On a win­ning streak, Heron rock­ets up 30% on PhI­Ib pain drug da­ta

More than dou­bling its stock since the first of the year, San Diego’s Heron Ther­a­peu­tics re­port­ed yet an­oth­er slam dunk Thurs­day morn­ing with news that its pain drug de­liv­ered in two more in­di­ca­tions. That’s af­ter the com­pa­ny re­port­ed stel­lar Phase III da­ta just three months ago, and a FDA OK on a dif­fer­ent drug be­fore that.

Bar­ry Quart

Heron’s in­vestors are pleased with the news, with the com­pa­ny’s stock $HRTX jump­ing 30% in pre-mar­ket trad­ing.

The com­pa­ny’s pain drug is a long-act­ing lo­cal anes­thet­ic made up of bupi­va­caine and meloxi­cam, which Heron calls HTX-011. The drug was test­ed in two Phase IIb stud­ies against the pain as­so­ci­at­ed with to­tal knee arthro­plas­ty and breast aug­men­ta­tion. Both stud­ies en­rolled be­tween 222 and 243 pa­tients, and were ran­dom­ized, place­bo-con­trolled, and dou­ble-blind. The pa­tients were split in­to four co­horts, with one group re­ceiv­ing HTX-011 as a monother­a­py, while the oth­ers ei­ther got an HTX-011 com­bo with ropi­va­caine, a place­bo, or the anes­thet­ic bupi­va­caine (the cur­rent stan­dard of care).

Heron met the pri­ma­ry end­points in both stud­ies, show­ing that HTX-011 and the com­bo worked sig­nif­i­cant­ly bet­ter at re­duc­ing pain than bupi­va­caine and the place­bo. In the knee study, The HTX-011 com­bo and HTX-011 alone re­sult­ed in re­duc­tions of 23% and 19% re­spec­tive­ly in pain in­ten­si­ty mea­sured at rest through 48 hours when com­pared to place­bo (p<0.0001 and p=0.0002, re­spec­tive­ly). That’s dou­ble the pain re­duc­tion than that of bupi­va­caine, which on­ly re­duced pain in­ten­si­ty by 11%.

The breast aug­men­ta­tion study re­sults were sim­i­lar­ly strong, with Heron’s drug achiev­ing near­ly triple the pain re­duc­tion than that of bupi­va­caine. HTX-011 re­sult­ed in re­duc­tions of 22% in pain in­ten­si­ty mea­sured at rest through 24 hours, while bupi­va­caine re­sult­ed in a re­duc­tion of 8%.

This is the sec­ond wave of good news for HTX-011, which wowed in­vestors in March for its ef­fi­ca­cy against post-surgery pain af­ter bunionec­to­my (bunion re­moval) and her­nia re­pair.

“With post­op­er­a­tive opi­oids serv­ing as a gate­way to ad­dic­tion, there is a large un­met need for non-opi­oid pain al­ter­na­tives,” said Bar­ry Quart, Heron’s CEO, in a state­ment. “With the re­sults re­port­ed to­day, we have seen pos­i­tive re­sults across 7 con­trolled clin­i­cal stud­ies and 5 di­verse sur­gi­cal mod­els, in­clud­ing her­nia re­pair, ab­domino­plas­ty, bunionec­to­my, to­tal knee arthro­plas­ty and breast aug­men­ta­tion.”

In a note to in­vestors ear­li­er this year, an­a­lysts at Jef­feries sug­gest­ed the piv­otal read­out for HTX-011 would be a “sig­nif­i­cant cat­a­lyst” for Heron. The com­pa­ny plans to file an NDA for the pro­gram lat­er this year.

The good news for the com­pa­ny fol­lows a reg­u­la­to­ry win late last year, when Heron scored FDA ap­proval of Cin­van­ti to pre­vent nau­sea and vom­it­ing for pa­tients on chemo. It was the sec­ond an­ti-nau­sea drug in Heron’s prod­uct port­fo­lio, with Sus­tol ap­proved last Au­gust for the same in­di­ca­tion.

Heron’s stock has climbed 88% since that Cin­van­ti win back in No­vem­ber, and could climb as much as 139% if Heron’s stock opens Thurs­day at its pre-mar­ket price.

Gilead baits new al­liance with $45M up­front, div­ing in­to the busy pro­tein degra­da­tion field

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

 

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.

A new num­ber 1 drug? Keytru­da tapped to top the 10 biggest block­busters on the world stage by 2024

Analysts may be fretting about Keytruda’s longterm prospects as a host of rival therapies elbow their way to the market. But the folks at Evaluate Pharma are confident that last year’s $7 billion earner is headed for glory, tapping it to beat out the current #1 therapy Humira as AbbVie watches that franchise swoon over the next 5 years.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.

In­vestor day prep at Mer­ck in­cludes a new strat­e­gy to pick up the pace on M&A — re­port

Mer­ck’s re­cent deals to buy up two bolt-on biotechs — Ti­los and Pelo­ton — weren’t an aber­ra­tion. In­stead, both ac­qui­si­tions mark a new strat­e­gy to beef up its dom­i­nant can­cer drug op­er­a­tions cen­tered on Keytru­da while look­ing to ad­dress grow­ing con­cerns that too many of its eggs are in the one I/O bas­ket for their PD-1 pro­gram. And Mer­ck is go­ing af­ter more small- and mid-sized buy­outs to calm those fears.

John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.

Dave Barrett, Brian Chee, Amir Nashat, Amy Schulman. Polaris

Bob Langer's first port of call — Po­laris Part­ners — maps $400M for ninth fund

Health and tech ven­ture group Po­laris Part­ners, which counts Alec­tor, Al­ny­lam and Ed­i­tas Med­i­cine as part of its port­fo­lio, is set­ting up its ninth fund, rough­ly two years af­ter it closed Po­laris VI­II with $435 mil­lion in the bank, sur­pass­ing its tar­get by $35 mil­lion.

The Boston-based firm, in an SEC fil­ing, said it in­tends to raise $400 mil­lion for the fund. Po­laris — which rou­tine­ly backs com­pa­nies mold­ed out of the work done in the lab of pro­lif­ic sci­en­tist Bob Langer of MIT  — typ­i­cal­ly in­vests ear­ly, and sticks around till com­pa­nies are in the green. Like its peers at Flag­ship and Third Rock, Po­laris is all about cham­pi­oning the lo­cal biotech scene with a steady flow of start­up cash.

Right back at you, Pfiz­er: BeiGene and a Pfiz­er spin­out launch a new­co to de­vel­op a MEK/BRAF in­hibitor that could ri­val $11.4B com­bo

A day af­ter Pfiz­er bought Ar­ray and its ap­proved can­cer com­bo, BeiGene and Pfiz­er spin­out Spring­Works have part­nered in launch­ing a new biotech that has an eye on the very same mar­ket the phar­ma gi­ant just paid bil­lions for. And they’re plan­ning on us­ing an ex-Pfiz­er drug to do it.

In a nut­shell, Chi­na’s BeiGene is toss­ing in a pre­clin­i­cal BRAF in­hibitor — BGB-3245, which cov­ers both V600 and non-V600 BRAF mu­ta­tions — for a big stake in a new, joint­ly con­trolled biotech called Map­Kure with Bain-backed Spring­Works.

Partners Innovation Fund

David de Graaf now has his $28.5M launch round in place, build­ing a coen­zyme A plat­form in his lat­est start­up

Long­time biotech ex­ec David de Graaf has the cash he needs to set up the pre­clin­i­cal foun­da­tion for his coen­zyme A me­tab­o­lism com­pa­ny Comet. A few high-pro­file in­vestors joined the ven­ture syn­di­cate to sup­ply Comet with $28.5 mil­lion in launch mon­ey — enough to get it two years in­to the plat­form-build­ing game, with­in knock­ing dis­tance of the clin­ic.

Canaan jumped in along­side ex­ist­ing in­vestor Sofinno­va Part­ners to co-lead the round, with par­tic­i­pa­tion by ex­ist­ing in­vestor INKEF Cap­i­tal and new in­vestor BioIn­no­va­tion Cap­i­tal.

Sanofi aligns it­self with Google to stream­line drug de­vel­op­ment

Tech­nol­o­gy is bleed­ing in­to health­care, and big phar­ma is rid­ing the wave. Sanofi $SNY ap­point­ed its first chief dig­i­tal of­fi­cer this Feb­ru­ary, fol­low­ing the foot­steps of its peers. By May, the French drug­mak­er and some of its big phar­ma com­pa­tri­ots joined forces with Google par­ent Al­pha­bet’s Ver­i­ly unit to aug­ment clin­i­cal tri­al re­search. On Tues­day, the Parisian com­pa­ny tied up with Google to ac­cess its cloud com­put­ing and ar­ti­fi­cial in­tel­li­gence tech to spur the de­vel­op­ment of new ther­a­pies.