Hus­tling to cap­ture top front­line NSCLC sta­tus, Roche scores a ‘break­through’ on Ale­cen­sa

San­dra Horn­ing, Roche CMO

The FDA has hand­ed Roche brag­ging rights to its sec­ond break­through drug des­ig­na­tion for Ale­cen­sa (alec­tinib), which is like­ly to help make the drug’s case as the new stan­dard for front-line treat­ment of ALK-pos­i­tive non-small cell lung can­cer.

BTDs are not in the least bit un­usu­al for big play­ers like Roche, which has now racked up a long string of them. But this one hits home, of­fer­ing ‘break­through’ sta­tus for this drug for pre­vi­ous­ly un­treat­ed pa­tients. Roche is fac­ing some ma­jor league com­pe­ti­tion on that score, and it won’t mind the added ben­e­fits a BTD of­fers in win­ning over reg­u­la­tors as well as in­flu­en­tial prac­ti­tion­ers.

San­dra Horn­ing ham­mered the front­line point in a state­ment. She said:

“The J-ALEX study that sup­ports the sec­ond Break­through Des­ig­na­tion for Ale­cen­sa showed su­pe­ri­or ef­fi­ca­cy ver­sus the stan­dard of care, crizo­tinib (Xalko­ri), in Japan­ese peo­ple with ad­vanced ALK-pos­i­tive dis­ease. The de­ci­sion by the FDA to grant a sec­ond break­through ther­a­py des­ig­na­tion is recog­ni­tion of the clin­i­cal­ly mean­ing­ful im­prove­ment in ef­fi­ca­cy and safe­ty that Ale­cen­sa brings to the care of peo­ple with ad­vanced ALK-pos­i­tive lung can­cer who have not re­ceived pri­or treat­ment with an ALK in­hibitor.”

A cou­ple of weeks ago No­var­tis out­lined plans to hus­tle to reg­u­la­tors with new late-stage da­ta on their can­cer drug Zyka­dia (cer­tinib), look­ing for an ap­proval to move up to first-line treat­ment of ALK-pos­i­tive non-small cell lung can­cer. In­ves­ti­ga­tors say the drug out­per­formed stan­dard chemo in pre­vi­ous­ly un­treat­ed pa­tients for pro­gres­sion-free sur­vival. There were al­so “clin­i­cal­ly mean­ing­ful” im­prove­ments in the over­all re­sponse rate and du­ra­tion of re­sponse, though that will need to be clar­i­fied when the da­ta is re­leased.

No­var­tis is look­ing to con­sid­er­ably en­hance its mar­ket for this drug, giv­en an ac­cel­er­at­ed ap­proval two years ago as a  sec­ond-line ther­a­py.

Late last year the FDA hand­ed out an ac­cel­er­at­ed first ap­proval to use Ale­cen­sa for pa­tients who had seen their dis­ease progress while on Xalko­ri.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

John Leonard, Intellia CEO

In­tel­li­a's CRISPR pro­gram that ed­its genes di­rect­ly in pa­tients shows dura­bil­i­ty in AT­TR amy­loi­do­sis

The first in vivo CRISPR/Cas9 gene editing program has some new durability data showing sustained reduction of a toxic protein in ATTR amyloidosis at all four dose levels in a small 15-patient study.

Intellia Therapeutics presented the much-anticipated data for its Regeneron-collaborated NTLA-2001 Friday morning, adding to the initial Phase I results it first delivered almost a year ago to the day.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”