Kerrie Brady, OcuTerra CEO

Low-pro­file eye drop de­vel­op­er spells out the game plan that drew Brent Saun­ders to the board — and it in­volves go­ing ear­li­er than an­ti-VEG­Fs

When Brent Saun­ders took on the chair­man role on OcuTer­ra Ther­a­peu­tics’ board of di­rec­tors a few months ago — his first biotech gig since sell­ing Al­ler­gan to Ab­b­Vie — he drew at­ten­tion to a start­up that wasn’t quite ready for it. The web­site of­fered a glimpse of the lead­er­ship team, a lead drug, but not much else.

Brent Saun­ders

That’s chang­ing now.

OcuTer­ra is step­ping in­to the lime­light with the fi­nal close of a $35 mil­lion Se­ries B, which is de­signed to fund a Phase II tri­al of its lead eye drop and there­by nail down proof of con­cept for what it calls a non-in­va­sive op­tion for a siz­able swath of pa­tients at the ear­ly stages of di­a­bet­ic reti­nal dis­ease and wet age-re­lat­ed mac­u­lar de­gen­er­a­tion.

While myr­i­ad ad­vance­ments in oph­thal­mol­o­gy di­ag­nos­tics have en­abled doc­tors to rec­og­nize and de­tect eye dis­eases ear­li­er, treat­ments haven’t re­al­ly caught up, CEO Ker­rie Brady told End­points News. Even though some an­ti-VEGF drugs are ap­proved in this set­ting, doc­tors are hes­i­tant to give pa­tients in­trav­it­re­al in­jec­tions be­fore pa­tients show symp­toms.

“Un­til now,” she said, “there’s still noth­ing you can do. You can just still watch and wait.”

Brady, a sea­soned deal­mak­er who had built Cen­trex­ion with ex-Pfiz­er chief Jeff Kindler, joined the com­pa­ny in June 2020 — when it was still known as Sci­Flu­or. The for­mer name al­ludes to the key tech­nol­o­gy be­hind OTT166: se­lec­tive flu­o­ri­na­tion of a mol­e­cule to change its phys­i­cal chem­i­cal pro­file and en­gi­neer in de­sired prop­er­ties.

Even though the tech­nol­o­gy had giv­en birth to oth­er can­di­dates for CNS dis­or­ders and fi­bro­sis, OTT166, a small mol­e­cule in­te­grin in­hibitor that could be giv­en as an eye drop, emerged as the most promis­ing, lead­ing to the ul­ti­mate name change.

Com­ing more than 15 years af­ter the in­tro­duc­tion of VEGF in­hibitors, which Brady cred­its as hav­ing “tremen­dous im­pact,” OTT166 is be­ing po­si­tioned as an easy-to-use way to man­age a chron­ic con­di­tion.

Thanks to the prece­dent set by those in­va­sive drugs, Brady added, “the ac­tu­al reg­u­la­to­ry end­point for ap­proval in this in­di­ca­tion is very clear.” For the Phase II tri­al, OcuTer­ra ex­pects to fol­low pa­tients for at least six months to mea­sure whether its drug can stave off dis­ease pro­gres­sion and im­prove pa­tients’ vi­sion scores, while ex­plor­ing a va­ri­ety of bio­mark­ers. Those re­sults would then pave the way to a Phase III.

With on­ly four peo­ple on the full-time pay­roll — in­clud­ing Brady, chief de­vel­op­ment and op­er­a­tions of­fi­cer Scott Ed­wards and CMO David Tanz­er — the broad­er net­work of con­sul­tants, ad­vi­sors and board mem­bers be­comes even more im­por­tant.

The con­nec­tion with Saun­ders came through OcuTer­ra’s bankers, ac­cord­ing to Brady, who came out of their first meet­ing slight­ly un­sure — un­til she heard that Saun­ders “goes qui­et like that” when he re­al­ly likes some­thing. Oth­er board mem­bers in­clude Big Phar­ma vet Robert Ruf­fo­lo and William Koster, for­mer­ly of Bris­tol My­ers Squibb, who each bring years of ex­pe­ri­ence in the trans­la­tion stage of drug de­vel­op­ment that Brady sees OcuTer­ra in.

“So to me, this is ac­tu­al­ly the most fun stage of a com­pa­ny,” Brady said.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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