FDA ex­perts shrug off retinopa­thy con­cerns, of­fer (near) unan­i­mous thumbs up for No­vo Nordisk's semaglu­tide

An FDA pan­el of out­side ex­perts to­day vot­ed al­most unan­i­mous­ly to en­dorse No­vo Nordisk’s next big di­a­betes/obe­si­ty drug semaglu­tide, like­ly set­ting up a near-term ap­proval for one of this year’s top block­busters in the pipeline. There was one ab­sten­tion and ze­ro op­po­si­tion to the key ques­tion.

No­vo Nordisk is a ma­jor play­er in di­a­betes and pre­dictably ran a thor­ough late-stage ef­fort to nail down their drug’s abil­i­ty to low­er HbA1c — a crit­i­cal mea­sure for the con­trol of the dis­ease. In the process, though, they al­so care­ful­ly tracked in­ci­dents of di­a­bet­ic retinopa­thy — dam­age to the blood ves­sels in the eye, which can lead to blind­ness — spot­light­ing what would be­come a big is­sue for its sci­en­tists on Wednes­day.

Ac­cord­ing to No­vo Nordisk, no one else has done sim­i­lar eye ex­ams as re­searchers de­cid­ed to do in their big SUS­TAIN 6 out­comes study. In their case, the sci­en­tists main­tained that the drug wasn’t di­rect­ly re­spon­si­ble for in­ci­dents of retinopa­thy, but rather pinned the blame for the cas­es on the sud­den drop in HbA1c which the drug was re­spon­si­ble for. And that risk could be man­aged, the com­pa­ny says, through the right warn­ing la­bel to alert pa­tients who are at risk.

The FDA, while of­fer­ing a clear nod for the drug’s ef­fi­ca­cy pro­file, made these retinopa­thy cas­es the cen­tral fea­ture of the pan­el dis­cus­sion, ask­ing the ex­perts to ei­ther sign off on the ad­verse safe­ty is­sue as some­thing that could be man­aged or stop the drug now un­til more da­ta could be gath­ered.

Eli Lil­ly has a lot rid­ing on the fi­nal out­come for No­vo Nordisk. In its last big Phase III tri­al, SUS­TAIN 7, re­searchers pit­ted semaglu­tide against Lil­ly’s up-and-com­ing GLP-1 drug Trulic­i­ty, and beat it. An ag­gres­sive mar­keter, No­vo will go toe-to-toe with Lil­ly in the glob­al di­a­betes mar­ket if it gets the chance.

No­vo is al­so de­vel­op­ing semaglu­tide specif­i­cal­ly for obe­si­ty, a mar­ket that has de­fied sev­er­al re­cent at­tempts by small biotechs with on­ly rel­a­tive­ly mod­est amounts of weight loss to boast about. And there is al­so a pro­gram un­der­way in NASH.

Pegged as a po­ten­tial $2.2 bil­lion drug in 5 years in one re­cent as­sess­ment, No­vo ex­ecs dur­ing their 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.

If semaglu­tide gets a clean bill of health from reg­u­la­tors, as ap­pears like­ly, No­vo can start test­ing those fore­casts.

It’s al­so worth not­ing that an ap­proval here would shove up the FDA’s record for 2017 to 35 or more, putting it on track to re­turn to the strong ap­proval rate for new drugs reg­u­la­tors scored in 2015, be­fore see­ing a big dropoff in 2016. The FDA has al­ready reg­is­tered a record num­ber of OKs on the gener­ics front, as new com­mis­sion­er Scott Got­tlieb fol­lows through on his list of goals at the FDA.

From left to right: Lilian Kim, Associate Director Business Development; John Moller, CEO; Yooni Kim, Executive Director, Asia Operations; Michelle Park, Director South Korea Operations.

Novotech CRO sees 26% growth in Asia tri­al ac­tiv­i­ty from biotechs, but still plen­ty of ca­pac­i­ty

As the Asia-Pacific clinical trials sector continues to grow rapidly, Novotech the Asia-Pacific-based CRO is seeing biotech clinical activity up by 26%. But says there is still plenty of capacity in the region that features advanced medical facilities, supportive regulatory environments, and more than 2.3 billion people, largely treatment naïve, living in urban areas.

China, South Korea and Australia have the most studies registered as recruiting or about to recruit according to ClinicalTrials.Gov.

Pfizer, South San Francisco — Jeff Rumans for Endpoints News

UP­DAT­ED: Pfiz­er takes aim at a flag­ship fran­chise at Sanofi and Re­gen­eron — and scores a few di­rect hits

Count Pfizer in as a top player in the blockbuster game of JAK1 inhibitors.

Over the weekend the pharma giant posted some stellar Phase III efficacy data for their heavyweight contender abrocitinib in atopic dermatitis (eczema) that lines up ahead of a booming Dupixent (dupilumab), a blockbuster in the portfolios of Regeneron and Sanofi. And they put some real distance ahead of Eli Lilly’s trailing Olumiant, which made a delayed initial arrival on the market for rheumatoid arthritis after the FDA hobbled it with some additional hurdles on safety concerns.

JADE-MONO-1 scores well for Pfizer, teeing up what will be an intensely followed breakdown of the JADE MONO-2 data, which the pharma giant recently top-lined as “similar” to the first Phase III when tested against a placebo — a control group that has been easily outclassed by all the drugs in this market niche.

As of now, Pfizer looks to be equipped to run into the review stage — advantaged by a breakthrough therapy designation that is intended to speed up the regulatory process.

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A preda­tor's world? Top an­a­lyst sees the 'haves' and the 'haven't­s' di­verge as biotech bub­bles form — and col­lapse

Josh Schimmer

We’ve all seen the deluge of cash that’s been pouring into biotech from every angle: VCs, IPOs and follow-ons have generated billions in capital for new and emerging drug developers with ready access to some powerful new tech. But Evercore ISI’s Josh Schimmer is asking where we’re headed from here.

His answer is neither apocalyptic nor universally blissful, but if he’s right — and this is a discussion we’re hearing much, much more about at a time of growing economic and industry uncertainty — we may well be at a crossroads that could affect valuations, M&A and the entire global industry that has formed over the past 5 years.

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US mulls tar­iffs on Swiss drug ex­ports, weigh­ing on No­var­tis and Roche –  re­port

The leading Swiss newspaper has reported that the US is considering placing tariffs on pharmaceuticals from Switzerland. Roche and Novartis stock each fell 1% after the news broke.

Neue Zürcher Zeitung reported that US Trade Representative Robert Lighthizer told pharmaceutical representatives the Trump administration was considering the move. Tariffs do not appear to be in the immediate offing, but they would potentially affect Swiss giants Novartis and Roche along with other companies that manufacture in Switzerland, including Merck KGaA and US biotech Biogen, which is currently constructing a new facility in the country.

Neil Kumar, Endpoints

Bridge­Bio drops bid to re­claim Ei­dos af­ter di­rec­tors spurn 3 of­fers

A couple of months ago a newly public BridgeBio turned some heads by disclosing that it had made a bid for subsidiary Eidos Therapeutics in hopes of gobbling up the 34% stake that it doesn’t already own. Two offers later, the parties are calling it off.

A special committee of independent directors at the smaller biotech led by RA Capital’s Rajeev Shah and ex-Portola CEO William Lis first rejected the parent company’s initial offer — which would swap 1.3 BridgeBio shares for each Eidos share — on September 12. In the latest announcement, BridgeBio revealed that it eventually raised the offer to 1.5 shares and made $110 million available for all-cash or mixed consideration options, but Eidos still wasn’t interested.

Mark Foley, Revance

HR vi­o­la­tion push­es Re­vance co-founder out, vault­ing for­mer Zel­tiq chief to the helm

Months after Revance amended the terms of its Botox biosimilar collaboration with Mylan, the Newark, California-based drug developer disclosed its co-founder Dan Browne is stepping down, in what appears to be mysterious circumstances.

The company — which is also developing a rival to Allergan’s formidable Botox franchise — on Monday said Browne is departing “due to misjudgment in handling an employee matter,” that has also culminated in his resignation from Revance’s board of directors.

In-house FDA re­view flags a sus­pi­cious im­bal­ance in deaths as Sh­iono­gi hunts an OK for an­tibi­ot­ic

Shionogi has some big questions to answer if they plan to win an FDA panel’s backing for their new antibiotic.

While investigators have provided positive efficacy data for their new product to treat cases of complex urinary tract infections, an FDA review has flagged an imbalance of deaths between the antibiotic and a control arm. And they want the agency’s outside advisers to take a good hard look at that when they meet on Wednesday.

Cell ther­a­py start­up rais­es $16 mil­lion to fund its quest for the Holy Grail in re­gen­er­a­tive med­i­cine

In 2006, Shinya Yamanaka shook stem cell research with his discovery that mature cells can be converted into stem cells, relieving a longstanding political-ethical blockage and throwing open medical research on everything from curbing eye degeneration to organ printing.

But that process still has pitfalls, including in risk and scalability, and some researchers are exploring another way first hinted at years ago: new technology to convert mature cells directly into other mature cells without the complex and time-consuming process of first making them into stem cells.

Eye­ing $86M, Galera leads a pack of three mod­est biotech IPOs push­ing past high pro­file stum­bles

Exactly one year after kicking off a pivotal Phase III study for its lead drug — a companion for cancer patients receiving radiotherapy — Galera is looking to the Nasdaq for some new cash to complete the clinical work and fuel its commercial drive.

CEO Mel Sorensen has penciled in an $86 million ask, which was filed on the same day as liver disease company 89bio and rare disease diagnostics shop Centogene. The trio marks the first batch of IPO filings in the wake of two highly anticipated but ultimately disappointing public debuts by BioNTech and Vir, signaling dwindling biotech fervor on Wall Street. 89bio and Centogene are seeking $70 million and $69 million, respectively.