Drug com­pa­nies reach $260M set­tle­ment just ahead of opi­oid tri­al; Oys­ter Point set terms for $85M IPO

→ Hours be­fore the first fed­er­al opi­oid tri­al was set to be­gin, three drug dis­trib­u­tors and an opi­oid man­u­fac­tur­er agreed to a $260 mil­lion agree­ment set­tle­ment, the Wall Street Jour­nal was the first to re­port. The deal — which will see McKesson, Car­di­nal Health and Amerisource­Ber­gen pay $215 mil­lion to Sum­mit and Cuya­hoga coun­ties, and Te­va deal out $35 mil­lion in cash and ad­dic­tion treat­ments — does not re­solve the pend­ing, na­tion­wide lit­i­ga­tion that may re­sult in a set­tle­ment worth up­wards of $40 bil­lion. Ne­go­tia­tors in that case, brought by 2,300 tribes, coun­ties and cities na­tion­wide and led by sev­er­al states’ at­tor­neys gen­er­al, worked through much of Fri­day with­out suc­cess. Josh Stein, the at­tor­ney gen­er­al for North Car­oli­na, said they were try­ing to put to­geth­er a $48 bil­lion deal.

Oys­ter Point Phar­ma has an­nounced the terms for its IPO, which will help ad­vance a nasal spray for­mu­la­tion for dry eye dis­ease. The Prince­ton, NJ-based com­pa­ny is plan­ning to of­fer 5 mil­lion shares at a price range of $16 to $18 to raise $85 mil­lion. At the mid­point of the pro­posed range, it would com­mand a ful­ly di­lut­ed mar­ket val­ue of $385 mil­lion. The joint bookrun­ners of the deal are JP Mor­gan, Cowen and Piper Jaf­fray. The biotech plans to list un­der the sym­bol $OYST and is ex­pect­ed to price on Wednes­day.

→ The board of di­rec­tors at Aer­pio Phar­ma­ceu­ti­cals is ini­ti­at­ing the process to ex­plore strate­gic al­ter­na­tives, which can be any­thing from ac­qui­si­tion, com­pa­ny sale, merg­er, busi­ness com­bi­na­tion, as­set sale, in-li­cense, out-li­cense to oth­er strate­gic trans­ac­tion. The com­pa­ny’s clin­i­cal as­sets— com­pounds that ac­ti­vate Tie2 to treat oc­u­lar dis­ease and di­a­bet­ic com­pli­ca­tions — and cash re­sources amount­ed to $48.2 mil­lion as of June 30, 2019. Ever­core, Laden­burg Thal­mann & Co and Du­ane Nash have been brought on as ad­vi­sors. Mean­while, Aer­pio is stream­lin­ing its op­er­a­tions to con­serve re­sources, with CEO Stephen Hoff­man and CFO Michael Rogers first to head out the door. The man­age­ment team will now be led by cur­rent pres­i­dent Joseph Gard­ner along with the com­pa­ny’s vice pres­i­dent of fi­nance Gi­na Marek.

© Han­nah Smiles

Bar­bara Fox will be the next CEO of im­munome­tab­o­lism start­up Rheos Med­i­cine. Fox served at the helm of Ti­los Ther­a­peu­tics, the an­ti-LAP an­ti­body com­pa­ny that scored a $773 mil­lion deal with Mer­ck. Rheos — which emerged from stealth mode in 2018 with $60 mil­lion in fund­ing — aims to use re­search on cells’ me­tab­o­lism to de­vel­op ther­a­pies for au­toim­mune dis­or­ders. The com­pa­ny has been with­out a per­ma­nent CEO since San­jay Keswani, a for­mer top Roche sci­en­tist, left in June, af­ter less than one year at the helm.

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

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 — biotechs that fit that general description.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Novus Ther­a­peu­tics plunges deep in­to pen­ny stock ter­ri­to­ry af­ter failed ear tri­al

After a more than 15-year run, a California-based biotech is exploring options, including a sale, after its lead experimental therapy failed an exploratory mid-stage study in patients with middle ear infections characterized by a build-up of fluid behind the eardrum.

The company, initially called Tokai Pharmaceuticals but subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM).

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Stephen Hahn, FDA commissioner (AP Images)

Stephen Hahn: FDA will make some changes amid Covid-19 per­ma­nent

The FDA will look to permanently implement some of the processes and policies adopted in its response to the Covid-19 pandemic, FDA commissioner Stephen Hahn said during a virtual briefing hosted by the Alliance for a Stronger FDA on Monday.

Hahn’s statements during the briefing closely mirrored statements he made in a pre-recorded video FDA uploaded to YouTube on Friday.

“As this pandemic has evolved, it was clear to all of us that some FDA processes needed to be adjusted to accommodate the urgency of the pandemic and I think the entire FDA team has now seen first-hand that we need to take a critical look at some of our processes and policies,” Hahn said.

Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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