Hovione executives Jean-Luc Herbeaux and Guy Villax stand in front of their booth at CPhI in Milan (Hovione PR)

Af­ter 25 years, Hov­ione's CEO will step down; Helsinn gains in­fi­gra­tinib li­cense from Bridge­Bio 

Hov­ione’s cur­rent COO will be­come its CEO on April 1.

The com­pa­ny an­nounced that Guy Vil­lax, the CEO for 25 years, will step down from his role. He will tran­si­tion to the role of board mem­ber and share­hold­er. The com­pa­ny grew 10-fold in his tenure, grow­ing to 2,000 team mem­bers and four pro­duc­tion sites in the US, Chi­na, Por­tu­gal and Ire­land.

“It has been a priv­i­lege and hon­or to lead Hov­ione over the last decades. Hov­ione is a great com­pa­ny be­cause of its peo­ple and its clients. It has been an amaz­ing en­tre­pre­neur­ial and hu­man jour­ney with so many projects and un­for­get­table suc­cess sto­ries. I have seen this com­pa­ny, found­ed by my par­ents, grow­ing, evolv­ing and con­stant­ly re-in­vent­ing it­self,” Vil­lax said in a state­ment.

Mean­while, Jean-Luc Her­beaux will take over the role of CEO. Be­fore com­ing to the CD­MO, he held high-lev­el roles at Evonik.

“Build­ing on Guy Vil­lax’s lega­cy of in­no­va­tion and cus­tomer in­ti­ma­cy, we will con­tin­ue to work to dri­ve long-term growth for both our­selves and our cus­tomers main­tain­ing the Hov­ione val­ues,” he said.

Helsinn gains in­fi­gra­tinib li­cense from Bridge­Bio 

Bridge­Bio Phar­ma will li­cense its on­col­o­gy drug in­fi­gra­tinib to Helsinn, the two com­pa­nies an­nounced Thurs­day.

Bridge­Bio will re­tain all the rights to de­vel­op, man­u­fac­ture and com­mer­cial­ize in­fi­gra­tinib in skele­tal dys­pla­sia, in­clud­ing achon­dropla­sia. Mean­while, Helsinn will get an ex­clu­sive li­cense to com­mer­cial­ize, man­u­fac­ture and de­vel­op the drug for every oth­er in­di­ca­tion.

The drug was grant­ed ac­cel­er­at­ed ap­proval from the FDA in 2021 for the treat­ment of adults with pre­vi­ous­ly treat­ed, un­re­sectable lo­cal­ly ad­vanced or metasta­t­ic cholan­gio­car­ci­no­ma with a fi­brob­last growth fac­tor re­cep­tor 2 fu­sion. The drug al­so gained con­di­tion­al ap­proval in Cana­da, and pro­vi­sion­al ap­proval in Aus­tralia.

Neil Ku­mar

“We are ex­pand­ing our part­ner­ship with Helsinn so that even more pa­tients with FGFR-dri­ven can­cers will ul­ti­mate­ly be able to ac­cess in­fi­gra­tinib. Fo­cused ex­e­cu­tion means re­duc­ing the scope of our in­ter­nal ac­tiv­i­ty,” Bridge­Bio CEO said in a press re­lease. “We will con­tin­ue to ad­vance high-qual­i­ty pro­grams in our pipeline, while al­low­ing Helsinn to de­vel­op and com­mer­cial­ize in­fi­gra­tinib in can­cer in­di­ca­tions for pa­tients in need.”

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Elisabeth Stampa, Medicines for Europe president

As win­ter ap­proach­es, a Eu­ro­pean gener­ics group rais­es alarm over en­er­gy prices for man­u­fac­tur­ers

While colder temperatures are fast approaching, the situation surrounding the rise of energy prices in Europe is hitting businesses of every kind, including generic drug manufacturers.

Medicines for Europe, a group that represents the generic industry on the continent, sent a letter addressed to energy ministers and commissioners concerning inflation and the costs of energy on the supply of generic medicines.

Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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Jerome Durso, Intercept Pharmaceuticals CEO

In­ter­cep­t's OCA fails a PhI­II NASH tri­al, rais­ing fresh doubts about its years­long quest for an OK

Intercept Pharmaceuticals has run into another big setback in its yearslong quest to win an approval for OCA in NASH. The biotech put out word Friday morning that its Phase III REVERSE study failed the primary endpoint for the liver disease, sending its share price into a tailspin.

There was no significant improvement in fibrosis among the patients suffering from cirrhosis who were treated with obeticholic acid, with investigators hunting for a minimum 1-stage histological improvement in the disease after 18 months of therapy.

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