Can No­vo’s block­buster push on obe­si­ty drug semaglu­tide suc­ceed where oth­ers failed?

An­a­lysts have some high ex­pec­ta­tions for No­vo Nordisk’s weight drug semaglu­tide, but they’re no high­er than the ones held by No­vo’s ex­ec­u­tive team.

Pegged as a po­ten­tial $2.2 bil­lion drug in 5 years in one re­cent as­sess­ment, No­vo ex­ecs dur­ing Wednes­day’s Q2 call re­viewed the Phase II obe­si­ty da­ta they had nailed down in June, out­lin­ing plans for a loom­ing Phase III that they be­lieve can show their GLP-1 drug can knock off up to around 15% of an obese per­son’s weight rel­a­tive to place­bo.

Lars Fruer­gaard Jor­gensen

In the mid-stage study, re­searchers tracked an av­er­age 17.8 kilo­gram (39 pound) weight loss from an av­er­age base­line weight of 111 ki­los, or 244 pounds, for all the pa­tients in the drug arm who com­plet­ed the one-year tri­al. That’s a 16.2% weight loss in the drug group, com­pared to 2.3% in the place­bo arm.

Their oth­er weight drug Sax­en­da is gen­er­al­ly re­lied on to knock off 5% to 10% of a per­son’s weight, mark­ing this new drug’s po­ten­tial to set a “new ef­fi­ca­cy stan­dard for an­ti-obe­si­ty med­i­cines,” in the words of R&D chief Mads Krogs­gaard Thom­sen in the call.

Five years ago a group of new weight drugs were wind­ing their way through the FDA ap­proval process. They made it, af­ter clear­ing some high hur­dles for drugs aim­ing at a big mar­ket, but the com­mer­cial re­cep­tion for the mar­gin­al weight loss they could be ex­pect­ed to de­liv­er was aw­ful. Are­na bailed on Ei­sai, leav­ing it with Belviq, Take­da dropped out of their Orex­i­gen pact and ri­val Vivus was left sell­ing Qsymia with a hand­ful of reps, with rev­enue falling.

No­vo thinks much bet­ter ef­fi­ca­cy can as­sure re­al suc­cess, and the phar­ma com­pa­ny is plan­ning to mount a new and even more am­bi­tious roll­out, if the Phase II da­ta hold up.

Sig­nif­i­cant­ly, No­vo is al­so re­ly­ing on a good safe­ty pro­file so far in obe­si­ty, with­out any ev­i­dence of reti­nal dis­ease, which has popped up in their di­a­betes study.

CEO Lars Fruer­gaard Jor­gensen al­so con­firmed that they are tak­ing the high­er, once-week­ly dos­es in­to Phase III, which will launch next year. In his words:

Yes, so we ba­si­cal­ly plan to con­duct a three, as you cor­rect­ly stat­ed, us­ing a once week­ly ap­pli­ca­tion and as we have done al­so in type two di­a­betes in more than 8,000 in­di­vid­u­als. The ba­sis for cal­cu­lat­ing the dose is ob­vi­ous­ly the usu­al ben­e­fit/risk as­sess­ment and since there were no un­ex­pect­ed risks or ad­verse events or side ef­fects as­so­ci­at­ed with semaglu­tide oth­er than those re­lat­ed to GLP-1 ag­o­nists ther­a­py, it’s ob­vi­ous that we will go to­wards the high­er end of the dose range.

And I can in­form you that go­ing in­to more de­tail that at both the high­est dos­es, 1.3 and 1.4, we are speak­ing to the tune of 15 to 17 plus kilo­gram weight loss af­ter a 1-year treat­ment in those pa­tients who com­plete. So that is what we are ex­pect­ing. And Sax­en­da in that very tri­al per­formed like it should do, giv­en the kind of ef­fi­ca­cy lev­el that we have seen in the SCALE stud­ies. So this is a new lev­el of ef­fi­ca­cy which is why we are al­ready now plan­ning for the Phase III pro­gram.

This time around No­vo says it can be dif­fer­ent. And it could use a new block­buster now as the di­a­betes mar­ket un­der­goes some marked changes.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

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Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.