In sud­den re­vamp, Cel­gene CEO Alles bids his COO good­bye and looks to re­gain con­fi­dence with man­age­ment shuf­fle

Stag­gered by a se­ries of late-stage set­backs capped by the FDA’s re­fusal to ac­cept its ap­pli­ca­tion on their lead­ing late-stage drug and look­ing vul­ner­a­ble on its num­bers, Cel­gene CEO and chair­man Mark Alles is re­vamp­ing the lead­er­ship struc­ture at the wob­bly biotech.

Scott Smith

Num­ber one on the to-do list: Scott Smith is out as pres­i­dent and COO, with im­me­di­ate ef­fect. He’s not re­tir­ing or off in search of new op­por­tu­ni­ties. He’s just out.

The man­age­ment re­vamp will leave Alles in charge of every­thing from clin­i­cal de­vel­op­ment to reg­u­la­to­ry, the all-im­por­tant hema­tol­ogy and on­col­o­gy fran­chise as well as in­flam­ma­tion and im­munol­o­gy.

Mark Alles

Re­port­ing di­rect­ly to him: Nadim Ahmed, pres­i­dent, glob­al hema­tol­ogy and on­col­o­gy; Ter­rie Cur­ran, pres­i­dent, glob­al in­flam­ma­tion and im­munol­o­gy; Jay Back­strom, chief med­ical of­fi­cer and head of glob­al reg­u­la­to­ry af­fairs; and Joanne Beck, ex­ec­u­tive vice pres­i­dent, glob­al phar­ma­ceu­ti­cal de­vel­op­ment and op­er­a­tions.

And the re­or­ga­ni­za­tion ap­pears to still be un­der way. Jef­feries’ Michael Yee not­ed Mon­day night: “The com­pa­ny is re­or­ga­niz­ing its ex­ec­u­tive team in the mean­time, and we could hear sev­er­al hires/pro­mo­tions over the com­ing months.”

The move comes short­ly af­ter Bob Hug­in’s de­par­ture as ex­ec­u­tive chair­man of the com­pa­ny he ran to great ac­claim for years. But the ap­plause has qui­et­ed sig­nif­i­cant­ly over the past year. Cel­gene’s $710 mil­lion cash roll of the dice on the in­flam­ma­to­ry bow­el dis­ease drug mon­gersen (GED-301) came up snake eyes in Phase III last fall. Most re­cent­ly the FDA re­ject­ed Cel­gene’s ap­pli­ca­tion for ozan­i­mod, an em­bar­rass­ment for a com­pa­ny that prid­ed it­self on its abil­i­ty to ex­e­cute ef­fec­tive­ly.

That could have been for­giv­en eas­i­ly enough, but in­vestors have been alarmed over weak fi­nan­cials un­der­scor­ing the com­pa­ny’s ex­tra­or­di­nary de­pen­dence on Revlim­id and the big, reg­u­lar price hikes it needs to keep on top of the game. Revlim­id’s patent po­si­tion is al­so un­der as­sault.

Just week’s ago Baird’s Bri­an Sko­r­ney not­ed that re­peat­ed sna­fus have cre­at­ed a sit­u­a­tion where “in­vestors are hes­i­tant to get back in­to what was once biotech’s poster child for con­tin­ued growth and sol­id ex­e­cu­tion.”

Alles wants it all back, and he now has fi­nal re­spon­si­bil­i­ty for all of it.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

In fi­nal re­port, ICER ap­pears to have a change of heart on new acute mi­graine ther­a­pies

ICER appears to have reversed course on the fresh crop of acute migraine therapies.

The cost-effectiveness watchdog in November issued a draft report suggesting that existing generic medicines are more effective and cheaper than Allergan’s December-approved CGRP ubrogepant, Biohaven rival molecule, rimegepant (which is under FDA review), and Lilly’s October-sanctioned lasmiditan, which binds to 5-HT1F receptors.

Bi­cy­cle Ther­a­peu­tics takes Roche's Genen­tech on an up to $2B im­muno-on­col­o­gy ride

Bicycle Therapeutics — which is developing a new class of chemically synthesized drugs designed to be pharmacologically as active as biologics, yet manufactured as small molecules —  has scored another big partner: Roche’s Genentech.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

When drug val­ue as­sess­ment meets re­al-world ev­i­dence: ICER en­lists Ae­tion in pric­ing eval­u­a­tion

In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value.

The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA.

Anthony Fauci, AP Images

First US Covid-19 tri­als set to get un­der­way in Ne­bras­ka and Wash­ing­ton, backed by NIH

The first US clinical trials on the novel coronavirus are scheduled to get underway next month at the University of Nebraska Medical Center, where American passengers were taken after being evacuated from the Diamond Princess cruise ship, and at the Kaiser Permanente Washington Health Research Institute. Both trials are sponsored by the NIH’s National Institute for Allergy and Infectious Diseases, which has led the US’s medical response to the outbreak.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.