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.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

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Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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A low-pro­file biotech bests Re­gen­eron in high-pro­file patent suit

For nearly a decade now, the low-profile Cambridge biotech Kymab has been battling in US, UK, Japanese and Australian courts with the biotech behemoth Regeneron.

Regeneron has turned itself into a $70 billion company off of a platform of transgenically humanized mice they can use to make antibodies for anything from Ebola to colorectal cancer. The technology took decades and billions to build, 20 years from the company’s founding to the first approved drug. And the company guards and touts it zealously, breaking their production process down into various branded components — Velocimmune, Velocigene, Velocimouse and four other Velocis — and sometimes suing would-be copycats. In 2014, most notably, they sued two Pfizer-backed entities for patent infringement.

Bull­ish biotech mar­ket pro­pels Pli­ant to $144M IPO — as No­var­tis pro­vides a $10M boost

After pharma partner Novartis boosted its IPO with a $10 million private placement, Pliant Therapeutics has wrapped its journey to the Nasdaq on a high note.

Pliant had penciled in a $86 million raise back in May. But as has become the norm in recent months, that initial number has turned out to be a mere placeholder, making way for the final haul of $144 million.

The South San Francisco biotech did so by pricing at $16, the high end of the range, while bringing the number of shares offered up to 9 million.

Cameron Durrant, Humanigen CEO (Columbia University Technology Ventures via YouTube)

Cameron Dur­rant hus­tled his way from the OTC side­lines right in­to the Covid-19 drug race. Death or glo­ry lies straight ahead

Over the past few months, Covid-19 has gone from being a monolithic threat to one of the biggest overnight boons the biopharma industry has ever seen. And amid all the furor over Moderna’s swelling stock price, plenty of chatter over what new drugs and vaccines will cost and investors’ uninhibited zeal for all things related to pandemic products, it’s been one little biotech’s golden ticket back from the land of the living dead.

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