IQVIA vet takes the helm at Chi­na's Foun­tain Med­ical; Michael Nazak pro­mot­ed to CFO post at Aridis

Lin Zhen Foun­tain Med­ical

Af­ter bag­ging $62 mil­lion in a Se­ries D fi­nanc­ing round, Foun­tain Med­ical De­vel­op­ment has tapped IQVIA vet Ling Zhen as CEO and co-chair­man of the board of di­rec­tors. Most re­cent­ly, Zhen served as a part­ner at Drap­er Drag­on Ven­ture Group. Dur­ing his time at IQVIA (for­mer­ly Quin­tiles), Zhen served as a glob­al SVP and gen­er­al man­ag­er of Greater Chi­na. Pri­or to IQVIA, Zhen served at Eli Lil­ly, GSK and Ernst & Young in the US.

→ Mi­cro­cap Aridis Phar­ma­ceu­ti­cals — who last Oc­to­ber snagged Take­da vet Paul Mendel­man to man the com­pa­ny as in­ter­im CMO af­ter a Phase II flophas pro­mot­ed Michael Nazak to CFO. Nazak is suc­ceed­ing Fred Kur­land, who is re­tir­ing. Nazak joined the com­pa­ny in No­vem­ber 2018 as VP, fi­nance. Pri­or to Aridis, Nazak was the SVP, fi­nance at Co­herus Bio­sciences. His pre­vi­ous stints in­clude serv­ing as se­nior di­rec­tor of fi­nance and ac­count­ing at In­teKrin Ther­a­peu­tics and as cor­po­rate con­troller at Re­liant Tech­nolo­gies.

DBV Tech­nolo­gies, who in Oc­to­ber an­nounced that the FDA had ac­cept­ed its lat­est BLA fil­ing for its peanut al­ler­gy patch, has named Ramzi Be­na­mar as CFO. Be­na­mar joins the com­pa­ny from Spark Ther­a­peu­tics, where he served as VP and head of fi­nan­cial plan­ning and analy­sis. Be­na­mar’s pri­or ex­pe­ri­ence in­cludes roles at Mer­ck, John­son & John­son and Shire.

Nu­Va­sive — fo­cused on spine tech­nol­o­gy — has ap­point­ed Matthew Har­baugh as EVP and CFO, who will suc­ceed Ra­jesh Asar­pota. Most re­cent­ly, Har­baugh was pres­i­dent of Mallinck­rodt, where he al­so for­mer­ly served as the com­pa­ny’s CFO. His oth­er stints in­clude roles at Co­vi­di­en Phar­ma­ceu­ti­cals and Mon­san­to Com­pa­ny.

→ Fol­low­ing a $24 mil­lion Se­ries B fi­nanc­ing round, health­care plat­form com­pa­ny Vim has tapped Mike Leonard as chief rev­enue of­fi­cer. Pri­or to his ap­point­ment at Vim, Leonard was the CCO at Cast­light Health. Be­fore that, Leonard was the EVP of sales and mar­ket­ing at Jiff (pur­chased by Cast­light in April 2017).

Re­bec­ca Fis­ch­er Belle­vue

En­zo Biochem has ap­point­ed Re­bec­ca Fis­ch­er to its board of di­rec­tors to suc­ceed re­tir­ing Gre­go­ry Bortz. Fis­ch­er is the CFO of Belle­vue Hos­pi­tal.

→ Texas-based can­cer drug de­vel­op­er Plus Ther­a­peu­tics wel­comed An van Es-Jo­hans­son, the chief med­ical of­fi­cer for Alze­Cure Phar­ma, an Alzheimer’s-fo­cused Swedish com­pa­ny to its board on Jan­u­ary 1.

Ti­tan Phar­ma­ceu­ti­cals — whose lead prod­uct Probuphine is used for long-term main­te­nance treat­ment of opi­oid de­pen­dence — has elect­ed the com­pa­ny’s EVP and CSO, Kate De­Var­ney, to its board of di­rec­tors.

The 20 un­der 40: In­side the next gen­er­a­tion of bio­phar­ma lead­ers

“Each generation needs a new music,” Francis Crick wrote in 1988, reflecting back on his landmark discovery. Crick was 35, then, in 1953, when he began working with a 23-year-old named James Watson, and 37 when the pair unveiled the double helix. Rosalind Franklin, whose diffraction work undergirded their metal model, was 32.

The model would become the score for a new era in biology, one devoted to cracking the basic structures turning inside life. Subsequent years would bring new conductors and new rhythms: Robert Swanson, 29 when he convinced a 39-year-old Herb Boyer to build a company off his work and call it Genentech; Phillip Sharp, 29 when he discovered RNA splicing and 34 when he co-founded Biogen; Frances Arnold, 36 when she pioneered directed evolution; Feng Zhang, 31 when he published his CRISPR paper.

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FDA Commissioner Stephen Hahn and President Donald Trump at a press briefing on March 19, 2020. (AP Images)

Biotech ex­ecs warn that the FDA is fum­bling their re­sponse to the Covid-19 open-door promise, de­lay­ing progress

A few days ago the FDA touted a procedure for Covid-19 meds that committed the agency to immediate action for developers, formalizing a high-speed response that’s been promised for weeks.

Bioregnum Opinion Column by John Carroll

Decisions that once required months would be measured in hours under the Coronavirus Treatment Acceleration Program. “In many cases” trial protocols could be hammered out in less than a single day. If you had a potential solution to the crisis, the appropriate staffer would be in touch “to get studies underway quickly.”

It would be the ultimate high-speed regulatory pathway from Phase I to approval. Red tape was banished.

But it’s clear that for some — and quite likely many — biopharma execs, the actual agency response has not measured up to the promise. Beyond the front ranks of advanced companies in the field, like Gilead, or for drugs endorsed by President Trump, it may not even come close.

“The first response is this form letter everyone gets,” says one biotech CEO who’s reached out to the FDA on Covid-19. And when you try to cut through that, the ball gets dropped as it is passed from top officials to the frontline staff actually charged with getting things done.

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GSK's Hal Bar­ron buys a $250M stake in George Scan­gos' Vir and makes a bee­line to the clin­ic with Covid-19 an­ti­bod­ies

GlaxoSmithKline is diving straight into the swirling waters of Covid-19 R&D work, and investing $250 million to grab a chunk of equity in one of the emerging stars in infectious disease research to make it official.

GSK put out word this morning that it is partnering with Vir Biotechnology $VIR, the infectious disease startup founded in the Bay Area by former Biogen CEO George Scangos. They’re planning a leap into Phase II studies for 2 preclinical antibody candidates — VIR-7831 and VIR-7832 — that have been engineered to target the SARS-CoV-2 spike protein.

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Ready to de­clare a de­fin­i­tive come­back in two months, Im­munomedics stops PhI­II ear­ly, re­cruits new CEO

More than a year ago, hit by a surprise complete response letter from the FDA, Immunomedics bid its then-CEO, Michael Pehl, adieu and began a 15-month quest to resolve the manufacturing issues cited in the CRL and seek a new leader — all the while moving forward with a Phase III study on its lead drug for metastatic triple-negative breast cancer.

Today the biotech said their stars are finally aligning. Not only is Novartis Oncology vet Harout Semerjian coming on board as CEO to steer what they believe will be a smooth sail to a new PDUFA date in June, Immunomedics has also been informed that their late-stage trial can be stopped early due to “compelling evidence of efficacy.”

An­oth­er day, an­oth­er boat­load for biotech. Deer­field adds $840M to rush of ven­ture dol­lars

The biotech dollars just keep rolling in.

Even as the world economy faces an economic contraction unprecedented in nature, biotech venture capital firms are announcing huge new investment pots. The latest? Deerfield Management Co.

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Small mol­e­cules, bi­o­log­ics and now gene ther­a­pies: Ger­many's Evotec adds an­oth­er feath­er to its R&D cap

German drug discovery company Evotec — which has a thriving rolodex of biopharma partners such as Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, Pfizer, Sanofi, and Takeda — is now venturing into gene therapies.

The company swallowed Seattle-based Just Biotherapeutics, a company focused on reducing the cost of manufacturing protein therapies last year. It is now setting up a dedicated R&D site for gene therapies in Austria, in an effort to achieve a “modality-agnostic” repertoire — small molecules, biologics and now gene therapies.

Gilead CEO Daniel O'Day attends a meeting with the President and other biopharma leaders at the White House on March 2, 2020 (AP Photo)

Ramp­ing up glob­al pro­duc­tion of remde­sivir, Gilead CEO Dan O’Day de­tails plans to dis­trib­ute 1.5M dos­es to fight Covid-19 — for free

Gilead is still some days away from turning the card on its first round of data on remdesivir’s ability to fight severe cases of Covid-19, but the big biotech is ramping up an emergency supply of a million courses of therapy as it starts free distribution of the drug to tens of thousands of patients under their compassionate use and expanded access program as well as clinical trials.

In his latest open letter posted over the weekend, Gilead CEO Dan O’Day outlined how the company has been successful in cutting production time on remdesivir while repurposing some of their own facilities and turning to contract manufacturers to build a near-term supply of 1.5 million doses. They are still working on efficacy and dosing, but that supply could cover 140,000 courses of treatment. That supply, he added, would be more widely available following a potential approval.

A pair of PhI­II fail­ures spells last rites for Men­lo’s once-promis­ing Mer­ck drug

Four months after an intercontinental merger, Menlo Therapeutics is counting yet another pair of trial failures — ones with significant consequences for the companies, their shareholders and the drug.

In two pivotal Phase III trials, Menlo’s lead drug serlopitant failed to treat pruritus associated with prurigo nodularis — basically itchiness from a particular skin disease that causes red lesions on a person’s arms or legs. Serlopitant has long been the company’s only drug and as recently as 2018, it looked promising enough to support a stock price of $37. In April of that year, a Phase II failure demolished the stock price overnight: $35 to $9. Other subsequent stumbles trickled the ticker down to just above $2.

Af­ter putting aside a bit­ter le­gal feud, Al­ny­lam and Dicer­na chiefs make nice with an RNAi col­lab­o­ra­tion

John Maraganore and Douglas Fambrough used to be at each other’s throats as Alnylam pursued claims that its RNAi rivals at Dicerna had improperly purloined the IP it had picked up from Merck in a bargain basement fire sale.

But that was all settled up close to 2 years ago with a settlement from Dicerna’s Fambrough. And now the two are moving ahead in a close R&D partnership that makes them collaborators on a couple of key disease targets.