A Seat­tle biotech of­floads lead eye drug in deal val­ued at $1B+ as it re­fo­cus­es on emerg­ing pipeline

An FDA-ap­proved drug used to main­tain pupil size in pa­tients dur­ing cataract surgery and re­duce post­op­er­a­tive eye pain has been sold to Rayn­er Sur­gi­cal in a deal that could ex­ceed $1 bil­lion af­ter mile­stones.

Seat­tle-based Omeros sold eye drug Omidria for an up­front pay­ment of $125 mil­lion, with an­oth­er $200 mil­lion in com­mer­cial mile­stone pay­ments and an­oth­er $34 mil­lion that comes with an ac­counts re­ceiv­able bal­ance. The sale will help Omeros se­cure a long-term fi­nan­cial stream, and al­low it to fo­cus on the rest of its cur­rent pipeline while cut­ting com­mer­cial costs.

The deal is ex­pect­ed to close by Dec. 31.

Rayn­er will pay Omeros roy­al­ties for sales both in­side and out­side of the US, with a roy­al­ty rate of 50% of US sales un­til ei­ther Jan. 1, 2025 or the $200 mil­lion-mark, af­ter which Omeros will get a 30% roy­al­ty rate. Out­side the US, Omeros will get a 15% rate through­out the life­time of the patent. In all, the deal is val­ued at about $1 bil­lion.

The drug will be a key prod­uct in Rayn­er’s oph­thal­mol­o­gy fran­chise, which al­ready in­cludes dry eye treat­ments, in­traoc­u­lar lens­es and oph­thalmic surgery de­vices. CEO Tim Clover called the prod­uct an “ide­al fit for Rayn­er,” as it ex­pands its fo­cus to help oph­thalmic sur­geons.

Dur­ing the Q&A por­tion of the in­vestors call, Col­in Bris­tol, the man­ag­ing di­rec­tor of biotech­nol­o­gy with UBS, asked if this sale in­di­cat­ed a sud­den in­crease in costs con­nect­ed to nar­so­plimab, the com­pa­ny’s mon­o­clon­al an­ti­body of MASP-2 of the ef­fec­tor en­zyme of the lectin path­way of the com­ple­ment sys­tem. CEO Greg De­mop­u­los in­sist­ed that the sale had noth­ing to do with that treat­ment.

“This should re­duce our ex­pen­di­tures in ex­cess of $30 mil­lion an­nu­al­ly … in re­spect to our plans go­ing for­ward, ob­vi­ous­ly this al­lows us to fo­cus on our biotech pipeline in­clud­ing pri­mar­i­ly our com­ple­ment fran­chise and the pro­grams be­hind it,” he said in the call. “I want to be clear that this in no way sig­nals that we are ex­pect­ing a sub­stan­tial in­crease in costs on nar­so­plimab. This is frankly, a very good deal, and it’s re­al­ly in­de­pen­dent of nar­so­plimab.”

The com­pa­ny has nev­er launched a drug in Eu­rope be­fore, De­mop­u­los said on the in­vestor call Thurs­day. Rayn­er’s pres­ence out­side of the US will help the launch of the prod­uct in the EU and UK, fol­low­ing EMA and UK reg­u­la­to­ry ap­proval. But Rayn­er will al­so as­sume the US-based com­mer­cial op­er­a­tions for Omidria, and the two com­pa­nies plan to add sales rep­re­sen­ta­tives in the US as well.

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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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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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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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.