Stock ac­tivists fire back at Al­ler­gan’s de­fen­sive moves, push for a com­pa­ny sale

Al­ler­gan’s at­tempt to as­suage its crit­ics — or at least shore up sup­port among in­vestors — by adding in­dus­try head­lin­er Bob Hug­in to the board and call­ing for an even­tu­al di­vi­sion of the chair­man and CEO roles at the com­pa­ny has in­spired a wicked back­lash.

David Tep­per (Carnegie Mel­lon)

Hours af­ter Al­ler­gan $AGN post­ed the move, say­ing it would sep­a­rate the two top roles dur­ing an even­tu­al lead­er­ship tran­si­tion, its ac­tivist crit­ics at Ap­paloosa LP — helmed by Car­oli­na Pan­thers own­er David Tep­per — post­ed a let­ter bash­ing Al­ler­gan’s move in no un­cer­tain terms. And they go on to say that it would be bet­ter for Al­ler­gan to go ahead and ex­plore oth­er op­tions, like a sale of the com­pa­ny.

Ex-Cel­gene CEO Hug­in was put on the board, you say? Not good enough, replies Tep­per.

(H)ad you se­ri­ous­ly in­tend­ed to take mean­ing­ful ac­tion, Bob Hug­in would have been a cred­i­ble can­di­date for Chair­man giv­en his stand­ing in the in­dus­try.

Ap­paloosa al­so goes on to prod Al­ler­gan for nu­mer­ous short­com­ings, from bil­lions in write-downs, em­bar­rass­ing le­gal ma­neu­vers (an ap­par­ent poke at the Mo­hawk patent gam­bit), big pay­days and a se­ri­ous­ly de­flat­ed stock price.

Their move to­day….

“…falls short of im­proved gov­er­nance and once again lays bare your re­luc­tance to hold man­age­ment ac­count­able for its dis­mal per­for­mance. This re­sponse, fol­low­ing three years of proxy pro­pos­als and prod­ding from large share­hold­ers such as Ap­paloosa, bears re­mark­able sim­i­lar­i­ty to last year’s abort­ed “Strate­gic Re­view” – that is, a lame at­tempt to de­flect pres­sure through to­ken mea­sures that side­step the Com­pa­ny’s de­fects and des­per­ate­ly pre­serve the man­age­r­i­al sta­tus quo.

Bob Hug­in

Tep­per adds that he in­tends to press for the sep­a­ra­tion and strate­gic re­view, call­ing the cur­rent board “sub­servient” and their res­o­lu­tion “tooth­less.”

More­over, your in­ef­fec­tu­al ef­forts sug­gest that this Board and man­age­ment team may be in­ca­pable of ex­e­cut­ing a busi­ness plan that will re­al­ize Al­ler­gan’s in­her­ent val­ue. If, in fact, the Board is un­able or un­will­ing to hold man­age­ment ac­count­able for its short­com­ings or find a suit­able re­place­ment, it is your fidu­cia­ry oblig­a­tion to ex­plore oth­er op­tions, in­clud­ing a merg­er or sale of the Com­pa­ny.

Al­ler­gan CEO Brent Saun­ders, though, isn’t go­ing for the redi­rec­tion from Tep­per, call­ing it dis­rup­tive.

Im­ple­ment­ing a lead­er­ship change in the man­ner Ap­paloosa is rec­om­mend­ing would be high­ly dis­rup­tive to the Com­pa­ny and di­min­ish Mr. Saun­ders’ abil­i­ty to con­tin­ue to ex­e­cute Al­ler­gan’s strat­e­gy to cre­ate a world-class glob­al bio­phar­ma­ceu­ti­cal busi­ness and de­vel­op the Com­pa­ny’s promis­ing pipeline.  In con­trast, the share­hold­er pro­pos­al that our Board sup­ports min­i­mizes dis­rup­tion and al­lows for the sep­a­ra­tion of the Chair and CEO po­si­tions with the next lead­er­ship change, as these res­o­lu­tions typ­i­cal­ly pro­vide.

 

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.

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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.

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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.

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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.

Mallinck­rodt, once the na­tion’s largest oxy­codone pro­duc­er, an­nounces ten­ta­tive $1.6B set­tle­ment

Three years after it first paid out fines for its role in the US opioid abuse epidemic, Mallinckrodt has announced an agreement-in-principle that will see the company pay out $1.6 billion and place its generics unit in bankruptcy.

The tentative deal would settle hundreds of lawsuits from state and local governments over Mallinckrodt’s role in the epidemic, while also helping address the company’s increasingly mountainous debt. Although Purdue Pharma has drawn the bulk of both public and legal acrimony for opioid sales, documents made public earlier this year showed that Mallinckrodt subsidiary SpecGx, along with the generic subsidiaries of Teva and Endo Pharmaceuticals, accounted for the vast majority of the 76 billion opioid pills distributed from 2006 to 2012. Mallinckrodt was at the top of that list.