Charles Riv­er bags a ri­val CRO play­er in $800M MPI Re­search buy­out

The on­go­ing con­sol­i­da­tion of the CRO busi­ness is con­tin­u­ing this morn­ing as Charles Riv­er Lab­o­ra­to­ries $CRL wraps up an $800 mil­lion cash deal to ac­quire MPI Re­search, one of its biggest com­peti­tors in the pre­clin­i­cal sphere.

The ear­ly-stage spe­cial­ists at Charles Riv­er saw a sweet line­up of dis­cov­ery ser­vices at the 25-year-old MPI that fits with its own mis­sion in the in­dus­try.

James Fos­ter

Charles Riv­er is a buy­er in the CRO world. Just weeks ago it ac­quired KWS BioTest and its in vi­vo and in vit­ro dis­cov­ery ser­vices for £15 mil­lion (rough­ly $20 mil­lion) up front. And it’s been wrack­ing up a long string of ac­qui­si­tions over the past few years as top play­ers con­tin­ue to carve out mar­ket share.

Share­hold­ers were told to ex­pect a $0.25 per share non-GAAP earn­ings boost in 2018 and ap­prox­i­mate­ly $0.60 in 2019. Charles Riv­er has been see­ing a grow­ing top and bot­tom line. For the first nine months of 2017 the CRO re­port­ed $1.38 bil­lion in rev­enue, com­pared to $1.21 bil­lion for the same pe­ri­od in 2016. And net in­come jumped from $111 mil­lion to $154 mil­lion, an in­crease of 38%.

And the Wilm­ing­ton, MA-based out­sourc­ing group liked the peo­ple and fa­cil­i­ties they’ll be join­ing with now.

“In ad­di­tion to meet­ing our dis­ci­plined ac­qui­si­tion cri­te­ria, MPI is an ex­cep­tion­al strate­gic fit for Charles Riv­er be­cause it in­cor­po­rates the key at­trib­ut­es we re­quire in an ac­qui­si­tion: ac­cess to grow­ing end mar­kets, high-qual­i­ty ser­vices, sci­en­tif­ic ex­per­tise, and com­ple­men­tary ca­pa­bil­i­ties,” says Charles Riv­er CEO James Fos­ter. “MPI’S one-mil­lion-square-foot, sin­gle-site fa­cil­i­ty in Michi­gan will pro­vide need­ed ca­pac­i­ty to meet cur­rent and fu­ture de­mand.”

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.

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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.