Thiel-backed Az­i­tra rais­es $3M for skin mi­cro­bio­me R&D; Crushed by clin­i­cal fail­ure, Avi­ra­gen launch­es strate­gic re­view

Travis Whit­fill

→  Farm­ing­ton, CT-based Az­i­tra has raised close to $3 mil­lion in a Se­ries A de­signed to fu­el its re­search on mi­cro­bio­me ther­a­pies for the skin. Seed­ed by Pe­ter Thiel’s Break­out Labs, the com­pa­ny iden­ti­fied a strain of bac­te­ria that can be used in lo­tions to treat con­di­tions like eczema and staph in­fec­tions. Bios Part­ners led the round. “The cur­rent ap­proach of on­ly ad­dress­ing a dis­ease’s symp­toms alone is in­ef­fec­tive, and the mi­cro­bio­me is a nascent area of ground­break­ing sci­ence that has enor­mous po­ten­tial,” said Az­i­tra co-founder Travis Whit­fill. “That’s why we were pas­sion­ate about launch­ing a com­mer­cial or­ga­ni­za­tion that har­ness­es the pow­er of the skin’s own mi­cro­bio­me to de­vel­op a new kind of der­ma­tol­ogy treat­ment. Such treat­ments are po­ten­tial­ly safer, more high­ly tar­get­ed, and work bet­ter with few­er side ef­fects than what’s cur­rent­ly avail­able for of­ten in­tractable con­di­tions.”

→ Cam­bridge, MA-based Sen­tien Biotech­nolo­gies closed a $12 mil­lion Se­ries A in­vest­ment round. The fi­nanc­ing was co-led by Boehringer In­gel­heim Ven­ture Fund USA and BioIn­no­va­tion Cap­i­tal, and joined by Chiesi Ven­tures, MBL Ven­ture Cap­i­tal and Mass Med­ical An­gels. The Se­ries A round will be used to fund ini­tial clin­i­cal de­vel­op­ment of Sen­tien’s SBI-101 for the treat­ment of acute kid­ney in­jury.

→ At­lanta-based Avi­ra­gen has be­gun a strate­gic re­view af­ter a clin­i­cal fail­ure left the biotech mired in pen­ny stock ter­ri­to­ry. In back-to-back set­backs, Avi­ra­gen Ther­a­peu­tics $AVIR said that its lead drug vapen­davir flunked a Phase IIb in mod­er­ate to se­vere asth­mat­ics with a rhi­novirus in­fec­tion. Every­thing is on the ta­ble, in­clud­ing a merg­er, in-li­cens­ing and an ac­qui­si­tion.

→ A new bill pro­vid­ing tax cred­its for con­tract re­search has been filed in the House of Rep­re­sen­ta­tives. The leg­is­la­tion, if ever passed, would ben­e­fit CROs.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Top 15 bio­phar­ma R&D spenders; The re­turn of Big Car­dio; Math­ai Mam­men takes biotech CEO role; Kris­ten Hege’s next trek; 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.

Please join us in welcoming Andrew Dunn, Jaimy Lee and Ryan Cross to the Endpoints team! They are coming on board this month and we can’t wait to start working with them.

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Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Af­ter Ako­rn's site clo­sures in the US, al­buterol re­mains in short­age

The beginning of March saw manufacturer Akorn Pharmaceuticals file for Chapter 7 bankruptcy protection, which led to the closure of all its US manufacturing plants and hundreds of layoffs. But this also had a cascading effect leading to a shortage of albuterol, specifically the 0.5% version, which is used to treat breathing issues.

The closures came at a time when the drug was already in short supply, with the FDA reporting that another manufacturer, Nephron, was in shortage too. The FDA’s drug shortage site states that the drug is still in shortage with no new supply coming from Akron, and Nephron with drug “on allocation.”

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Phar­ma in­dus­try rep­u­ta­tion scores pos­i­tive bump from in­sulin pric­ing news — Har­ris Poll

Insulin drug prices and out-of-pocket costs have been hot topics — and a drag on pharma industry reputation — for years. But now recent news from a trio of drugmakers pledging to cap extra costs for consumers helped push the entire industry reputation upward, according to The Harris Poll.

In polling meant to gauge the impact of the Silicon Valley Bank crash and crisis, Harris found that the pharma industry was only one of two industries among 10 verticals tracked to record a gain between the time before and after the crash. Positive view of pharma grew 49%, up 4% from the beginning to the end of March, the Harris survey found. Government was the other sector gaining with a 1% increase over the month.

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US Solicitor General Elizabeth Prelogar

US gov­ern­ment to SCO­TUS: Take up the Te­va-GSK 'skin­ny' gener­ic drug la­bel case

The US Solicitor General is calling on the Supreme Court to take up a fiercely debated case that could have a chilling effect on generic drug companies’ willingness to bring their copycats to market under so-called “skinny” labels, meaning the generic can only be approved for some of the reference product’s indications.

The case in question relates to GSK’s win over Teva in a long-running battle over the generic giant’s skinny label for GSK’s beta-blocker Coreg (carvedilol). At the time in 2007, Teva’s generic label first included two of the three Coreg indications, but Teva did not initially win approval for the third indication for congestive heart failure.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors Archimed and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Karim Mikhail, departing Amarin CEO

Saris­sa tight­ens its grip on Amarin as CEO re­signs

Sarissa Capital gained another foothold in its takeover of Amarin with the departure of the Irish drugmaker’s CEO.

Amarin revealed Friday in an SEC filing that Karim Mikhail resigned as president and CEO earlier this week. However, there’s still an ongoing dispute between Mikhail and Amarin, with the now ex-CEO insisting that he has a claim to severance as a result of his resignation. However, Amarin says it disagrees and plans to dispute that claim.