No­vo Nordisk's block­buster di­a­betes drug blows the doors off in obe­si­ty, prov­ing high­ly ef­fec­tive in dri­ving weight loss

As the obe­si­ty epi­dem­ic in Amer­i­ca wors­ened through­out the years, many biotechs cropped up hop­ing to de­vel­op weight-loss drugs that would help stem this tide. But now, No­vo Nordisk’s di­a­betes cash cow semaglu­tide is show­ing such star­tling­ly ef­fec­tive re­sults in obe­si­ty that it may have a head start in cor­ner­ing the mar­ket.

In near­ly a 2,000-per­son tri­al, par­tic­i­pants in­ject­ed them­selves with ei­ther semaglu­tide or place­bo for 68 weeks. Pa­tients in the drug arm saw an av­er­age 15% weight loss, com­pared with just 2.4% on place­bo, and al­most a third lost more than 20% of their weight. Re­searchers pub­lished the da­ta Wednes­day in the New Eng­land Jour­nal of Med­i­cine, and all p-val­ues came out to p<0.001.

Robert Kush­n­er

Those re­sults mark a “game-chang­er” in an obe­si­ty field that, to this point, has not seen re­sults as ef­fec­tive as these, study leader Robert Kush­n­er told the New York Times.

The da­ta al­so mark an im­por­tant mile­stone in re­gards to di­a­betes. There are no ap­proved obe­si­ty med­ica­tions in the US that al­so pre­vent or treat type 2 di­a­betes. But giv­en that semaglu­tide is al­ready OK’ed in that in­di­ca­tion, the re­sults sug­gest No­vo could end up killing two birds with one stone here.

In an ex­plorato­ry end­point, clin­i­cians looked at pa­tients clas­si­fied as “pre­di­a­betes” and saw nu­mer­i­cal im­prove­ments in gly­cat­ed he­mo­glo­bin lev­els. Among those in that group, 84.1% in the semaglu­tide arm saw im­prove­ments in these lev­els, com­pared with 47.8% in the place­bo group. Re­searchers did not run a p-val­ue in this end­point.

Obe­si­ty has proved a chal­leng­ing field to treat for years, and not just with drugs. Typ­i­cal weight man­age­ment strate­gies are of­ten not enough to achieve full con­trol, and those who fol­low with bariatric surgery to al­ter the di­ges­tive tract end up re­gain­ing weight more of­ten than not.

That the­sis ap­peared to be con­firmed again in this tri­al, Kush­n­er said, as every­one in the study par­tic­i­pat­ed in a di­et and ex­er­cise pro­gram, re­gard­less of whether they re­ceived semaglu­tide.

Some con­cerns re­main over the drug’s safe­ty, per a NE­JM ed­i­to­r­i­al pub­lished along­side the da­ta. Though sim­i­lar lev­els of side ef­fects were seen in both groups, 89.7% in the drug arm and 86.4% in con­trol, there was a high­er rate of gas­troin­testi­nal events among those tak­ing semaglu­tide — 74.2% vs. 47.9%.

Most of these fell in­to the mild or mod­er­ate cat­e­gories, but se­ri­ous gas­troin­testi­nal dis­or­ders ac­count­ed for the dif­fer­ence in to­tal se­vere ad­verse event rates, the study au­thors said. Se­ri­ous ad­verse events were re­port­ed in 9.8% and 6.4% of semaglu­tide and place­bo par­tic­i­pants, re­spec­tive­ly, with 1.4% of par­tic­i­pants on semaglu­tide re­port­ing a se­vere GI event and 0% in the place­bo group.

The tri­al pop­u­la­tion al­so did not prove rep­re­sen­ta­tive of the US pop­u­la­tion as a whole, with most par­tic­i­pants be­ing women (74.1%) and White (75.1%). Over­all, how­ev­er, the re­sults proved to be a sig­nif­i­cant step in the right di­rec­tion, the au­thor wrote.

The GLP-1 drug has al­ready reaped bil­lions for No­vo Nordisk, tak­ing in $1.64 bil­lion in 2019 and $1.5 bil­lion in the first half of 2020. In ad­di­tion to di­a­betes, the com­pa­ny al­so has re­ceived break­through ther­a­py des­ig­na­tion for semaglu­tide in NASH, an­oth­er area filled with speed bumps.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Mod­er­na's Stéphane Ban­cel plans to dou­ble down on vac­cine pro­duc­tion, new vari­ants as mR­NA rules in pan­dem­ic fight

Stéphane Bancel thought he’d be sleeping more by now.

The 48-year-old Moderna CEO figured that by 2021 he’d have his vaccine through the clinic, authorized, and in mass production — that the hard part would be over. Instead, he’s still working Saturdays and Sundays, talking with his lab and manufacturing teams and fielding calls with two to three world leaders a day to answer their concerns about supply and emerging new variants.

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S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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