Bi­cy­cle signs on new clin­i­cal ex­ecs in pipeline dri­ve; Howard Stern signs on as Fog­Phar­ma CSO

→ On Thurs­day, Bi­cy­cle Ther­a­peu­tics an­nounced the ap­point­ments of Lisa Mahnke as se­nior vice pres­i­dent and head of clin­i­cal and Ter­rence West as vice pres­i­dent and head of pro­gram man­age­ment to help ex­pand and ad­vance its clin­i­cal pipeline.

Lisa Mahnke

“As Bi­cy­cle ex­pands its pipeline and our pro­grams ma­ture, it is crit­i­cal that we de­liv­er an ef­fec­tive clin­i­cal strat­e­gy, and these two new clin­i­cal team mem­bers are an in­te­gral part of our strat­e­gy,” said Kevin Lee, CEO of Bi­cy­cle Ther­a­peu­tics. “Lisa and Ter­ry have ex­cep­tion­al track records as se­nior lead­ers nav­i­gat­ing pro­grams through the clin­ic. I am very pleased to wel­come them both to the Bi­cy­cle team.”

Fog­Phar­ma an­nounced on Mon­day the ap­point­ment of Howard Stern as CSO and Pe­ter Fekkes as vice pres­i­dent of dis­cov­ery bio­science.

“Howard brings a pen­e­trat­ing, ad­ven­tur­ous in­tel­lect and ex­cep­tion­al knowl­edge in drug dis­cov­ery across mul­ti­ple modal­i­ties and dis­ease ar­eas, plus out­stand­ing ex­per­tise in trans­la­tion­al sci­ence and ex­per­i­men­tal med­i­cine. His in­sights and lead­er­ship will be crit­i­cal as we dri­ve a suc­ces­sion of in­no­v­a­tive, first-in-class drugs to the clin­ic, tar­get­ing pro­teins that have nev­er been drugged be­fore,” said Gre­go­ry Ver­dine, chair­man, pres­i­dent and CEO of Fog­Phar­ma. “Pe­ter brings tremen­dous depth and breadth of skill in pro­gress­ing tar­gets to clin­i­cal can­di­dates, and he will serve a cru­cial role in our R&D or­ga­ni­za­tion, as we write the play­book for ef­fi­cient dis­cov­ery of cell-pen­e­trat­ing minipro­tein med­i­cines. The ad­di­tion of Howard and Pe­ter to our team rep­re­sents a quan­tum leap for­ward for Fog­Phar­ma as a ma­ture, pow­er­ful and ef­fec­tive new modal­i­ty drug dis­cov­ery or­ga­ni­za­tion.”

Mo­hammed Dar

→ Less than three months af­ter As­traZeneca CEO Pas­cal So­ri­ot pushed Mo­hammed Dar out of the com­pa­ny’s sub­sidiary Med­Im­mune due to re­struc­tur­ing, Dar has now tak­en charge as CMO at Im­muno­core. This re­unites him with some old col­leagues, such as Bahi­ja Jal­lal — now CEO of Im­muno­core and David Berman, head of R&D for Im­muno­core.

Ni­va Al­maula

Ac­tini­um an­nounced on Tues­day the ap­point­ment of Ni­va Al­maula as CBO of the com­pa­ny. Al­maula pre­vi­ous­ly worked as head, busi­ness de­vel­op­ment at Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions — a com­pa­ny fo­cused on nu­clear med­i­cine and tar­get­ed ther­a­pies like Lu­tathera — which was bought for $3.9 bil­lion by No­var­tis in Jan­u­ary 2018.

In­ter­sect ENT CEO Lisa Earn­hardt an­nounced Mon­day that she will be step­ping down from her role on June 5, 2019. In the mean­time, Kier­an Gal­lahue, cur­rent­ly the com­pa­ny’s lead di­rec­tor, will step up as the in­ter­im CEO — ef­fec­tive June 5, 2019 — and has been ap­point­ed ex­ec­u­tive chair­man of the board of di­rec­tors — ef­fec­tive May 7, 2019. De­spite step­ping down, Ms. Earn­hardt will re­main a mem­ber of the In­ter­sect ENT board. The com­pa­ny said that its board has ini­ti­at­ed a search process to iden­ti­fy a per­ma­nent CEO and has en­gaged a lead­ing ex­ec­u­tive search firm to as­sist with this process.

In­go Lehrke

In­go Lehrke was an­nounced Tues­day as the CEO of Al­giax Phar­ma­ceu­ti­cals and Gui­do Koop­mans as the CSO, both po­si­tions were ef­fec­tive as of May 1, 2019. Be­fore this, Lehrke had been work­ing for the last 10 years as man­ag­ing di­rec­tor of tesa Labtec GmbH, a drug-de­liv­ery com­pa­ny part of the Beiers­dorf Group of com­pa­nies. Koop­mans is a neu­ro­sci­en­tist who co-found­ed Al­giax, as well as de­vel­oped AP-325. Co-founder and share­hold­er of Al­giax Jür­gen Schu­mach­er, who pre­vi­ous­ly held the po­si­tion of CEO will be the chair­man of Al­giax’ new ad­vi­so­ry board.

Gui­do Koop­mans

The com­pa­ny said that it in­tends to start a Phase IIa clin­i­cal study for its lead can­di­date AP-325 in chron­ic neu­ro­path­ic pain. “We are ex­cit­ed to ini­ti­ate the next de­vel­op­ment stage of AP-325 with the goal to show its proof-of-con­cept in pa­tients, soon” said Dr. Koop­mans. “We plan to have the first pa­tient in­clud­ed in the fourth quar­ter of this year and ex­pect first re­sults in 2020.”

→ On Thurs­day Bruce Horowitz was ap­point­ed as COO at Provec­tus. The com­pa­ny said that Mr. Horowitz pre­vi­ous­ly served as its chief op­er­a­tions con­sul­tant since 2017 and has al­so served as a mem­ber of the com­pa­ny’s board of di­rec­tors since 2017.

“Bruce’s in­flu­ence has en­abled Provec­tus to be­gin strate­gi­cal­ly piv­ot­ing the fo­cus­es of the clin­i­cal de­vel­op­ment pro­gram of the Com­pa­ny’s in­ves­ti­ga­tion­al can­cer im­munother­a­py PV-10 to­wards neoad­ju­vant ther­a­py for ear­ly-stage can­cer where all dis­ease can be treat­ed swift­ly with PV-10, and com­bi­na­tion ther­a­py with stan­dard of care for lat­er-stage dis­ease where prim­ing and ac­ti­va­tion of the func­tion­al im­mune re­sponse to PV-10 treat­ment can be aug­ment­ed by an­oth­er treat­ment or treat­ments,” said Ed Per­sh­ing, CPA, chair of the Provec­tus’ board.

Jef­frey Ecsedy

→ On Tues­day, Boston-based Kyn Ther­a­peu­tics an­nounced the ap­point­ment of Jef­frey Ecsedy as CSO and Ja­son Sager as CMO. Both in­di­vid­u­als have been with Kyn since 2017. Ecsedy pre­vi­ous­ly worked at Take­da Phar­ma­ceu­ti­cals as part of their on­col­o­gy R&D lead­er­ship and Sager pre­vi­ous­ly held po­si­tions as med­ical di­rec­tor at No­var­tis and Genen­tech and se­nior med­ical di­rec­tor at Sanofi.

Ja­son Sager

“Ja­son and Jeff’s guid­ance and ex­per­tise have been in­valu­able to Kyn through the de­sign and ex­e­cu­tion of the two on­go­ing Phase Ib/II clin­i­cal stud­ies of our lead can­di­date ARY-007, an EP4 re­cep­tor an­tag­o­nist. Their in­put was al­so es­sen­tial to our de­liv­ery of im­por­tant pre­clin­i­cal mile­stones that val­i­dat­ed the nov­el bi­ol­o­gy un­der­ly­ing our pro­grams,” said Mark Man­fre­di, Kyn’s pres­i­dent, and CEO. “We are now plan­ning en­try in­to the clin­ic for our AHR and Ky­nase pro­grams, both part­nered with Cel­gene. Jeff and Ja­son’s lead­er­ship will play a crit­i­cal role dur­ing this sig­nif­i­cant phase of Kyn’s growth and de­vel­op­ment.”

Med­ica Group Plc an­nounced Thurs­day that start­ing Sep­tem­ber 1, 2019,

Stu­art Quin

will take on the role of CEO of Med­ica and join its board of di­rec­tors. John Gra­ham will re­main as CEO un­til that time. Quin comes to Med­ica from Syn­lab, where he is cur­rent­ly head of Cen­tral and East­ern Eu­rope, Mid­dle East and Africa. Pre­vi­ous­ly he was Syn­lab’s group CCO and chief ex­ec­u­tive of its UK op­er­a­tions.

 

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.