Check­mate Phar­ma­ceu­ti­cals brings two new ex­ecs on board; Take­da sheds 30 drugs, gains $200M in Aci­no deal

→ Amid a $22 mil­lion fi­nanc­ing round led by Decheng Cap­i­tal last year, Check­mate Phar­ma­ceu­ti­cals CEO Art Krieg an­nounced that he was turn­ing in his tile to Bar­ry Labinger and, in­stead, mov­ing to a CSO role with­in the com­pa­ny. Now, the Cam­bridge, Mass­a­chu­setts-based com­pa­ny wel­comes two new ex­ecs to the team: James Wooldridge as CMO and Steven Ham­burg­er as vice pres­i­dent of reg­u­la­to­ry af­fairs.

“In the past year, we have made tremen­dous progress in ad­vanc­ing the de­vel­op­ment of our lead com­pound, CMP-001, that is cur­rent­ly in clin­i­cal tri­als in com­bi­na­tion with an­ti-PD-1/L1 an­ti­bod­ies for mul­ti­ple sol­id tu­mor types,” said Labinger.

Wooldridge jumps over af­ter a stint as the CMO of Ae­glea Bio­Ther­a­peu­tics. His pre­vi­ous roles in­clude serv­ing at Eli Lil­ly, where he served as CSO for im­muno-on­col­o­gy clin­i­cal de­vel­op­ment, and con­duct­ing re­search as a fac­ul­ty mem­ber at the Uni­ver­si­ty of Mis­souri in Co­lum­bia and the Uni­ver­si­ty of Iowa. Ham­burg­er hops aboard af­ter a stint as vice pres­i­dent of reg­u­la­to­ry af­fairs & qual­i­ty as­sur­ance at Tarve­da Ther­a­peu­tics. His pre­vi­ous stints in­clude roles at Cas­tle Creek Phar­ma­ceu­ti­cal, Im­munomedics, John­son & John­son, Mil­len­ni­um/Take­da and Eli Lil­ly.

→ Ea­ger to of­fload some non-core as­sets in pur­suit of a stream­lined struc­ture in­te­grat­ed with Shire, Take­da has found a buy­er for 30 prod­ucts in its pri­ma­ry care port­fo­lio — both pre­scrip­tion and OTC — in parts of the Mid­dle East and Africa plus Ukraine. Swiss phar­ma Aci­no is pay­ing $200 mil­lion for rights to “se­lect­ed pain man­age­ment, gas­troen­terol­o­gy, car­dio­vas­cu­lar and res­pi­ra­to­ry prod­ucts. Take­da will con­tin­ue to man­u­fac­ture the meds, but the sales and mar­ket­ing re­spon­si­bil­i­ties will shift to Aci­no and some staff will move over as part of the deal.

Rel­ma­da Ther­a­peu­tics — fo­cused on de­vel­op­ing treat­ments of cen­tral ner­vous sys­tem (CNS) dis­eases — has pre­sent­ed da­ta from its Phase II clin­i­cal tri­al of REL-1017 as an ad­junc­tive treat­ment in pa­tients with treat­ment-re­sis­tant de­pres­sion. The study eval­u­at­ed the safe­ty, tol­er­a­bil­i­ty and ef­fi­ca­cy of two dos­es of REL-1017 (dex­tromethadone), 25 mg once a day and 50 mg once a day. Find­ings show that both pa­tients dosed with the 25 mg and 50 mg of REL-1017 ex­pe­ri­ence sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment of their de­pres­sion com­pared to sub­jects in the place­bo group on all ef­fi­ca­cy mea­sures.

→ Med­ical der­ma­tol­ogy com­pa­ny Az­i­tra has closed a $14 mil­lion Se­ries A fi­nanc­ing round — bring­ing their to­tal fi­nanc­ing to date to $17 mil­lion. KdT Ven­tures led the fi­nanc­ing with ex­ist­ing in­vestor Bios Part­ners, along with Con­necti­cut In­no­va­tions and God­frey Cap­i­tal. The com­pa­ny says that the round will be used to ex­pand the man­age­ment team and to ad­vance Az­i­tra’s med­ical der­ma­tol­ogy prod­ucts in the clin­ic.

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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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.