No­var­tis los­es biosim­i­lar ap­peal as court up­holds a 31-year mo­nop­oly by Am­gen's En­brel

A new court rul­ing has strength­ened Am­gen’s grip on the IP es­tate around En­brel, keep­ing biosim­i­lars of the au­toim­mune and in­flam­ma­to­ry drug at bay un­til 2029.

No­var­tis, the patent chal­lenger, isn’t throw­ing in the tow­el yet. In a state­ment not­ing the failed ap­peal, its gener­ics di­vi­sion San­doz not­ed its re­view­ing op­tions, “in­clud­ing po­ten­tial ap­peal to US Supreme Court.”

It’s been al­most four years since the FDA ap­proved Erelzi, San­doz’s copy­cat ver­sion of En­brel. While sales of the Pfiz­er-part­nered drug in the US — the mar­ket Am­gen is in charge of — have dipped slight­ly dur­ing that time, it re­mains a sol­id megablock­buster with 2019 rev­enue slight­ly above $5 bil­lion.

But No­var­tis ar­gues that it’s long past due for a low­er-cost knock­off to en­ter the mar­ket.

The orig­i­nal patent of En­brel, which launched in 1998, ex­pired in 2012. What No­var­tis is chal­leng­ing is the patents cov­er­ing the ac­tive pro­tein, etan­er­cept, and the process of mak­ing the TNF in­hibitor.

“Our com­pa­ny re­spects valid in­tel­lec­tu­al prop­er­ty, how­ev­er San­doz con­tin­ues to be­lieve the patents as­sert­ed by Am­gen are not valid, and that it should not be able to use them to ex­tend the drug’s ex­clu­siv­i­ty,” Car­ol Lynch, pres­i­dent of San­doz US and head of North Amer­i­ca, said in a state­ment.

The US Dis­trict Court of New Jer­sey first ruled against that line last Au­gust, and while many an­a­lysts con­sid­er the case closed with the judge’s “care­ful­ly craft­ed” de­ci­sion, No­var­tis went on to file an ap­peal with the Fed­er­al Cir­cuit.

Erelzi is al­so ap­proved in Cana­da and Eu­rope (both in 2017).

So­cial im­age cred­it: AP, Shut­ter­stock

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Covid-19 roundup: BAR­DA qui­et­ly pulls plug on IL-6 drugs; BioN­Tech and Fo­s­un be­gin mR­NA tri­al

IL-6 inhibitors showed some early promise in potentially treating Covid-19 patients, but recent trial flops have dashed hopes. Now it appears BARDA has officially pulled the plug.

The HHS office’s website has quietly updated to reflect that it is “no longer supporting product development” for Covid-19 in both Actemra (tocilizumab) and Kevzara (sarilumab), dealing a blow to the Roche and Regeneron/Sanofi drugs. This all but assures that IL-6 drugs repurposed to treat Covid-19 are essentially dead in the water.

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CF Foun­da­tion, Long­wood team on new in­cu­ba­tor for com­pa­nies with cut­ting-edge CF treat­ments

Nine months after launching a $500 million hunt for a cure for cystic fibrosis, the Cystic Fibrosis Foundation said it will use a portion of those funds to do something it has never done before: help launch new companies.

The CF Foundation, whose venture philanthropy efforts helped fund Vertex’s line of powerful CF drugs, is teaming with Longwood Fund to create a CF incubator. The incubator will identify new companies with platforms or technologies that can be applied in the rare genetic condition. The partners can then finance early development in exchange for a commitment from the companies to focus on applications in cystic fibrosis.

Kiersten Stead, John Hamer (DCVC Bio)

Deep tech, round 2: DCVC Bio bags $350M fund to chase the tip of the life sci­ence spear

It took one trip from San Francisco to Vancouver for Kiersten Stead and her DCVC Bio crew to feel confident about throwing their weight — and cash — behind AbCellera.

CEO Carl Hansen’s academic background and the potential of the platform, which combined machine vision and robotics with microfluidics, were promising. But the site visit sealed the Series A deal, where DCVC was the lead and only investor.

Stephen Hahn, FDA commissioner (AP Images)

FDA touts ad­vanced man­u­fac­tur­ing to ad­dress Covid-19 short­falls

Advanced manufacturing techniques can be employed to help address some of the manufacturing and supply chain problems the US has seen during the Covid-19 pandemic, Stephen Hahn, FDA commissioner, and Anand Shah, FDA deputy commissioner for medical and scientific affairs, wrote in a blog post on the FDA website.

“The potential public health value of advanced manufacturing is even greater in the context of the ongoing COVID-19 pandemic, which has highlighted the strain on supply chains and the need for adaptive manufacturing systems to accelerate the production of medical countermeasures,” Hahn and Shah wrote. “The FDA has established a strong regulatory foundation to support the uptake of advanced manufacturing, and COVID-19 provides the unique impetus to spur further advancement of medical manufacturing.”

Igor Splawski (CureVac)

Cure­Vac nabs a top No­var­tis sci­en­tist for CSO slot as mR­NA vac­cines seize the spot­light

One of the key players in the race to develop a new mRNA vaccine to fight Covid-19 has reshuffled the top spots in the executive suite. And they’re bringing in a Novartis vet out of Harvard to spearhead their work on mRNA.

CureVac, which just filed for an IPO that’s still taking shape, has formally handed Franz-Werner Haas the CEO title, after giving it to him on an interim basis. And the still rather stealthy German biotech largely owned by billionaire Dietmar Hopp has recruited Igor Splawski as its chief scientific officer.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

OWS' Mon­cef Slaoui lam­basts ‘in­sult­ing’ me­dia cov­er­age: 'How are you help­ing in this pan­dem­ic?'

Ten weeks into his job as the chief advisor of Operation Warp Speed, Moncef Slaoui has found a new hurdle to the challenge of bringing a Covid-19 vaccine unprecedented speed: the media.

In an official podcast by the Department of Health and Human Services, Slaoui — a veteran of GlaxoSmithKline who came out of his retirement to take on the role, relinquishing several board directorships and selling shares in the process — counted himself naive in assuming that the press was aiming to inform.

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