PPD, Schrödinger, Beam set terms for IPO; FDA ex­pands use of Mer­ck­'s Di­fi­cid

→ With slow­er rates of pa­tient en­roll­ment than ex­pect­ed for their Phase III tri­al of its PARP in­hibitor pami­parib vs place­bo — as a ther­a­py in pa­tients with in­op­er­a­ble lo­cal­ly ad­vanced or metasta­t­ic gas­tric can­cer who have re­spond­ed to plat­inum-based first line chemother­a­py — BeiGene is con­vert­ing the tri­al to a Phase II. Pa­tient en­roll­ment be­gan in Ju­ly 2018 and the com­pa­ny has thus far reg­is­tered ap­prox­i­mate­ly 120 pa­tients glob­al­ly.

→ More than 8 years ago in a $3.9 bil­lion deal, PPD was tak­en pri­vate, but now the com­pa­ny has launched its IPO by of­fer­ing 60 mil­lion shares of its com­mon stock. The ex­pect­ed price per share is be­tween $24 and $27. The com­pa­ny plans to list un­der the sym­bol $PPD.

The of­fer­ing is be­ing made through an un­der­writ­ing group led by bookrun­ning man­agers: Bar­clays, JP Mor­gan, Mor­gan Stan­ley and Gold­man Sachs. Bo­fA Se­cu­ri­ties, Cred­it Su­isse, Jef­feries, UBS In­vest­ment Bank, Cit­i­group, Deutsche Bank Se­cu­ri­ties, Ever­core ISI, HS­BC and Mizuho Se­cu­ri­ties are act­ing as joint bookrun­ning man­agers. Baird, William Blair and Drex­el Hamil­ton are act­ing as co-man­agers.

→ Drug dis­cov­ery soft­ware play­er Schrödinger has set the terms for its IPO. The New York-based com­pa­ny is of­fer­ing 10 mil­lion shares at $14 to $16 each — which would see it raise about $160 mil­lion at the top of that range. Mor­gan Stan­ley, Bo­fA Se­cu­ri­ties, Jef­feries and BMO Cap­i­tal Mar­kets are un­der­writ­ing the deal. It plans to list un­der the sym­bol $SG­DR.

→ Fol­low­ing a four-month wait, the gene edit­ing ex­perts at Beam Ther­a­peu­tics fi­nal­ly have the terms for their $100 mil­lion IPO: 6.3 mil­lion shares at a price range of $15 to $17. At the mid­point of that range, the start­up — found­ed by pi­o­neers Feng Zhang, David Liu and Kei­th Joung — would com­mand a ful­ly di­lut­ed mar­ket val­ue of $686 mil­lion, ac­cord­ing to Re­nais­sance Cap­i­tal.

Eli Lil­ly‘s JAK in­hibitor Olu­mi­ant, whose ad­dress­able pa­tient pop­u­la­tion has been nixed by safe­ty con­cerns, helped pa­tients in an atopic der­mati­tis late-stage study, the com­pa­ny re­port­ed on Mon­day. Ini­tial­ly re­ject­ed by the US agency for use in rheuma­toid arthri­tis due to da­ta that showed a clear cor­re­la­tion with throm­bot­ic events or platelet in­creas­es — the drug was even­tu­al­ly giv­en the green light for the low­er dose. Lil­ly’s part­ner, In­cyte, in 2019 elect­ed to walk away from co-fund­ing the drug’s de­vel­op­ment as fears about the ben­e­fit-risk pro­file of the class of drugs ac­cu­mu­lat­ed. “Olu­mi­ant has lim­it­ed po­ten­tial in mod­er­ate-to-se­vere atopic der­mati­tis, giv­en the suc­cess of Re­gen­eron/ Sanofi’s Dupix­ent (which we view as much safer), and the po­ten­tial for oth­er nov­el se­lec­tive JAK in­hibitors (e.g., Pfiz­er’s abroc­i­tinib) which may have a bet­ter risk/ ben­e­fit pro­file,” Cred­it Su­isse an­a­lysts wrote in a note.

→ Near­ly a decade af­ter scor­ing ap­proval for Di­fi­cid to treat C. diff-as­so­ci­at­ed di­ar­rhea in adult pa­tients — Mer­ck, one of the few re­main­ing big phar­ma play­ers to linger in the be­lea­guered field of an­tibi­otics, has con­vinced the FDA to ex­pand the use of the drug in chil­dren aged six months and old­er.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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News brief­ing: Eli Lil­ly com­pletes $1B+ Pre­vail buy­out; El­zon­ris ap­proved in Eu­rope for adults

Eli Lilly’s $1.04 billion takeover of Prevail Therapeutics is officially complete, the company announced Friday.

The sides had entered into the buyout agreement last month with Lilly focusing on Prevail’s pipeline of gene therapies, highlighting two AAV9 programs in Parkinson’s disease and frontotemporal dementia as potential winners. Lilly paid $22.50 per share, which amounted to an 82% premium over the previous day’s closing price and a 117% premium over Prevail’s 60-day average.

Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.