Su­per­nus touts AD­HD Phase III da­ta, but re­sults ap­pear to fall short of ex­pec­ta­tions

CNS-fo­cused Su­per­nus Phar­ma­ceu­ti­cals $SUPN re­port­ed pos­i­tive da­ta from keen­ly watched twin stud­ies test­ing its non-stim­u­lant AD­HD drug in chil­dren on Thurs­day, but the re­sults sug­gest­ed the treat­ment does not have a leg up over an ex­ist­ing gener­ic drug on the mar­ket.

Shares of the Rockville, Mary­land based-com­pa­ny were down about 13% in ear­ly trad­ing.

Two dos­es of the drug SPN-812 were test­ed against a place­bo in each study —  100mg/200mg in study P301, and 200mg/400 mg in study P303.

In the 6-week P301 study, SPN-812 100mg and 200mg had an ef­fect size of 0.54 and 0.57 re­spec­tive­ly, the com­pa­ny re­port­ed, meet­ing the main goal of re­duc­ing symp­toms on an AD­HD rat­ing scale. And in the 8-week P303 tri­al, pa­tients re­ceiv­ing 200mg and 400mg had an ef­fect size of 0.46 and 0.49.

In 2002, Lil­ly’s $LLY Strat­tera was the first non-stim­u­lant med­ica­tion ap­proved for AD­HD. It went gener­ic last year and will di­rect­ly com­pete against SPN-812 if Su­per­nus’ drug is ap­proved. Strat­tera achieved an ef­fect size of 0.4-0.6 in tri­als.

Su­per­nus Chief Jack Khat­tar re­it­er­at­ed his en­thu­si­asm for the drug on Thurs­day: “We be­lieve these da­ta from the two piv­otal Phase III stud­ies…demon­strate that SPN-812 is a well-dif­fer­en­ti­at­ed nov­el non-stim­u­lant treat­ment op­tion for many chil­dren with AD­HD.”

An­oth­er mea­sure that might help dif­fer­en­ti­ate SPN-812 is on­set of ac­tion. In study P301, SPN-812 showed a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment over the place­bo as ear­ly as the first week, a feat the drug was un­able to re­pro­duce in study P303.

De­spite in­vestor dis­con­tent, Cowen’s Ken Cac­cia­tore sug­gest­ed the da­ta was en­cour­ag­ing: “What the Street ap­pears to be miss­ing to­day is that par­ents/care­givers have very lim­it­ed op­tions in the treat­ment of AD­HD and re­lat­ed be­hav­ioral dis­or­ders, and there­fore there is a re­al and large need to add to the treat­ment par­a­digm,” he wrote.

“SPN-812 com­pares fa­vor­ably with mar­ket-lead­ing non-stim­u­lant Strat­tera, but un­like Strat­tera SPN-812 has a much more rapid on­set of ac­tion (1 week ver­sus 4-6 weeks), as well as what ap­pears to be a clean­er safe­ty pro­file. De­spite Strat­tera’s lim­i­ta­tions, it reached $535 mil­lion in the U.S. be­fore go­ing gener­ic. Ad­di­tion­al­ly, the re­sults com­pare fa­vor­ably to Shire’s non-stim­u­lant In­tu­niv, which with­in on­ly a few years on the mar­ket was on a run-rate of $340 mil­lion in sales be­fore it went gener­ic.”

SPN-812 is al­so be­ing test­ed in ado­les­cents. One phase III study in this pa­tient pop­u­la­tion will read­out by the end of the year, while an­oth­er is ex­pect­ed by the first quar­ter of 2019. The biotech ex­pects to sub­mit a mar­ket­ing ap­pli­ca­tion for the drug in the sec­ond half of next year.

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.

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Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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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.