Andy Boy­er joins Te­va ex­o­dus; Achao­gen shuf­fles ex­ec­u­tive line­up

Te­va’s US chief Andy Boy­er has re­signed and is leav­ing the com­pa­ny at the end of Q1 next year, ac­cord­ing to Wells Far­go’s David Mar­ris. It has been a tur­bu­lent week at the Is­raeli gener­ics busi­ness, as new CEO Kåre Schultz un­veiled a mas­sive re­or­ga­ni­za­tion plan Thurs­day, which in­volves ax­ing 14,000 work­ers, shut­ter­ing R&D and man­u­fac­tur­ing fa­cil­i­ties and rad­i­cal­ly par­ing down $3 bil­lion in costs glob­al­ly. In a sig­nal of the in­tense fall­out, on Wednes­day, for­mer chair­man and in­ter­im CEO Yitzhak Pe­ter­burg abrupt­ly re­signed with im­me­di­ate ef­fect.

→ Next March, John Mar­tin of Gilead will tran­si­tion from ex­ec­u­tive chair­man to chair­man of the board of di­rec­tors. Mar­tin is a vet­er­an of the com­pa­ny $GILD, hav­ing served as CEO for two decades be­fore John Mil­li­gan took over. The brief an­nounce­ment did not cite a rea­son for the change, but it can be seen as a move to lessen op­er­a­tional in­volve­ment with the com­pa­ny in prepa­ra­tion for re­tire­ment.

→ Not on­ly did CMO David Apelian sell off his Achillion stock ear­li­er this month, he is now plan­ning to ex­it the New Haven, CT-based com­pa­ny at the end of the year.

→ Play­ing slow and steady, Achao­gen has an­nounced an ex­ec­u­tive switch up in the ex­ec­u­tive ranks in prepa­ra­tion for the ap­proval of its first drug, pla­zomicin. Pres­i­dent and COO Blake Wise will move to the CEO role, while cur­rent CEO Ken­neth Hillan takes the pres­i­dent po­si­tion and heads up R&D. One of the few late-stage play­ers in new an­tibi­otics, the biotech $AKAO has shown enough promise to gain in­vest­ment from the Gates Foun­da­tion. “… Blake’s ex­pe­ri­ence scal­ing and lead­ing com­mer­cial or­ga­ni­za­tions is per­fect­ly suit­ed to max­i­miz­ing this stage of growth, and val­ue, of the com­pa­ny,” said board chair­man Bryan Roberts in a state­ment. “At the same time, we are ex­treme­ly for­tu­nate to have Ken­neth in a role that ful­ly lever­ages his pas­sion and suc­cess at the in­ter­sec­tion of pre­clin­i­cal re­search and clin­i­cal drug de­vel­op­ment.”

→ Af­ter two decades at Glax­o­SmithK­line de­vel­op­ment busi­ness and pur­su­ing deals, Damien McDe­vitt has joined Aca­dia Phar­ma­ceu­ti­cals $ACAD as SVP, cor­po­rate de­vel­op­ment. The San Diego-based biotech is study­ing oth­er in­di­ca­tions for its Parkin­son’s drug Nu­plazid (pi­ma­vanserin), but al­so look­ing to “ex­plore the po­ten­tial for ex­pand­ing” their cen­tral ner­vous sys­tem port­fo­lio. In the same state­ment, the com­pa­ny not­ed that Jim Nash, SVP, tech­nol­o­gy de­vel­op­ment and op­er­a­tions, will be re­tir­ing from the com­pa­ny as of Jan­u­ary 2018. Bob Mis­chler will pick up Nash’s re­spon­si­bil­i­ties in a new role.

Pa­tri­cia Zil­liox is the new CEO at French biotech Eye­ven­sys, fol­low­ing pre­de­ces­sor Raffy Kazand­jian’s low pro­file de­par­ture in No­vem­ber (ac­cord­ing to LinkedIn). An oph­thalmic ex­pert, Zil­liox has had plen­ty of time to learn about the Paris-based com­pa­ny since join­ing its board in 2016. Pre­vi­ous­ly, she was chief drug de­vel­op­ment of­fi­cer of the Clin­i­cal Re­search In­sti­tute at the Foun­da­tion Fight­ing Blind­ness in Co­lum­bia, MD. Now, she is tasked with ad­vanc­ing Eye­ven­sys’ non-vi­ral gene ther­a­pies.

Aveo On­col­o­gy $AVEO has ap­point­ed Nikhil Mehta as its se­nior VP, reg­u­la­to­ry and qual­i­ty as­sur­ance. With big names like Bax­al­ta, Mer­ck and Shire un­der his belt, Mehta has a broad man­date to over­see all as­pects of the com­pa­ny’s reg­u­la­to­ry, qual­i­ty or tech­ni­cal op­er­a­tions. His ap­point­ment marks an­oth­er step to­wards the com­pa­ny’s quest for a do-over, as its FDA-re­ject­ed drug tivozanib scored an OK in the EU back in Au­gust.

→ En­ter­ing a new phase of growth, Kalei­do Bio­sciences has named Gen­zyme vet Al­i­son Law­ton as its pres­i­dent and COO. Af­ter a 20-plus-year run at Gen­zyme, Law­ton test­ed wa­ters at small­er biotechs like Au­ra Bio­sciences and Ova­Science be­fore join­ing the Flag­ship Ven­tures-backed start­up zoom­ing in­to the mi­cro­bio­me.

→ Rapid di­ag­nos­tics de­vel­op­er At­las Ge­net­ics has brought in Marc Jones as COO and CFO, who will team up with CEO Jef­frey Lu­ber in strate­gic di­rec­tion and ex­e­cu­tion out­side of his main func­tions. Jones and Lu­ber are old part­ners, hav­ing worked to­geth­er at Good Start Ge­net­ics in the ex­act same roles. Af­ter Good Start was ac­quired by In­vi­tae, Lu­ber got the top job at At­las al­most im­me­di­ate­ly. Now that the young com­pa­ny has ad­vanced from clin­i­cal proof of con­cept to a com­mer­cial phase, he is count­ing on his friend’s wide range of CFO ex­pe­ri­ence which al­so in­cludes T2 Biosys­tems and Ivenix.

→ Hav­ing worked on the fi­nan­cial side of things, An­drew Oh is giv­ing biotech a try as the CFO at Ru­bius Ther­a­peu­tics. An in­vestor and an­a­lyst, Oh was most re­cent­ly the chief in­vest­ment of­fi­cer and chief op­er­at­ing of­fi­cer of Leerink Phar­ma­ceu­ti­cal In­vest­ments. “Ru­bius is one of the most ex­cit­ing biotech com­pa­nies I have seen in my in­vest­ing ca­reer and has the po­ten­tial to trans­form care for peo­ple suf­fer­ing from a broad range of se­ri­ous dis­eases,” said Oh in a state­ment. “I am hon­ored to be part of a team ded­i­cat­ed to pi­o­neer­ing the next gen­er­a­tion of cel­lu­lar ther­a­pies and the de­vel­op­ment of break­through ther­a­pies for pa­tients in need.”

→ Sin­ga­pore’s Tes­sa Ther­a­peu­tics has ap­point­ed Desmond Lim as CFO. Lim joins the biotech, which fo­cus­es on cel­lu­lar im­munother­a­py for sol­id tu­mors, from out­sourc­ing com­pa­ny Hep­ta­gon.

→ At Flex­ion Ther­a­peu­tics, Scott Kel­ley has been pro­mot­ed as CMO to suc­ceed Yamo Deniz. Kel­ley moves up from VP of med­ical af­fairs, a po­si­tion he took af­ter a stint at Sanofi over­see­ing glob­al da­ta. A new as­set un­der his watch will be non-opi­oid painkiller for the knee FX-201, which Flex­ion $FLXN just ac­quired from GeneQuine Bio­ther­a­peu­tics.

→ In de­vel­op­ing AML drug Id­hi­fa, Agios had en­joyed work­ing with Cel­gene vet Jack­ie Fouse so much that it has brought her on­to its board of di­rec­tors. Since leav­ing Cel­gene, Fouse had start­ed run­ning Der­ma­vant — an­oth­er “vant” by Vivek Ra­maswamy that works on med­ical der­ma­tol­ogy.

Im­mune Phar­ma­ceu­ti­cals has re­cruit­ed John Zhang from Tesaro as VP of R&D. Zhang’s fo­cus will be on non-clin­i­cal as­pects of drug de­vel­op­ment, but will al­so pro­vide sup­port for clin­i­cal, reg­u­la­to­ry and man­u­fac­tur­ing ac­tiv­i­ties.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Mark Mal­lon charts post-Iron­wood course by tak­ing CEO job at NeoGe­nomics; Glax­o­SmithK­line vet Feng Ren joins In­sil­i­co as CSO

Mark Mallon steps aside at Ironwood on March 12 after close to two years at the helm, and he already has a new change of scenery squared away. Beginning April 19, Mallon takes charge as CEO of cancer-focused genetic test maker NeoGenomics out of Fort Myers, FL while his predecessor, Douglas VanOort, is retiring after 12 years as NeoGenomics’ chairman and CEO.

It’s a fresh start for Mallon after what will amount to a tumultuous 23 months as Ironwood’s chief executive. Last year was marked by trial failures that spelled double trouble, leaving the Ironwood cupboard bare: first, a Linzess reformulation for irritable bowel syndrome with diarrhea (IBS-D) in May, and then the drug IW-3718 for persistent acid reflux in September. After IW-3718’s discontinuation, Ironwood chopped its staff by 35%. On Feb. 8, Mallon announced his departure at Ironwood, with president Tom McCourt getting bumped up to interim CEO.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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J&J ad­comm live blog: Com­mit­tee votes 22-0 to rec­om­mend an FDA OK for the J&J vac­cine, set­ting up 3rd US Covid-19 jab

The US could have a third authorized Covid-19 vaccine within hours.

The FDA’s advisory committee voted unanimously — 22-0 — to recommend the agency issue an emergency use authorization for J&J’s vaccine. If they follow the precedent of the Pfizer and Moderna vaccine,  the FDA will likely authorize the vaccine by Saturday, immediately adding a few million doses to the US supply and adding a 100 million by June. An authorization would give the world its first single-dose vaccine, a major weapon in the effort to vaccinate the world and bring the virus to heel, particularly in rural and developing areas.