrae

UP­DAT­ED: Bio­gen makes an­oth­er bold Alzheimer’s bet, drop­ping $350M up­front to part­ner with genome-edit­ing fo­cused Sang­amo

While the fate of Biogen’s resurrected Alzheimer’s drug aducanumab remains uncertain, the Cambridge, MA-based drugmaker is joining forces with genome editing company Sangamo Therapeutics to develop therapies for neurological conditions.

Sangamo is set to receive a meaty $350 million upfront in cash and stock and is eligible to receive up to $2.37 billion in milestone payments, in addition to royalties. In return, Biogen gets the rights to two Sangamo preclinical compounds: ST-501 (for use in tauopathies including Alzheimer’s disease) and ST-502 (for synucleinopathies including Parkinson’s disease).

“The partnership represents a lower-cost way to expand its work in neurologic disease,” Credit Suisse’s Evan Seigerman said in a note, referring to Biogen.

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Spark los­es an­oth­er top ex­ec in the wake of $4.3B takeover by Roche — re­port

Days after bidding farewell to co-founder Kathy High, Spark Therapeutics — now operating under Roche — has one more opening on its C-suite.

Kathy Reape

Kathy Reape, who joined the Philadelphia-based biotech in 2016 as head of clinical R&D and became chief medical officer in 2018, is reportedly set to leave.

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'The head­lines are the head­lines, but': Bio­Marin talks up po­ten­tial sav­ings as he­mo­phil­ia gene ther­a­py launch looms

BioMarin execs are still staying tight-lipped about their pricing plans for what is poised to be the world’s first hemophilia gene therapy. But as the company enters the final regulatory stretch and approaches a potential launch this summer, they are also dropping more hints to get investors ready.

First thing to know: They really, really don’t expect an advisory committee to be convened for valrox, which is under priority review, to pop up before its PDUFA date on August 21.

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Vlad Coric (Photo Credit: Andrew Venditti)

Bio­haven scores CGRP OK for acute mi­graine — can the com­mer­cial team catch up with Al­ler­gan on its de­but?

Seven years after spinning out of Yale, Biohaven has entered the ranks of commercial-stage biotechs.

The FDA handed down an OK for its CGRP drug, rimegepant, as an acute treatment. Dubbed Nurtec, the orally dissolving pill will join Allergan’s (soon to be AbbVie’s) Ubrelvy and Lilly’s Reyvow on the market amid a new wave of migraine therapies reshaping the disease space.

In a pivotal Phase III trial, Nurtec hit the co-primary endpoints on pain freedom and freedom from most bothersome symptoms at two hours post dose, proving superior to placebo.

Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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