Amarin’s fish oil em­pire may be slip­ping out of its grasp.

On Wednes­day, in the lat­est twist in a long le­gal bat­tle, the ap­peal pan­el of judges was an­nounced for the patent dis­pute be­tween Amarin with two gener­ic drug­mak­ers that are look­ing to make off-brand de­ci­sion. No rul­ing has yet been made — the hear­ing starts at 10:30 this morn­ing — but an­a­lysts be­lieved that the de­ci­sion could come down to which judges were cho­sen, and that these judges may be un­like­ly to de­cide in Amarin’s fa­vor. The stock fell 17% pre-mar­ket.

In a note, Stifel’s Derek Archi­la said the judges’ view on Amarin was mixed, but giv­en that a low per­cent­age of such dis­putes are re­versed on ap­peal, the se­lec­tion did not bode well. “Giv­en the low rates of suc­cess for a re­ver­sal in these types of cas­es (10-20%), we think this doesn’t im­prove the odds,” he wrote.

SVB Leerink’s Ami Fa­dia struck a sim­i­lar tone. “Bot­tom line: Over­all, we don’t be­lieve this 3-judge pan­el im­proves Amarin’s chances at win­ning the Vas­cepa patent lit­i­ga­tion ap­peal.” And Jef­feries’ Michael Yee may have been the bluntest: “Judge pan­el looks mixed at best,” he wrote.

Last De­cem­ber, the FDA opened a path for Amarin’s fish oil drug Vas­cepa to be­come a block­buster, ex­pand­ing its ap­proval to in­clude pre­ven­tion of heart at­tacks and stroke. But just four months lat­er a fed­er­al judge ruled that Amarin’s patents on the drug were in­valid, set­ting up Hik­ma Phar­ma­ceu­ti­cals and Dr. Red­dy’s to mar­ket gener­ic al­ter­na­tives. Amarin ap­pealed, lead­ing to to­day’s hear­ing. — Ja­son Mast

San­thera wheels and deals its way to glob­al Duchenne rights

In a three-way deal, San­thera has picked up glob­al rights to the Duchenne drug it signed on­to two years ago.

The drug, known as va­morolone, is a steroid that is de­signed to have the same ef­fects as the cor­ti­cos­teroids Duchenne pa­tients now take to slow dis­ease progress but with­out the sys­tem­at­ic side ef­fects those steroids cause. Rever­a­Gen de­vel­oped the com­pounds and signed an op­tion agree­ment with Actel­lion in 2016. Two years lat­er, Actel­lion — now known as Idor­sia — sold the op­tion to San­thera.

So far, on­ly Phase IIa da­ta com­par­ing pa­tients on the drug to nat­ur­al his­to­ry com­para­tors have come out. San­thera’s op­tion al­lowed them to wait un­til Phase IIb da­ta emerged, but they chose to act ear­ly, giv­ing Idor­sia 366,667 shares and an ex­change­able note for 10 mil­lion CHF ($11 mil­lion) to re­struc­ture the deal. Rever­a­gen, in turn, will re­ceive $7 mil­lion — giv­en in month­ly in­stall­ments of $500,000 to con­tin­ue de­vel­op­ment.

With San­thera trad­ing at $7.35, Idor­sia’s new shares are worth about $2.7 mil­lion.  — Ja­son Mast

Small Is­raeli pain biotech finds scant pur­chase for IPO

As the biotech boom surged in the US, the Is­raeli biotech PainRe­form sought to get in on the ac­tion and raise $25 mil­lion to ad­vance their top­i­cal post-op pain drug. The com­pa­ny, though, has strug­gled to find buy­ers. They of­fi­cial­ly filed to raise $23 mil­lion by sell­ing shares be­tween $8 and $10, but yes­ter­day an­nounced they priced on the low end, ul­ti­mate­ly net­ting $20 mil­lion.

That should still be enough, though, to cov­er the cost of clin­i­cal tri­als. In their F-1, the cit­ed $16 mil­lion as the es­ti­mat­ed cost of two piv­otal tri­als for their lead drug, ropi­va­caine. — Ja­son Mast

Clene NanoMed­i­cine SPACs its way to pub­lic mar­kets

Clene Nanomed­i­cine, a com­pa­ny re­search­ing the use of gold nanocrys­tals for neu­rode­gen­er­a­tive dis­eases, has an­nounced plans to go pub­lic. The com­pa­ny is go­ing the SPAC route, earn­ing a $542.5 mil­lion val­u­a­tion and net­ting a $25 mil­lion pay­ment from Tot­ten­ham Ac­qui­si­tion I Lim­it­ed in the process.

Wednes­day’s news comes on the heels of a $42.5 mil­lion Se­ries D round last week. Thus far, ALS has been Clene’s lead in­di­ca­tion, as the com­pa­ny was re­cent­ly se­lect­ed to par­tic­i­pate in the first-ever plat­form tri­al for the dis­ease. Pit­ting its CNM-Au8 against two oth­er ALS can­di­dates and place­bo, the Phase III study be­gan en­rolling pa­tients last month. Clene has al­so seen signs that the same can­di­date could po­ten­tial­ly treat pa­tients with mul­ti­ple scle­ro­sis and Parkin­son’s dis­ease. It is run­ning con­cur­rent Phase II tri­als in those in­di­ca­tions, as well as ALS.  — Max Gel­man

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”