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.

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Merck’s new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO  — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

‘I think it is super worrisome,’ Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, ‘This is not going to be good.’

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Fujifilm Diosynth Biotechnologies is in the middle of a monumental point in the company’s 10-year history, and the CDMO is about to grow even more, as it sets out to be the ‘beating heart’ of the UK’s North East Life Sciences ecosystem.

A site in Billingham, Teeside, UK will receive a $453.72 million investment package from the manufacturer to double the existing footprint and create the largest multi-modal biopharmaceutical manufacturing site in the UK, bringing another 350 jobs to the region by late 2023.

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Novartis is plopping down $150 million in cash to pick up an experimental Parkinson’s drug and grab an option to another, a move that puts it on an increasingly popular path in the field’s search for disease-modifying therapies.

Belgium’s UCB is its partner of choice, supplying two small molecule alpha-synuclein misfolding inhibitors in a deal that can add up to nearly $1.5 billion.

Out of the pair, UCB0599 is already in Phase II trials, making Novartis confident enough to pull the trigger on co-development and commercialization, including to foot half of the R&D bill. The pharma giant will make a decision on UCB7853 once UCB wraps the ongoing Phase I program.

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Samsung Biologics has entered an agreement with South Korean biotech GreenLight BioSciences to manufacture its mRNA Covid-19 vaccine at commercial scale, the two companies announced.

Samsung Biologics, one of the fastest growing manufacturers in the world right now, will use its vaccine manufacturing expertise to help patients in lower-income countries, CEO John Rim said in a press release. This will help expand their capabilities from drug substance to aseptic fill-finish and all the way to commercial release from one site.

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GSK and Oxford have kickstarted a five-year collaboration aimed at spurring R&D breakthroughs across a range of hard-to-treat diseases like Alzheimer’s and Parkinson’s through the use of genomic testing and machine learning, the partners said Wednesday.

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Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ‘069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.
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