Su­per­nus bags ear­ly-stage CNS drug for $15M up­front in re­newed epilep­sy R&D ef­forts

A few years in­to mar­ket­ing their two epilep­sy drugs, the neu­rol­o­gy and psy­chi­a­try ex­perts at Su­per­nus Phar­ma are go­ing back to the draw­ing board with a new as­set.

Su­per­nus $SUPN is pay­ing $15 mil­lion up­front to ac­quire Bis­cayne Neu­rother­a­peu­tics and their Phase I pro­gram, with de­vel­op­ment and sales mile­stones to­talling $73 mil­lion and $95 mil­lion re­spec­tive­ly. A low sin­gle dig­it roy­al­ty would al­so be due should the drug ever reach the mar­ket.

While the num­bers are small, it’s a con­sid­er­able win for Mi­a­mi-based Bis­cayne Neu­rother­a­peu­tics, which spun out of Bis­cayne Phar­ma less than two years ago with $3 mil­lion in fund­ing.

Steven Schachter

Their epilep­sy treat­ment — now called SPN-817 — is a syn­thet­ic form of hu­perzine A, a sup­ple­ment with roots in Chi­nese med­i­cine that peo­ple some­times take for mem­o­ry im­pair­ment. It in­hibits the acetyl­cholinesterase en­zyme, there­by reg­u­lat­ing a neu­ro­trans­mit­ter re­spon­si­ble for send­ing sig­nals to mus­cles called acetyl­choline.

“In ad­di­tion to its pow­er­ful an­ti­seizure ac­tiv­i­ty in pre­clin­i­cal mod­els of se­vere epilep­sy, BIS-001 has ex­hib­it­ed the cog­ni­tion-en­hanc­ing prop­er­ties seen with oth­er AChE drugs, but with much bet­ter cen­tral ner­vous sys­tem and sys­temic tol­er­a­bil­i­ty and safe­ty than cur­rent­ly avail­able agents,” Steven Schachter, a Har­vard pro­fes­sor who co-found­ed Bis­cayne, said at its launch. “At a min­i­mum, we are op­ti­mistic it will be de­void of the detri­men­tal ef­fects on cog­ni­tion seen with many ex­ist­ing antiepilep­tic drugs.”

Jack Khat­tar

Su­per­nus has a long way to go in prov­ing that op­ti­mism — and a num­ber of ri­vals to con­tend with. GW Phar­ma scored the very first cannabis-de­rived drug ap­proval weeks ago to treat Dravet syn­drome, the ex­act form of rare pe­di­atric epilep­sy that Su­per­nus plans to start with. Zo­genix is lin­ing up with their pitch for the same in­di­ca­tion with a ther­a­py backed by a slate of pos­i­tive Phase III da­ta.

But it’s al­so had some time to nav­i­gate the epilep­sy mar­ket with their ex­tend­ed re­lease pills Ox­tel­lar XR (ox­car­bazepine) and Tro­k­en­di (top­i­ra­mate), with which SPN-817 will be a “strong strate­gic fit” ac­cord­ing to CEO Jack Khat­tar.

The pri­or­i­ty now is to de­vel­op an ex­tend­ed re­lease oral dosage for the drug, while fin­ish­ing up a proof-of-con­cept in adult pa­tients with re­frac­to­ry com­plex par­tial seizures.

Oth­er pro­grams in Su­per­nus’ pipeline tar­get AD­HD, bipo­lar dis­or­der, and de­pres­sion.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Zo­genix plans quick re­turn to the FDA with their spurned ap­pli­ca­tion on Dravet syn­drome drug — shares spike

Zo­genix shares are claw­ing back some of the val­ue they lost 2 months ago af­ter the FDA hit the biotech with a refuse-to-file no­tice on their ex­per­i­men­tal ther­a­py for Dravet syn­drome. 

Com­pa­ny ex­ecs said this morn­ing that they worked out reg­u­la­tors’  is­sues with the ap­pli­ca­tion for Fin­tepla, which cen­tered on a pair of big prob­lems: the ab­sence of non-clin­i­cal stud­ies need­ed to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine and the in­clu­sion of an in­cor­rect ver­sion of a clin­i­cal dataset. Now they plan to re­sub­mit in Q3 af­ter get­ting off the hook on both scores — which trig­gered a sigh of re­lief among in­vestors.

Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Top an­a­lyst finds a sil­ver lin­ing in Ab­b­Vie’s $63B Al­ler­gan buy­out — but there’s a catch

After getting beat up on all sides from market observers who don’t much care for the latest mega-deal to arrive in biopharma, at least one prominent analyst now is starting to like what he sees in the numbers for AbbVie/Allergan.

But it’s going to take some encouragement if AbbVie execs want it to last.

AbbVie’s market cap declined $20 billion on Tuesday as the stock took a 17% hit during the day. And SVB Leerink’s Geoffrey Porges can see a distinct outline of an upside after reviewing the fundamentals of the deal.

Key to this bullish position is Porges’ belief that AbbVie can slice more than $2 billion in “synergies” post-merger while crediting the pharma giant with an industry-leading commercial team that can handle these new products — primarily Botox and medical aesthetics — even better than Allergan.

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Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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