Af­ter a $200M fi­nanc­ing, High­land Ther­a­peu­tics falls silent on AD­HD drug’s fate as PDU­FA sails by

David Lick­r­ish

Back at the be­gin­ning of this year, the folks at Toron­to-based High­land Ther­a­peu­tics cel­e­brat­ed a $200 mil­lion fi­nanc­ing com­plet­ed through Mor­gan Stan­ley. That cash, they said, would go to com­mer­cial­iz­ing their AD­HD drug HLD200 through their whol­ly owned sub­sidiary Iron­shore, tout­ing a drug they have fre­quent­ly her­ald­ed as a break­through in the field as it faced a Ju­ly 30 PDU­FA date. They even hired some Shire vets to help grab mar­ket share.

But that PDU­FA dead­line has come and gone and there’s no word on what the FDA has done with it. And the com­pa­ny CEO tells me there isn’t go­ing to be.

Con­tact­ed by phone, David Lick­r­ish told me ear­li­er to­day that “we’re still in dis­cus­sions with the agency.” Pressed that the FDA would ei­ther re­ject the drug, OK it or de­lay the de­ci­sion — pick one — Lick­r­ish told me I’d caught him at a bad time and he’d get back to me.

In an email, he stuck with no com­ment.

With re­spect to the fil­ing, as a pri­vate­ly held com­pa­ny, and for com­pet­i­tive rea­sons, we are not com­ment­ing on the sta­tus of our NDA.  Hav­ing said that our pack­age con­tained 10 tri­als in­clud­ing two piv­otal stud­ies which at­tempt to eval­u­ate AD­HD dur­ing both the ear­ly morn­ing rou­tine and evening rou­tine pe­ri­ods, us­ing rat­ing scales not cur­rent­ly in Clin­i­cal Out­comes and As­sess­ment Com­pendi­um.  Be­yond this we won’t be com­ment­ing fur­ther on the on­go­ing in­ter­ac­tions with the Agency.

I asked the FDA for com­ment, which has stuck with a strict no com­ment pol­i­cy of its own be­fore Scott Got­tlieb ar­rived and ad­vo­cat­ed pub­lish­ing the CRLs.

They haven’t changed — yet. Their re­sponse:

Please un­der­stand that in­for­ma­tion about an ap­pli­ca­tion is con­fi­den­tial un­less it has been pub­licly dis­closed by a spon­sor.

At the time of the fi­nanc­ing in Jan­u­ary, Craig Lewis, pres­i­dent of Iron­shore Phar­ma­ceu­ti­cals, cel­e­brat­ed the com­pa­ny’s loom­ing trans­for­ma­tion from an R&D com­pa­ny to a full-fledged op­er­a­tion with a com­mer­cial­iza­tion wing. HLD200, he said in a state­ment, was on its way to be­com­ing a stan­dard ther­a­py for AD­HD. He added: “Our com­mer­cial or­ga­ni­za­tion is be­ing pur­pose-built with this ob­jec­tive in mind.”

In the mean­time, the com­pa­ny al­so her­ald­ed the ar­rival of two Shire vet­er­ans — Bar­ry K. Her­man as SVP, head of med­ical af­fairs and Paul J. Casano­va as SVP of sales. Shire has a ma­jor AD­HD fran­chise.

I would sus­pect that af­ter all the buildup, an ap­proval would have been shout­ed from the roof tops. So there may well have been at least been a snag in their plans. Or worse. The way the rules work now, a pri­vate com­pa­ny is free to say what­ev­er it likes. Or noth­ing at all.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

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Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

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Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.

Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

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Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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