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

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Langer, Ciechanover god­fa­ther the lat­est AI up­start; Ipsen forges $446M AML de­vel­op­ment pact

There’s a new AI player jumping into the drug discovery game. And they have some high-powered scientific advisors in their corner.

Tel Aviv-based Quris has built what it calls a “patient-on-a-chip” AI platform that it’s touting as a way to circumvent unreliable animal testing with a more efficient way to judge safety and efficacy. Animal testing, particularly involving mice, has proven a notoriously unreliable way to do preclinical testing — though it is well-established with regulators.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.