Bausch Health sells off Amoun for $740M; Achilles de­buts on Nas­daq with $175.5M IPO

Look­ing to pay down debt ahead of the big Bausch + Lomb spin­off, Bausch Health CEO Joseph Pa­pa has struck a deal to sell one of its units in Egypt for $740 mil­lion.

Abu Dhabi-based hold­ing com­pa­ny ADB is hand­ing over the cash for Amoun Phar­ma­ceu­ti­cal, which makes and mar­kets brand­ed gener­ics and an­i­mal health prod­ucts, will be the new own­er.

“The sale of Amoun marks sig­nif­i­cant progress in our ef­forts to re­duce over­all Bausch Health debt as we con­tin­ue to pur­sue all op­por­tu­ni­ties to dri­ve val­ue for our share­hold­ers, in­clud­ing prepar­ing for the spin­off of Bausch + Lomb,” said Joseph Pa­pa, chair­man and CEO, Bausch Health.

Some an­a­lysts have been look­ing for a sig­nif­i­cant in­crease in mar­ket val­ue for Bausch + Lomb af­ter it goes so­lo. “An in­de­pen­dent Bausch & Lomb unit could have more room and fo­cus to ex­pand its glob­al mar­ket share, but lever­age re­duc­tion may still be a pri­or­i­ty af­ter its spin­off,” not­ed Bloomberg In­tel­li­gence an­a­lyst Ann-Hunter van Kirk. — John Car­roll

Britain’s Achilles Ther­a­peu­tics de­buts on Nas­daq with $175.5M IPO

An­oth­er day, an­oth­er IPO in the seem­ing­ly end­less cas­cade of pub­lic biotech de­buts.

The newest win­ner is Lon­don-based Achilles Ther­a­peu­tics, prep­ping to hit the Nas­daq af­ter pric­ing at $18 per ADS on Tues­day evening. No stray ar­rows took down this ef­fort, as Achilles pulled in a $175.5 mil­lion raise as it takes its T cell ther­a­pies tar­get­ing clon­al neoanti­gens to Nas­daq.

Achilles will trade un­der the tick­er $ACHL.

Co-found­ed by Char­lie Swan­ton of the Fran­cis Crick In­sti­tute, Achilles aims to lever­age heavy se­quenc­ing to iden­ti­fy a pa­tient-spe­cif­ic set of tu­mor mu­ta­tions that it can tar­get. Un­like oth­er neoanti­gen pi­o­neers like Grit­stone On­col­o­gy, Neon Ther­a­peu­tics and BioN­Tech, Achilles is look­ing to di­rect­ly de­liv­er can­cer killing T cells rather than stim­u­lat­ing an im­mune re­sponse via a vac­cine.

Achilles got a boost in Sep­tem­ber 2019 with a $121 mil­lion Se­ries B thanks to a syn­di­cate led by RA Cap­i­tal. And in No­vem­ber 2020, the biotech pulled in an­oth­er $69.7 mil­lion for an over­sub­scribed Se­ries C. — Max Gel­man

Seat­tle’s On­coRe­sponse nets $40M+ Se­ries C

Two and a half years since its last fundraise, On­coRe­sponse is back with some more cash.

The Seat­tle-based com­pa­ny raised $40.6 mil­lion in a Se­ries C fi­nanc­ing, led by mem­bers of the Mag­ne­tar Group with par­tic­i­pa­tion from ad­di­tion­al new in­vestors Yon­jin Ven­ture and Bering Cap­i­tal. Funds will pri­mar­i­ly go to­ward get­ting the biotech’s lead an­ti­body, OR2805, in­to clin­i­cal de­vel­op­ment in mul­ti­ple tu­mor types and build­ing up a pipeline of pre­clin­i­cal as­sets to IND.

“OR2805 was de­rived from a can­cer pa­tient who had an ex­cep­tion­al re­sponse to an­ti-PD-1 ther­a­py and re­lieves the im­muno­sup­pres­sive ef­fect of macrophages found in the [tu­mor mi­croen­vi­ron­ment] to pro­mote tu­mor killing by T cells,” CEO Clif­ford Stocks said in a state­ment. “We will be en­ter­ing clin­i­cal stud­ies in mul­ti­ple tu­mor types lat­er this year.”

Ex­ist­ing in­vestors River­Vest Ven­ture Part­ners, Qatar In­vest­ment Au­thor­i­ty (QIA), Red­mile Group, 3B Fu­ture Health Fund (Helsinn In­vest­ment Fund), Canaan Part­ners and ARCH Ven­ture Part­ners al­so par­tic­i­pat­ed. — Max Gel­man

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Scynex­is takes out $60M loan ahead of ex­pect­ed ap­proval; Com­pass Ther­a­peu­tics ac­quires new bis­pe­cif­ic an­ti­body in buy­out

As the PDUFA date for their vaginal yeast infections quickly approaches, Scynexis is taking out a loan to ensure it can hit the ground running for a potential commercial launch.

Scynexis closed terms on a $60 million loan with Hercules Capital and Silicon Valley Bank, the New Jersey biotech announced Friday, with its ibrexafungerp candidate set for a June 1 PDUFA. Approval of the program is anticipated, the company said, after which the oral antifungal will be branded as Brexafemme.

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

UP­DAT­ED: Apel­lis bags FDA nod for Soliris chal­lenger with a dif­fer­ent path­way to PNH — but can it slay the gi­ant?

With a blockbuster rare disease giant in its sights in Alexion’s Soliris, small biotech Apellis has reason to think its competitor is worthy of the spotlight. Now, with the FDA on its side, Apellis will get its chance to be the David to Alexion’s Goliath.

The FDA on Friday approved Empaveli (pegcetacoplan), a C3 complement inhibitor the biotech thinks can prove a worthy challenger to Alexion’s C5 inhibitors Soliris and follow-up drug Ultomiris in rare disease paroxysmal nocturnal hemoglobinuria (PNH).