Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even af­ter Utah-based Clene failed to hit its pri­ma­ry end­points for its ALS drug last year, the state of Mary­land is putting its mon­ey at least be­hind Clene’s man­u­fac­tur­ing fa­cil­i­ty.

The Mary­land Board of Pub­lic Works has fi­nal­ized a $3 mil­lion, 60-month loan fa­cil­i­ty with Clene Nanomed­i­cine. The loan was pro­vid­ed by the state’s Neigh­bor­hood Busi­ness­Works pro­gram with­in the Mary­land De­part­ment of Hous­ing and Com­mu­ni­ty De­vel­op­ment.

This loan will be go­ing to­ward equip­ment pur­chas­es that will sup­port the ex­pan­sion of Clene’s op­er­a­tions in Ce­cil Coun­ty, MD. Clene’s new 75,000-square-foot com­mer­cial man­u­fac­tur­ing fa­cil­i­ty will pro­duce its lead drug can­di­date, CNM-Au8, a gold nanocrys­tal sus­pen­sion meant to treat ALS. The pur­chased cap­i­tal equip­ment will se­cure the loan.

The com­pa­ny an­tic­i­pates the po­ten­tial com­mer­cial­iza­tion of CNM-Au8and, their can­di­date in ALS pa­tients, to present topline da­ta in the third quar­ter of 2022 from a Phase II/III study.

How­ev­er, Clene has put stock in its can­di­date be­fore, with not-so-pos­i­tive re­sults. Clene re­port­ed Phase II as its can­di­date, say­ing the com­pound did not reach sta­tis­ti­cal sig­nif­i­cance on the pri­ma­ry or sec­ondary end­points. And though Clene claimed to see pos­i­tive sig­nals in ex­plorato­ry end­points that could sup­port an NDA, ex­perts at the time were not bull­ish on Clene’s prospects.

De­spite this, the state gov­ern­ment is still sup­port­ing Clene’s fa­cil­i­ty as in De­cem­ber of last year, when they re­ceived a $1 mil­lion grant award from the Mary­land De­part­ment of Hous­ing and Com­mu­ni­ty De­vel­op­ment (DHCD) to fur­ther sup­port the re­de­vel­op­ment of their fa­cil­i­ty. Mary­land Gov. Lar­ry Hogan took a tour of the fa­cil­i­ty and ac­cord­ing to the lo­cal news­pa­per the Ce­cil Whig. CSO Mark Morten­son said in the gov­er­nor’s tour that they would be­gin sell­ing the drug in 2024 if they clear all the FDA hur­dles and spark the need for more man­u­fac­tur­ing fa­cil­i­ties.

Al­though Mary­land’s sup­port did help Clene’s stock $CLNN in­crease to­day by over 14%, they still have a huge hill to climb as their price has been down al­most 50% over the past six months.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; 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.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.

Fu­ji­film in­vests an­oth­er $1.6B in­to its CD­MO arm to up­grade facil­lites in the US and Eu­rope

Fujifilm’s spending spree into its CDMO arm is not slowing down.

The multinational announced on Wednesday that it will invest $1.6 billion to enhance and expand the cell culture manufacturing services of the CDMO arm of the Japanese conglomerate Fujifilm Diosynth.

The investment will enhance Fujifilm Diosynth Biotechnologies’ sites in Hillerød, Denmark, and College Station, TX. The investment is expected to create approximately 450 jobs across both facilities.

Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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Credit: Shutterstock

Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.