Per­cep­tive's fourth — yes, fourth — SPAC jumps to Nas­daq as the blank check tree con­tin­ues to ripen

The biotech SPAC boom has gone al­most hand-in-hand with the in­dus­try’s IPO gold rush, and this week saw more blank check com­pa­nies hop aboard the train.

James Huang

Lead­ing the way is Per­cep­tive Ad­vi­sors’ fourth SPAC, ap­pro­pri­ate­ly named Arya Sci­ences Ac­qui­si­tion IV, which priced Fri­day morn­ing af­ter rais­ing $130 mil­lion. And on top of that, new Zio­pharm ex­ec­u­tive chair James Huang is launch­ing his own SPAC with MSD Part­ners and Panacea Ven­ture, fil­ing S-1 pa­per­work Thurs­day with plans to raise $200 mil­lion.

Both moves come as biotech SPAC ac­tiv­i­ty con­tin­ues to speed­i­ly ramp up, with even ec­cen­tric bil­lion­aire Richard Bran­son jump­ing in­to the game ear­li­er this month by tak­ing 23andMe pub­lic.

Joseph Edel­man

Per­cep­tive’s Joseph Edel­man is no stranger to the hold­ing com­pa­nies that have now come to dom­i­nate the mar­ket, how­ev­er, as Arya IV prices just a few weeks af­ter Arya III an­nounced its plans to re­verse-merge with Nau­tilus. The VC firm filed Arya IV’s S-1 just one day af­ter that an­nounce­ment, in­di­cat­ing Edel­man is steer­ing a well-oiled SPAC ma­chine with no plans of slow­ing down.

Much of that foun­da­tion has os­ten­si­bly been built on­ly over the last 12 months. The first Arya ac­qui­si­tion out­fit went pub­lic in 2018, but didn’t find a part­ner un­til March 2020 when it com­bined with TCR play­er Im­mat­ics. That deal helped CEO Harpreet Singh ad­vance their work on cre­at­ing new cell ther­a­pies to go af­ter sol­id tu­mors.

Then, this past Ju­ly, Edel­man found a mar­riage for Arya II with for­mer Pfiz­er spin­out Cerev­el Ther­a­peu­tics. Tony Coles led Cerev­el through murky wa­ters af­ter the Big Phar­ma abrupt­ly shut down its en­tire neu­ro­science di­vi­sion, earn­ing the con­fi­dence of a $350 mil­lion in­vest­ment from Bain Cap­i­tal to ad­vance its work in Parkin­son’s and oth­er neu­ro­log­i­cal dis­eases.

The Arya III merg­er with Nau­tilus then came to­geth­er ear­li­er this month, with the hold­ing com­pa­ny hav­ing filed for an IPO one week af­ter its old­er sib­ling took Cerev­el pub­lic. Those pro­ceeds are be­ing used to ad­vance Nau­tilus’ pro­tein analy­sis plat­form, which has the back­ing of mega­bil­lion­aire Jeff Be­zos and al­so saw in­vest­ment from the late Paul Allen.

Like its three pre­de­ces­sors, Arya IV is aim­ing to go af­ter biotechs that want to take a quick­er route to Nas­daq than through the tra­di­tion­al IPO route. Arya IV’s pa­per­work of­fered on­ly lim­it­ed in­sight in­to the biotechs it will be tar­get­ing, but not­ed they’re look­ing at com­pa­nies with mar­ket val­u­a­tions be­tween $300 mil­lion and $500 mil­lion, or more, with the po­ten­tial to be worth $1 bil­lion-plus.

Huang’s SPAC, mean­while, comes on the same day that Zio­pharm On­col­o­gy an­nounced its CEO Lau­rence Coop­er is leav­ing the com­pa­ny. Huang joined the Zio­pharm board in Ju­ly 2020 and was elect­ed ex­ec­u­tive chair­man of Zio­pharm last month fol­low­ing an ac­tivist at­tack.

SPACs have start­ed mak­ing up more and more of the mar­ket, ac­count­ing for on­ly 3% of the IPO mar­ket in 2014 but swelling to more than 35% last year. It re­mains to be seen how quick­ly ei­ther SPAC can find a part­ner, though, as the num­ber of hold­ing com­pa­nies on­ly con­tin­ues to grow.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.