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.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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Federal Trade Commission commissioner Rohit Chopra testifies on Capitol Hill (AP Photo/Susan Walsh)

FTC clears Bris­tol-My­ers’ $74B deal to buy Cel­gene — but Dems sig­nal a po­ten­tial hard shift against Big Phar­ma M&A

Bristol-Myers Squibb’s record $74 billion takeover of Celgene is a done deal. And it will all be over — except for the lingering complaints from die-hard Celgene investors — on Wednesday.

Like much else that’s going on in Washington these days, the vote among the 5 FTC commissioners split along party lines, with the 3 Republicans voting to clear the way and the 2 Democrats steamed over what they see as a major M&A move that will lessen competition and innovation. And that split has big implications for the M&A side of the business if the Dems take the White House in 2020.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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