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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

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Advertising for constipation treatments often uses light-hearted humor in an effort to spur open discussions about the sometimes stigmatized topic. However, that may not be enough to get people to take the condition seriously, a new patient report from Phreesia finds.

Fewer than one-fifth (17%) of patients with constipation surveyed understand the longer-term health risks of constipation such as hemorrhoids and bowel incontinence. Many are trying to manage their condition with over-the-counter medicines, but often for much longer than recommended. An equal 68% say they use home remedies or OTC meds to manage constipation. But while 90% understand that OTCs are not intended for long-term use, 50% have used an OTC constipation medicine for more than a year.

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Cell and gene ther­a­pies from acad­e­mia: EMA to help 5 projects go­ing af­ter un­met clin­i­cal needs

The European Medicines Agency said Thursday that it’s launching a new pilot program to help academic and other nonprofit researchers developing advanced therapy medicinal products, which includes cell and gene therapies.

Academics have proven to be enormously useful in feeding new products, like chimeric antigen receptor (CAR)-T cell therapies first developed by Memorial Sloan Kettering, and ushered to the market by biopharma companies. Jean Bennett, formerly with the University of Pennsylvania, also saw her research lead to the approval of gene therapy Luxturna, which Roche now owns.

Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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Phillip Gomez, Siga Technologies CEO

Siga nabs $10.7M from the US gov­ern­ment in deal for its mon­key­pox an­tivi­ral

The US government is all set to buy $10.7 million worth of Siga Technologies’ monkeypox oral antiviral, the company announced Thursday.

Of the total doses, $5.1 million worth of oral antivirals called Tpoxx (tecovirimat) will be delivered this year, with the US Department of Defense having the option of buying the rest at a later point.

The new contract follows an earlier one in which the government had purchased $7.4 million worth of Tpoxx from the company.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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