News brief­ing: Amar­in's pan­el could put Vas­cepa patents in jeop­ardy; San­thera nabs a Duchenne drug

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

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Chica­go-area biotech sends 2nd drug to In­di­a's reg­u­la­tors; Pen­ny stock play­er spins out PhI­II can­cer can­di­date in­to new com­pa­ny

Pharmazz is on its way to India’s drug regulator for the second time as its investigational treatment passed muster in a Phase III study in patients with acute ischemic stroke.

The Chicago suburbs-based biotech said its drug sovateltide led to better improvement than placebo on certain measurements of neurological outcomes.

Sovateltide led an improvement of ≥2 points on mRS and an increase of ≥6 points on NIHSS at day 90 in the trial of 158 adults in India. The modified Rankin scale looks at the degree of dependence in the daily activities of people post-stroke event, and the NIH stroke scale measures the stroke-related neurologic deficit.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

Te­va, Al­ler­gan reach yet an­oth­er opi­oid set­tle­ment — ef­fec­tive­ly end­ing WV tri­al

Teva and Allergan have reached settlements with multiple states over their involvement in the opioid crisis. Their latest is worth 9 figures.

West Virginia attorney general Patrick Morrisey announced the newest settlement, worth $161.5 million, at a press conference on Wednesday. The deal would resolve claims that the companies helped fuel the state’s opioid epidemic. If it goes through, it could become the largest state-negotiated settlement in West Virginia’s history, according to Reuters.